Import Alert 99-20
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 99-20
Published Date: 06/10/2013
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Of Imported Food Products Due to NLEA Violations"
Reason for Alert:
The Nutritional Labeling and Education Act (NLEA) of 1990 provided FDA with specific authority to require nutrition labeling of most foods regulated by the Agency, both import and domestic, and to require that all nutrient content claims (e.g., "high fiber", "low fat", etc.) and health claims be made consistent with the Agency regulations. Regulations implementing the NLEA labeling provision issued on January 6, 1993. The regulations became effective for health claims and ingredient declarations on May 8, 1993, and became effective for nutrition labeling and other provisions on May 8, 1994.
On March 21, 1994, letters were sent to the foreign embassies advising them about the May 8, 1994 effective date for nutrition labeling and the small business exemption provisions.
NOTE: Effective date of the regulation was subsequently postponed from May 8, 1994 until August 8, 1994.
In conjunction with the guidance in this import alert, the Nutrition Labeling of Imported Foods assignment, which instructs the field to perform label exams on imported foods, began September 19, 1994. This alert will track manufacturer/product/container size (net weight or fluid measure) combinations subject to detention without physical examination because of NLEA violations.
On March 21, 1994, letters were sent to the foreign embassies advising them about the May 8, 1994 effective date for nutrition labeling and the small business exemption provisions.
NOTE: Effective date of the regulation was subsequently postponed from May 8, 1994 until August 8, 1994.
In conjunction with the guidance in this import alert, the Nutrition Labeling of Imported Foods assignment, which instructs the field to perform label exams on imported foods, began September 19, 1994. This alert will track manufacturer/product/container size (net weight or fluid measure) combinations subject to detention without physical examination because of NLEA violations.
Guidance:
The manufacturer/product/container size combinations identified in the attachmnet for this alert are subject to DWPE.
The first time a specific product from a foreign manufacturer/shipper is found to be in violation, districts should issue a Release Notice With Comments in accordance with the instructions listed in the assignment. If the same product from the same manufacturer/shipper is found to be in violation 60 or more days after the initial Release with Comment has been issued, a recommendation for detention should be made in accordance with the assignment. Once a detention has been approved, the manufacturer/shipper and product will be added to the attachmnet for this import alert and will be subject to the detention without physical examination guidance.
The first time a specific product from a foreign manufacturer/shipper is found to be in violation, districts should issue a Release Notice With Comments in accordance with the instructions listed in the assignment. If the same product from the same manufacturer/shipper is found to be in violation 60 or more days after the initial Release with Comment has been issued, a recommendation for detention should be made in accordance with the assignment. Once a detention has been approved, the manufacturer/shipper and product will be added to the attachmnet for this import alert and will be subject to the detention without physical examination guidance.
Product Description:
Various (see attachment)
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts panel) [Misbranded, Section 403 (q)]".
OASIS Charge code "Nutrit LBL" PAF's NIS or LBL
And/Or
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling bears an unauthorized nutrient content/health claim (specify) [Misbranded, Section 403(r)(1)(A)/(B)]".
OASIS Charge Code "Health C" PAF's NIS or LBL
And/Or
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear required information (specify, e.g. common or usual name of each ingredient in a standardized food, percent of juice, names of certified colors) [Misbranded, Section 403(I)(2)]".
OASIS Charge Codes LIST INGRE or JUICE % PAF LBL
OASIS Charge code "Nutrit LBL" PAF's NIS or LBL
And/Or
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling bears an unauthorized nutrient content/health claim (specify) [Misbranded, Section 403(r)(1)(A)/(B)]".
OASIS Charge Code "Health C" PAF's NIS or LBL
And/Or
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear required information (specify, e.g. common or usual name of each ingredient in a standardized food, percent of juice, names of certified colors) [Misbranded, Section 403(I)(2)]".
OASIS Charge Codes LIST INGRE or JUICE % PAF LBL
BANGLADESH
Bagerhat Sea Food Industries
Date Published : 09/16/2009
Town Nowapara, Fakirhat , Bagarhat, BD-NOTA BANGLADESH
16 J - - 05 Shrimp & Prawns
Date Published: 11/12/2009
Desc:Raw Black Tiger Shrimp
Notes:Product is misbranded under Section 403(q) in that trans fat is not listed; hairline is incorrect; bolding is not used; serving size and servings/container are not consistent [21 CFR 101.9]; Product is further misbranded under Section 403(i)(1)in that the label does not list each ingredient by its common or usual name [21 CFR 101.4]; Product is further misbranded under Section 403(e)(1) in that the label fails to bear the ingredient statement and the name and address of the manufacturer without other intervening material [21 CFR 101.2(e)] 12/5/07
Notes:Product is misbranded under Section 403(q) in that trans fat is not listed; hairline is incorrect; bolding is not used; serving size and servings/container are not consistent [21 CFR 101.9]; Product is further misbranded under Section 403(i)(1)in that the label does not list each ingredient by its common or usual name [21 CFR 101.4]; Product is further misbranded under Section 403(e)(1) in that the label fails to bear the ingredient statement and the name and address of the manufacturer without other intervening material [21 CFR 101.2(e)] 12/5/07
16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 11/12/2009
Desc:Raw Black Tiger Shrimp
Notes:Product is misbranded under Section 403(q) in that trans fat is not listed; hairline is incorrect; bolding is not used; serving size and servings/container are not consistent [21 CFR 101.9]; Product is further misbranded under Section 403(i)(1)in that the label does not list each ingredient by its common or usual name [21 CFR 101.4]; Product is further misbranded under Section 403(e)(1) in that the label fails to bear the ingredient statement and the name and address of the manufacturer without other intervening material [21 CFR 101.2(e)] 12/5/07
Notes:Product is misbranded under Section 403(q) in that trans fat is not listed; hairline is incorrect; bolding is not used; serving size and servings/container are not consistent [21 CFR 101.9]; Product is further misbranded under Section 403(i)(1)in that the label does not list each ingredient by its common or usual name [21 CFR 101.4]; Product is further misbranded under Section 403(e)(1) in that the label fails to bear the ingredient statement and the name and address of the manufacturer without other intervening material [21 CFR 101.2(e)] 12/5/07
Janata Foods
Date Published : 09/16/2009
Zaman Chamber ( 4th Floor ) , 47 Dilkusha C/A , Dhaka, BD-13 BANGLADESH
03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 11/12/2009
Desc:Date Cake
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07 ;
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07 ;
03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 11/12/2009
Desc:Date Cake
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07
22 K - - 99 Other Fruits and Fruit Products, Other Fruit Juices or Concentrates, N.E.C.
Date Published: 11/12/2009
Desc:Date Cake
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07
Janata Foods
Date Published : 09/16/2009
Zaman Chamber 47, Dilkusha C/a (4th Fl) , Dhaka, BD-13 BANGLADESH
03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 11/12/2009
Desc:Date Cake
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07
03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 11/12/2009
Desc:Date Cake
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07
22 K - - 99 Other Fruits and Fruit Products, Other Fruit Juices or Concentrates, N.E.C.
Date Published: 11/12/2009
Desc:Date Cake
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07
BOLIVIA
Import & Export Santa Catalina INC.
Date Published : 09/16/2009
Av. Petrolera Km. 4 1/2 # 1358 , Av. Ayacucho # 127 , Cochabamba, BO-C BOLIVIA
28 A - - 45 Spearmint, Whole (Spice)
Date Published: 11/12/2009
Desc:Spearmint Leaves
Notes:Product is misbranded under Section 403(a)(1) in that the amounts of Vitamin C, calcium, and iron are less than 80% of declared amounts; for tea) Product is further misbranded under Section 403(q) in that the nutrition label does not comply with format requirements in 21CFR 101.9 (type size and bolding requirements are not met; Total Fat/ Saturated Fat amounts are not correctly declared); Product is further misbranded in that the Nutrition Facts panel fails to base the nutrient information on the proper serving size [21 CFR 101.12(b)(2)]; Product is further misbranded in that the Nutrition Facts panel fails to declare the vitamins and minerals as specified by 21 CFR 101.9 (c)(8)(ii) 10/31/07
Notes:Product is misbranded under Section 403(a)(1) in that the amounts of Vitamin C, calcium, and iron are less than 80% of declared amounts; for tea) Product is further misbranded under Section 403(q) in that the nutrition label does not comply with format requirements in 21CFR 101.9 (type size and bolding requirements are not met; Total Fat/ Saturated Fat amounts are not correctly declared); Product is further misbranded in that the Nutrition Facts panel fails to base the nutrient information on the proper serving size [21 CFR 101.12(b)(2)]; Product is further misbranded in that the Nutrition Facts panel fails to declare the vitamins and minerals as specified by 21 CFR 101.9 (c)(8)(ii) 10/31/07
31 K - - 99 Tea, N.E.C.
Date Published: 11/12/2009
Desc:Q'uillquina (Dried herbs for tea)
Notes:Product is misbranded under Section 403(a)(1) in that the amounts of Vitamin C; calcium; and iron are less than 80% of declared amounts; for tea) Product is further misbranded under Section 403(q) in that the nutrition label does not comply with format requirements in 21CFR 101.9 (type size and bolding requirements are not met; Total Fat/ Saturated Fat amounts are not correctly declared); Product is further misbranded in that the Nutrition Facts panel fails to base the nutrient information on the proper serving size [21 CFR 101.12(b)(2)]; Product is further misbranded in that the Nutrition Facts panel fails to declare the vitamins and minerals as specified by 21 CFR 101.9 (c)(8) (ii) 10/31/07
Notes:Product is misbranded under Section 403(a)(1) in that the amounts of Vitamin C; calcium; and iron are less than 80% of declared amounts; for tea) Product is further misbranded under Section 403(q) in that the nutrition label does not comply with format requirements in 21CFR 101.9 (type size and bolding requirements are not met; Total Fat/ Saturated Fat amounts are not correctly declared); Product is further misbranded in that the Nutrition Facts panel fails to base the nutrient information on the proper serving size [21 CFR 101.12(b)(2)]; Product is further misbranded in that the Nutrition Facts panel fails to declare the vitamins and minerals as specified by 21 CFR 101.9 (c)(8) (ii) 10/31/07
BRAZIL
Agro Industrial Jandaia Ltda
Date Published : 11/12/2009
Rodovia BR 116 Km 52 - Sala A - Pacajus , Pacajus, BR-CE BRAZIL
21 V - - 01 Acerola, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 11/12/2009
Desc:Acerola Juice
Notes:Product is misbranded within the meaning of Section 403(f) of the Act in that the Principal Display Panel does not bear a statement of identity in English as required by 21 CFR 101.15(c). Product is further misbranded within the meaning of Section 403(q) in that the Nutrition Facts information is not in the appropriate format as defined in 21 CFR 101.9. Product is also misbranded within the meaning of section 403(i)(2) in that the label fails to list each ingredient in the ingredient statement as required by 21 CFR 101.4(a)(1). 9/18/09
Notes:Product is misbranded within the meaning of Section 403(f) of the Act in that the Principal Display Panel does not bear a statement of identity in English as required by 21 CFR 101.15(c). Product is further misbranded within the meaning of Section 403(q) in that the Nutrition Facts information is not in the appropriate format as defined in 21 CFR 101.9. Product is also misbranded within the meaning of section 403(i)(2) in that the label fails to list each ingredient in the ingredient statement as required by 21 CFR 101.4(a)(1). 9/18/09
Bauducco & Cia, Ltd.
Date Published : 09/16/2009
Rua Endres, 191 , Guarulhos, Sao Paulo, BRAZIL
03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 11/12/2009
Desc:Cake with Chocolate Chips
Notes:The labeling is false. Label declares a 70 g serving contains 11 gof fat; analysis found 14.8 g of fat per 70 g serving 3/9/04
Notes:The labeling is false. Label declares a 70 g serving contains 11 gof fat; analysis found 14.8 g of fat per 70 g serving 3/9/04
03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 11/12/2009
Desc:Cake with Chocolate Chips
Notes:The labeling is false. Label declares a 70 g serving contains 11 g of fat; analysis found 14.8 g of fat per 70 g serving 3/9/04
Notes:The labeling is false. Label declares a 70 g serving contains 11 g of fat; analysis found 14.8 g of fat per 70 g serving 3/9/04
Industrial E Comercial Jandaia Ltda
Date Published : 11/12/2009
Br 116 Km 53 , Pacajus, BRAZIL
21 V - - 01 Acerola, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 11/12/2009
Desc:Acerola Juice
Notes:Product is misbranded within the meaning of Section 403(f) of the Act in that the Principal Display Panel does not bear a statement of identity in English as required by 21 CFR 101.15(c). Product is further misbranded within the meaning of Section 403(q) in that the Nutrition Facts information is not in the appropriate format as defined in 21 CFR 101.9. Product is also misbranded within the meaning of section 403(i)(2) in that the label fails to list each ingredient in the ingredient statement as required by 21 CFR 101.4(a)(1). 9/18/09
Notes:Product is misbranded within the meaning of Section 403(f) of the Act in that the Principal Display Panel does not bear a statement of identity in English as required by 21 CFR 101.15(c). Product is further misbranded within the meaning of Section 403(q) in that the Nutrition Facts information is not in the appropriate format as defined in 21 CFR 101.9. Product is also misbranded within the meaning of section 403(i)(2) in that the label fails to list each ingredient in the ingredient statement as required by 21 CFR 101.4(a)(1). 9/18/09
Sucos Do Brasil S/A
Date Published : 11/12/2009
Br 116, Km 54 , Pacajus, BRAZIL
21 V - - 01 Acerola, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 11/12/2009
Desc:Acerola Juice
Notes:Product is misbranded within the meaning of Section 403(f) of the Act in that the Principal Display Panel does not bear a statement of identity in English as required by 21 CFR 101.15(c). Product is further misbranded within the meaning of Section 403(q) in that the Nutrition Facts information is not in the appropriate format as defined in 21 CFR 101.9. Product is also misbranded within the meaning of section 403(i)(2) in that the label fails to list each ingredient in the ingredient statement as required by 21 CFR 101.4(a)(1). 9/18/09
Notes:Product is misbranded within the meaning of Section 403(f) of the Act in that the Principal Display Panel does not bear a statement of identity in English as required by 21 CFR 101.15(c). Product is further misbranded within the meaning of Section 403(q) in that the Nutrition Facts information is not in the appropriate format as defined in 21 CFR 101.9. Product is also misbranded within the meaning of section 403(i)(2) in that the label fails to list each ingredient in the ingredient statement as required by 21 CFR 101.4(a)(1). 9/18/09
Sucos do Brasil S/A
Date Published : 11/12/2009
BR 116, KM 54, Nascente , Pacajus, BR-CE BRAZIL
21 V - - 01 Acerola, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 11/12/2009
Desc:Acerola Juice
Notes:Product is misbranded within the meaning of Section 403(f) of the Act in that the Principal Display Panel does not bear a statement of identity in English as required by 21 CFR 101.15(c). Product is further misbranded within the meaning of Section 403(q) in that the Nutrition Facts information is not in the appropriate format as defined in 21 CFR 101.9. Product is also misbranded within the meaning of section 403(i)(2) in that the label fails to list each ingredient in the ingredient statement as required by 21 CFR 101.4(a)(1). 9/18/09
Notes:Product is misbranded within the meaning of Section 403(f) of the Act in that the Principal Display Panel does not bear a statement of identity in English as required by 21 CFR 101.15(c). Product is further misbranded within the meaning of Section 403(q) in that the Nutrition Facts information is not in the appropriate format as defined in 21 CFR 101.9. Product is also misbranded within the meaning of section 403(i)(2) in that the label fails to list each ingredient in the ingredient statement as required by 21 CFR 101.4(a)(1). 9/18/09
BULGARIA
Vemo 99
Date Published : 06/10/2013
13 Shumen Str , Sofia, BULGARIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 06/10/2013
Desc:Tribulus Terrestris VemoHerb Nutritional Supplement
Notes:Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
Notes:Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
54 E - - 89 Tribulus (Herbal & Botanical Teas)
Date Published: 06/10/2013
Desc:Tribulus Terrestris VemoHerb Nutritional Supplement
Notes:Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement
Notes:Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement
54 F - - 89 Tribulus (Herbal & Botanicals, not Teas)
Date Published: 06/10/2013
Desc:Tribulus Terrestris VemoHerb Nutritional Supplement
Notes:Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement
Notes:Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/10/2013
Desc:Tribulus Terrestris VemoHerb Nutritional Supplement
Notes:Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement
Notes:Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/10/2013
Desc:Tribulus Terrestris VemoHerb Nutritional Supplement
Notes:Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement
Notes:Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/10/2013
Desc:Tribulus Terrestris VemoHerb Nutritional Supplement
Notes:Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement
Notes:Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement
CAMEROON
Brasseries du Cameroun
Date Published : 03/24/2011
B.P. 4036 , Douala, CM-LT CAMEROON
21 D - - 01 Fruit Coctail, Mixed Fruit, Juices or Concentrates
Date Published: 03/24/2011
Desc:Fruit Cocktail Drink
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));
29 B - - 04 Soft Drink, Mixed Fruit Flavored, Carbonated
Date Published: 03/24/2011
Desc:Fruit Cocktail Drink
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));
Dessco International Company Cameroon
Date Published : 03/24/2011
Carrefour Mosque, Rail , Bonaberi, Douala, Cameroon , Bamenda, CM-NW CAMEROON
20 K - - 02 Grapefruit, Citrus Fruit Juices or Concentrates
Date Published: 03/24/2011
Desc:Grapefruit Drink
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product depicts a grapefruit and declares grapefruit extract in the Composition statement. A product that depicts a fruit on the labeling and contains fruit juice must declare the percentage of the fruit juice by the words "Contains _ percent (or %)__juice" or " _ percent (or %) juice" (21 CFR 101.30(b)(I)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product lists citric acid and sodium benzoate, but does not describe the function of the additives in accordance with 21 CFR 101.220. If a food contains an added chemical preservative, the label must state both the common or usual name of the ingredients and a separate description of its function, e.g., "preservative"; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a);
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product depicts a grapefruit and declares grapefruit extract in the Composition statement. A product that depicts a fruit on the labeling and contains fruit juice must declare the percentage of the fruit juice by the words "Contains _ percent (or %)__juice" or " _ percent (or %) juice" (21 CFR 101.30(b)(I)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product lists citric acid and sodium benzoate, but does not describe the function of the additives in accordance with 21 CFR 101.220. If a food contains an added chemical preservative, the label must state both the common or usual name of the ingredients and a separate description of its function, e.g., "preservative"; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a);
21 D - - 01 Fruit Coctail, Mixed Fruit, Juices or Concentrates
Date Published: 03/24/2011
Desc:Fruit Cocktail Drink
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));
29 B - - 02 Soft Drink, Citrus Fruit Flavored, Carbonated
Date Published: 03/24/2011
Desc:Grapefruit Drink
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product depicts a grapefruit and declares grapefruit extract in the Composition statement. A product that depicts a fruit on the labeling and contains fruit juice must declare the percentage of the fruit juice by the words "Contains _ percent (or %)__juice" or " _ percent (or %) juice" (21 CFR 101.30(b)(I)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product lists citric acid and sodium benzoate, but does not describe the function of the additives in accordance with 21 CFR 101.220. If a food contains an added chemical preservative, the label must state both the common or usual name of the ingredients and a separate description of its function, e.g., "preservative"; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a);
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product depicts a grapefruit and declares grapefruit extract in the Composition statement. A product that depicts a fruit on the labeling and contains fruit juice must declare the percentage of the fruit juice by the words "Contains _ percent (or %)__juice" or " _ percent (or %) juice" (21 CFR 101.30(b)(I)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product lists citric acid and sodium benzoate, but does not describe the function of the additives in accordance with 21 CFR 101.220. If a food contains an added chemical preservative, the label must state both the common or usual name of the ingredients and a separate description of its function, e.g., "preservative"; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a);
29 B - - 04 Soft Drink, Mixed Fruit Flavored, Carbonated
Date Published: 03/24/2011
Desc:Fruit Cocktail Drink
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));
Les Brasseries du Cameroun SABC
Date Published : 03/24/2011
Balli , Douala, CM-LT CAMEROON
21 D - - 01 Fruit Coctail, Mixed Fruit, Juices or Concentrates
Date Published: 03/24/2011
Desc:Fruit Cocktail Drink
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));
29 B - - 04 Soft Drink, Mixed Fruit Flavored, Carbonated
Date Published: 03/24/2011
Desc:Fruit Cocktail Drink
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));
Union Camerounaise de Brasseries
Date Published : 03/24/2011
Zone Industrielle BASSA , B.P. 638 , Douala, CM-LT CAMEROON
20 K - - 02 Grapefruit, Citrus Fruit Juices or Concentrates
Date Published: 03/24/2011
Desc:Grapefruit Drink
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product depicts a grapefruit and declares grapefruit extract in the Composition statement. A product that depicts a fruit on the labeling and contains fruit juice must declare the percentage of the fruit juice by the words "Contains _ percent (or %)__juice" or " _ percent (or %) juice" (21 CFR 101.30(b)(I)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product lists citric acid and sodium benzoate, but does not describe the function of the additives in accordance with 21 CFR 101.220. If a food contains an added chemical preservative, the label must state both the common or usual name of the ingredients and a separate description of its function, e.g., "preservative"; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a);
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product depicts a grapefruit and declares grapefruit extract in the Composition statement. A product that depicts a fruit on the labeling and contains fruit juice must declare the percentage of the fruit juice by the words "Contains _ percent (or %)__juice" or " _ percent (or %) juice" (21 CFR 101.30(b)(I)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product lists citric acid and sodium benzoate, but does not describe the function of the additives in accordance with 21 CFR 101.220. If a food contains an added chemical preservative, the label must state both the common or usual name of the ingredients and a separate description of its function, e.g., "preservative"; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a);
29 B - - 02 Soft Drink, Citrus Fruit Flavored, Carbonated
Date Published: 03/24/2011
Desc:Grapefruit Drink
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product depicts a grapefruit and declares grapefruit extract in the Composition statement. A product that depicts a fruit on the labeling and contains fruit juice must declare the percentage of the fruit juice by the words "Contains _ percent (or %)__juice" or " _ percent (or %) juice" (21 CFR 101.30(b)(I)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product lists citric acid and sodium benzoate, but does not describe the function of the additives in accordance with 21 CFR 101.220. If a food contains an added chemical preservative, the label must state both the common or usual name of the ingredients and a separate description of its function, e.g., "preservative"; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a);
Notes:Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product depicts a grapefruit and declares grapefruit extract in the Composition statement. A product that depicts a fruit on the labeling and contains fruit juice must declare the percentage of the fruit juice by the words "Contains _ percent (or %)__juice" or " _ percent (or %) juice" (21 CFR 101.30(b)(I)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product lists citric acid and sodium benzoate, but does not describe the function of the additives in accordance with 21 CFR 101.220. If a food contains an added chemical preservative, the label must state both the common or usual name of the ingredients and a separate description of its function, e.g., "preservative"; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a);
CANADA
DESI MILLS INC.
Date Published : 12/27/2011
Unknown , Scarborough, ON CANADA
02 F - - 02 Farina, Wheat
Date Published: 12/27/2011
Desc:Suji Fine Farina Wheat
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
02 F - - 99 Wheat, Milled Product, N.E.C.
Date Published: 12/27/2011
Desc:Pearled Soft White Winter Wheat
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
24 A - - 19 Adzuki beans
Date Published: 12/27/2011
Desc:Adzuki Beans
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
24 A - - 20 Chana Dal
Date Published: 12/27/2011
Desc:Chana Dal
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
24 A - - 51 Peas
Date Published: 12/27/2011
Desc:Yellow Split Peas
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
24 E - - 70 Lentils
Date Published: 12/27/2011
Desc:Brown Lentils
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
24 E - - 70 Lentils
Date Published: 12/27/2011
Desc:Red Lentils
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
24 E - - 70 Lentils
Date Published: 12/27/2011
Desc:Mooth Whole Haleen Mix Mixed Lentils
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
28 B - - 08 Capsicums (Cayenne Chili, Hot Peppers), Ground, Cracked (Spice)
Date Published: 12/27/2011
Desc:Crushed Chili
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
Desi Mills Inc
Date Published : 12/27/2011
Unknown , Toronto, Ontario CANADA
02 F - - 02 Farina, Wheat
Date Published: 12/27/2011
Desc:Sui Fine Farina Wheat
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
02 F - - 99 Wheat, Milled Product, N.E.C.
Date Published: 12/27/2011
Desc:Pearled Soft White Winter Wheat
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
24 A - - 19 Adzuki beans
Date Published: 12/27/2011
Desc:Adzuki Beans
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
24 A - - 20 Chana Dal
Date Published: 12/27/2011
Desc:Chana Dal
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
24 A - - 51 Peas
Date Published: 12/27/2011
Desc:Yellow Split Peas
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
24 E - - 70 Lentils
Date Published: 12/27/2011
Desc:Red Lentils
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
24 E - - 70 Lentils
Date Published: 12/27/2011
Desc:Mooth Whole Haleen Mix Mixed Lentils
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
24 E - - 70 Lentils
Date Published: 12/27/2011
Desc:Brown Lentils
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
28 B - - 08 Capsicums (Cayenne Chili, Hot Peppers), Ground, Cracked (Spice)
Date Published: 12/27/2011
Desc:Crushed Chili
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
ITN Food Corporation
Date Published : 12/27/2011
40 Commander Blvd , Toronto, Ontario, On CANADA
02 F - - 02 Farina, Wheat
Date Published: 12/27/2011
Desc:Suji Fine Farina Wheat
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
02 F - - 99 Wheat, Milled Product, N.E.C.
Date Published: 12/27/2011
Desc:Pearled Soft White Winter Wheat
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
24 A - - 19 Adzuki beans
Date Published: 12/27/2011
Desc:Adzuki Beans
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
24 A - - 20 Chana Dal
Date Published: 12/27/2011
Desc:Chana Dal
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
24 A - - 51 Peas
Date Published: 12/27/2011
Desc:Yellow Split Peas
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
24 E - - 70 Lentils
Date Published: 12/27/2011
Desc:Brown Lentils
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
24 E - - 70 Lentils
Date Published: 12/27/2011
Desc:Mooth Whole Haleen Mix Mixed Lentils
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
Notes:VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.
28 B - - 08 Capsicums (Cayenne Chili, Hot Peppers), Ground, Cracked (Spice)
Date Published: 12/27/2011
Desc:Crushed Chili
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
Notes:VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4
Newco Enterprises Inc.
Date Published : 04/24/2013
402-5723 10th St Ne , Calgary, Ab CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/24/2013
Desc:Brocco Gen 10 Sulforaphane Glucosinolate Capsules Dietary Supplements
Notes:VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that the label or labeling appears to be misbranded; in that it fails to bear the required nutrition information [Misbranded; 403(q)(5)(F)]; it fails to bear the common or usual name of the food [Misbranded; 403(i)(1)]; and it fails to bear the common or usual name of the ingredients [Misbranded; 403(i)(2)].
Notes:VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that the label or labeling appears to be misbranded; in that it fails to bear the required nutrition information [Misbranded; 403(q)(5)(F)]; it fails to bear the common or usual name of the food [Misbranded; 403(i)(1)]; and it fails to bear the common or usual name of the ingredients [Misbranded; 403(i)(2)].
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2013
Desc:Brocco Gen 10 Sulforaphane Glucosinolate Capsules Dietary Supplements
Notes:VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that the label or labeling appears to be misbranded; in that it fails to bear the required nutrition information [Misbranded; 403(q)(5)(F)]; it fails to bear the common or usual name of the food [Misbranded; 403(i)(1)]; and it fails to bear the common or usual name of the ingredients [Misbranded; 403(i)(2)].
Notes:VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that the label or labeling appears to be misbranded; in that it fails to bear the required nutrition information [Misbranded; 403(q)(5)(F)]; it fails to bear the common or usual name of the food [Misbranded; 403(i)(1)]; and it fails to bear the common or usual name of the ingredients [Misbranded; 403(i)(2)].
Rapid Snack Inc.
Date Published : 03/22/2013
7232 Rue Cordner , Lasalle, QC CANADA
07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 03/22/2013
Desc:Vanilla Crispy Treats
Notes:VIOLATION (IN NOTES): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because, the trans fat and saturated fat are not declared in accordance with [21 CFR 101.9(c) (2)], the percent daily value is not provided for cholesterol [21 CFR 101.9(d)(7)], the declaration "Servings Per Container" is missing [21 CFR 101.9(d)(3)], the declaration of "Calories from fat" is missing [21 CFR 101.9(c)(1)(ii)], the complete heading "Amount Per Serving" is missing [21 CFR 101.9(d)(4)], the complete heading "Total Fat" or "Fat, total" is missing [21 CFR 101.9(c)(2)], the complete heading "Dietary Fiber" is missing [21 CFR 101.9(c)(6)], the footnote is missing [21 CFR 101.9(d)(9)], the percent daily value does not contain at least the value for Iron as declared on the label as required by 21 CFR 101.9(g)(4); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because The ingredients are not declared in accordance with [21 CFR lOl.4(b)(2)] because "vitamin mixture" appears to be a multi-component ingredient; however, the sub-ingredients do not appear to be declared.
Notes:VIOLATION (IN NOTES): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because, the trans fat and saturated fat are not declared in accordance with [21 CFR 101.9(c) (2)], the percent daily value is not provided for cholesterol [21 CFR 101.9(d)(7)], the declaration "Servings Per Container" is missing [21 CFR 101.9(d)(3)], the declaration of "Calories from fat" is missing [21 CFR 101.9(c)(1)(ii)], the complete heading "Amount Per Serving" is missing [21 CFR 101.9(d)(4)], the complete heading "Total Fat" or "Fat, total" is missing [21 CFR 101.9(c)(2)], the complete heading "Dietary Fiber" is missing [21 CFR 101.9(c)(6)], the footnote is missing [21 CFR 101.9(d)(9)], the percent daily value does not contain at least the value for Iron as declared on the label as required by 21 CFR 101.9(g)(4); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because The ingredients are not declared in accordance with [21 CFR lOl.4(b)(2)] because "vitamin mixture" appears to be a multi-component ingredient; however, the sub-ingredients do not appear to be declared.
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 03/22/2013
Desc:Vanilla Crispy Treats
Notes:VIOLATION (IN NOTES): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because, the trans fat and saturated fat are not declared in accordance with [21 CFR 101.9(c) (2)], the percent daily value is not provided for cholesterol [21 CFR 101.9(d)(7)], the declaration "Servings Per Container" is missing [21 CFR 101.9(d)(3)], the declaration of "Calories from fat" is missing [21 CFR 101.9(c)(1)(ii)], the complete heading "Amount Per Serving" is missing [21 CFR 101.9(d)(4)], the complete heading "Total Fat" or "Fat, total" is missing [21 CFR 101.9(c)(2)], the complete heading "Dietary Fiber" is missing [21 CFR 101.9(c)(6)], the footnote is missing [21 CFR 101.9(d)(9)], the percent daily value does not contain at least the value for Iron as declared on the label as required by 21 CFR 101.9(g)(4); The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because The ingredients are not declared in accordance with [21 CFR lOl.4(b)(2)] because "vitamin mixture" appears to be a multi-component ingredient; however, the sub-ingredients do not appear to be declared.
Notes:VIOLATION (IN NOTES): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because, the trans fat and saturated fat are not declared in accordance with [21 CFR 101.9(c) (2)], the percent daily value is not provided for cholesterol [21 CFR 101.9(d)(7)], the declaration "Servings Per Container" is missing [21 CFR 101.9(d)(3)], the declaration of "Calories from fat" is missing [21 CFR 101.9(c)(1)(ii)], the complete heading "Amount Per Serving" is missing [21 CFR 101.9(d)(4)], the complete heading "Total Fat" or "Fat, total" is missing [21 CFR 101.9(c)(2)], the complete heading "Dietary Fiber" is missing [21 CFR 101.9(c)(6)], the footnote is missing [21 CFR 101.9(d)(9)], the percent daily value does not contain at least the value for Iron as declared on the label as required by 21 CFR 101.9(g)(4); The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because The ingredients are not declared in accordance with [21 CFR lOl.4(b)(2)] because "vitamin mixture" appears to be a multi-component ingredient; however, the sub-ingredients do not appear to be declared.
Soylutions Inc.
Date Published : 08/14/2010
1629 Av Des Affaires , Quebec, Qc CANADA
14 B - - 01 Imitation Milk, Fluid Milk Type Product
Date Published: 03/15/2011
Desc:Unsweetened Original Hemp Bliss Organic Hemp Milk
Notes:VIOLATION: The nutritional labeling does not comply with 21 CFR 101.54 requirements. The following violations were observed: Label declares that the product is rich in essential nutrients. Rich in is a synonym for high per 21 CFR 101.54(b)(1). The product does not qualify for a high nutrient claim for any nutrients. Label declared "Plus' is a relative nutrient content claim and in order to meet the requirements, the product must contain at least 10% or more of the RDI for vitamins or minerals per reference amount customarily consumed than an appropriate reference food per 21 CFR 101.54(e)(l)(i). -The identity of the reference food and the percentage (or fraction) that the nutrient is greater relative to the RDI are not declared in immediate proximity to the most prominent such claim per 21 CFR 101.54(e)(1)(iii).
Notes:VIOLATION: The nutritional labeling does not comply with 21 CFR 101.54 requirements. The following violations were observed: Label declares that the product is rich in essential nutrients. Rich in is a synonym for high per 21 CFR 101.54(b)(1). The product does not qualify for a high nutrient claim for any nutrients. Label declared "Plus' is a relative nutrient content claim and in order to meet the requirements, the product must contain at least 10% or more of the RDI for vitamins or minerals per reference amount customarily consumed than an appropriate reference food per 21 CFR 101.54(e)(l)(i). -The identity of the reference food and the percentage (or fraction) that the nutrient is greater relative to the RDI are not declared in immediate proximity to the most prominent such claim per 21 CFR 101.54(e)(1)(iii).
14 B - - 01 Imitation Milk, Fluid Milk Type Product
Date Published: 03/15/2011
Desc:Hemp Dream Hemp Drink
Notes:9/20/10; update product description 3/15/11 Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically; the nutrient content of the composite is not at least equal to 80 percent of the value for the nutrient declared on the label for magnesium; as required by 21 CFR 101.9(g)(4)(ii); In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in that product fails to qualify for the claim; "Excellent source of... Magnesium" because the analytical findings indicate that the product contains less than 20 percent ofthe DRV per RACC; as required by 21 CFR 101.54(b); In addition; the side panel contains the nutrient content claim "Cholesterol Free" but fails to disclose that cholesterol is not usually present in the food (e.g.; "applesauce; cholesterol-free food") as required by 21 CFR 101.62 (d)(1)(i)(D) and 101.12(e)(2); Lastly; the claims "enriched with Vitamins A; B12; D; and Calcium" appear on the product label but the label does not include the additional information required under 21 CFR 101.54(e)(1) (iii) and 101. 13(j)(2) for relative claims (e.g.; information regarding the reference food);
Notes:9/20/10; update product description 3/15/11 Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically; the nutrient content of the composite is not at least equal to 80 percent of the value for the nutrient declared on the label for magnesium; as required by 21 CFR 101.9(g)(4)(ii); In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in that product fails to qualify for the claim; "Excellent source of... Magnesium" because the analytical findings indicate that the product contains less than 20 percent ofthe DRV per RACC; as required by 21 CFR 101.54(b); In addition; the side panel contains the nutrient content claim "Cholesterol Free" but fails to disclose that cholesterol is not usually present in the food (e.g.; "applesauce; cholesterol-free food") as required by 21 CFR 101.62 (d)(1)(i)(D) and 101.12(e)(2); Lastly; the claims "enriched with Vitamins A; B12; D; and Calcium" appear on the product label but the label does not include the additional information required under 21 CFR 101.54(e)(1) (iii) and 101. 13(j)(2) for relative claims (e.g.; information regarding the reference food);
14 B - - 99 Imitation Milk or Milk Type Product, N.E.C.
Date Published: 03/15/2011
Desc:Unsweetened Original Hemp Bliss Organic Hemp Milk
Notes:VIOLATION: The nutritional labeling does not comply with 21 CFR 101.54 requirements. The following violations were observed: -Label declares that the product is rich in essential nutrients. Rich in is a synonym for high per 21 CFR 101.54(b)(1). The product does not qualify for a high nutrient claim for any nutrients. - Label declared "Plus' is a relative nutrient content claim and in order to meet the requirements, the product must contain at least 10% or more of the RDI for vitamins or minerals per reference amount customarily consumed than an appropriate reference food per 21 CFR 101.54(e)(l)(i). -The identity of the reference food and the percentage (or fraction) that the nutrient is greater relative to the RDI are not declared in immediate proximity to the most prominent such claim per 21 CFR 101.54(e)(1)(iii).
Notes:VIOLATION: The nutritional labeling does not comply with 21 CFR 101.54 requirements. The following violations were observed: -Label declares that the product is rich in essential nutrients. Rich in is a synonym for high per 21 CFR 101.54(b)(1). The product does not qualify for a high nutrient claim for any nutrients. - Label declared "Plus' is a relative nutrient content claim and in order to meet the requirements, the product must contain at least 10% or more of the RDI for vitamins or minerals per reference amount customarily consumed than an appropriate reference food per 21 CFR 101.54(e)(l)(i). -The identity of the reference food and the percentage (or fraction) that the nutrient is greater relative to the RDI are not declared in immediate proximity to the most prominent such claim per 21 CFR 101.54(e)(1)(iii).
14 B - - 99 Imitation Milk or Milk Type Product, N.E.C.
Date Published: 03/15/2011
Desc:Hemp Dream Hemp Drink
Notes:9/20/10; update product description 3/15/11 Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically; the nutrient content of the composite is not at least equal to 80 percent of the value for the nutrient declared on the label for magnesium; as required by 21 CFR 101.9(g)(4) (ii); In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in that product fails to qualify for the claim; "Excellent source of... Magnesium" because the analytical findings indicate that the product contains less than 20 percent ofthe DRV per RACC; as required by 21 CFR 101.54(b); In addition; the side panel contains the nutrient content claim "Cholesterol Free" but fails to disclose that cholesterol is not usually present in the food (e.g.; "applesauce; cholesterol-free food") as required by 21 CFR 101.62(d)(1)(i)(D) and 101.12(e)(2); Lastly; the claims "enriched with Vitamins A; B12; D; and Calcium" appear on the product label but the label does not include the additional information required under 21 CFR 101.54(e)(1)(iii) and 101. 13(j)(2) for relative claims (e.g.; information regarding the reference food);
Notes:9/20/10; update product description 3/15/11 Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically; the nutrient content of the composite is not at least equal to 80 percent of the value for the nutrient declared on the label for magnesium; as required by 21 CFR 101.9(g)(4) (ii); In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in that product fails to qualify for the claim; "Excellent source of... Magnesium" because the analytical findings indicate that the product contains less than 20 percent ofthe DRV per RACC; as required by 21 CFR 101.54(b); In addition; the side panel contains the nutrient content claim "Cholesterol Free" but fails to disclose that cholesterol is not usually present in the food (e.g.; "applesauce; cholesterol-free food") as required by 21 CFR 101.62(d)(1)(i)(D) and 101.12(e)(2); Lastly; the claims "enriched with Vitamins A; B12; D; and Calcium" appear on the product label but the label does not include the additional information required under 21 CFR 101.54(e)(1)(iii) and 101. 13(j)(2) for relative claims (e.g.; information regarding the reference food);
Sunny Crunch Foods
Date Published : 09/16/2009
310 Steelcase Rd , Markham, ON CANADA
41 E - - 99 Meal Replacements (Not labeled for treatment of disease)
Date Published: 11/12/2009
Desc:Double Berry Soy Protein Supplement Bar
Notes:Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically the Potassium levels found Were 62% of the label declaration. 3/22/04
Notes:Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically the Potassium levels found Were 62% of the label declaration. 3/22/04
41 E - - 99 Meal Replacements (Not labeled for treatment of disease)
Date Published: 11/12/2009
Desc:Body Zone Choco Crisp Nutrition Bar
Notes:Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically the Calcium levels found Were 78.4% and 76.8% of the label declaration. 10/1/03
Notes:Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically the Calcium levels found Were 78.4% and 76.8% of the label declaration. 10/1/03
CHINA
CHENGHAI NATIVE PRODUCE IMP.&EXP.COMPANY OF GUANGDONG
Date Published : 10/01/2010
8TH ZHONGSHANZHONG RD., CHENGHAI , SHANTOU CITY, GUANGDONG PROVINCE , SHANTOU, CN-44 CHINA
33 - - - -- Candy W/O Choc/Special/Chew Gum
Date Published: 10/01/2010
Notes:The product is misbranded within the meaning of section 403(e)(1) of the Act because the label fails to include the identity of the place of business
as required in 21 CFR 101.5(d);
The product is misbranded within the meaning of section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c); if a product label contains any representation in a foreign language or foreign characters; all words; statements; and other information required by or under authority of the Act to appear on the label must appear in the foreign language;
In addition; the product fails to list the statement of ingredients on the information panel as required; but instead lists them on the principal display panel; as required by 21 CFR 101.2;
In addition; the
Changle Yongxin Food Co., Ltd.
Date Published : 09/16/2009
No. 150, Xindongyang, Jinfeng Zhen , Changle, Fujian, CHINA
23 A - - 07 Peanut, In Shell
Date Published: 11/12/2009
Notes:PRODUCT: Peanuts in Shell -
Product is misbranded under Section 403 (q) in that the labeling (Nutrition
Facts Panel) does not comply with nutritional labeling format requirements {21
CFR 101.9(d)}; Product is further misbranded in that the net contents are not
stated in ounces/pounds {21 CFR 101.105 (b)(1)}; Product is further misbranded
in that the labeling uses "Edible Flavor" to list a flavor ingredient {21 CFR
101.22(i)} 6/21/07
33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 11/12/2009
Notes:PRODUCT: Peanuts in Shell -
Product is misbranded under Section 403 (q) in that the labeling (Nutrition
Facts Panel) does not comply with nutritional labeling format requirements {21
CFR 101.9(d)}; Product is further misbranded in that the net contents are not
stated in ounces/pounds {21 CFR 101.105 (b)(1)}; Product is further misbranded
in that the labeling uses "Edible Flavor" to list a flavor ingredient {21 CFR
101.22(i)} 6/21/07
Changle Yongxin Food Co., Ltd.
Date Published : 09/16/2009
Liulin Jenfeng , Changle City, Fujian, CHINA
23 A - - 07 Peanut, In Shell
Date Published: 11/12/2009
Desc:Peanuts in Shell
Notes:Product is misbranded under Section 403 (q) in that the labeling (Nutrition Facts Panel) does not comply with nutritional labeling format requirements {21 CFR 101.9(d)}; Product is further misbranded in that the net contents are not stated in ounces/pounds {21 CFR 101.105 (b)(1)}; Product is further misbranded in that the labeling uses "Edible Flavor" to list a flavor ingredient {21 CFR 101.22(i)} 6/21/07
Notes:Product is misbranded under Section 403 (q) in that the labeling (Nutrition Facts Panel) does not comply with nutritional labeling format requirements {21 CFR 101.9(d)}; Product is further misbranded in that the net contents are not stated in ounces/pounds {21 CFR 101.105 (b)(1)}; Product is further misbranded in that the labeling uses "Edible Flavor" to list a flavor ingredient {21 CFR 101.22(i)} 6/21/07
33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 11/12/2009
Notes:PRODUCT: Peanuts in Shell - Product is misbranded under Section 403 (q) in
that the labeling (Nutrition
Facts Panel) does not comply with nutritional labeling format requirements {21
CFR 101.9(d)}; Product is further misbranded in that the net contents are not
stated in ounces/pounds {21 CFR 101.105 (b)(1)}; Product is further misbranded
in that the labeling uses "Edible Flavor" to list a flavor ingredient {21 CFR
101.22(i)} 6/21/07
Hainan Resurgence Natural Healthy F
Date Published : 10/12/2012
105 Numbersof , Guangzhou Cityguangzhou City, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/12/2012
Desc:Fruta Bio Dietary Supplement
Notes:VIOLATION (IN NOTES); 1. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) in that the label or labeling fails to bear the required nutrition information (e.g.; Nutrition Facts panel).
Notes:VIOLATION (IN NOTES); 1. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) in that the label or labeling fails to bear the required nutrition information (e.g.; Nutrition Facts panel).
Jiangmen Pengjiang Huiming Trading Company
Date Published : 09/16/2009
116 Flat 11 No. 13 Mingxing Road Xinhui , Guangdong, CHINA
23 A - - 07 Peanut, In Shell
Date Published: 11/12/2009
Notes:PRODUCT: Peanuts in Shell - Product is misbranded under Section 403 (q) in
that the labeling (Nutrition Facts Panel) does not comply with nutritional
labeling format requirements {21 CFR 101.9(d)}; Product is further misbranded
in that the net contents are not stated in ounces/pounds {21 CFR 101.105 (b)
(1)}; Product is further misbranded in that the labeling uses "Edible Flavor"
to list a flavor ingredient {21 CFR 101.22(i)} 6/21/07
33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 11/12/2009
Notes:PRODUCT: Peanuts in Shell - Product is misbranded under Section 403 (q) in
that the labeling (Nutrition Facts Panel) does not comply with nutritional
labeling format requirements {21 CFR 101.9(d)}; Product is further misbranded
in that the net contents are not stated in ounces/pounds {21 CFR 101.105 (b)
(1)}; Product is further misbranded in that the labeling uses "Edible Flavor"
to list a flavor ingredient {21 CFR 101.22(i)} 6/21/07
Jiangmen Pengjiang Huiming Trading Company
Date Published : 09/16/2009
Unit A,12/F,Dongxing Ge,Donghua , Building,128 Gangkou Road,China , Jiangmen, CN-NOTA CHINA
23 A - - 07 Peanut, In Shell
Date Published: 11/12/2009
Notes:PRODUCT: Peanuts in Shell - Product is misbranded under Section 403 (q) in that
the labeling (Nutrition Facts Panel) does not comply with nutritional labeling
format requirements {21 CFR 101.9(d)}; Product is further misbranded in that
the net contents are not stated in ounces/pounds {21 CFR 101.105 (b) (1)};
Product is further misbranded in that the labeling uses "Edible Flavor" to list
a flavor ingredient {21 CFR 101.22(i)} 6/21/07 ;
33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 11/12/2009
Notes:PRODUCT: Peanuts in Shell - Product is misbranded under Section 403 (q) in that
the labeling (Nutrition Facts Panel) does not comply with nutritional labeling
format requirements {21 CFR 101.9(d)}; Product is further misbranded in that
the net contents are not stated in ounces/pounds {21 CFR 101.105 (b) (1)};
Product is further misbranded in that the labeling uses "Edible Flavor" to list
a flavor ingredient {21 CFR 101.22(i)} 6/21/07 ;
SHANGHAI AB FOOD & BEVERAGES LTD.
Date Published : 07/31/2012
No.8 LANCUN RD.,MINHANG ECON,TECH& , DEV.ZONE , Shanghai, Shanghaishi CHINA
34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 07/31/2012
Desc:Ovaltine
Notes:VIOLATION (IN NOTES): 1. 403(r)(1)(A) ; 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) in that the label or labeling bears an unauthorized nutrient content claim. For example, the label declares that it contains high amounts of calcium and vitamin A. However, based on the serving size information provided, these nutrients are not present at 20 percent or more of the RDI or the DRV per reference amount customarily consumed (RACC) [21 CFR 101.54(b)];2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.9. For example: The serving size is not declared in common household measure or common household unit in accordance with 21 CFR 101.9(b)(5); The declaration of Nutrition Information is not presented using the nutrient names specified and in the order and format specified in 21 CFR 101.9(c); The label is not formatted (e.g., bolding, indenting, and rounding) appropriately as specified in 21 CFR 101.9(d);3. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2): The ingredients are not declared in accordance with 21 CFR 101.4. For example, vegetable fat must be declared by its specific common or usual name of the individual vegetable fat in parenthesis [21 CFR 101.4 (b)(14)] and the term acidity regulator (E504i) is not the common or usual name of this ingredient.
Notes:VIOLATION (IN NOTES): 1. 403(r)(1)(A) ; 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) in that the label or labeling bears an unauthorized nutrient content claim. For example, the label declares that it contains high amounts of calcium and vitamin A. However, based on the serving size information provided, these nutrients are not present at 20 percent or more of the RDI or the DRV per reference amount customarily consumed (RACC) [21 CFR 101.54(b)];2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.9. For example: The serving size is not declared in common household measure or common household unit in accordance with 21 CFR 101.9(b)(5); The declaration of Nutrition Information is not presented using the nutrient names specified and in the order and format specified in 21 CFR 101.9(c); The label is not formatted (e.g., bolding, indenting, and rounding) appropriately as specified in 21 CFR 101.9(d);3. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2): The ingredients are not declared in accordance with 21 CFR 101.4. For example, vegetable fat must be declared by its specific common or usual name of the individual vegetable fat in parenthesis [21 CFR 101.4 (b)(14)] and the term acidity regulator (E504i) is not the common or usual name of this ingredient.
Shandong Sunwell Green Food Co., Ltd.
Date Published : 01/05/2010
The Ind. Garden of Shouguang Dev. Zone , Shouguang, CN-37 CHINA
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 01/05/2010
Desc:Mixed Vegetable Chips
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amounts of iron (14%) and potassium (25%) are less than 80% of the declared amounts; Product is further misbranded within the meaning of Section 403(r) (1)(A) in that the product label bears the nutrient content claim ?Excellent source-Vitamin A..? but the % DV for Vitamin A declared in the nutrition label is 6%; Product is also misbranded within the meaning of section 403(r)(1)(A) in that the product label bears the nutrient content claim ?With fewer calories than traditional potato chips..? but does not meet the requirements of 21 CFR 101.60(b)(4) and 21 CFR 101.13(j); Under Section 403(r)(1)(A) the product is misbranded as it bears the nutrient content claim ?healthy? as part of a labeling statement when the product does not meet the requirements for the term healthy under 21 CFR 101.65(d); Product is misbranded within the meaning of section 403(q) in that the serving size declaration is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12; Product is also misbranded within the meaning of 403(q) in that calcium and iron must be declared before Vitamin E as required by 21 CFR 101.9(c)(8).
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amounts of iron (14%) and potassium (25%) are less than 80% of the declared amounts; Product is further misbranded within the meaning of Section 403(r) (1)(A) in that the product label bears the nutrient content claim ?Excellent source-Vitamin A..? but the % DV for Vitamin A declared in the nutrition label is 6%; Product is also misbranded within the meaning of section 403(r)(1)(A) in that the product label bears the nutrient content claim ?With fewer calories than traditional potato chips..? but does not meet the requirements of 21 CFR 101.60(b)(4) and 21 CFR 101.13(j); Under Section 403(r)(1)(A) the product is misbranded as it bears the nutrient content claim ?healthy? as part of a labeling statement when the product does not meet the requirements for the term healthy under 21 CFR 101.65(d); Product is misbranded within the meaning of section 403(q) in that the serving size declaration is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12; Product is also misbranded within the meaning of 403(q) in that calcium and iron must be declared before Vitamin E as required by 21 CFR 101.9(c)(8).
07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 01/05/2010
Desc:Mixed Vegetable Chips
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amounts of iron (14%) and potassium (25%) are less than 80% of the declared amounts; Product is further misbranded within the meaning of Section 403(r) (1)(A) in that the product label bears the nutrient content claim ?Excellent source-Vitamin A..? but the % DV for Vitamin A declared in the nutrition label is 6%; Product is also misbranded within the meaning of section 403(r)(1)(A) in that the product label bears the nutrient content claim ?With fewer calories than traditional potato chips..? but does not meet the requirements of 21 CFR 101.60(b)(4) and 21 CFR 101.13(j); Under Section 403(r)(1)(A) the product is misbranded as it bears the nutrient content claim ?healthy? as part of a labeling statement when the product does not meet the requirements for the term healthy under 21 CFR 101.65(d); Product is misbranded within the meaning of section 403(q) in that the serving size declaration is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12; Product is also misbranded within the meaning of 403(q) in that calcium and iron must be declared before Vitamin E as required by 21 CFR 101.9(c)(8).
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amounts of iron (14%) and potassium (25%) are less than 80% of the declared amounts; Product is further misbranded within the meaning of Section 403(r) (1)(A) in that the product label bears the nutrient content claim ?Excellent source-Vitamin A..? but the % DV for Vitamin A declared in the nutrition label is 6%; Product is also misbranded within the meaning of section 403(r)(1)(A) in that the product label bears the nutrient content claim ?With fewer calories than traditional potato chips..? but does not meet the requirements of 21 CFR 101.60(b)(4) and 21 CFR 101.13(j); Under Section 403(r)(1)(A) the product is misbranded as it bears the nutrient content claim ?healthy? as part of a labeling statement when the product does not meet the requirements for the term healthy under 21 CFR 101.65(d); Product is misbranded within the meaning of section 403(q) in that the serving size declaration is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12; Product is also misbranded within the meaning of 403(q) in that calcium and iron must be declared before Vitamin E as required by 21 CFR 101.9(c)(8).
07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 01/05/2010
Desc:Mixed Vegetable Chips
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amounts of iron (14%) and potassium (25%) are less than 80% of the declared amounts; Product is further misbranded within the meaning of Section 403(r) (1)(A) in that the product label bears the nutrient content claim ?Excellent source-Vitamin A..? but the % DV for Vitamin A declared in the nutrition label is 6%; Product is also misbranded within the meaning of section 403(r)(1)(A) in that the product label bears the nutrient content claim ?With fewer calories than traditional potato chips..? but does not meet the requirements of 21 CFR 101.60(b)(4) and 21 CFR 101.13(j); Under Section 403(r)(1)(A) the product is misbranded as it bears the nutrient content claim ?healthy? as part of a labeling statement when the product does not meet the requirements for the term healthy under 21 CFR 101.65(d); Product is misbranded within the meaning of section 403(q) in that the serving size declaration is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12; Product is also misbranded within the meaning of 403(q) in that calcium and iron must be declared before Vitamin E as required by 21 CFR 101.9(c)(8).
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amounts of iron (14%) and potassium (25%) are less than 80% of the declared amounts; Product is further misbranded within the meaning of Section 403(r) (1)(A) in that the product label bears the nutrient content claim ?Excellent source-Vitamin A..? but the % DV for Vitamin A declared in the nutrition label is 6%; Product is also misbranded within the meaning of section 403(r)(1)(A) in that the product label bears the nutrient content claim ?With fewer calories than traditional potato chips..? but does not meet the requirements of 21 CFR 101.60(b)(4) and 21 CFR 101.13(j); Under Section 403(r)(1)(A) the product is misbranded as it bears the nutrient content claim ?healthy? as part of a labeling statement when the product does not meet the requirements for the term healthy under 21 CFR 101.65(d); Product is misbranded within the meaning of section 403(q) in that the serving size declaration is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12; Product is also misbranded within the meaning of 403(q) in that calcium and iron must be declared before Vitamin E as required by 21 CFR 101.9(c)(8).
Shandong Sunwell Green Food Co., Ltd.
Date Published : 01/05/2010
The Ind. Garden of Shouguang Dev. Zone , Shouguang, CN-37 CHINA
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 01/05/2010
Desc:Mixed Vegetable Chips
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amounts of iron (14%) and potassium (25%) are less than 80% of the declared amounts; Product is further misbranded within the meaning of Section 403(r) (1)(A) in that the product label bears the nutrient content claim ?Excellent source-Vitamin A..? but the % DV for Vitamin A declared in the nutrition label is 6%; Product is also misbranded within the meaning of section 403(r)(1)(A) in that the product label bears the nutrient content claim ?With fewer calories than traditional potato chips..? but does not meet the requirements of 21 CFR 101.60(b)(4) and 21 CFR 101.13(j); Under Section 403(r)(1)(A) the product is misbranded as it bears the nutrient content claim ?healthy? as part of a labeling statement when the product does not meet the requirements for the term healthy under 21 CFR 101.65(d); Product is misbranded within the meaning of section 403(q) in that the serving size declaration is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12; Product is also misbranded within the meaning of 403(q) in that calcium and iron must be declared before Vitamin E as required by 21 CFR 101.9(c)(8).
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amounts of iron (14%) and potassium (25%) are less than 80% of the declared amounts; Product is further misbranded within the meaning of Section 403(r) (1)(A) in that the product label bears the nutrient content claim ?Excellent source-Vitamin A..? but the % DV for Vitamin A declared in the nutrition label is 6%; Product is also misbranded within the meaning of section 403(r)(1)(A) in that the product label bears the nutrient content claim ?With fewer calories than traditional potato chips..? but does not meet the requirements of 21 CFR 101.60(b)(4) and 21 CFR 101.13(j); Under Section 403(r)(1)(A) the product is misbranded as it bears the nutrient content claim ?healthy? as part of a labeling statement when the product does not meet the requirements for the term healthy under 21 CFR 101.65(d); Product is misbranded within the meaning of section 403(q) in that the serving size declaration is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12; Product is also misbranded within the meaning of 403(q) in that calcium and iron must be declared before Vitamin E as required by 21 CFR 101.9(c)(8).
07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 01/05/2010
Desc:Mixed Vegetable Chips
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amounts of iron (14%) and potassium (25%) are less than 80% of the declared amounts; Product is further misbranded within the meaning of Section 403(r) (1)(A) in that the product label bears the nutrient content claim ?Excellent source-Vitamin A..? but the % DV for Vitamin A declared in the nutrition label is 6%; Product is also misbranded within the meaning of section 403(r)(1)(A) in that the product label bears the nutrient content claim ?With fewer calories than traditional potato chips..? but does not meet the requirements of 21 CFR 101.60(b)(4) and 21 CFR 101.13(j); Under Section 403(r)(1)(A) the product is misbranded as it bears the nutrient content claim ?healthy? as part of a labeling statement when the product does not meet the requirements for the term healthy under 21 CFR 101.65(d); Product is misbranded within the meaning of section 403(q) in that the serving size declaration is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12; Product is also misbranded within the meaning of 403(q) in that calcium and iron must be declared before Vitamin E as required by 21 CFR 101.9(c)(8).
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amounts of iron (14%) and potassium (25%) are less than 80% of the declared amounts; Product is further misbranded within the meaning of Section 403(r) (1)(A) in that the product label bears the nutrient content claim ?Excellent source-Vitamin A..? but the % DV for Vitamin A declared in the nutrition label is 6%; Product is also misbranded within the meaning of section 403(r)(1)(A) in that the product label bears the nutrient content claim ?With fewer calories than traditional potato chips..? but does not meet the requirements of 21 CFR 101.60(b)(4) and 21 CFR 101.13(j); Under Section 403(r)(1)(A) the product is misbranded as it bears the nutrient content claim ?healthy? as part of a labeling statement when the product does not meet the requirements for the term healthy under 21 CFR 101.65(d); Product is misbranded within the meaning of section 403(q) in that the serving size declaration is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12; Product is also misbranded within the meaning of 403(q) in that calcium and iron must be declared before Vitamin E as required by 21 CFR 101.9(c)(8).
07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 01/05/2010
Desc:Mixed Vegetable Chips
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amounts of iron (14%) and potassium (25%) are less than 80% of the declared amounts; Product is further misbranded within the meaning of Section 403(r) (1)(A) in that the product label bears the nutrient content claim ?Excellent source-Vitamin A..? but the % DV for Vitamin A declared in the nutrition label is 6%; Product is also misbranded within the meaning of section 403(r)(1)(A) in that the product label bears the nutrient content claim ?With fewer calories than traditional potato chips..? but does not meet the requirements of 21 CFR 101.60(b)(4) and 21 CFR 101.13(j); Under Section 403(r)(1)(A) the product is misbranded as it bears the nutrient content claim ?healthy? as part of a labeling statement when the product does not meet the requirements for the term healthy under 21 CFR 101.65(d); Product is misbranded within the meaning of section 403(q) in that the serving size declaration is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12; Product is also misbranded within the meaning of 403(q) in that calcium and iron must be declared before Vitamin E as required by 21 CFR 101.9(c)(8).
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amounts of iron (14%) and potassium (25%) are less than 80% of the declared amounts; Product is further misbranded within the meaning of Section 403(r) (1)(A) in that the product label bears the nutrient content claim ?Excellent source-Vitamin A..? but the % DV for Vitamin A declared in the nutrition label is 6%; Product is also misbranded within the meaning of section 403(r)(1)(A) in that the product label bears the nutrient content claim ?With fewer calories than traditional potato chips..? but does not meet the requirements of 21 CFR 101.60(b)(4) and 21 CFR 101.13(j); Under Section 403(r)(1)(A) the product is misbranded as it bears the nutrient content claim ?healthy? as part of a labeling statement when the product does not meet the requirements for the term healthy under 21 CFR 101.65(d); Product is misbranded within the meaning of section 403(q) in that the serving size declaration is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12; Product is also misbranded within the meaning of 403(q) in that calcium and iron must be declared before Vitamin E as required by 21 CFR 101.9(c)(8).
Xing Hua Food Co. Ltd
Date Published : 09/16/2009
He Bin Road South, Daze Town , Xinhui District, Jiangmen CIty , Guangdong Province, Cn-44 CHINA
24 T - H -- Leaf / Stem Veg
Date Published: 11/12/2009
Desc:Cole; dehydrated
Notes:Product is misbranded within the meaning of section 403(i)(2) of the Act because the label fails to list each ingredient in the ingredient statement (21 CFR 101.4(a)(1)). Undeclared sulfites. Product is further mislabeled in that the label does not identify sulfite as a preservative (21 CFR 101.22(j)). Note; Cole refers to a family of vegetables; which includes kale; collard greens; broccoli; cauliflower; brussel sprouts; and kohlrabi. 11/14/08
Notes:Product is misbranded within the meaning of section 403(i)(2) of the Act because the label fails to list each ingredient in the ingredient statement (21 CFR 101.4(a)(1)). Undeclared sulfites. Product is further mislabeled in that the label does not identify sulfite as a preservative (21 CFR 101.22(j)). Note; Cole refers to a family of vegetables; which includes kale; collard greens; broccoli; cauliflower; brussel sprouts; and kohlrabi. 11/14/08
24 U - - -- Leaf/Stem Veg Dried/Paste
Date Published: 11/12/2009
Desc:Cole; dehydrated
Notes:Product is misbranded within the meaning of section 403(i)(2) of the Act because the label fails to list each ingredient in the ingredient statement (21 CFR 101.4(a)(1)). Undeclared sulfites. Product is further mislabeled in that the label does not identify sulfite as a preservative (21 CFR 101.22(j)). Note; Cole refers to a family of vegetables; which includes kale; collard greens; broccoli; cauliflower; brussel sprouts; and kohlrabi. 11/14/08
Notes:Product is misbranded within the meaning of section 403(i)(2) of the Act because the label fails to list each ingredient in the ingredient statement (21 CFR 101.4(a)(1)). Undeclared sulfites. Product is further mislabeled in that the label does not identify sulfite as a preservative (21 CFR 101.22(j)). Note; Cole refers to a family of vegetables; which includes kale; collard greens; broccoli; cauliflower; brussel sprouts; and kohlrabi. 11/14/08
ZHONGSHAN KUN BO FOODSTUFF IMPORT & EXPORT CO.,LTD
Date Published : 09/16/2009
changmingshui precinct wuguishan town , Zhongshan, Yandongsheng CHINA
22 A - - 07 Winter Melon (Vine Fruit)
Date Published: 11/12/2009
Desc:Sweet Wintermelon
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii). 6/6/07
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii). 6/6/07
23 K - - 06 Lotus Seed (Edible)
Date Published: 11/12/2009
Desc:Sweet Lotus Nuts
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii). 6/6/07
Notes:The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii). 6/6/07
Zhuhai Economic Special Zone General Non-Staple Food Corp.
Date Published : 09/16/2009
1092 Jiuzhou Road , Zhuhai, Guangdong, CHINA
25 J - - 14 Turnip (Root & Tuber Vegetable)
Date Published: 11/12/2009
Desc:Salted Turnip
Notes:Product is misbranded within the meaning of section 403(i)(2) of the Act because the label fails to list each ingredient in the ingredient statement (21 CFR 101.4(a)(1)). Undeclared sulfites 4/11/08
Notes:Product is misbranded within the meaning of section 403(i)(2) of the Act because the label fails to list each ingredient in the ingredient statement (21 CFR 101.4(a)(1)). Undeclared sulfites 4/11/08
COLOMBIA
Alpina Productos Alimenticios S.A.
Date Published : 09/16/2009
Vereda El Eden 200m Salida a Manizales , Chinchina, Caldas COLOMBIA
21 R - - 05 Mango (Subtropical and Tropical Fruit Purees)
Date Published: 11/12/2009
Desc:Baby compote - mango
Notes:Product is misbranded under Section 430(a)(1) in that it does not meet the label declaration for calcium - the content is 5% of the labeled value. 4/17/08
Notes:Product is misbranded under Section 430(a)(1) in that it does not meet the label declaration for calcium - the content is 5% of the labeled value. 4/17/08
40 K - - 99 Pudding and Custard, N.E.C. (Baby)
Date Published: 11/12/2009
Desc:Baby compote - Mango
Notes:Product is misbranded under Section 430(a)(1) in that it does not meet the label declaration for calcium - the content is 5% of the labeled value. 4/17/08
Notes:Product is misbranded under Section 430(a)(1) in that it does not meet the label declaration for calcium - the content is 5% of the labeled value. 4/17/08
40 Y - - -- Baby Food N.E.C.
Date Published: 11/12/2009
Desc:Baby compote - Mango
Notes:Product is misbranded under Section 430(a)(1) in that it does not meet the label declaration for calcium - the content is 5% of the labeled value. 4/17/08
Notes:Product is misbranded under Section 430(a)(1) in that it does not meet the label declaration for calcium - the content is 5% of the labeled value. 4/17/08
C.I. SOCIEDAD INDUSTRIAL DE GRASAS VEGETALES, SIGRA S.A.
Date Published : 03/05/2010
Carrera 46 No. 13-56, Calle 17 No.68B-68 , Bogota, Distrito Capital COLOMBIA
26 E - - -- Oleomargarine
Date Published: 03/05/2010
Desc:Margarine
Notes:Violation; Product is misbranded within the meaning of Sec. 403 in that the product is labeled as margarine but fails to meet the standard of identity for ?Margarine? under 21 CFR 166.110 because the product fails to contain vitamin A.
Notes:Violation; Product is misbranded within the meaning of Sec. 403 in that the product is labeled as margarine but fails to meet the standard of identity for ?Margarine? under 21 CFR 166.110 because the product fails to contain vitamin A.
26 F - - 99 Vegetable Shortening, N.E.C.
Date Published: 03/05/2010
Desc:Margarine
Notes:Violation;Product is misbranded within the meaning ofSec. 403 in that theproduct is labeled asmargarine but failsto meet the standardof identity for ?Margarine? under 21CFR 166.110 becausethe product fails tocontain vitamin A.
Notes:Violation;Product is misbranded within the meaning ofSec. 403 in that theproduct is labeled asmargarine but failsto meet the standardof identity for ?Margarine? under 21CFR 166.110 becausethe product fails tocontain vitamin A.
COSTA RICA
Unilever
Date Published : 02/18/2011
del Cruce San Antonio, Belen , 400 O y 800 N , San Antonio de Belen, CR-H COSTA RICA
37 J - - 08 Tomato Sauce (with Other Ingredients)
Date Published: 02/18/2011
Desc:Tomato Sauce with Cheese (Salsita Lista de Tomate con Queso)
Notes:VIOLATION; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(q) because; The product declares the serving size as 56 g (2 spoons); however the established Reference Amount Customarily Consumed (RACC) for Major main entre sauces; e.g.; spaghetti sauce[21 CFR 101.12(b); Table 2; under Sauces; Dips; Gravies and Condiments] is 125 g. therefore the nutrition information is not accurate per serving because it is not based on the established RACC provided for this product; The serving size is not expressed in a common household measure as required by 21 CFR 101.9(b)(5); The product fails to meet the requirements on rounding for the following nutrients; calories; saturated fat; cholesterol; carbohydrate; dietary fiber protein; Vitamin A; calcium and iron. In addition; the declaration for potassium does not follow the order of presentation of nutrient information because the declaration for potassium follows the declaration of iron rather than the declaration of sodium [21 CFR 101.9(c)].
Notes:VIOLATION; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(q) because; The product declares the serving size as 56 g (2 spoons); however the established Reference Amount Customarily Consumed (RACC) for Major main entre sauces; e.g.; spaghetti sauce[21 CFR 101.12(b); Table 2; under Sauces; Dips; Gravies and Condiments] is 125 g. therefore the nutrition information is not accurate per serving because it is not based on the established RACC provided for this product; The serving size is not expressed in a common household measure as required by 21 CFR 101.9(b)(5); The product fails to meet the requirements on rounding for the following nutrients; calories; saturated fat; cholesterol; carbohydrate; dietary fiber protein; Vitamin A; calcium and iron. In addition; the declaration for potassium does not follow the order of presentation of nutrient information because the declaration for potassium follows the declaration of iron rather than the declaration of sodium [21 CFR 101.9(c)].
Unilever Centroamerica
Date Published : 02/18/2011
San Antonio de Belen Heredia. Del Cruce , 400 Mts Oeste y 800 Mts Norte , San Jose, San Jose COSTA RICA
37 J - - 08 Tomato Sauce (with Other Ingredients)
Date Published: 02/18/2011
Desc:Tomato Sauce with cheese (Salsita Lista de Tomate con Queso)
Notes:VIOLATION; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(q) because; The product declares the serving size as 56 g (2 spoons); however the established Reference Amount Customarily Consumed (RACC) for Major main entre sauces; e.g.; spaghetti sauce[21 CFR 101.12(b); Table 2; under Sauces; Dips; Gravies and Condiments] is 125 g. therefore the nutrition information is not accurate per serving because it is not based on the established RACC provided for this product; The serving size is not expressed in a common household measure as required by 21 CFR 101.9(b)(5); The product fails to meet the requirements on rounding for the following nutrients; calories; saturated fat; cholesterol; carbohydrate; dietary fiber protein; Vitamin A; calcium and iron. In addition; the declaration for potassium does not follow the order of presentation of nutrient information because the declaration for potassium follows the declaration of iron rather than the declaration of sodium [21 CFR 101.9(c)].
Notes:VIOLATION; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(q) because; The product declares the serving size as 56 g (2 spoons); however the established Reference Amount Customarily Consumed (RACC) for Major main entre sauces; e.g.; spaghetti sauce[21 CFR 101.12(b); Table 2; under Sauces; Dips; Gravies and Condiments] is 125 g. therefore the nutrition information is not accurate per serving because it is not based on the established RACC provided for this product; The serving size is not expressed in a common household measure as required by 21 CFR 101.9(b)(5); The product fails to meet the requirements on rounding for the following nutrients; calories; saturated fat; cholesterol; carbohydrate; dietary fiber protein; Vitamin A; calcium and iron. In addition; the declaration for potassium does not follow the order of presentation of nutrient information because the declaration for potassium follows the declaration of iron rather than the declaration of sodium [21 CFR 101.9(c)].
Unilever Centroamerica
Date Published : 02/18/2011
San Antonio de Belen Heredia. Del Cruce , 400 Mts Oeste y 800 Mts Norte , San Jose, San Jose COSTA RICA
37 J - - 08 Tomato Sauce (with Other Ingredients)
Date Published: 02/18/2011
Desc:Tomato Sauce with Cheese (Salsita Lista de Tomate con Queso)
Notes:VIOLATION; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(q) because; The product declares the serving size as 56 g (2 spoons); however the established Reference Amount Customarily Consumed (RACC) for Major main entre sauces; e.g.; spaghetti sauce[21 CFR 101.12(b); Table 2; under Sauces; Dips; Gravies and Condiments] is 125 g. therefore the nutrition information is not accurate per serving because it is not based on the established RACC provided for this product; The serving size is not expressed in a common household measure as required by 21 CFR 101.9(b)(5); The product fails to meet the requirements on rounding for the following nutrients; calories; saturated fat; cholesterol; carbohydrate; dietary fiber protein; Vitamin A; calcium and iron. In addition; the declaration for potassium does not follow the order of presentation of nutrient information because the declaration for potassium follows the declaration of iron rather than the declaration of sodium [21 CFR 101.9 (c)].
Notes:VIOLATION; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(q) because; The product declares the serving size as 56 g (2 spoons); however the established Reference Amount Customarily Consumed (RACC) for Major main entre sauces; e.g.; spaghetti sauce[21 CFR 101.12(b); Table 2; under Sauces; Dips; Gravies and Condiments] is 125 g. therefore the nutrition information is not accurate per serving because it is not based on the established RACC provided for this product; The serving size is not expressed in a common household measure as required by 21 CFR 101.9(b)(5); The product fails to meet the requirements on rounding for the following nutrients; calories; saturated fat; cholesterol; carbohydrate; dietary fiber protein; Vitamin A; calcium and iron. In addition; the declaration for potassium does not follow the order of presentation of nutrient information because the declaration for potassium follows the declaration of iron rather than the declaration of sodium [21 CFR 101.9 (c)].
ECUADOR
Nelly del Carmen Alvarez Cedeno
Date Published : 05/12/2011
Cdla.alborada Cuarta Etapa Mz F-B S.2 , Guayaquil, EC-G ECUADOR
28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 05/12/2011
Desc:Mama Tere Seasoning
Notes:The article appears to be misbranded within the meaning of section 403(q) because the nutrition label does not meet the requirements of 21 CFR 101.9: The product fails to properly declare the serving size as specified by 21 CFR 101.9 (b) and 101.12(b); therefore, the nutrition information is not correct. The nutrition label fails to declare all of the required nutrition information in accordance with 21 CFR 101.9(c). Specifically, the nutrition label has five nutrients missing (trans fat, vitamin A, vitamin C, calcium, and iron). FDA could not determine label format, in that, it appears the product could qualify for the simplified format of the nutrition label, which requires the product to contain insignificant amounts of eight or more of the nutrients listed in 21 CFR 101.9(f) and placement of an asterisk at the bottom of the label followed by the statement "Percent Daily Values are based on a 2,000 calorie diet" when the footnote is omitted [21 CFR 101.9(f)(5)]. The product label is further misbranded, in that, the quantitative amounts for total fat, saturated fat, total carbohydrate, and protein are not in accordance with 21 CFR 101.9(d)(7)(i). Specifically, the nutrient amount should be appended with a "g" for grams. The product label is further misbranded within the meaning of section 403(f) because all required words, statements and other information on the label must be included in both languages. The place of business is only in English. (21 CFR 101.15 (c)(1))
Notes:The article appears to be misbranded within the meaning of section 403(q) because the nutrition label does not meet the requirements of 21 CFR 101.9: The product fails to properly declare the serving size as specified by 21 CFR 101.9 (b) and 101.12(b); therefore, the nutrition information is not correct. The nutrition label fails to declare all of the required nutrition information in accordance with 21 CFR 101.9(c). Specifically, the nutrition label has five nutrients missing (trans fat, vitamin A, vitamin C, calcium, and iron). FDA could not determine label format, in that, it appears the product could qualify for the simplified format of the nutrition label, which requires the product to contain insignificant amounts of eight or more of the nutrients listed in 21 CFR 101.9(f) and placement of an asterisk at the bottom of the label followed by the statement "Percent Daily Values are based on a 2,000 calorie diet" when the footnote is omitted [21 CFR 101.9(f)(5)]. The product label is further misbranded, in that, the quantitative amounts for total fat, saturated fat, total carbohydrate, and protein are not in accordance with 21 CFR 101.9(d)(7)(i). Specifically, the nutrient amount should be appended with a "g" for grams. The product label is further misbranded within the meaning of section 403(f) because all required words, statements and other information on the label must be included in both languages. The place of business is only in English. (21 CFR 101.15 (c)(1))
FIJI
Hardip Narayan & Sons Ltd.
Date Published : 09/16/2009
P.o. Box 12407 , Lot 97/98 Pritam Singh Road , Suva, FIJI
04 C - - 07 Noodles, Instant
Date Published: 11/12/2009
Desc:Maggi 2 Minute Noodle
Notes:Product is misbranded within the meaning of Section 403 in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9 [Misbranded; Section 403(q)]. 10/30/07 MANUFACTURER; Nestle Trading (Fiji) Ltd.
Notes:Product is misbranded within the meaning of Section 403 in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9 [Misbranded; Section 403(q)]. 10/30/07 MANUFACTURER; Nestle Trading (Fiji) Ltd.
National Exports Limited
Date Published : 09/16/2009
22 Potts Street , Lautoka, BA, FJ-NOTA FIJI
09 C - H -- Milk/Cream
Date Published: 11/12/2009
Desc:Powdered Milk
Notes:The product is misbranded in that the nutrition information that appears on the label is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403 (q)]. MANUFACTURER; Punja & Sons Ltd. 12/13/05
Notes:The product is misbranded in that the nutrition information that appears on the label is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403 (q)]. MANUFACTURER; Punja & Sons Ltd. 12/13/05
Nestle Trading(Fiji) Ltd
Date Published : 09/16/2009
P.O BOX 3042 , Lot 1 Wailekutu Sub - Division , Lami, Fj-C FIJI
04 C - - 07 Noodles, Instant
Date Published: 11/12/2009
Desc:Maggi 2 Minute Noodle
Notes:Product is misbranded within the meaning of Section 403 in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9 [Misbranded; Section 403(q)]. 10/30/07 SHIPPER: Hardip Narayan & Sons Ltd.
Notes:Product is misbranded within the meaning of Section 403 in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9 [Misbranded; Section 403(q)]. 10/30/07 SHIPPER: Hardip Narayan & Sons Ltd.
Punja & Sons Ltd.
Date Published : 09/16/2009
63 Vitogo Parade , P.O. Box 125 , Lautoka, Fj-W FIJI
09 C - H -- Milk/Cream
Date Published: 11/12/2009
Desc:Powdered Milk
Notes:The product is misbranded in that the nutrition information that appears on the label is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403 (q)]. SHIPPER: National Exports Ltd. 12/13/05
Notes:The product is misbranded in that the nutrition information that appears on the label is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403 (q)]. SHIPPER: National Exports Ltd. 12/13/05
Rewa Co-Operative Dairy Co.Ltd
Date Published : 09/13/2010
P.O. Box 3678 , Samabula, FIJI
09 Y - - 99 Fluid/Dry Milk Products Not Elsewhere Mentioned, N.E.C.
Date Published: 09/13/2010
Desc:Rewa Milk Powder
Notes:Product is misbranded within the meaning of Section 403(r)(1)(A) in that the labeling is false. Specifically, because the product bears the claim ¿... contains...energy" which is an undefined nutrient content claim. In addition, the article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(q)(1) of the Act in that the nutrition information is not declared in the required format (21 CFR 101.9(d)(1). In addition, the serving size information is not declared in common household measure and is not based on the Reference Amount Customarily Consumed, in accordance with 21 CFR 101.9(b)(5). Furthermore, the nutrient panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV, in accordance with 21 CFR 101.9(d)(7)(ii) and the product also bears the claim ¿...contains.... protein..." but fails to bear the level of protein and the percent Daily Value for protein in accordance to 21 CFR 101.9(c)(7) and 21 CFR 101.9(c)(7)(ii).
Notes:Product is misbranded within the meaning of Section 403(r)(1)(A) in that the labeling is false. Specifically, because the product bears the claim ¿... contains...energy" which is an undefined nutrient content claim. In addition, the article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(q)(1) of the Act in that the nutrition information is not declared in the required format (21 CFR 101.9(d)(1). In addition, the serving size information is not declared in common household measure and is not based on the Reference Amount Customarily Consumed, in accordance with 21 CFR 101.9(b)(5). Furthermore, the nutrient panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV, in accordance with 21 CFR 101.9(d)(7)(ii) and the product also bears the claim ¿...contains.... protein..." but fails to bear the level of protein and the percent Daily Value for protein in accordance to 21 CFR 101.9(c)(7) and 21 CFR 101.9(c)(7)(ii).
Rewa Co-operative Dairy Co Ltd
Date Published : 09/13/2010
Kings Road , Nabua , Suva, FJ-E FIJI
09 Y - - 99 Fluid/Dry Milk Products Not Elsewhere Mentioned, N.E.C.
Date Published: 09/13/2010
Desc:Rewa Milk Powder
Notes:Product is misbranded within the meaning of Section 403(r)(1)(A) in that the labeling is false. Specifically, because the product bears the claim ¿... contains...energy" which is an undefined nutrient content claim. In addition, the article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(q)(1) of the Act in that the nutrition information is not declared in the required format (21 CFR 101.9(d)(1). In addition, the serving size information is not declared in common household measure and is not based on the Reference Amount Customarily Consumed, in accordance with 21 CFR 101.9(b)(5). Furthermore, the nutrient panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV, in accordance with 21 CFR 101.9(d)(7)(ii) and the product also bears the claim ¿...contains.... protein..." but fails to bear the level of protein and the percent Daily Value for protein in accordance to 21 CFR 101.9(c)(7) and 21 CFR 101.9(c)(7)(ii).
Notes:Product is misbranded within the meaning of Section 403(r)(1)(A) in that the labeling is false. Specifically, because the product bears the claim ¿... contains...energy" which is an undefined nutrient content claim. In addition, the article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(q)(1) of the Act in that the nutrition information is not declared in the required format (21 CFR 101.9(d)(1). In addition, the serving size information is not declared in common household measure and is not based on the Reference Amount Customarily Consumed, in accordance with 21 CFR 101.9(b)(5). Furthermore, the nutrient panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV, in accordance with 21 CFR 101.9(d)(7)(ii) and the product also bears the claim ¿...contains.... protein..." but fails to bear the level of protein and the percent Daily Value for protein in accordance to 21 CFR 101.9(c)(7) and 21 CFR 101.9(c)(7)(ii).
Southern Cross Foods Ltd
Date Published : 05/20/2013
P.O. Box 165 , Suva, FIJI
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 05/20/2013
Desc:Jason's Peanut Ruffs Baked Snack
Notes:VIOLATION (IN NOTES) The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each ingredient. Flavour Enhancer (621), Vegetable Oils (Antioxidant (306) (from Soy)), and Palm Olein (Antioxidant (319)) are not provided for in 21 CFR 101.4; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the label fails to bear the required nutrition information
Notes:VIOLATION (IN NOTES) The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each ingredient. Flavour Enhancer (621), Vegetable Oils (Antioxidant (306) (from Soy)), and Palm Olein (Antioxidant (319)) are not provided for in 21 CFR 101.4; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the label fails to bear the required nutrition information
Southern Cross Foods Ltd
Date Published : 05/20/2013
Kings Road , Yalalevu , Ba, FJ-NOTA FIJI
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 05/20/2013
Desc:Jason's Peanut Ruffs Baked Snack
Notes:VIOLATION (IN NOTES) The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each ingredient. Flavour Enhancer (621), Vegetable Oils (Antioxidant (306) (from Soy)), and Palm Olein (Antioxidant (319)) are not provided for in 21 CFR 101.4; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the label fails to bear the required nutrition information
Notes:VIOLATION (IN NOTES) The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each ingredient. Flavour Enhancer (621), Vegetable Oils (Antioxidant (306) (from Soy)), and Palm Olein (Antioxidant (319)) are not provided for in 21 CFR 101.4; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the label fails to bear the required nutrition information
GERMANY
Hans Riegelein & Sohn
Date Published : 12/28/2012
Tiembacher Strasse 11-13 , Cadolzburg, Bayern GERMANY
34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 12/28/2012
Desc:Monster eyes filled with cream
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9;In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the declaration of ingredients is not consistent as required by 21 CFR 10 1.4. The label lists "E numbers" rather than the name of the ingredient by common or usual name and the vegetable fat ingredient is not listed by a specific common or usual name.
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9;In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the declaration of ingredients is not consistent as required by 21 CFR 10 1.4. The label lists "E numbers" rather than the name of the ingredient by common or usual name and the vegetable fat ingredient is not listed by a specific common or usual name.
34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 12/28/2012
Desc:Halloween Party Chocolate
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9; In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9; In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;
34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 12/28/2012
Desc:Halloween Figurines
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9; In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9; In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;
34 F - - 09 Chocolate Candy, Taffy Type (Chewy Rolls, Etc.), without Nuts and Fruit
Date Published: 12/28/2012
Desc:Monster eyes filled with cream
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9;In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the declaration of ingredients is not consistent as required by 21 CFR 10 1.4. The label lists "E numbers" rather than the name of the ingredient by common or usual name and the vegetable fat ingredient is not listed by a specific common or usual name. ;
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9;In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the declaration of ingredients is not consistent as required by 21 CFR 10 1.4. The label lists "E numbers" rather than the name of the ingredient by common or usual name and the vegetable fat ingredient is not listed by a specific common or usual name. ;
34 F - - 09 Chocolate Candy, Taffy Type (Chewy Rolls, Etc.), without Nuts and Fruit
Date Published: 12/28/2012
Desc:Halloween Figurines
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9.;In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105.
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9.;In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105.
34 F - - 09 Chocolate Candy, Taffy Type (Chewy Rolls, Etc.), without Nuts and Fruit
Date Published: 12/28/2012
Desc:Halloween Party Chocolate
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9; In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9; In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;
34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C.
Date Published: 12/28/2012
Desc:Halloween Figurines
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9; In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9; In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;
34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C.
Date Published: 12/28/2012
Desc:Halloween Party Chocolate
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9; In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9; In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;
34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C.
Date Published: 12/28/2012
Desc:Monster eyes filled with cream
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9;In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the declaration of ingredients is not consistent as required by 21 CFR 10 1.4. The label lists "E numbers" rather than the name of the ingredient by common or usual name and the vegetable fat ingredient is not listed by a specific common or usual name. ;
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9;In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the declaration of ingredients is not consistent as required by 21 CFR 10 1.4. The label lists "E numbers" rather than the name of the ingredient by common or usual name and the vegetable fat ingredient is not listed by a specific common or usual name. ;
34 Y - - 99 Chocolate and Cocoa Products, N.E.C.
Date Published: 12/28/2012
Desc:Halloween Figurines
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9; In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9; In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;
34 Y - - 99 Chocolate and Cocoa Products, N.E.C.
Date Published: 12/28/2012
Desc:Monster eyes filled with cream
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9;In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the declaration of ingredients is not consistent as required by 21 CFR 10 1.4. The label lists "E numbers" rather than the name of the ingredient by common or usual name and the vegetable fat ingredient is not listed by a specific common or usual name. ;
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9;In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the declaration of ingredients is not consistent as required by 21 CFR 10 1.4. The label lists "E numbers" rather than the name of the ingredient by common or usual name and the vegetable fat ingredient is not listed by a specific common or usual name. ;
34 Y - - 99 Chocolate and Cocoa Products, N.E.C.
Date Published: 12/28/2012
Desc:Halloween Party Chocolate
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9; In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the label bears nutrition information but it does not bear nutrition labeling as required by 21 CFR 101.9; In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) because the declaration of quantity of contents is not in avoirdupois pounds and ounces. In addition, the net weight is not located on the principal display panel as required by 21 CFR 101.105;
Sedent Ltd
Date Published : 08/26/2011
Dusselberger Str 4 , Haan, Nordrhein-westfalen GERMANY
54 A - - 99 Vitamin, N.E.C.
Date Published: 08/26/2011
Desc:Sanomit (Dietary Supplement)
Notes:REASON; Label is in a foreign language failing to bear the supplement facts panel.
Notes:REASON; Label is in a foreign language failing to bear the supplement facts panel.
GREECE
Franca S.A.
Date Published : 09/16/2009
P.O. Box 46010 133 01 A. Liossia , Athens Greece, GREECE
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 11/12/2009
Desc:Fat Free Garlic Bagel Chips
Notes:label bears the claim "fat free" but the product fails to meet the requirements for the claim
Notes:label bears the claim "fat free" but the product fails to meet the requirements for the claim
G.S.PAPANIKOLAOU BROS O.E.
Date Published : 10/07/2011
2 Messinis str. , Kalamata, GR-17 GREECE
21 G - - 09 Olives (Pit Fruit)
Date Published: 10/07/2011
Desc:Kalamata Olives (Packed in olive Oil)
Notes:VIOLATION (IN NOTES); 1. 403(q) 2. 403(r)(1)(B) 1. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(q) because the product does not declare trans fat in accordance with 21 CFR 101.9(c)(2)(ii). 2. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(r) because the product label makes unauthorized health claims. We note we have a qualified health claim where we have provided enforcement discretion for monounsaturated fatty acids from olive oil and coronary heart disease; however; we note that the statements on this product label do not meet the requirements for making such a claim.
Notes:VIOLATION (IN NOTES); 1. 403(q) 2. 403(r)(1)(B) 1. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(q) because the product does not declare trans fat in accordance with 21 CFR 101.9(c)(2)(ii). 2. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(r) because the product label makes unauthorized health claims. We note we have a qualified health claim where we have provided enforcement discretion for monounsaturated fatty acids from olive oil and coronary heart disease; however; we note that the statements on this product label do not meet the requirements for making such a claim.
GUATEMALA
INDUSTRIAS UNIDAS, S.A.
Date Published : 03/11/2011
KM. 14.8 CARRETERA A VILLA CANALES , BOCA DEL MONTE , GUATEMALA, GT-GU GUATEMALA
05 A - - 02 Oat Flakes, Rolled Oats,Puffs,Krispies,Loops Ready To Eat
Date Published: 03/11/2011
Desc:Oak Flakes
Notes:VIOLATION; The article is subject to refusal of admission pursuant to section 801 (a) (3) of the Act in that the label appears to be misbranded under section 403(r) because the product bears an unauthorized health claim but does not meet the requirements for the claims. The claim states; "You can reduce cholesterol by eating oats daily". There is an authorized health claim for soluble fiber from certain foods; such as oats; and risk of coronary heart disease in 21 CFR 101.81; however; the claim "You can reduce cholesterol by eating oats daily" is not consistent with the language provided in the regulation; The article is subject to refusal of admission pursuant to section 801(a) (3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9; There is no quantitative amount provided for total carbohydrate in accordance with 21 CFR 101.9(c)(6)(i); There is no quantitative amount provided for dietary fiber in accordance with 21 CFR 101.9(c)(6)(i)(A); There is no percent DV's provided for dietary fiber in accordance with 21 CFR 101.9(c)(7)(ii); In addition; the label does not include a declaration of Trans fat as required in 21 CFR 101.9(c)(2)(ii); The nutrition information does not meet the format requirements defined in 21 CFR 101.9(d);
Notes:VIOLATION; The article is subject to refusal of admission pursuant to section 801 (a) (3) of the Act in that the label appears to be misbranded under section 403(r) because the product bears an unauthorized health claim but does not meet the requirements for the claims. The claim states; "You can reduce cholesterol by eating oats daily". There is an authorized health claim for soluble fiber from certain foods; such as oats; and risk of coronary heart disease in 21 CFR 101.81; however; the claim "You can reduce cholesterol by eating oats daily" is not consistent with the language provided in the regulation; The article is subject to refusal of admission pursuant to section 801(a) (3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9; There is no quantitative amount provided for total carbohydrate in accordance with 21 CFR 101.9(c)(6)(i); There is no quantitative amount provided for dietary fiber in accordance with 21 CFR 101.9(c)(6)(i)(A); There is no percent DV's provided for dietary fiber in accordance with 21 CFR 101.9(c)(7)(ii); In addition; the label does not include a declaration of Trans fat as required in 21 CFR 101.9(c)(2)(ii); The nutrition information does not meet the format requirements defined in 21 CFR 101.9(d);
05 B - - 99 Breakfast Food Quick or Instant Cooking, N.E.C.
Date Published: 03/11/2011
Desc:Oak Flakes
Notes:VIOLATION; The article is subject to refusal of admission pursuant to section 801 (a) (3) of the Act in that the label appears to be misbranded under section 403(r) because the product bears an unauthorized health claim but does not meet the requirements for the claims. The claim states; "You can reduce cholesterol by eating oats daily". There is an authorized health claim for soluble fiber from certain foods; such as oats; and risk of coronary heart disease in 21 CFR 101.81; however; the claim "You can reduce cholesterol by eating oats daily" is not consistent with the language provided in the regulation; The article is subject to refusal of admission pursuant to section 801(a) (3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9; There is no quantitative amount provided for total carbohydrate in accordance with 21 CFR 101.9(c)(6)(i); There is no quantitative amount provided for dietary fiber in accordance with 21 CFR 101.9(c)(6)(i)(A); There is no percent DV's provided for dietary fiber in accordance with 21 CFR 101.9(c)(7)(ii); In addition; the label does not include a declaration of Trans fat as required in 21 CFR 101.9(c)(2)(ii); The nutrition information does not meet the format requirements defined in 21 CFR 101.9(d);
Notes:VIOLATION; The article is subject to refusal of admission pursuant to section 801 (a) (3) of the Act in that the label appears to be misbranded under section 403(r) because the product bears an unauthorized health claim but does not meet the requirements for the claims. The claim states; "You can reduce cholesterol by eating oats daily". There is an authorized health claim for soluble fiber from certain foods; such as oats; and risk of coronary heart disease in 21 CFR 101.81; however; the claim "You can reduce cholesterol by eating oats daily" is not consistent with the language provided in the regulation; The article is subject to refusal of admission pursuant to section 801(a) (3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9; There is no quantitative amount provided for total carbohydrate in accordance with 21 CFR 101.9(c)(6)(i); There is no quantitative amount provided for dietary fiber in accordance with 21 CFR 101.9(c)(6)(i)(A); There is no percent DV's provided for dietary fiber in accordance with 21 CFR 101.9(c)(7)(ii); In addition; the label does not include a declaration of Trans fat as required in 21 CFR 101.9(c)(2)(ii); The nutrition information does not meet the format requirements defined in 21 CFR 101.9(d);
HONG KONG
CHOI YUE TRADING COMPANY
Date Published : 09/16/2009
G/f Shop 8 Belcher Court , 2 Sai Cheung Strteet, Western, Hk , HK, HK-NA HONG KONG
38 C - - 99 Dried Soup, N.E.C.
Date Published: 11/12/2009
Notes:PRODUCT: Fish Abdomen with Agaricus Blazei Soup (Dried Soup Mix) -
Product is misbranded under Sec.403(i)(2) in that the ingredient statement
fails toidentify each ingredient by its common or usual name. For example, the
Ingredient listed as "Fish Abdomen¿ fails to identify the species of fish.
Product is further misbranded in that the label does not bear nutrition
information in the proper format.
Nin Jiom Medicine Manufactory (HK) Ltd.
Date Published : 06/08/2012
Block A, 16/F, Texaco Industries Centre, , 256 Texaco Road , Hong Kong, HONG KONG
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 06/08/2012
Desc:Herbal Candy Super Mint
Notes:VIOLATION (IN NOTES): 1. 403(q) ; 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded under section 403(q) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the nutrition information on the labels are provided in a format not consistent with the requirements under 21 CFR 101.9. Specifically, the nutrients are not listed in order as specified under 21 CFR 101.9 (c) and that ¿Calories¿ is not declared as required under 21 CFR 101.9(c)(1). Also, the %DVs are not declared under 21 CFR 101.9(d)(7)(ii). The nutrition information does not meet the formatting requirements under 21 CFR 101.9(d)(1)(i), which states, in part, that the nutrition must be printed on a white or other neutral contrasting background whenever practical. 2. The article is subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded under sections 403 (i)(2) of the Act, in that ingredient statement does not correctly label the ¿Flavour & Flavouring¿ ingredient in accordance with 21 CFR 101.22.
Notes:VIOLATION (IN NOTES): 1. 403(q) ; 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded under section 403(q) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the nutrition information on the labels are provided in a format not consistent with the requirements under 21 CFR 101.9. Specifically, the nutrients are not listed in order as specified under 21 CFR 101.9 (c) and that ¿Calories¿ is not declared as required under 21 CFR 101.9(c)(1). Also, the %DVs are not declared under 21 CFR 101.9(d)(7)(ii). The nutrition information does not meet the formatting requirements under 21 CFR 101.9(d)(1)(i), which states, in part, that the nutrition must be printed on a white or other neutral contrasting background whenever practical. 2. The article is subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded under sections 403 (i)(2) of the Act, in that ingredient statement does not correctly label the ¿Flavour & Flavouring¿ ingredient in accordance with 21 CFR 101.22.
INDIA
BRITANNIA INDUSTRIES LIMITED
Date Published : 09/16/2009
5/1a, Hungerford Street , Kolkata , KOLKATA, IN-WB INDIA
03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 11/12/2009
Desc:Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04
03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 11/12/2009
Desc:Vita Maria Gold Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
03 H - - 01 Vanilla Plain Cookie,Biscuit and Wafer
Date Published: 11/12/2009
Desc:Vita Maria Gold Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
03 H - - 01 Vanilla Plain Cookie,Biscuit and Wafer
Date Published: 11/12/2009
Desc:Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04
03 H - - 02 Chocolate Plain Cookies,Biscuits and Wafers
Date Published: 11/12/2009
Desc:Good Day Choco-nut Biscuits
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06
03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 11/12/2009
Desc:Nice Time Sugar Showered Coconut Biscuits
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06
03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 11/12/2009
Desc:Good Day Cashew Biscuits
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06
03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 11/12/2009
Desc:Good Day Choco-nut Biscuits
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06 ;
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06 ;
03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 11/12/2009
Desc:Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04 ;
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04 ;
03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 11/12/2009
Desc:Vita Maria Gold Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 11/12/2009
Desc:50-50 Biscuits
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; dough conditioner (E223); acidity regulator (E330); improvers (E1100; 1101); antioxidant (INS319); and synthetic Food colours (E102; 124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; dough conditioner (E223); acidity regulator (E330); improvers (E1100; 1101); antioxidant (INS319); and synthetic Food colours (E102; 124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 11/12/2009
Desc:Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 11/12/2009
Desc:Vita Maria Gold Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 11/12/2009
Desc:Marie Gold Biscuits
Notes:Product is misbranded under Sec. 403(i)(2) in that the ingredient Statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; emulsifier (E471); dough conditioner (E223); antioxidant (INS319); and natural & synthetic food colours (E102; 124; 150) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06
Notes:Product is misbranded under Sec. 403(i)(2) in that the ingredient Statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; emulsifier (E471); dough conditioner (E223); antioxidant (INS319); and natural & synthetic food colours (E102; 124; 150) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06
E A Currim Pvt Ltd
Date Published : 08/06/2010
19 Kazi Sayed St Ground Flr , Mumbai, INDIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 08/06/2010
Desc:Umber SF Supplement
Notes:Product is labeled as a dietary supplement but fails to bear nutrition labeling ("Supplement Facts" panel) as required by Section 403(q)(5)(F) and 21 CFR 101.36. Product is misbranded within the meaning of Section 403(i)(2) of the Act because the label fails to list each ingredient, specifically, the capsule ingredients, in the ingredient statement (21 CFR 101.4(a)(1)). The label fails to identify the product using the term "dietary supplement" as part of the statement of identity on the principal display panel (21 CFR 101.3(a) and (g)). The product fails to provide the appropriate "Disclaimer" in accordance with 21 CFR 101.93(a-e).
Notes:Product is labeled as a dietary supplement but fails to bear nutrition labeling ("Supplement Facts" panel) as required by Section 403(q)(5)(F) and 21 CFR 101.36. Product is misbranded within the meaning of Section 403(i)(2) of the Act because the label fails to list each ingredient, specifically, the capsule ingredients, in the ingredient statement (21 CFR 101.4(a)(1)). The label fails to identify the product using the term "dietary supplement" as part of the statement of identity on the principal display panel (21 CFR 101.3(a) and (g)). The product fails to provide the appropriate "Disclaimer" in accordance with 21 CFR 101.93(a-e).
Grenera Nutrients
Date Published : 09/30/2010
16 Prakasam Street , Erode, IN-TN INDIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 09/30/2010
Desc:Yelixir Moringa capsules/extract aka Malunggay capsules or powder
Notes:The article appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required Nutrition information (e.g.; Nutrition Facts Panel)[Misbranded; Section 403(q)]; and The product is mis-branded under section 403(s)(2)(B) of the Act And 21 CFR 101.3(g). Statement of identity is insufficient.
Notes:The article appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required Nutrition information (e.g.; Nutrition Facts Panel)[Misbranded; Section 403(q)]; and The product is mis-branded under section 403(s)(2)(B) of the Act And 21 CFR 101.3(g). Statement of identity is insufficient.
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 09/30/2010
Desc:Yelixir Moringa capsules/extract aka Malunggay capsules or powder
Notes:;The article appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required Nutrition information (e.g.; Nutrition Facts Panel)[Misbranded; Section 403(q)]; and The product is mis-branded under section 403(s)(2)(B) of the Act And 21 CFR 101.3(g). Statement of identity is insufficient. ;
Notes:;The article appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required Nutrition information (e.g.; Nutrition Facts Panel)[Misbranded; Section 403(q)]; and The product is mis-branded under section 403(s)(2)(B) of the Act And 21 CFR 101.3(g). Statement of identity is insufficient. ;
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2010
Desc:Yelixir Moringa capsules/extract aka Malunggay capsules or powder
Notes:The article appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required Nutrition information (e.g.; Nutrition Facts Panel)[Misbranded; Section 403(q)]; and The product is mis-branded under section 403(s)(2)(B) of the Act And 21 CFR 101.3(g). Statement of identity is insufficient
Notes:The article appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required Nutrition information (e.g.; Nutrition Facts Panel)[Misbranded; Section 403(q)]; and The product is mis-branded under section 403(s)(2)(B) of the Act And 21 CFR 101.3(g). Statement of identity is insufficient
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2010
Desc:Yelixir Moringa capsules/extract aka Malunggay capsules or powder
Notes:The article appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required Nutrition information (e.g.; Nutrition Facts Panel)[Misbranded; Section 403(q)]; and The product is mis-branded under section 403(s)(2)(B) of the Act And 21 CFR 101.3(g). Statement of identity is insufficient. ;
Notes:The article appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required Nutrition information (e.g.; Nutrition Facts Panel)[Misbranded; Section 403(q)]; and The product is mis-branded under section 403(s)(2)(B) of the Act And 21 CFR 101.3(g). Statement of identity is insufficient. ;
INDO NISSAN FOODS LIMITED
Date Published : 09/16/2009
CENTENARY BUILDING 28 M.G. ROAD , Bangalore, Karnataka INDIA
04 C - - 07 Noodles, Instant
Date Published: 11/12/2009
Desc:Top Ramen Curry Noodles
Notes:Product is misbranded within the meaning of Section 403(i)(2) in that the label fails to bear required information as required in 21 CFR 101.4(a)(1); e.g. common or usual name of each ingredient; label fails to declare sodium as required in 21 CFR 101.9(g) in that the nutrient content is greater than 20% in excess of the declared value on the label. Product fails to declare iron are required by CFR 101.9(g)(4)(ii). 2/9/09
Notes:Product is misbranded within the meaning of Section 403(i)(2) in that the label fails to bear required information as required in 21 CFR 101.4(a)(1); e.g. common or usual name of each ingredient; label fails to declare sodium as required in 21 CFR 101.9(g) in that the nutrient content is greater than 20% in excess of the declared value on the label. Product fails to declare iron are required by CFR 101.9(g)(4)(ii). 2/9/09
NESTLE INDIA LTD. ( BICHOLIM FACTORY)
Date Published : 11/12/2009
Pb No.1 , Village Mauliguem (north) , BICHOLIM TALUKA, IN-GA INDIA
04 - - - -- Macaroni/Noodle Prod
Date Published: 11/12/2009
Desc:Maggi Noodles Masala with Tastemaker
Notes:Product is misbranded within the meaning of section 403 in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9 Also; product fails to declare the source of all the major food allergens present in this product; such as; a specific tree nut(s). Specifically; the ingredient list declares the ingredient ¿Hydrolysed groundnut protein¿ but does not identify the specific ¿nut¿ ingredient by its common or usual name. Also; the food is fabricated from two or more ingredients and the label fails to list the common or usual name of each ingredient. Specifically; the product fails to declare the common or usual name of the vegetable oil [see 21 CFR 101.4(b)(14)) and Mineral (170(i)); hydrolysed groundnut protein; edible starch; acidifying agent (330); Colour (150d); Flavour enhancers (627 & 631) and raising agent (500 (ii)) as required under 21 CFR 101.4 Also; the net quantity of contents is not declared as specified under 21 CFR 101.105. The statement of weight must be in terms of avoirdupois pound and ounce as specified under 21CFR 101.105(b)(1). Also; the food purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations but fails to conform to such definition and standard. Specifically; the product purports to be a ¿noodle" product; which is defined under 21CFR 139.150; but fails to contain any egg ingredient(s). Also; the label appears to bear a foreign language. We note that 21 CFR 101.15(c) states that if any representation is made on the label in a foreign language; all the required elements must be presented in the foreign language; in addition to the required English.
Notes:Product is misbranded within the meaning of section 403 in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9 Also; product fails to declare the source of all the major food allergens present in this product; such as; a specific tree nut(s). Specifically; the ingredient list declares the ingredient ¿Hydrolysed groundnut protein¿ but does not identify the specific ¿nut¿ ingredient by its common or usual name. Also; the food is fabricated from two or more ingredients and the label fails to list the common or usual name of each ingredient. Specifically; the product fails to declare the common or usual name of the vegetable oil [see 21 CFR 101.4(b)(14)) and Mineral (170(i)); hydrolysed groundnut protein; edible starch; acidifying agent (330); Colour (150d); Flavour enhancers (627 & 631) and raising agent (500 (ii)) as required under 21 CFR 101.4 Also; the net quantity of contents is not declared as specified under 21 CFR 101.105. The statement of weight must be in terms of avoirdupois pound and ounce as specified under 21CFR 101.105(b)(1). Also; the food purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations but fails to conform to such definition and standard. Specifically; the product purports to be a ¿noodle" product; which is defined under 21CFR 139.150; but fails to contain any egg ingredient(s). Also; the label appears to bear a foreign language. We note that 21 CFR 101.15(c) states that if any representation is made on the label in a foreign language; all the required elements must be presented in the foreign language; in addition to the required English.
Nestle India Limited - Moga Factory
Date Published : 11/12/2009
Pb No.11, , Ludhiana-ferozepur Road, , Moga, IN-PB INDIA
04 - - - -- Macaroni/Noodle Prod
Date Published: 11/12/2009
Desc:Maggi Noodles Masala with Tastemaker
Notes:Product is misbranded within the meaning of section 403 in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9 Also; product fails to declare the source of all the major food allergens present in this product; such as; a specific tree nut(s). Specifically; the ingredient list declares the ingredient ¿Hydrolysed groundnut protein¿ but does not identify the specific ¿nut¿ ingredient by its common or usual name. Also; the food is fabricated from two or more ingredients and the label fails to list the common or usual name of each ingredient. Specifically; the product fails to declare the common or usual name of the vegetable oil [see 21 CFR 101.4(b)(14)) and Mineral (170(i)); hydrolysed groundnut protein; edible starch; acidifying agent (330); Colour (150d); Flavour enhancers (627 & 631) and raising agent (500 (ii)) as required under 21 CFR 101.4 Also; the net quantity of contents is not declared as specified under 21 CFR 101.105. The statement of weight must be in terms of avoirdupois pound and ounce as specified under 21CFR 101.105(b)(1). Also; the food purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations but fails to conform to such definition and standard. Specifically; the product purports to be a ¿noodle" product; which is defined under 21CFR 139.150; but fails to contain any egg ingredient(s). Also; the label appears to bear a foreign language. We note that 21 CFR 101.15(c) states that if any representation is made on the label in a foreign language; all the required elements must be presented in the foreign language; in addition to the required English.
Notes:Product is misbranded within the meaning of section 403 in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9 Also; product fails to declare the source of all the major food allergens present in this product; such as; a specific tree nut(s). Specifically; the ingredient list declares the ingredient ¿Hydrolysed groundnut protein¿ but does not identify the specific ¿nut¿ ingredient by its common or usual name. Also; the food is fabricated from two or more ingredients and the label fails to list the common or usual name of each ingredient. Specifically; the product fails to declare the common or usual name of the vegetable oil [see 21 CFR 101.4(b)(14)) and Mineral (170(i)); hydrolysed groundnut protein; edible starch; acidifying agent (330); Colour (150d); Flavour enhancers (627 & 631) and raising agent (500 (ii)) as required under 21 CFR 101.4 Also; the net quantity of contents is not declared as specified under 21 CFR 101.105. The statement of weight must be in terms of avoirdupois pound and ounce as specified under 21CFR 101.105(b)(1). Also; the food purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations but fails to conform to such definition and standard. Specifically; the product purports to be a ¿noodle" product; which is defined under 21CFR 139.150; but fails to contain any egg ingredient(s). Also; the label appears to bear a foreign language. We note that 21 CFR 101.15(c) states that if any representation is made on the label in a foreign language; all the required elements must be presented in the foreign language; in addition to the required English.
Nestle India Ltd
Date Published : 11/12/2009
M 54 Connaught Circus , New Delhi, INDIA
04 - - - -- Macaroni/Noodle Prod
Date Published: 11/12/2009
Desc:Maggi Noodles Masala with Tastemaker
Notes:Product is misbranded within the meaning of section 403 in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9 Also; product fails to declare the source of all the major food allergens present in this product; such as; a specific tree nut(s). Specifically; the ingredient list declares the ingredient ¿Hydrolysed groundnut protein¿ but does not identify the specific ¿nut¿ ingredient by its common or usual name. Also; the food is fabricated from two or more ingredients and the label fails to list the common or usual name of each ingredient. Specifically; the product fails to declare the common or usual name of the vegetable oil [see 21 CFR 101.4(b)(14)) and Mineral (170(i)); hydrolysed groundnut protein; edible starch; acidifying agent (330); Colour (150d); Flavour enhancers (627 & 631) and raising agent (500 (ii)) as required under 21 CFR 101.4 Also; the net quantity of contents is not declared as specified under 21 CFR 101.105. The statement of weight must be in terms of avoirdupois pound and ounce as specified under 21CFR 101.105(b)(1). Also; the food purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations but fails to conform to such definition and standard. Specifically; the product purports to be a ¿noodle" product; which is defined under 21CFR 139.150; but fails to contain any egg ingredient(s). Also; the label appears to bear a foreign language. We note that 21 CFR 101.15(c) states that if any representation is made on the label in a foreign language; all the required elements must be presented in the foreign language; in addition to the required English.
Notes:Product is misbranded within the meaning of section 403 in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9 Also; product fails to declare the source of all the major food allergens present in this product; such as; a specific tree nut(s). Specifically; the ingredient list declares the ingredient ¿Hydrolysed groundnut protein¿ but does not identify the specific ¿nut¿ ingredient by its common or usual name. Also; the food is fabricated from two or more ingredients and the label fails to list the common or usual name of each ingredient. Specifically; the product fails to declare the common or usual name of the vegetable oil [see 21 CFR 101.4(b)(14)) and Mineral (170(i)); hydrolysed groundnut protein; edible starch; acidifying agent (330); Colour (150d); Flavour enhancers (627 & 631) and raising agent (500 (ii)) as required under 21 CFR 101.4 Also; the net quantity of contents is not declared as specified under 21 CFR 101.105. The statement of weight must be in terms of avoirdupois pound and ounce as specified under 21CFR 101.105(b)(1). Also; the food purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations but fails to conform to such definition and standard. Specifically; the product purports to be a ¿noodle" product; which is defined under 21CFR 139.150; but fails to contain any egg ingredient(s). Also; the label appears to bear a foreign language. We note that 21 CFR 101.15(c) states that if any representation is made on the label in a foreign language; all the required elements must be presented in the foreign language; in addition to the required English.
P. J. Exports
Date Published : 09/16/2009
PJ House - Z3, Shri Arihant Compound , Reti Bunder Road , Kalher, Maharashtra INDIA
04 C - - 07 Noodles, Instant
Date Published: 11/12/2009
Desc:Top Ramen Curry Noodles
Notes:Product is misbranded within the meaning of Section 403(i)(2) in that the label fails to bear required information as required in 21 CFR 101.4(a)(1); e.g. common or usual name of each ingredient; label fails to declare sodium as required in 21 CFR 101.9(g) in that the nutrient content is greater than 20% in excess of the declared value on the label. Product fails to declare iron are required by CFR 101.9(g)(4)(ii). 2/9/09
Notes:Product is misbranded within the meaning of Section 403(i)(2) in that the label fails to bear required information as required in 21 CFR 101.4(a)(1); e.g. common or usual name of each ingredient; label fails to declare sodium as required in 21 CFR 101.9(g) in that the nutrient content is greater than 20% in excess of the declared value on the label. Product fails to declare iron are required by CFR 101.9(g)(4)(ii). 2/9/09
Ruchi Worldwide Soy Industries Limited
Date Published : 09/16/2009
614 Chembur , Nariman Point , Mumbai, Maharashtra INDIA
02 Y - - 99 Milled Grain Products, N.E.C.
Date Published: 11/12/2009
Desc:Nutrela High Protein Soya Chunks
Notes:Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07
Notes:Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07
02 Y - - 99 Milled Grain Products, N.E.C.
Date Published: 11/12/2009
Desc:Nutrela High Protein Soya Granules
Notes:Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07
Notes:Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07
37 C - - 99 Food Pack Requir Mix/Cook, n.e.c.
Date Published: 11/12/2009
Desc:Nutrela High Protein Soya Granules
Notes:Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07
Notes:Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07
37 C - - 99 Food Pack Requir Mix/Cook, n.e.c.
Date Published: 11/12/2009
Desc:Nutrela High Protein Soya Chunks
Notes:Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07
Notes:Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07
Tastel
Date Published : 09/16/2009
2, Veena Vihar, Dayal Das Road , Vile Parle East , Mumbai, IN-MH INDIA
03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 11/12/2009
Desc:Vita Maria Gold Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 11/12/2009
Desc:Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04
03 H - - 01 Vanilla Plain Cookie,Biscuit and Wafer
Date Published: 11/12/2009
Desc:Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04
03 H - - 01 Vanilla Plain Cookie,Biscuit and Wafer
Date Published: 11/12/2009
Desc:Vita Maria Gold Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
03 H - - 02 Chocolate Plain Cookies,Biscuits and Wafers
Date Published: 11/12/2009
Desc:Good Day Choco-nut Biscuits
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06
03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 11/12/2009
Desc:Good Day Cashew Biscuits
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06
03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 11/12/2009
Desc:Good Day Choco-nut Biscuits
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06
03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 11/12/2009
Desc:Nice Time Sugar Showered Coconut Biscuits
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06
03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 11/12/2009
Desc:Vita Maria Gold Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 11/12/2009
Desc:Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 11/12/2009
Desc:Marie Gold Biscuits
Notes:Product is misbranded under Sec. 403(i)(2) in that the ingredient Statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; emulsifier (E471); dough conditioner (E223); antioxidant (INS319); and natural & synthetic food colours (E102; 124; 150) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06
Notes:Product is misbranded under Sec. 403(i)(2) in that the ingredient Statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; emulsifier (E471); dough conditioner (E223); antioxidant (INS319); and natural & synthetic food colours (E102; 124; 150) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 11/12/2009
Desc:Vita Maria Gold Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
Notes:Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 11/12/2009
Desc:Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04
Notes:Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 11/12/2009
Desc:50-50 Biscuits
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; dough conditioner (E223); acidity regulator (E330); improvers (E1100; 1101); antioxidant (INS319); and synthetic Food colours (E102; 124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06
Notes:Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; dough conditioner (E223); acidity regulator (E330); improvers (E1100; 1101); antioxidant (INS319); and synthetic Food colours (E102; 124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06
Tropicana World Trade Pvt Ltd.
Date Published : 09/16/2009
16/453 Thoppumpady Cochin , Kerala, INDIA
16 Y - - 03 Fish Paste, Fishery Products, n.e.c.
Date Published: 11/12/2009
Desc:Kerala Fish Curry Sauce
Notes:Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04
Notes:Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04
16 Y - - 09 Fish Sauce, Fishery Products, n.e.c.
Date Published: 11/12/2009
Desc:Kerala Fish Curry Sauce
Notes:Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04
Notes:Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04
16 Y - - 17 Sauce, seafood (n.e.c.), Fishery Products, n.e.c.
Date Published: 11/12/2009
Desc:Kerala Fish Curry Sauce
Notes:Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04
Notes:Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04
16 Y - - 99 Fishery Products, N.E.C.
Date Published: 11/12/2009
Desc:Kerala Fish Curry Sauce
Notes:Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04
Notes:Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04
37 J - - 05 Soy Sauce
Date Published: 11/12/2009
Desc:Kerala Fish Curry Sauce
Notes:Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04
Notes:Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04
37 J - - 23 Curry Sauce
Date Published: 11/12/2009
Desc:Kerala Fish Curry Sauce
Notes:Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04
Notes:Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04
37 J - - 99 Sauces, n.e.c.
Date Published: 11/12/2009
Desc:Kerala Fish Curry Sauce
Notes:Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04
Notes:Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04
INDONESIA
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
Date Published : 09/16/2009
JL. Raya Cimareme 131 Padalarang , Kab. Bandung Barat , BANDUNG, Id-Jk INDONESIA
21 T - - 05 Mango, Dried or Paste
Date Published: 11/12/2009
Desc:Mango Slice (Manisan Mangga)
Notes:Product is misbranded within the meaning of section 403(q) of the Act for failing to declare sodium as required by 21 CFR 101.9(c)(4) and trans fat as required by 21 CFR 101.9(c)(2)(ii). Also Vitamin A; Calcium and Iron are incorrectly declared as 0.1%; 0.2% or 1% rectively. 1/28/08
Notes:Product is misbranded within the meaning of section 403(q) of the Act for failing to declare sodium as required by 21 CFR 101.9(c)(4) and trans fat as required by 21 CFR 101.9(c)(2)(ii). Also Vitamin A; Calcium and Iron are incorrectly declared as 0.1%; 0.2% or 1% rectively. 1/28/08
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
Date Published : 09/16/2009
JL. Raya Cimareme 131 Padalarang , Kab. Bandung Barat , BANDUNG, Id-Jk INDONESIA
21 T - - 05 Mango, Dried or Paste
Date Published: 09/16/2009
Notes:Mango Slice (Manisan Mangga)
ISRAEL
Angel Bakeries
Date Published : 02/09/2012
1 Kaneif Nesharim Stpo Box 201 , Jerusalem, ISRAEL
03 J - - 06 Fruit Filled Filled/Iced Cookies,Biscuits and Wafers
Date Published: 02/09/2012
Desc:Strawberry Hamantashen
Notes:VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ;1.The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically;2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically;3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;
Notes:VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ;1.The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically;2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically;3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;
03 J - - 09 Fruit/Fruit Flavored Filled/Iced Cookies,Biscuits and Wafers
Date Published: 02/09/2012
Desc:Strawberry Hamantashen
Notes:VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ; 1. The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically; 2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically; 3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;
Notes:VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ; 1. The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically; 2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically; 3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;
Angel Confectionery Ltd
Date Published : 02/09/2012
Industrial Area , Beit Shemesh, ISRAEL
03 J - - 06 Fruit Filled Filled/Iced Cookies,Biscuits and Wafers
Date Published: 02/09/2012
Desc:Strawberry Hamantashen
Notes:VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ;1.The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically;2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically;3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;
Notes:VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ;1.The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically;2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically;3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;
03 J - - 09 Fruit/Fruit Flavored Filled/Iced Cookies,Biscuits and Wafers
Date Published: 02/09/2012
Desc:Strawberry Hamantashen
Notes:VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ; 1. The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically; 2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically; 3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;
Notes:VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ; 1. The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically; 2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically; 3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;
Arza Winery LTD
Date Published : 04/03/2012
15 Hacharuvit , Maale Adumim, IL-JM ISRAEL
20 D - - 99 Berry Juice, N.E.C. Berry Juice or Concentrates
Date Published: 04/03/2012
Desc:Grape Juice
Notes:Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the article purports to be a beverage containing fruit or vegetable juice and the label fails to bear a percent juice declaration as required by 21 CFR 101.30. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the product is false and misleading in that it bears a Natural claim but fails to meet the requirements to bear such claim. FDA has not established a regulatory definition for the term natural; however, the Agency has a long-standing policy that restricts the use of the term ¿natural¿ when a product is formulated with added color, synthetic substances, and flavors as stated in 21 CFR 101.22 (see 58 FR 2407 (January 6, 1993)). Among other things, this policy states that the term natural means that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food. This product appears to contain sulfur dioxide, which is listed in the ingredient statement as a preservative. Therefore, the product name can not include the term Natural. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] because the product label does not contain a complete name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
Notes:Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the article purports to be a beverage containing fruit or vegetable juice and the label fails to bear a percent juice declaration as required by 21 CFR 101.30. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the product is false and misleading in that it bears a Natural claim but fails to meet the requirements to bear such claim. FDA has not established a regulatory definition for the term natural; however, the Agency has a long-standing policy that restricts the use of the term ¿natural¿ when a product is formulated with added color, synthetic substances, and flavors as stated in 21 CFR 101.22 (see 58 FR 2407 (January 6, 1993)). Among other things, this policy states that the term natural means that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food. This product appears to contain sulfur dioxide, which is listed in the ingredient statement as a preservative. Therefore, the product name can not include the term Natural. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] because the product label does not contain a complete name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
Country Pie LTD.
Date Published : 08/22/2011
42 Uruguay St. , Jerusalem, IL-JM ISRAEL
03 N - - 01 Cake,Custard or Cream Filled
Date Published: 08/22/2011
Desc:Cakes (Black Forest Torte)
Notes:Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E- 415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;
Notes:Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E- 415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;
03 N - - 01 Cake,Custard or Cream Filled
Date Published: 01/18/2012
Desc:Cakes (Chocolate Party Cake)
Notes:VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).
Notes:VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).
03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 08/22/2011
Desc:Cakes (Black Forest Torte)
Notes:Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E-415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;
Notes:Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E-415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;
03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 01/18/2012
Desc:Cakes (Chocolate Party Cake)
Notes:VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).
Notes:VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).
Kapulsky
Date Published : 08/22/2011
P.O Box 8172 , Netanya, ISRAEL
03 N - - 01 Cake,Custard or Cream Filled
Date Published: 01/18/2012
Desc:Cakes Chocolate Party Cake
Notes:VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).
Notes:VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).
03 N - - 01 Cake,Custard or Cream Filled
Date Published: 08/22/2011
Desc:Cake (Black Forest Torte)
Notes:Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E- 415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;
Notes:Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E- 415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;
03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 01/18/2012
Desc:Cakes Chocolate Party Cake
Notes:VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).
Notes:VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).
03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 08/22/2011
Desc:Cakes (Black Forest Torte)
Notes:Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E-415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;
Notes:Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E-415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;
Materna Industries, Limited Partnership
Date Published : 09/16/2009
Kibbutz Maabarot , Maabarot, IL-NOTA ISRAEL
40 B - - -- Cereal (Baby)
Date Published: 01/06/2012
Desc:Infant Cereal
Notes:Notes;The label fails to bear nutritional information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9; The label fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. minerals; dietary fiber; and vitamins 403(i)(2). 2/5/07 MANUFACTURER; Materna Laboratorios Ltd; 11/12/09
Notes:Notes;The label fails to bear nutritional information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9; The label fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. minerals; dietary fiber; and vitamins 403(i)(2). 2/5/07 MANUFACTURER; Materna Laboratorios Ltd; 11/12/09
40 N - - 01 Milk Base
Date Published: 01/06/2012
Desc:Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.
40 N - - 99 Other Formula Products, N.E.C.
Date Published: 01/06/2012
Desc:Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.
40 O - - 01 Milk Base
Date Published: 01/06/2012
Desc:Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients; as required by 21 CFR 101.4.
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients; as required by 21 CFR 101.4.
40 O - - 99 Other Formula Products, N.E.C.
Date Published: 01/06/2012
Desc:Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients; as required by 21 CFR 101.4.
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients; as required by 21 CFR 101.4.
40 P - - 01 Milk Base
Date Published: 01/06/2012
Desc:Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.
40 P - - 99 Other Formula Products, N.E.C.
Date Published: 01/06/2012
Desc:Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.
40 Y - - 99 Baby and Junior Food N.E.C.
Date Published: 01/06/2012
Desc:Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.
41 G - - 01 Nutritionally Complete Formulations
Date Published: 01/06/2012
Desc:Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ? 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ? 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.
Materna Industries, Limited Partnership
Date Published : 09/16/2009
Kibbutz Maabarot , Maabarot, IL-NOTA ISRAEL
40 B - - -- Cereal (Baby)
Date Published: 11/12/2009
Desc:Infant cereal
Notes:The label fails to bear nutritional information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9; The label fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. minerals; dietary fiber; and vitamins 403(i)(2). 2/5/07 SHIPPER; Maabarot Products Ltd.
Notes:The label fails to bear nutritional information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9; The label fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. minerals; dietary fiber; and vitamins 403(i)(2). 2/5/07 SHIPPER; Maabarot Products Ltd.
41 G - - 01 Nutritionally Complete Formulations
Date Published: 01/05/2012
Desc:Materna Mehadrin Stage 3 Toddler Formula (1 yr and up)
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients; as required by 21 CFR 101.4.
Notes:VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients; as required by 21 CFR 101.4.
ITALY
I.R.C. William Di Carlo Srl
Date Published : 12/23/2009
Viale Del Lavoro 15 17 , Sulmona, AQ ITALY
34 C - - 02 Chocolate Candy Pieces, with Nuts or Nut Products (not Coconut)
Date Published: 12/23/2009
Notes:(Sugared Nuts)
Product is misbranded under Section 403(q) in that the labeling
(Nutrition Facts Panel) does not comply with nutritional labeling format
requirements (21 CFR 101.9(d)); does not list the net quantity of contents (21
CFR 101.105); and all required statements; such as the statement of identity
are not in both Italian and English (21 CFR 101.15(c))
NOTE; this product is also indicated for detention because its labeling fails
to declare the presence of the major food allergen
Spumador Spa
Date Published : 11/08/2012
Via Dordone 43vimodrone , Felegarafelegara, ITALY
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 11/08/2012
Desc:Venga Calorie Burn Orange Flavor
Notes:VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).
Notes:VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 11/08/2012
Desc:Venga Calorie Burn Cranberry Flavor
Notes:VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).
Notes:VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).
Spumador Spa
Date Published : 11/08/2012
Via Alla Fonte 13 , Cadorago, CO ITALY
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 11/08/2012
Desc:Venga Calorie Burn Orange Flavor
Notes:VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).
Notes:VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 11/08/2012
Desc:Venga Calorie Burn Cranberry Flavor
Notes:VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).
Notes:VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).
JAPAN
DR.BAELTZ CO.,LTD
Date Published : 08/29/2012
SENSUI 2-3-23 , ASAKA, JP-11 JAPAN
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/29/2012
Desc:Puerafica Anti-Aging Supplement
Notes:VIOLATION (IN NOTES): 1. 403(q) ; 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] because the label fails to bear nutrition labeling (Supplement Facts panel) in the proper format, which is required under 21 CFR 101.36. For example: The caloric content is expressed in kcal rather than Calories. The Percent Daily Value for dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) are not declared. Specifically, the product does not list the percent daily values for Vitamin A, Vitamin C, Vitamin D, Vitamin E, thiamin(Vitamin B1), niacin (Vitamin B3), folate (folic acid), Vitamin B12, pantothenic acid as required by 21 CFR 101.36(b)(2)(iii). The quantitative amount by weight per serving for each dietary ingredient are not declared as required by 21 CFR 101.36(b)(2) and 101.36(b)(3). The correct nomenclature for some of the dietary ingredients is not declared, as required by 21 CFR 101.36(b)(2)(B). For example, niacin is incorrectly listed as nicotinamide. The dietary ingredients are not listed in the proper order. Specifically, Vitamin B6, Vitamin E, sodium, Vitamin C, niacin, pantothenic acid, thiamin, folic acid, Vitamin B12, Vitamin A, and Vitamin Dare not in the correct order, as required by 21 CFR 10 1.36(b )(2)(i)(B).
Notes:VIOLATION (IN NOTES): 1. 403(q) ; 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] because the label fails to bear nutrition labeling (Supplement Facts panel) in the proper format, which is required under 21 CFR 101.36. For example: The caloric content is expressed in kcal rather than Calories. The Percent Daily Value for dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) are not declared. Specifically, the product does not list the percent daily values for Vitamin A, Vitamin C, Vitamin D, Vitamin E, thiamin(Vitamin B1), niacin (Vitamin B3), folate (folic acid), Vitamin B12, pantothenic acid as required by 21 CFR 101.36(b)(2)(iii). The quantitative amount by weight per serving for each dietary ingredient are not declared as required by 21 CFR 101.36(b)(2) and 101.36(b)(3). The correct nomenclature for some of the dietary ingredients is not declared, as required by 21 CFR 101.36(b)(2)(B). For example, niacin is incorrectly listed as nicotinamide. The dietary ingredients are not listed in the proper order. Specifically, Vitamin B6, Vitamin E, sodium, Vitamin C, niacin, pantothenic acid, thiamin, folic acid, Vitamin B12, Vitamin A, and Vitamin Dare not in the correct order, as required by 21 CFR 10 1.36(b )(2)(i)(B).
KOREA, REPUBLIC OF (SOUTH)
CHEONGJUNGNARU FOOD
Date Published : 09/16/2009
316-1 SONGDAE-RI OCHANG-MYEON , CHEONGWON-GUN CHUNGBUK PROVINCE , Chungcheongbukdo, KR-43 KOREA, REPUBLIC OF (SOUTH)
16 E - - 02 Clams
Date Published: 11/12/2009
Desc:Salted Clams; Frozen
Notes:Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d). 3/4/08
Notes:Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d). 3/4/08
16 E - - 03 Oysters
Date Published: 11/12/2009
Desc:Salted Seasoned Oyster; Frozen
Notes:Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d) 3/4/08 NOTE; The oyster product is also indicated for detention in that the ingredient statement declares ingredients not found in the product per the manufacturing process statement [Section 403(a)(1)]. The label declares Millet Jelly; Garlic; and Ginger; but Salt and Red Pepper Powder are the only ingredients added in the manufacturing statement.
Notes:Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d) 3/4/08 NOTE; The oyster product is also indicated for detention in that the ingredient statement declares ingredients not found in the product per the manufacturing process statement [Section 403(a)(1)]. The label declares Millet Jelly; Garlic; and Ginger; but Salt and Red Pepper Powder are the only ingredients added in the manufacturing statement.
16 X - - 30 Clams, Aquaculture Harvested Fishery/Seafood Products
Date Published: 11/12/2009
Desc:Salted Clams; Frozen
Notes:Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d). 3/4/08
Notes:Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d). 3/4/08
16 X - - 32 Oysters, Aquaculture Harvested Fishery/Seafood Products
Date Published: 11/12/2009
Desc:Salted Seasoned Oyster; Frozen
Notes:Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d) 3/4/08 NOTE; The oyster product is also indicated for detention in that the ingredient statement declares ingredients not found in the product per the manufacturing process statement [Section 403(a)(1)]. The label declares Millet Jelly; Garlic; and Ginger; but Salt and Red Pepper Powder are the only ingredients added in the manufacturing statement.
Notes:Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d) 3/4/08 NOTE; The oyster product is also indicated for detention in that the ingredient statement declares ingredients not found in the product per the manufacturing process statement [Section 403(a)(1)]. The label declares Millet Jelly; Garlic; and Ginger; but Salt and Red Pepper Powder are the only ingredients added in the manufacturing statement.
HAITAI CONFECTIONERY @FOODS CO., LTD
Date Published : 12/08/2010
15/F., SANHAK FOUNDATION BLDG., , 1337-31, SEOCHO-DONG, SEOCHO-GU, , Seoul, SEOUL KOREA, REPUBLIC OF (SOUTH)
03 F - - 02 Flavored or Party Crackers
Date Published: 12/08/2010
Desc:Almond Crackers
Notes:VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Label format does not meet the following requirements, as specified in 21 CFR 101.9. Specifically, the serving size is not expressed as a common household measure (21 CFR 101.9(b)(7)), the percent of calories from fat is not provided (21 CFR 101.9(c)(1)(ii)), the heading "Amount per Serving" is not provided (21 CFR 101.9(d)(4)), the amounts of vitamins and minerals are not expressed only as percent of Daily Value in accordance with 21 CFR 101.9(c)(8)), and the quantitative amounts of the nutrients and the percent Daily Values are not rounded in accordance with the requirements in 21 CFR 101.9(c). In addition, the article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) because the required name and place of business are not provided, as required by 21 CFR 101.5.
Notes:VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Label format does not meet the following requirements, as specified in 21 CFR 101.9. Specifically, the serving size is not expressed as a common household measure (21 CFR 101.9(b)(7)), the percent of calories from fat is not provided (21 CFR 101.9(c)(1)(ii)), the heading "Amount per Serving" is not provided (21 CFR 101.9(d)(4)), the amounts of vitamins and minerals are not expressed only as percent of Daily Value in accordance with 21 CFR 101.9(c)(8)), and the quantitative amounts of the nutrients and the percent Daily Values are not rounded in accordance with the requirements in 21 CFR 101.9(c). In addition, the article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) because the required name and place of business are not provided, as required by 21 CFR 101.5.
03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 12/08/2010
Desc:Almond Crackers
Notes:VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Label format does not meet the following requirements, as specified in 21 CFR 101.9. Specifically, the serving size is not expressed as a common household measure (21 CFR 101.9(b)(7)), the percent of calories from fat is not provided (21 CFR 101.9(c)(1)(ii)), the heading "Amount per Serving" is not provided (21 CFR 101.9(d)(4)), the amounts of vitamins and minerals are not expressed only as percent of Daily Value in accordance with 21 CFR 101.9(c)(8)), and the quantitative amounts of the nutrients and the percent Daily Values are not rounded in accordance with the requirements in 21 CFR 101.9(c). In addition, the article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) because the required name and place of business are not provided, as required by 21 CFR 101.5.
Notes:VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Label format does not meet the following requirements, as specified in 21 CFR 101.9. Specifically, the serving size is not expressed as a common household measure (21 CFR 101.9(b)(7)), the percent of calories from fat is not provided (21 CFR 101.9(c)(1)(ii)), the heading "Amount per Serving" is not provided (21 CFR 101.9(d)(4)), the amounts of vitamins and minerals are not expressed only as percent of Daily Value in accordance with 21 CFR 101.9(c)(8)), and the quantitative amounts of the nutrients and the percent Daily Values are not rounded in accordance with the requirements in 21 CFR 101.9(c). In addition, the article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) because the required name and place of business are not provided, as required by 21 CFR 101.5.
MALAYSIA
COCOALAND INDUSTRY SDN BHD (203054-X)
Date Published : 06/08/2012
LOT 100, RAWANG INTERGRATED IND PARK, , 48000 RAWANG, , Sleangor, Selangor MALAYSIA
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 06/08/2012
Desc:Herbal Candy Super Mint
Notes:VIOLATION (IN NOTES): 1. 403(q) ; 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded under section 403(q) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the nutrition information on the labels are provided in a format not consistent with the requirements under 21 CFR 101.9. Specifically, the nutrients are not listed in order as specified under 21 CFR 101.9 (c) and that ¿Calories¿ is not declared as required under 21 CFR 101.9(c)(1). Also, the %DVs are not declared under 21 CFR 101.9(d)(7)(ii). The nutrition information does not meet the formatting requirements under 21 CFR 101.9(d)(1)(i), which states, in part, that the nutrition must be printed on a white or other neutral contrasting background whenever practical. 2. The article is subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded under sections 403 (i)(2) of the Act, in that ingredient statement does not correctly label the ¿Flavour & Flavouring¿ ingredient in accordance with 21 CFR 101.22.
Notes:VIOLATION (IN NOTES): 1. 403(q) ; 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded under section 403(q) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the nutrition information on the labels are provided in a format not consistent with the requirements under 21 CFR 101.9. Specifically, the nutrients are not listed in order as specified under 21 CFR 101.9 (c) and that ¿Calories¿ is not declared as required under 21 CFR 101.9(c)(1). Also, the %DVs are not declared under 21 CFR 101.9(d)(7)(ii). The nutrition information does not meet the formatting requirements under 21 CFR 101.9(d)(1)(i), which states, in part, that the nutrition must be printed on a white or other neutral contrasting background whenever practical. 2. The article is subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded under sections 403 (i)(2) of the Act, in that ingredient statement does not correctly label the ¿Flavour & Flavouring¿ ingredient in accordance with 21 CFR 101.22.
Thomyam Food Industries Private Limited(Sdn.Bhd.)
Date Published : 09/16/2009
Lot 76 No Industria Estate Jalan Semambu , Kuantan, Pahang MALAYSIA
35 D - - 99 Pudding (Pie Filling) Mix, N.E.C. (Not Custard)
Date Published: 11/12/2009
Desc:Dragonfly Brand Mango Pudding
Notes:Product is misbranded under 403(i)(2) in that the label fails to declare all ingredients in the ingredient statement by their common or usual name as required by 21CFR101.4. Specifically; sodium caseinate. Also; Product is misbranded under 403(q) in that the label does not comply with the labeling requirements in 21CFR101.9. Specifically; the label does not list trans fat and the format of the nutrition information is incorrect. Product is further misbranded under 403(q)in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3). 5/4/07
Notes:Product is misbranded under 403(i)(2) in that the label fails to declare all ingredients in the ingredient statement by their common or usual name as required by 21CFR101.4. Specifically; sodium caseinate. Also; Product is misbranded under 403(q) in that the label does not comply with the labeling requirements in 21CFR101.9. Specifically; the label does not list trans fat and the format of the nutrition information is incorrect. Product is further misbranded under 403(q)in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3). 5/4/07
35 D - - 99 Pudding (Pie Filling) Mix, N.E.C. (Not Custard)
Date Published: 11/12/2009
Desc:Dragonfly Brand Mini Pudding Tropical Fruit
Notes:Product is misbranded under 403(i)(2) in that the label fails to declare all ingredients in the ingredient statement as required by 21CFR101.4. Specifically; sodium caseinate. Also; the product is misbranded under 403(q) in that the format for the nutrition facts label does not comply with 21CFR101.9. Product is further misbranded under 403(q) in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3) 5/4/07
Notes:Product is misbranded under 403(i)(2) in that the label fails to declare all ingredients in the ingredient statement as required by 21CFR101.4. Specifically; sodium caseinate. Also; the product is misbranded under 403(q) in that the format for the nutrition facts label does not comply with 21CFR101.9. Product is further misbranded under 403(q) in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3) 5/4/07
35 D - - 99 Pudding (Pie Filling) Mix, N.E.C. (Not Custard)
Date Published: 11/12/2009
Desc:Dragonfly Brand Assorted Pudding
Notes:Product is misbranded under 403(i)(2) in that the listing of sodium caseinate as a sub-ingredient of the non-dairy creamer does not include a parenthetical term such as ?a milk derivative? as required by 21CFR101.4(d) Also; Product is misbranded under 403(q) in that the label does not comply with the labeling requirements in 21CFR101.9. Specifically; the label does not list trans fat and the format of the nutrition information is incorrect. Product is further misbranded under 403(q)in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3). 5/4/07
Notes:Product is misbranded under 403(i)(2) in that the listing of sodium caseinate as a sub-ingredient of the non-dairy creamer does not include a parenthetical term such as ?a milk derivative? as required by 21CFR101.4(d) Also; Product is misbranded under 403(q) in that the label does not comply with the labeling requirements in 21CFR101.9. Specifically; the label does not list trans fat and the format of the nutrition information is incorrect. Product is further misbranded under 403(q)in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3). 5/4/07
35 D - - 99 Pudding (Pie Filling) Mix, N.E.C. (Not Custard)
Date Published: 11/12/2009
Desc:Dragonfly Brand Pandan Flavor Pudding
Notes:Product is misbranded under 403(i)(2) in that the label fails to declare all ingredients in the ingredient statement by their common of usual names required by 21CFR101.4. Specifically; sodium caseinate. Also; product is misbranded under 403(q) in that the label does not comply with the labeling requirements in 21CFR101.9. Specifically; the label does not list trans fat and the format of the nutrition information is incorrect. Product is further misbranded under 403(q)in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3) 5/5/07
Notes:Product is misbranded under 403(i)(2) in that the label fails to declare all ingredients in the ingredient statement by their common of usual names required by 21CFR101.4. Specifically; sodium caseinate. Also; product is misbranded under 403(q) in that the label does not comply with the labeling requirements in 21CFR101.9. Specifically; the label does not list trans fat and the format of the nutrition information is incorrect. Product is further misbranded under 403(q)in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3) 5/5/07
MEXICO
API-ROYAL, S.A DE CV
Date Published : 09/16/2009
Calle 7a #237 Altos Col. San Luis , San Luis Potosi, MX-SLP MEXICO
30 J - - -- Imit Flav Beverage Base
Date Published: 11/12/2009
Desc:Ultra Manzana Lax powder (powder drink mix)
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06
30 J - - -- Imit Flav Beverage Base
Date Published: 11/12/2009
Desc:Linzaa powder (powder drink mix)
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
30 J - - -- Imit Flav Beverage Base
Date Published: 11/12/2009
Desc:Ultra Pina Linzaa (powder drink mix)
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
30 Y - - -- Beverage Base N.E.C.
Date Published: 11/12/2009
Desc:Linzaa powder (powder drink mix)
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
30 Y - - -- Beverage Base N.E.C.
Date Published: 11/12/2009
Desc:Ultra Manzana Lax powder (powder drink mix)
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06
30 Y - - -- Beverage Base N.E.C.
Date Published: 11/12/2009
Desc:Ultra Pina Linzaa (powder drink mix)
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
54 I - - 99 Fiber, N.E.C.
Date Published: 11/12/2009
Desc:Linzaa powder (powder drink mix)
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
54 I - - 99 Fiber, N.E.C.
Date Published: 11/12/2009
Desc:Ultra Pina Linzaa (powder drink mix)
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
54 I - - 99 Fiber, N.E.C.
Date Published: 11/12/2009
Desc:Ultra Manzana Lax powder (powder drink mix)
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/12/2009
Desc:Ultra Manzana Lax powder (powder drink mix)
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/12/2009
Desc:Ultra Pina Linzaa (powder drink mix)
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/12/2009
Desc:Linzaa powder (powder drink mix)
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
Notes:The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06
Agrojugos, S.A. De C.V.
Date Published : 12/17/2012
Km. 15 Carretera A Bahia Kinc , Hermosillo, Sonora, MEXICO
24 T - - 99 Leaf & Stem Vegetables, N.E.C.
Date Published: 12/17/2012
Desc:Spicy Dried Cactus (Nopalitos Deshidratados)
Notes:VIOLATION: This product is misbranded within the meaning of 403(q). The statement of the number of grams of Trans Fat is not declared as required by section 21 CFR 101.9(c)(2)(ii). The Serving Size shall be expressed in common household measure and shall be followed by the equivalent metric quantity in parenthesis (fluids in milliliters) 21 CFR 101.9(b)(7)
Notes:VIOLATION: This product is misbranded within the meaning of 403(q). The statement of the number of grams of Trans Fat is not declared as required by section 21 CFR 101.9(c)(2)(ii). The Serving Size shall be expressed in common household measure and shall be followed by the equivalent metric quantity in parenthesis (fluids in milliliters) 21 CFR 101.9(b)(7)
Aide concepcion ruiz mtz
Date Published : 02/06/2013
Morlos #33-C San Jeronimo Tlacochahuaya , Oaxaca, Mexico C.P. MEXICO
03 Y - - 09 Tortillas
Date Published: 02/06/2013
Desc:Handmade Tortillas
Notes:VIOLATION (IN NOTES); 1. 403(i)(2) 1. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded under Section 403(i)(2) of the Act because the food is fabricated from two or more ingredients; and the product label does not bear a list of ingredients
Notes:VIOLATION (IN NOTES); 1. 403(i)(2) 1. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded under Section 403(i)(2) of the Act because the food is fabricated from two or more ingredients; and the product label does not bear a list of ingredients
BARQUILLOS LUPITA, S.A. DE C.V.
Date Published : 12/08/2010
Emilio Madero# 7 , COL. STA . ACATITLA , MEXICO, MX-DIF MEXICO
33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)
Date Published: 12/08/2010
Desc:Marshmallows
Notes:VIOLATION; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) because the Principle Display Panel (PDP) and ingredients statement appear to bear nutrient content claims. Specifically the PDP declares ?adicionado con vitamina A; fibra? which means ?added with vitamins and fiber? and ?added with vitamin A; fiber? respectively. The term ?added? when used to describe the level of a nutrient is a nutrient content claim synonymous for ?more?. The regulation that defines ?more? [21 CFR 101.54(e)] requires that the food contain at least 10 percent or more of the Recommended Daily Intake (RDI) for vitamins or minerals or of the Daily Reference Value (DRV) for protein; dietary fiber; or potassium per reference amount customarily consumed than an appropriate reference food. The product?s nutrition label fails to declare any vitamins or dietary fiber in order to determine if the product meets the claim. Therefore; the product fails to meet the conditions of the nutrient content claims and appears to be misbrand the product within the meaning of 403(r)(1)(A).
Notes:VIOLATION; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) because the Principle Display Panel (PDP) and ingredients statement appear to bear nutrient content claims. Specifically the PDP declares ?adicionado con vitamina A; fibra? which means ?added with vitamins and fiber? and ?added with vitamin A; fiber? respectively. The term ?added? when used to describe the level of a nutrient is a nutrient content claim synonymous for ?more?. The regulation that defines ?more? [21 CFR 101.54(e)] requires that the food contain at least 10 percent or more of the Recommended Daily Intake (RDI) for vitamins or minerals or of the Daily Reference Value (DRV) for protein; dietary fiber; or potassium per reference amount customarily consumed than an appropriate reference food. The product?s nutrition label fails to declare any vitamins or dietary fiber in order to determine if the product meets the claim. Therefore; the product fails to meet the conditions of the nutrient content claims and appears to be misbrand the product within the meaning of 403(r)(1)(A).
33 L - - 09 Marshmallow Candy, Soft, without Nuts and Fruit (without Chocolate)
Date Published: 12/08/2010
Desc:Marshmallows
Notes:VIOLATION; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) because the Principle Display Panel (PDP) and ingredients statement appear to bear nutrient content claims. Specifically the PDP declares ?adicionado con vitamina A; fibra? which means ?added with vitamins and fiber? and ?added with vitamin A; fiber? respectively. The term ?added? when used to describe the level of a nutrient is a nutrient content claim synonymous for ?more?. The regulation that defines ?more? [21 CFR 101.54(e)] requires that the food contain at least 10 percent or more of the Recommended Daily Intake (RDI) for vitamins or minerals or of the Daily Reference Value (DRV) for protein; dietary fiber; or potassium per reference amount customarily consumed than an appropriate reference food. The product?s nutrition label fails to declare any vitamins or dietary fiber in order to determine if the product meets the claim. Therefore; the product fails to meet the conditions of the nutrient content claims and appears to be misbrand the product within the meaning of 403(r)(1)(A).
Notes:VIOLATION; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) because the Principle Display Panel (PDP) and ingredients statement appear to bear nutrient content claims. Specifically the PDP declares ?adicionado con vitamina A; fibra? which means ?added with vitamins and fiber? and ?added with vitamin A; fiber? respectively. The term ?added? when used to describe the level of a nutrient is a nutrient content claim synonymous for ?more?. The regulation that defines ?more? [21 CFR 101.54(e)] requires that the food contain at least 10 percent or more of the Recommended Daily Intake (RDI) for vitamins or minerals or of the Daily Reference Value (DRV) for protein; dietary fiber; or potassium per reference amount customarily consumed than an appropriate reference food. The product?s nutrition label fails to declare any vitamins or dietary fiber in order to determine if the product meets the claim. Therefore; the product fails to meet the conditions of the nutrient content claims and appears to be misbrand the product within the meaning of 403(r)(1)(A).
33 T - - 99 Toppings without Fruit, Nuts or Chocolate N.E.C.
Date Published: 12/08/2010
Desc:Marshmallows
Notes:VIOLATION; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) because the Principle Display Panel (PDP) and ingredients statement appear to bear nutrient content claims. Specifically the PDP declares ?adicionado con vitamina A; fibra? which means ?added with vitamins and fiber? and ?added with vitamin A; fiber? respectively. The term ?added? when used to describe the level of a nutrient is a nutrient content claim synonymous for ?more?. The regulation that defines ?more? [21 CFR 101.54(e)] requires that the food contain at least 10 percent or more of the Recommended Daily Intake (RDI) for vitamins or minerals or of the Daily Reference Value (DRV) for protein; dietary fiber; or potassium per reference amount customarily consumed than an appropriate reference food. The product?s nutrition label fails to declare any vitamins or dietary fiber in order to determine if the product meets the claim. Therefore; the product fails to meet the conditions of the nutrient content claims and appears to be misbrand the product within the meaning of 403(r)(1)(A).
Notes:VIOLATION; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) because the Principle Display Panel (PDP) and ingredients statement appear to bear nutrient content claims. Specifically the PDP declares ?adicionado con vitamina A; fibra? which means ?added with vitamins and fiber? and ?added with vitamin A; fiber? respectively. The term ?added? when used to describe the level of a nutrient is a nutrient content claim synonymous for ?more?. The regulation that defines ?more? [21 CFR 101.54(e)] requires that the food contain at least 10 percent or more of the Recommended Daily Intake (RDI) for vitamins or minerals or of the Daily Reference Value (DRV) for protein; dietary fiber; or potassium per reference amount customarily consumed than an appropriate reference food. The product?s nutrition label fails to declare any vitamins or dietary fiber in order to determine if the product meets the claim. Therefore; the product fails to meet the conditions of the nutrient content claims and appears to be misbrand the product within the meaning of 403(r)(1)(A).
Barquillos Lupita S.A. de C.V.
Date Published : 12/07/2010
Emilio Madero #7 , Col. Santa Martha Acatitlan , Mexico, MX-DIF MEXICO
33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)
Date Published: 12/07/2010
Desc:Marshmallows
Notes:VIOLATION: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) because the Principle Display Panel (PDP) and ingredients statement appear to bear nutrient content claims. Specifically the PDP declares ¿adicionado con vitamina A, fibra¿ which means ¿added with vitamins and fiber¿ and ¿added with vitamin A, fiber¿ respectively. The term ¿added¿ when used to describe the level of a nutrient is a nutrient content claim synonymous for ¿more¿. The regulation that defines ¿more¿ [21 CFR 101.54(e)] requires that the food contain at least 10 percent or more of the Recommended Daily Intake (RDI) for vitamins or minerals or of the Daily Reference Value (DRV) for protein, dietary fiber, or potassium per reference amount customarily consumed than an appropriate reference food. The product¿s nutrition label fails to declare any vitamins or dietary fiber in order to determine if the product meets the claim. Therefore, the product fails to meet the conditions of the nutrient content claims and appears to be misbrand the product within the meaning of 403(r)(1)(A).
Notes:VIOLATION: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) because the Principle Display Panel (PDP) and ingredients statement appear to bear nutrient content claims. Specifically the PDP declares ¿adicionado con vitamina A, fibra¿ which means ¿added with vitamins and fiber¿ and ¿added with vitamin A, fiber¿ respectively. The term ¿added¿ when used to describe the level of a nutrient is a nutrient content claim synonymous for ¿more¿. The regulation that defines ¿more¿ [21 CFR 101.54(e)] requires that the food contain at least 10 percent or more of the Recommended Daily Intake (RDI) for vitamins or minerals or of the Daily Reference Value (DRV) for protein, dietary fiber, or potassium per reference amount customarily consumed than an appropriate reference food. The product¿s nutrition label fails to declare any vitamins or dietary fiber in order to determine if the product meets the claim. Therefore, the product fails to meet the conditions of the nutrient content claims and appears to be misbrand the product within the meaning of 403(r)(1)(A).
33 L - - 08 Licorice Candy, Soft, without Nuts and Fruit (without Chocolate)
Date Published: 12/07/2010
Desc:Marshmallows
Notes:VIOLATION: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) because the Principle Display Panel (PDP) and ingredients statement appear to bear nutrient content claims. Specifically the PDP declares ¿adicionado con vitamina A, fibra¿ which means ¿added with vitamins and fiber¿ and ¿added with vitamin A, fiber¿ respectively. The term ¿added¿ when used to describe the level of a nutrient is a nutrient content claim synonymous for ¿more¿. The regulation that defines ¿more¿ [21 CFR 101.54(e)] requires that the food contain at least 10 percent or more of the Recommended Daily Intake (RDI) for vitamins or minerals or of the Daily Reference Value (DRV) for protein, dietary fiber, or potassium per reference amount customarily consumed than an appropriate reference food. The product¿s nutrition label fails to declare any vitamins or dietary fiber in order to determine if the product meets the claim. Therefore, the product fails to meet the conditions of the nutrient content claims and appears to be misbrand the product within the meaning of 403(r)(1)(A).
Notes:VIOLATION: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) because the Principle Display Panel (PDP) and ingredients statement appear to bear nutrient content claims. Specifically the PDP declares ¿adicionado con vitamina A, fibra¿ which means ¿added with vitamins and fiber¿ and ¿added with vitamin A, fiber¿ respectively. The term ¿added¿ when used to describe the level of a nutrient is a nutrient content claim synonymous for ¿more¿. The regulation that defines ¿more¿ [21 CFR 101.54(e)] requires that the food contain at least 10 percent or more of the Recommended Daily Intake (RDI) for vitamins or minerals or of the Daily Reference Value (DRV) for protein, dietary fiber, or potassium per reference amount customarily consumed than an appropriate reference food. The product¿s nutrition label fails to declare any vitamins or dietary fiber in order to determine if the product meets the claim. Therefore, the product fails to meet the conditions of the nutrient content claims and appears to be misbrand the product within the meaning of 403(r)(1)(A).
33 T - - 99 Toppings without Fruit, Nuts or Chocolate N.E.C.
Date Published: 12/07/2010
Desc:Marshmallows
Notes:VIOLATION: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) because the Principle Display Panel (PDP) and ingredients statement appear to bear nutrient content claims. Specifically the PDP declares ¿adicionado con vitamina A, fibra¿ which means ¿added with vitamins and fiber¿ and ¿added with vitamin A, fiber¿ respectively. The term ¿added¿ when used to describe the level of a nutrient is a nutrient content claim synonymous for ¿more¿. The regulation that defines ¿more¿ [21 CFR 101.54(e)] requires that the food contain at least 10 percent or more of the Recommended Daily Intake (RDI) for vitamins or minerals or of the Daily Reference Value (DRV) for protein, dietary fiber, or potassium per reference amount customarily consumed than an appropriate reference food. The product¿s nutrition label fails to declare any vitamins or dietary fiber in order to determine if the product meets the claim. Therefore, the product fails to meet the conditions of the nutrient content claims and appears to be misbrand the product within the meaning of 403(r)(1)(A).
Notes:VIOLATION: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) because the Principle Display Panel (PDP) and ingredients statement appear to bear nutrient content claims. Specifically the PDP declares ¿adicionado con vitamina A, fibra¿ which means ¿added with vitamins and fiber¿ and ¿added with vitamin A, fiber¿ respectively. The term ¿added¿ when used to describe the level of a nutrient is a nutrient content claim synonymous for ¿more¿. The regulation that defines ¿more¿ [21 CFR 101.54(e)] requires that the food contain at least 10 percent or more of the Recommended Daily Intake (RDI) for vitamins or minerals or of the Daily Reference Value (DRV) for protein, dietary fiber, or potassium per reference amount customarily consumed than an appropriate reference food. The product¿s nutrition label fails to declare any vitamins or dietary fiber in order to determine if the product meets the claim. Therefore, the product fails to meet the conditions of the nutrient content claims and appears to be misbrand the product within the meaning of 403(r)(1)(A).
CANAS Y PILONCILLOS DE NAYARTI SPR DE RL
Date Published : 09/16/2009
CAMINO UZETA-AMATLAN DE CANAS KM 1.5 , UZETA, MX-NAY MEXICO
36 A - - 02 Brown Sugar (Sucrose from Cane)
Date Published: 11/12/2009
Desc:Brown Sugar
Notes:The product is misbranded in that the label or labeling fails to bear the required nutrition information as required by 403(q) of the FD&C Act and 21 101.9. 3/7/07
Notes:The product is misbranded in that the label or labeling fails to bear the required nutrition information as required by 403(q) of the FD&C Act and 21 101.9. 3/7/07
36 A - - 03 Cane Sugar (Sucrose)
Date Published: 11/12/2009
Desc:Brown Sugar
Notes:The product is misbranded in that the label or labeling fails to bear the required nutrition information as required by 403(q) of the FD&C Act and 21 101.9. 3/7/07
Notes:The product is misbranded in that the label or labeling fails to bear the required nutrition information as required by 403(q) of the FD&C Act and 21 101.9. 3/7/07
36 A - - 99 Sugar Products, N.E.C.
Date Published: 11/12/2009
Desc:Brown Sugar
Notes:The product is misbranded in that the label or labeling fails to bear the required nutrition information as required by 403(q) of the FD&C Act and 21 101.9. 3/7/07
Notes:The product is misbranded in that the label or labeling fails to bear the required nutrition information as required by 403(q) of the FD&C Act and 21 101.9. 3/7/07
Canas Y Piloncillos de Nayarit SPR de RL
Date Published : 09/16/2009
Camino Uzeta-Amatlan de Canas KM 1.5 UZ , Municipio de Ahuacatlan , Nayarit, MX-NAY MEXICO
36 A - - 02 Brown Sugar (Sucrose from Cane)
Date Published: 11/12/2009
Desc:Brown Sugar
Notes:The product is misbranded in that the label or labeling fails to bear the required nutrition information as required by 403(q) of the FD&C Act and 21 101.9. 3/7/07
Notes:The product is misbranded in that the label or labeling fails to bear the required nutrition information as required by 403(q) of the FD&C Act and 21 101.9. 3/7/07
36 A - - 03 Cane Sugar (Sucrose)
Date Published: 11/12/2009
Desc:Brown Sugar
Notes:The product is misbranded in that the label or labeling fails to bear the required nutrition information as required by 403(q) of the FD&C Act and 21 101.9. 3/7/07
Notes:The product is misbranded in that the label or labeling fails to bear the required nutrition information as required by 403(q) of the FD&C Act and 21 101.9. 3/7/07
36 A - - 99 Sugar Products, N.E.C.
Date Published: 11/12/2009
Desc:Brown Sugar
Notes:The product is misbranded in that the label or labeling fails to bear the required nutrition information as required by 403(q) of the FD&C Act and 21 101.9. 3/7/07
Notes:The product is misbranded in that the label or labeling fails to bear the required nutrition information as required by 403(q) of the FD&C Act and 21 101.9. 3/7/07
Cereales Y Semillas Hernandez
Date Published : 09/16/2009
Chicalote #2622, Mercado De Abastos , Guadalajara, MX-JAL MEXICO
36 A - - 02 Brown Sugar (Sucrose from Cane)
Date Published: 11/12/2009
Desc:Brown Sugar
Notes:Product is misbranded under Section 403(a)(1) in that it does meet the label declaration for calcium; Product is further misbranded in that the nutrition label does not comply with format requirements in 21 CFR 101.9 (nutrition information is not set in a box by use of hairlines; nutrient order incorrect; incorrect increments; serving size not declared; serving per container not declared) 3/12/07
Notes:Product is misbranded under Section 403(a)(1) in that it does meet the label declaration for calcium; Product is further misbranded in that the nutrition label does not comply with format requirements in 21 CFR 101.9 (nutrition information is not set in a box by use of hairlines; nutrient order incorrect; incorrect increments; serving size not declared; serving per container not declared) 3/12/07
36 A - - 03 Cane Sugar (Sucrose)
Date Published: 11/12/2009
Desc:Brown Sugar
Notes:Product is misbranded under Section 403(a)(1) in that it does meet the label declaration for calcium; Product is further misbranded in that the nutrition label does not comply with format requirements in 21 CFR 101.9 (nutrition information is not set in a box by use of hairlines; nutrient order incorrect; incorrect increments; serving size not declared; serving per container not declared) 3/12/07
Notes:Product is misbranded under Section 403(a)(1) in that it does meet the label declaration for calcium; Product is further misbranded in that the nutrition label does not comply with format requirements in 21 CFR 101.9 (nutrition information is not set in a box by use of hairlines; nutrient order incorrect; incorrect increments; serving size not declared; serving per container not declared) 3/12/07
Chuy's Crunchie Charal
Date Published : 09/16/2009
Creston De Mazatlan #209 , Hoga Del Pescador , Mazatlan, Mx-Sin MEXICO
16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 11/12/2009
Notes:Product is misbranded within the meaning of Section 403 in that the amount of
sodium exceeds the declared amount [239%];
Product is further misbranded within the meaning of Section 403 in that the
labeling [Nutrition Facts panel] does not comply with format
requirements of 21 CFR 101.9 (d) [Required hairlines are missing; ?Calories
from fat? is missing; Vitamin A; Vitamin C; iron and calcium are not declared;
the format is improperly split; saturated and trans fat are not declared in
proper increments; the nutrients required to be highlighted are not bolded; the
nutrients are not indented as required; the required bars are missing];
Product is further misbranded in that the vegetable oil ingredient is not
declared in accordance with 21 CFR 101.4(b)(14).
NOTE; this product is also indicated for detention because its labeling fails
to declare the presence of the major food allergen
9/24/08
Cobos Gonzalez Asociados, Sa De
Date Published : 09/16/2009
Cebolla 74 Central de Abastos , Reynosa, FN MEXICO
34 B - - 05 Chocolate Liquor, Bitter Chocolate, Bitter Chocolate Coatings, Etc. (except Choc. Candy and Choc. Be
Date Published: 11/12/2009
Desc:Cocolate Popular Para Mesa
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 MANUFACTURER; Fabrica de Chocolates La Popular; FEI #3000172674
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 MANUFACTURER; Fabrica de Chocolates La Popular; FEI #3000172674
34 B - - 99 Chocolate and Cocoa, N.E.C.
Date Published: 11/12/2009
Desc:Chocolate Popular Para Mesa
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 MANUFACTURER; Fabrica de Chocolates La Popular; FEI #3000172674
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 MANUFACTURER; Fabrica de Chocolates La Popular; FEI #3000172674
34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 11/12/2009
Desc:Chocolate Popular Para Mesa
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 MANUFACTURER; Fabrica de Chocolates La Popular; FEI #3000172674
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 MANUFACTURER; Fabrica de Chocolates La Popular; FEI #3000172674
34 Y - - 99 Chocolate and Cocoa Products, N.E.C.
Date Published: 11/12/2009
Desc:Chocolate Popular Para Mesa
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 MANUFACTURER; Fabrica de Chocolates La Popular; FEI #3000172674
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 MANUFACTURER; Fabrica de Chocolates La Popular; FEI #3000172674
Comercializadora BA-CAL S.A. de C.V.
Date Published : 09/16/2009
Calle Sebastian Vizcaino No. 412 Fracc. , Garita De Otay , Tijuana, MX-BCN MEXICO
29 C - - 99 Nonalcoholic Beverages, n.e.c.
Date Published: 11/12/2009
Desc:Refrreshing Natural Beverage with Maguey Extract
Notes:Product is misbranded under 403(a)(1)in that the declared value for carbohydrates is false & misleading; Product is further misbranded under 403(q) in that the nutrition label does not comply with format requirements in 21 CFR 101.9; The statement of identity in English does not describe the food appropriately (21 CFR 101.3(b) 4/20/07
Notes:Product is misbranded under 403(a)(1)in that the declared value for carbohydrates is false & misleading; Product is further misbranded under 403(q) in that the nutrition label does not comply with format requirements in 21 CFR 101.9; The statement of identity in English does not describe the food appropriately (21 CFR 101.3(b) 4/20/07
30 A - - 06 Beverage Base, Subtropical or Tropical Fruit
Date Published: 11/12/2009
Desc:Refrreshing Natural Beverage with Maguey Extract
Notes:Product is misbranded under 403(a)(1)in that the declared value for carbohydrates is false & misleading; Product is further misbranded under 403(q) in that the nutrition label does not comply with format requirements in 21 CFR 101.9; The statement of identity in English does not describe the food appropriately (21 CFR 101.3(b) 4/20/07
Notes:Product is misbranded under 403(a)(1)in that the declared value for carbohydrates is false & misleading; Product is further misbranded under 403(q) in that the nutrition label does not comply with format requirements in 21 CFR 101.9; The statement of identity in English does not describe the food appropriately (21 CFR 101.3(b) 4/20/07
30 N - - 99 Combination True and Imitation Fruit Flavored Beverage Bases, N.E.C.
Date Published: 11/12/2009
Desc:Refrreshing Natural Beverage with Maguey Extract
Notes:Product is misbranded under 403(a)(1)in that the declared value for carbohydrates is false & misleading; Product is further misbranded under 403(q) in that the nutrition label does not comply with format requirements in 21 CFR 101.9; The statement of identity in English does not describe the food appropriately (21 CFR 101.3(b) 4/20/07
Notes:Product is misbranded under 403(a)(1)in that the declared value for carbohydrates is false & misleading; Product is further misbranded under 403(q) in that the nutrition label does not comply with format requirements in 21 CFR 101.9; The statement of identity in English does not describe the food appropriately (21 CFR 101.3(b) 4/20/07
Comercializadora Cadena, S.A. de C.V.
Date Published : 02/20/2013
Calle 2 , Venustiano Carranza , Mexico, MX-NOTA MEXICO
31 P - - 99 Tea Substitutes, N.E.C.
Date Published: 02/20/2013
Desc:La Carabela Apple Cinnamon Tea
Notes:VIOLATION (IN NOTES); 1. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act in that the label or labeling fails to bear the required nutrition information in accordance with the requirements under 21 CFR 101.9.
Notes:VIOLATION (IN NOTES); 1. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act in that the label or labeling fails to bear the required nutrition information in accordance with the requirements under 21 CFR 101.9.
Comercializadora Gofer S.A. de C.V.
Date Published : 11/13/2012
Acatl No. 359 , Fracc. Ind. San Antonio , Azcapotzalco, Mx-Dif MEXICO
03 H - - 07 Mixed Plain Cookies,Biscuits and Wafers
Date Published: 11/13/2012
Desc:Rancheras Cookies
Notes:VIOLATION: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) in that the label or labeling fails to bear the required nutrition information (e.g., Nutrition Facts panel); In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in that Trans Fat is not declared as required [101.9(c)(2)(ii)],the increments for Calories, Calories from fat, Sodium, Vitamin C, and Iron are expressed incorrectly 101.9(c); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(a) of the Act in that the label is false and misleading because laboratory analysis demonstrates that the amount of Calcium found in the product is 1.60 and 1.56 of the amount declared on the product label respectively;The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(f) of the Act because the product label contains information in two languages, but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c) (2), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the foreign language.
Notes:VIOLATION: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) in that the label or labeling fails to bear the required nutrition information (e.g., Nutrition Facts panel); In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in that Trans Fat is not declared as required [101.9(c)(2)(ii)],the increments for Calories, Calories from fat, Sodium, Vitamin C, and Iron are expressed incorrectly 101.9(c); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(a) of the Act in that the label is false and misleading because laboratory analysis demonstrates that the amount of Calcium found in the product is 1.60 and 1.56 of the amount declared on the product label respectively;The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(f) of the Act because the product label contains information in two languages, but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c) (2), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the foreign language.
Coyoacan Quimica, S.A. De C.V.
Date Published : 07/27/2011
Carret. Central Km. 419.1 Zona , San Luis Potosi,, MEXICO
54 B - - 08 Magnesium (Mineral)
Date Published: 07/27/2011
Desc:Magnesium Carbonate
Notes:Notes; VIOLATION; Product label fails to bear the required nutrition information (e.g. Supplemental Facts panel)
Notes:Notes; VIOLATION; Product label fails to bear the required nutrition information (e.g. Supplemental Facts panel)
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/27/2011
Desc:Magnesium Carbonate
Notes:Notes; VIOLATION; Product label fails to bear the required nutrition information (e.g. Supplemental Facts panel)
Notes:Notes; VIOLATION; Product label fails to bear the required nutrition information (e.g. Supplemental Facts panel)
60 S - - 13 Magnesium Carbonate (Antacid)
Date Published: 07/27/2011
Desc:Magnesium Carbonate
Notes:Notes; VIOLATION; Product label fails to bear the required nutrition information (e.g. Supplemental Facts panel)
Notes:Notes; VIOLATION; Product label fails to bear the required nutrition information (e.g. Supplemental Facts panel)
DULCERIA LA TAPATIA
Date Published : 09/16/2009
Priv 2a Benito Juarez 15228 , RIO TIJUANA 3RA ETAPA , Tijuana, Bc MEXICO
33 H - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Coconut (without Chocolate)
Date Published: 11/12/2009
Desc:Coconut Candy Rolls
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 MANUFACTURER; El Azteca SA DE CV; FEI #3004203298
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 MANUFACTURER; El Azteca SA DE CV; FEI #3004203298
33 H - - 12 Mixed/Assorted Soft Candy with Coconut (without Chcocolate)
Date Published: 11/12/2009
Desc:Coconut Candy Rolls
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 MANUFACTURER; El Azteca SA DE CV; FEI #3004203298
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 MANUFACTURER; El Azteca SA DE CV; FEI #3004203298
33 H - - 99 Soft Candy with Coconut, N.E.C. (without Chocolate)
Date Published: 11/12/2009
Desc:Coconut Candy Rolls
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 MANUFACTURER; El Azteca SA DE CV; FEI #3004203298
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 MANUFACTURER; El Azteca SA DE CV; FEI #3004203298
33 S - - 05 Marzipan, Coconut Roll (without Chocolate)
Date Published: 11/12/2009
Desc:Coconut Candy Rolls
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 MANUFACTURER; El Azteca SA DE CV; FEI #3004203298
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 MANUFACTURER; El Azteca SA DE CV; FEI #3004203298
33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 11/12/2009
Desc:Coconut Candy Rolls
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 MANUFACTURER; El Azteca SA DE CV; FEI #3004203298
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 MANUFACTURER; El Azteca SA DE CV; FEI #3004203298
DULCES MEXICANOS MIGUEL ROBLES
Date Published : 09/07/2011
CENTRAL DE ABASTOS LOC. 19 , Iztapalapa, Edomex MEXICO
25 J - - 12 Sweet Potato, Yams (Root & Tuber Vegetable)
Date Published: 09/07/2011
Notes:Notes: VIOLATION; Ingredients used in this product are not listed in the
ingredients statement. The only ingredient listed is "Yam Candy." Original analyst
detected Sodium Benzoate in the sample at 0.11% by weigh by HPLC with UV
detection. As per 21CFR184, the tolerance for Sodium Benzoate is 0.1%.
Nutritional information incomplete and not
in English.
33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 09/07/2011
Notes:Notes: VIOLATION; Ingredients used in this product are not listed in the
ingredients statement. The only ingredient listed is "Yam Candy." Original analyst
detected Sodium Benzoate in the sample at 0.11% by weigh by HPLC with UV
detection. As per 21CFR184, the tolerance for Sodium Benzoate is 0.1%.
Nutritional information incomplete and not
in English.
Dulces Mexicanos
Date Published : 09/16/2009
Revolucion No 14sta Cruz De Las Huertas , Tonala, Jalisco, MEXICO
33 H - - 99 Soft Candy with Coconut, N.E.C. (without Chocolate)
Date Published: 11/12/2009
Desc:Coconut Candy Rolls
Notes:Total and Sat. Fat Labeled as 0% Product assayed 7.45 and 6.35gms respectively per Serving 4/4/00
Notes:Total and Sat. Fat Labeled as 0% Product assayed 7.45 and 6.35gms respectively per Serving 4/4/00
Dulces Monarcates, S.A. De C.V.
Date Published : 09/20/2010
Unknown Street , Morelia, Michoacan, MEXICO
33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 09/22/2010
Desc:Ate De Membrillo Fruit Candy
Notes:The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4. ; ;
Notes:The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4. ; ;
33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 09/22/2010
Notes:The products label fails to bear nutrition information as required by
Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not
exempt under 403(q)(5) of the Act.
In addition; the product label bears a foreign language but does not
provide the ingredients and place of business in that foreign language as
required by 21 CFR 101.l5(c).
Furthermore; the declaration of ingredients lists
33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 09/22/2010
Desc:Ate De Mango Fruit Candy
Notes:The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4. ; ;
Notes:The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4. ; ;
33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 09/21/2010
Desc:Ate De Tejocote Fruit Candy
Notes:The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act. In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c). Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4.
Notes:The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act. In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c). Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4.
33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 09/22/2010
Desc:Ate De Duranzo Fruit Paste Candy
Notes:The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act. In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c). Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4.
Notes:The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act. In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c). Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4.
33 U - - 99 Chewing Gum, N.E.C. (without Chocolate)
Date Published: 09/22/2010
Notes:The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 09/22/2010
Desc:Ate De Duranzo Fruit Paste Candy
Notes:The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4. ;
Notes:The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4. ;
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 09/22/2010
Desc:Ate De Membrillo Fruit Candy
Notes:The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4. ; ;
Notes:The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4. ; ;
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 09/22/2010
Desc:Ate De Mango Fruit Candy
Notes:The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4. ; ;
Notes:The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4. ; ;
Dulces Yely, S.A. de C.V.
Date Published : 09/16/2009
Av. de los Astros 550-7 , Monterrey, MX-NLE MEXICO
28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 11/12/2009
Desc:Mango and Chili Flavored Seasoning (Checo Lim Mango)
Notes:Product is misbranded under Section 403(a) in that the sodium content is greater than 20% of the value declared on the label [21 CFR 101.9(g)(5); Product is further misbranded under Section 403(q) for failure to declare trans fat [21 CFR 101.9(c)(2)(ii)]; Product is further misbranded under Section 403(q) in that the nutritional labeling does not comply with the requirements of 21 CFR 101.9 (d) [lacks proper hairlines; calories/amount per serving/daily values are not properly bolded; inadequate width of nutrition facts; Percent Daily Values declared for fats and sugars in the Facts panel) 12/16/08
Notes:Product is misbranded under Section 403(a) in that the sodium content is greater than 20% of the value declared on the label [21 CFR 101.9(g)(5); Product is further misbranded under Section 403(q) for failure to declare trans fat [21 CFR 101.9(c)(2)(ii)]; Product is further misbranded under Section 403(q) in that the nutritional labeling does not comply with the requirements of 21 CFR 101.9 (d) [lacks proper hairlines; calories/amount per serving/daily values are not properly bolded; inadequate width of nutrition facts; Percent Daily Values declared for fats and sugars in the Facts panel) 12/16/08
28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 11/12/2009
Desc:Salt-Lemon Seasoning (Checo Lim)
Notes:Product is misbranded under Section 403(a)(1)in that the sodium content is greater than 20% of the value declared on the label {21 CFR 101.9(g)(5)}; Product is further misbranded in that product fails to declare trans fat on outer and individual packages {21 CFR 101.9(c)(2)(ii)}; Product is further misbranded in that product label does not include the metric equivalent{21 CFR 101.9(b)(7)}; Product is further misbranded in that the format for the Spanish and English nutrition labels do not comply with the requirements in 21 CFR 101.9(d) 6/6/07
Notes:Product is misbranded under Section 403(a)(1)in that the sodium content is greater than 20% of the value declared on the label {21 CFR 101.9(g)(5)}; Product is further misbranded in that product fails to declare trans fat on outer and individual packages {21 CFR 101.9(c)(2)(ii)}; Product is further misbranded in that product label does not include the metric equivalent{21 CFR 101.9(b)(7)}; Product is further misbranded in that the format for the Spanish and English nutrition labels do not comply with the requirements in 21 CFR 101.9(d) 6/6/07
33 C - - 99 Hard Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 11/12/2009
Desc:Mango and Chili Flavored Seasoning (Checo Lim Mango)
Notes:Product is misbranded under Section 403(a) in that the sodium content is greater than 20% of the value declared on the label [21 CFR 101.9(g)(5); Product is further misbranded under Section 403(q) for failure to declare trans fat [21 CFR 101.9(c)(2)(ii)]; Product is further misbranded under Section 403(q) in that the nutritional labeling does not comply with the requirements of 21 CFR 101.9 (d) [lacks proper hairlines; calories/amount per serving/daily values are not properly bolded; inadequate width of nutrition facts; Percent Daily Values declared for fats and sugars in the Facts panel) 12/16/08
Notes:Product is misbranded under Section 403(a) in that the sodium content is greater than 20% of the value declared on the label [21 CFR 101.9(g)(5); Product is further misbranded under Section 403(q) for failure to declare trans fat [21 CFR 101.9(c)(2)(ii)]; Product is further misbranded under Section 403(q) in that the nutritional labeling does not comply with the requirements of 21 CFR 101.9 (d) [lacks proper hairlines; calories/amount per serving/daily values are not properly bolded; inadequate width of nutrition facts; Percent Daily Values declared for fats and sugars in the Facts panel) 12/16/08
33 C - - 99 Hard Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 11/12/2009
Desc:Salt-Lemon Seasoning (Checo Lim)
Notes:Product is misbranded under Section 403(a)(1)in that the sodium content is greater than 20% of the value declared on the label {21 CFR 101.9(g)(5)}; Product is further misbranded in that product fails to declare trans fat on outer and individual packages {21 CFR 101.9(c)(2)(ii)}; Product is further misbranded in that product label does not include the metric equivalent{21 CFR 101.9(b)(7)}; Product is further misbranded in that the format for the Spanish and English nutrition labels do not comply with the requirements in 21 CFR 101.9(d) 6/6/07
Notes:Product is misbranded under Section 403(a)(1)in that the sodium content is greater than 20% of the value declared on the label {21 CFR 101.9(g)(5)}; Product is further misbranded in that product fails to declare trans fat on outer and individual packages {21 CFR 101.9(c)(2)(ii)}; Product is further misbranded in that product label does not include the metric equivalent{21 CFR 101.9(b)(7)}; Product is further misbranded in that the format for the Spanish and English nutrition labels do not comply with the requirements in 21 CFR 101.9(d) 6/6/07
33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 11/12/2009
Desc:Salt-Lemon Seasoning (Checo Lim)
Notes:Product is misbranded under Section 403(a)(1)in that the sodium content is greater than 20% of the value declared on the label {21 CFR 101.9(g)(5)}; Product is further misbranded in that product fails to declare trans fat on outer and individual packages {21 CFR 101.9(c)(2)(ii)}; Product is further misbranded in that product label does not include the metric equivalent{21 CFR 101.9(b)(7)}; Product is further misbranded in that the format for the Spanish and English nutrition labels do not comply with the requirements in 21 CFR 101.9(d) 6/6/07
Notes:Product is misbranded under Section 403(a)(1)in that the sodium content is greater than 20% of the value declared on the label {21 CFR 101.9(g)(5)}; Product is further misbranded in that product fails to declare trans fat on outer and individual packages {21 CFR 101.9(c)(2)(ii)}; Product is further misbranded in that product label does not include the metric equivalent{21 CFR 101.9(b)(7)}; Product is further misbranded in that the format for the Spanish and English nutrition labels do not comply with the requirements in 21 CFR 101.9(d) 6/6/07
33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 11/12/2009
Desc:Mango and Chili Flavored Seasoning (Checo Lim Mango)
Notes:Product is misbranded under Section 403(a) in that the sodium content is greater than 20% of the value declared on the label [21 CFR 101.9(g)(5); Product is further misbranded under Section 403(q) for failure to declare trans fat [21 CFR 101.9(c)(2)(ii)]; Product is further misbranded under Section 403(q) in that the nutritional labeling does not comply with the requirements of 21 CFR 101.9 (d) [lacks proper hairlines; calories/amount per serving/daily values are not properly bolded; inadequate width of nutrition facts; Percent Daily Values declared for fats and sugars in the Facts panel) 12/16/08
Notes:Product is misbranded under Section 403(a) in that the sodium content is greater than 20% of the value declared on the label [21 CFR 101.9(g)(5); Product is further misbranded under Section 403(q) for failure to declare trans fat [21 CFR 101.9(c)(2)(ii)]; Product is further misbranded under Section 403(q) in that the nutritional labeling does not comply with the requirements of 21 CFR 101.9 (d) [lacks proper hairlines; calories/amount per serving/daily values are not properly bolded; inadequate width of nutrition facts; Percent Daily Values declared for fats and sugars in the Facts panel) 12/16/08
33 S - - 06 Lollipop (without Chocolate)
Date Published: 11/12/2009
Desc:Mango and Chili Flavored Seasoning (Checo Lim Mango)
Notes:Product is misbranded under Section 403(a) in that the sodium content is greater than 20% of the value declared on the label [21 CFR 101.9(g)(5); Product is further misbranded under Section 403(q) for failure to declare trans fat [21 CFR 101.9(c)(2)(ii)]; Product is further misbranded under Section 403(q) in that the nutritional labeling does not comply with the requirements of 21 CFR 101.9 (d) [lacks proper hairlines; calories/amount per serving/daily values are not properly bolded; inadequate width of nutrition facts; Percent Daily Values declared for fats and sugars in the Facts panel) 12/16/08
Notes:Product is misbranded under Section 403(a) in that the sodium content is greater than 20% of the value declared on the label [21 CFR 101.9(g)(5); Product is further misbranded under Section 403(q) for failure to declare trans fat [21 CFR 101.9(c)(2)(ii)]; Product is further misbranded under Section 403(q) in that the nutritional labeling does not comply with the requirements of 21 CFR 101.9 (d) [lacks proper hairlines; calories/amount per serving/daily values are not properly bolded; inadequate width of nutrition facts; Percent Daily Values declared for fats and sugars in the Facts panel) 12/16/08
33 S - - 06 Lollipop (without Chocolate)
Date Published: 11/12/2009
Desc:Salt-Lemon Seasoning (Checo Lim)
Notes:Product is misbranded under Section 403(a)(1)in that the sodium content is greater than 20% of the value declared on the label {21 CFR 101.9(g)(5)}; Product is further misbranded in that product fails to declare trans fat on outer and individual packages {21 CFR 101.9(c)(2)(ii)}; Product is further misbranded in that product label does not include the metric equivalent{21 CFR 101.9(b)(7)}; Product is further misbranded in that the format for the Spanish and English nutrition labels do not comply with the requirements in 21 CFR 101.9(d) 6/6/07
Notes:Product is misbranded under Section 403(a)(1)in that the sodium content is greater than 20% of the value declared on the label {21 CFR 101.9(g)(5)}; Product is further misbranded in that product fails to declare trans fat on outer and individual packages {21 CFR 101.9(c)(2)(ii)}; Product is further misbranded in that product label does not include the metric equivalent{21 CFR 101.9(b)(7)}; Product is further misbranded in that the format for the Spanish and English nutrition labels do not comply with the requirements in 21 CFR 101.9(d) 6/6/07
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 11/12/2009
Desc:Salt-Lemon Seasoning (Checo Lim)
Notes:Product is misbranded under Section 403(a)(1)in that the sodium content is greater than 20% of the value declared on the label {21 CFR 101.9(g)(5)}; Product is further misbranded in that product fails to declare trans fat on outer and individual packages {21 CFR 101.9(c)(2)(ii)}; Product is further misbranded in that product label does not include the metric equivalent{21 CFR 101.9(b)(7)}; Product is further misbranded in that the format for the Spanish and English nutrition labels do not comply with the requirements in 21 CFR 101.9(d) 6/6/07
Notes:Product is misbranded under Section 403(a)(1)in that the sodium content is greater than 20% of the value declared on the label {21 CFR 101.9(g)(5)}; Product is further misbranded in that product fails to declare trans fat on outer and individual packages {21 CFR 101.9(c)(2)(ii)}; Product is further misbranded in that product label does not include the metric equivalent{21 CFR 101.9(b)(7)}; Product is further misbranded in that the format for the Spanish and English nutrition labels do not comply with the requirements in 21 CFR 101.9(d) 6/6/07
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 11/12/2009
Desc:Mango and Chili Flavored Seasoning (Checo Lim Mango)
Notes:Product is misbranded under Section 403(a) in that the sodium content is greater than 20% of the value declared on the label [21 CFR 101.9(g)(5); Product is further misbranded under Section 403(q) for failure to declare trans fat [21 CFR 101.9(c)(2)(ii)]; Product is further misbranded under Section 403(q) in that the nutritional labeling does not comply with the requirements of 21 CFR 101.9 (d) [lacks proper hairlines; calories/amount per serving/daily values are not properly bolded; inadequate width of nutrition facts; Percent Daily Values declared for fats and sugars in the Facts panel) 12/16/08
Notes:Product is misbranded under Section 403(a) in that the sodium content is greater than 20% of the value declared on the label [21 CFR 101.9(g)(5); Product is further misbranded under Section 403(q) for failure to declare trans fat [21 CFR 101.9(c)(2)(ii)]; Product is further misbranded under Section 403(q) in that the nutritional labeling does not comply with the requirements of 21 CFR 101.9 (d) [lacks proper hairlines; calories/amount per serving/daily values are not properly bolded; inadequate width of nutrition facts; Percent Daily Values declared for fats and sugars in the Facts panel) 12/16/08
El Azteca De Mexico
Date Published : 09/16/2009
Las Flores No. 113 , Col. Victor Hugo , Zapopan, Jalisco MEXICO
28 K - - -- Gnd/Crk Mix Spice/Season W/Salt
Date Published: 11/12/2009
Desc:Lemon Flavored Salt Powder (Limoncito)
Notes:Product is misbranded within the meaning of Section 403(q) in that labeling does not comply with nutrition labeling format requirements [incorrect hairlines; bolding; indenting]; 21 CFR 101.9; Product is further misbranded under Section 403(q)in that the nutrition facts panel in Spanish does not comply with nutrition labeling requirements; 21 CFR 101.9; Product is further misbranded under Section 403(a) in that the sodium content is greater than 20% in excess of the declared value; 21 CFR 101.9(g)(5); Product is further misbranded under Section 403(a) in that the net quantity of contents does not comply with the requirements of 21 CFR 101.105(s); if the product is sold as a multi-unit package. 10/17/08
Notes:Product is misbranded within the meaning of Section 403(q) in that labeling does not comply with nutrition labeling format requirements [incorrect hairlines; bolding; indenting]; 21 CFR 101.9; Product is further misbranded under Section 403(q)in that the nutrition facts panel in Spanish does not comply with nutrition labeling requirements; 21 CFR 101.9; Product is further misbranded under Section 403(a) in that the sodium content is greater than 20% in excess of the declared value; 21 CFR 101.9(g)(5); Product is further misbranded under Section 403(a) in that the net quantity of contents does not comply with the requirements of 21 CFR 101.105(s); if the product is sold as a multi-unit package. 10/17/08
33 C - - 99 Hard Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 11/12/2009
Desc:Lemon Flavored Salt Powder (Limoncito)
Notes:Product is misbranded within the meaning of Section 403(q) in that labeling does not comply with nutrition labeling format requirements [incorrect hairlines; bolding; indenting]; 21 CFR 101.9; Product is further misbranded under Section 403(q)in that the nutrition facts panel in Spanish does not comply with nutrition labeling requirements; 21 CFR 101.9; Product is further misbranded under Section 403(a) in that the sodium content is greater than 20% in excess of the declared value; 21 CFR 101.9(g)(5); Product is further misbranded under Section 403(a) in that the net quantity of contents does not comply with the requirements of 21 CFR 101.105(s); if the product is sold as a multi-unit package. 10/17/08
Notes:Product is misbranded within the meaning of Section 403(q) in that labeling does not comply with nutrition labeling format requirements [incorrect hairlines; bolding; indenting]; 21 CFR 101.9; Product is further misbranded under Section 403(q)in that the nutrition facts panel in Spanish does not comply with nutrition labeling requirements; 21 CFR 101.9; Product is further misbranded under Section 403(a) in that the sodium content is greater than 20% in excess of the declared value; 21 CFR 101.9(g)(5); Product is further misbranded under Section 403(a) in that the net quantity of contents does not comply with the requirements of 21 CFR 101.105(s); if the product is sold as a multi-unit package. 10/17/08
33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 11/12/2009
Desc:Lemon Flavored Salt Powder (Limoncito)
Notes:Product is misbranded within the meaning of Section 403(q) in that labeling does not comply with nutrition labeling format requirements [incorrect hairlines; bolding; indenting]; 21 CFR 101.9; Product is further misbranded under Section 403(q)in that the nutrition facts panel in Spanish does not comply with nutrition labeling requirements; 21 CFR 101.9; Product is further misbranded under Section 403(a) in that the sodium content is greater than 20% in excess of the declared value; 21 CFR 101.9(g)(5); Product is further misbranded under Section 403(a) in that the net quantity of contents does not comply with the requirements of 21 CFR 101.105(s); if the product is sold as a multi-unit package. 10/17/08
Notes:Product is misbranded within the meaning of Section 403(q) in that labeling does not comply with nutrition labeling format requirements [incorrect hairlines; bolding; indenting]; 21 CFR 101.9; Product is further misbranded under Section 403(q)in that the nutrition facts panel in Spanish does not comply with nutrition labeling requirements; 21 CFR 101.9; Product is further misbranded under Section 403(a) in that the sodium content is greater than 20% in excess of the declared value; 21 CFR 101.9(g)(5); Product is further misbranded under Section 403(a) in that the net quantity of contents does not comply with the requirements of 21 CFR 101.105(s); if the product is sold as a multi-unit package. 10/17/08
33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 11/12/2009
Desc:Lemon Flavored Salt Powder (Limoncito)
Notes:Product is misbranded within the meaning of Section 403(q) in that labeling does not comply with nutrition labeling format requirements [incorrect hairlines; bolding; indenting]; 21 CFR 101.9; Product is further misbranded under Section 403(q)in that the nutrition facts panel in Spanish does not comply with nutrition labeling requirements; 21 CFR 101.9; Product is further misbranded under Section 403(a) in that the sodium content is greater than 20% in excess of the declared value; 21 CFR 101.9(g)(5); Product is further misbranded under Section 403(a) in that the net quantity of contents does not comply with the requirements of 21 CFR 101.105(s); if the product is sold as a multi-unit package. 10/17/08
Notes:Product is misbranded within the meaning of Section 403(q) in that labeling does not comply with nutrition labeling format requirements [incorrect hairlines; bolding; indenting]; 21 CFR 101.9; Product is further misbranded under Section 403(q)in that the nutrition facts panel in Spanish does not comply with nutrition labeling requirements; 21 CFR 101.9; Product is further misbranded under Section 403(a) in that the sodium content is greater than 20% in excess of the declared value; 21 CFR 101.9(g)(5); Product is further misbranded under Section 403(a) in that the net quantity of contents does not comply with the requirements of 21 CFR 101.105(s); if the product is sold as a multi-unit package. 10/17/08
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 11/12/2009
Desc:Lemon Flavored Salt Powder (Limoncito)
Notes:Product is misbranded within the meaning of Section 403(q) in that labeling does not comply with nutrition labeling format requirements [incorrect hairlines; bolding; indenting]; 21 CFR 101.9; Product is further misbranded under Section 403(q)in that the nutrition facts panel in Spanish does not comply with nutrition labeling requirements; 21 CFR 101.9; Product is further misbranded under Section 403(a) in that the sodium content is greater than 20% in excess of the declared value; 21 CFR 101.9(g)(5); Product is further misbranded under Section 403(a) in that the net quantity of contents does not comply with the requirements of 21 CFR 101.105(s); if the product is sold as a multi-unit package. 10/17/08
Notes:Product is misbranded within the meaning of Section 403(q) in that labeling does not comply with nutrition labeling format requirements [incorrect hairlines; bolding; indenting]; 21 CFR 101.9; Product is further misbranded under Section 403(q)in that the nutrition facts panel in Spanish does not comply with nutrition labeling requirements; 21 CFR 101.9; Product is further misbranded under Section 403(a) in that the sodium content is greater than 20% in excess of the declared value; 21 CFR 101.9(g)(5); Product is further misbranded under Section 403(a) in that the net quantity of contents does not comply with the requirements of 21 CFR 101.105(s); if the product is sold as a multi-unit package. 10/17/08
El Azteca De Mexico
Date Published : 10/25/2010
Blvd. Manuel Cavazos Lerma , Y Colima 1-a , H. Matamoros, Tamaulipas MEXICO
33 G - - 99 Soft Candy with Nuts or Nut Products, N.E.C. (without Chocolate)
Date Published: 10/25/2010
Desc:Glorias Pecan Milk Candy
Notes:VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the nutrition facts panel does not meet the requirements in 21 CFR 101.9. Specifically, the Nutrition Facts Panel on the multi-unit container does not contain a listing of the percent of the Daily Recommended Value (DRV) given in a column aligned under the heading "% DV*", and the serving size is not given in common household units, the protein content is not expressed in grams. Additionally, the product is further misbranded within the meaning of Section 403(e) because the declaration of net quantity of contents on the multi-unit container does not state the quantity of each individual unit as required by 21 CFR l01.105(s).
Notes:VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the nutrition facts panel does not meet the requirements in 21 CFR 101.9. Specifically, the Nutrition Facts Panel on the multi-unit container does not contain a listing of the percent of the Daily Recommended Value (DRV) given in a column aligned under the heading "% DV*", and the serving size is not given in common household units, the protein content is not expressed in grams. Additionally, the product is further misbranded within the meaning of Section 403(e) because the declaration of net quantity of contents on the multi-unit container does not state the quantity of each individual unit as required by 21 CFR l01.105(s).
El Azteca S.A. de C.V.
Date Published : 09/16/2009
Calzada Independencia Norte 445 , Guadalajara, Jalisco MEXICO
33 H - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Coconut (without Chocolate)
Date Published: 11/12/2009
Desc:Coconut Candy Rolls
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 SHIPPER: Dulceria La Tapatio Mayoreo; FEI #3003369184
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 SHIPPER: Dulceria La Tapatio Mayoreo; FEI #3003369184
33 H - - 12 Mixed/Assorted Soft Candy with Coconut (without Chcocolate)
Date Published: 11/12/2009
Desc:Coconut Candy Rolls
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403 (e) (2)of the FD&C Act and 21 CFR 101.105. 8/16/05 SHIPPER; Dulceria La Tapatio Mayoreo; FEI #3003369184
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403 (e) (2)of the FD&C Act and 21 CFR 101.105. 8/16/05 SHIPPER; Dulceria La Tapatio Mayoreo; FEI #3003369184
33 H - - 99 Soft Candy with Coconut, N.E.C. (without Chocolate)
Date Published: 11/12/2009
Desc:Coconut Candy Rolls
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e) (2)of the FD&C Act and 21 CFR 101.105. 8/16/05 SHIPPER: Dulceria La Tapatio Mayoreo; FEI #3003369184
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e) (2)of the FD&C Act and 21 CFR 101.105. 8/16/05 SHIPPER: Dulceria La Tapatio Mayoreo; FEI #3003369184
33 S - - 05 Marzipan, Coconut Roll (without Chocolate)
Date Published: 11/12/2009
Desc:Coconut Candy Rolls
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403 (e) (2)of the FD&C Act and 21 CFR 101.105. 8/16/05 SHIPPER: Dulceria La Tapatio Mayoreo; FEI #3003369184
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403 (e) (2)of the FD&C Act and 21 CFR 101.105. 8/16/05 SHIPPER: Dulceria La Tapatio Mayoreo; FEI #3003369184
33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 11/12/2009
Desc:Coconut Candy Rolls
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403 (e) (2)of the FD&C Act and 21 CFR 101.105. 8/16/05 SHIPPER: Dulceria La Tapatio Mayoreo; FEI #3003369184
Notes:The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403 (e) (2)of the FD&C Act and 21 CFR 101.105. 8/16/05 SHIPPER: Dulceria La Tapatio Mayoreo; FEI #3003369184
Extracciones Naturales SA de CV
Date Published : 01/20/2012
Carretera Panamericana Km 320 , Salamanca, GTO MEXICO
21 M - - 05 Subtropical Fruit Flavored Imitation Fruit
Date Published: 01/20/2012
Desc:Prickly Pear Puree Health Drink
Notes:Mexico
Notes:Mexico
Extracciones Naturales Sa De Cv
Date Published : 01/20/2012
Carretera Panamericana Km 320 , Salamanca, Gto Mexico, MEXICO
21 M - - 05 Subtropical Fruit Flavored Imitation Fruit
Date Published: 01/20/2012
Desc:Prickly Pear Puree Health Drink
Notes:Mexico
Notes:Mexico
Fabrica De Chocolates La Popular
Date Published : 09/16/2009
Aramberri Ote. 112 Apdo 343 , Monterrey Nl, FN MEXICO
34 B - - 05 Chocolate Liquor, Bitter Chocolate, Bitter Chocolate Coatings, Etc. (except Choc. Candy and Choc. Be
Date Published: 11/12/2009
Desc:Chocolate Popular Para Mesa
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 SHIPPER; Cobos Gonzalez Asociados; FEI #3002697832
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 SHIPPER; Cobos Gonzalez Asociados; FEI #3002697832
34 B - - 99 Chocolate and Cocoa, N.E.C.
Date Published: 11/12/2009
Desc:Chocolate Popular Para Mesa
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 SHIPPER; Cobos Gonzalez Asociados; FEI #3002697832 ;
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 SHIPPER; Cobos Gonzalez Asociados; FEI #3002697832 ;
34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 11/12/2009
Desc:Chocolate Popular Para Mesa
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 SHIPPER; Cobos Gonzalez Asociados; FEI #3002697832 ;
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 SHIPPER; Cobos Gonzalez Asociados; FEI #3002697832 ;
34 Y - - 99 Chocolate and Cocoa Products, N.E.C.
Date Published: 11/12/2009
Desc:Chocolate Popular Para Mesa
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 SHIPPER; Cobos Gonzalez Asociados; FEI #3002697832
Notes:The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 SHIPPER; Cobos Gonzalez Asociados; FEI #3002697832
GiaLive S.A. de C.V.
Date Published : 08/09/2010
Av Aguascalientess 732 Local 1 , Col Valle del Rio San Pedro , Aguascalientes, MX-AGU MEXICO
14 B - - 99 Imitation Milk or Milk Type Product, N.E.C.
Date Published: 08/09/2010
Desc:GIA Lactium F
Notes:labeling is false. Specifically the calcium levels found were 46.6% and 48.2% of the label declaration.
Notes:labeling is false. Specifically the calcium levels found were 46.6% and 48.2% of the label declaration.
23 C - - 07 Peanut, Butter
Date Published: 08/09/2010
Desc:GIA Lactium F
Notes:labeling is false. Specifically the calcium levels found were 46.6% and 48.2% of the label declaration. ;
Notes:labeling is false. Specifically the calcium levels found were 46.6% and 48.2% of the label declaration. ;
Gialive, Sa De Cv
Date Published : 08/10/2010
Carretera Aguascalientes-Zacatecaskm , Aguascalientesaguascalientes, MEXICO
14 B - - 99 Imitation Milk or Milk Type Product, N.E.C.
Date Published: 08/10/2010
Desc:GIA Lactium F
Notes:Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically; the Calcium levels found were 46.6% and 48.2% of the label declaration.
Notes:Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically; the Calcium levels found were 46.6% and 48.2% of the label declaration.
23 C - - 07 Peanut, Butter
Date Published: 08/10/2010
Desc:GIA Lactium F
Notes:Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically; the Calcium levels found were 46.6% and 48.2% of the label declaration.
Notes:Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically; the Calcium levels found were 46.6% and 48.2% of the label declaration.
Gloria Lopez
Date Published : 02/25/2010
Rep. De Chile #112 Col. Las Cumbres , Matehuala, MEXICO
33 L - - 99 Soft Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 02/25/2010
Desc:Obleas Con Cajeta De Leche de Cabra and Mini Obleas Con Cajeta
Notes:Product is misbranded within the meaning of Section 403(f) of the Act because the label fails to declare all words; statements; and other information required by the act to appear on the label in the English language as required by 21 CFR 101.l5(c)(l).
Notes:Product is misbranded within the meaning of Section 403(f) of the Act because the label fails to declare all words; statements; and other information required by the act to appear on the label in the English language as required by 21 CFR 101.l5(c)(l).
Importadora y Comercializadora de Uncaria Tormentosa SA DE C
Date Published : 09/16/2009
Avenida Patria 1357 , Colonia Mirador del Sol , Zapopan, Mx-Jal MEXICO
34 B - - 06 Chocolate Syrup (except Chocolate Candy and Chocolate Beverage Base)
Date Published: 11/12/2009
Desc:Chocolate Fiber for Kids
Notes:Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07
Notes:Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07
34 B - - 99 Chocolate and Cocoa, N.E.C.
Date Published: 11/12/2009
Desc:Chocolate Fiber for Kids
Notes:Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07
Notes:Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07
34 H - - 02 Chocolate Dairy Mix
Date Published: 11/12/2009
Desc:Chocolate Fiber for Kids
Notes:Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07
Notes:Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07
34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 11/12/2009
Desc:Cocolate Fiber for Kids
Notes:Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07
Notes:Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07
34 Y - - 99 Chocolate and Cocoa Products, N.E.C.
Date Published: 11/12/2009
Desc:Chocolate Fiber for Kids
Notes:Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07
Notes:Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/12/2009
Desc:Chocolate Fiber for Kids
Notes:Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07
Notes:Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07
Jugomex, S.A. de C.V.
Date Published : 09/16/2009
Km 12.5 Ant. Carr Mex-pachuca Xalostoc , Mexico, MX-MEX MEXICO
21 D - - 99 Mixed Fruit, Juices or Concentrates N.E.C.,
Date Published: 11/12/2009
Desc:Jumex Blends Exotic Medley Juice Drink
Notes:Analysis determined that the product does not contain 10% of the RDI for Vitamin A & C as declared on the label. Therefore the product is misbranded under Section [403(r)(1)(A)] of the FFD&C Act. In addition the product appears to contain only a small percentage of the label-declared amount of iron [Misbranding;403(a)(1)] 6/26/07
Notes:Analysis determined that the product does not contain 10% of the RDI for Vitamin A & C as declared on the label. Therefore the product is misbranded under Section [403(r)(1)(A)] of the FFD&C Act. In addition the product appears to contain only a small percentage of the label-declared amount of iron [Misbranding;403(a)(1)] 6/26/07
21 D - - 99 Mixed Fruit, Juices or Concentrates N.E.C.,
Date Published: 11/12/2009
Desc:Pau Pau Cherry Juice Drink
Notes:Analysis determined that the product does not contain 10% of the RDI for Vitamin C as declared on the label. Therefore the product is misbranded under Section 403(r)(1) of the FFD&C Act because it bears the nutrient content claim ?enriched with Vitamins A; C; B1; B2;? however the label declaration for vitamins A (4%); B1(6%); and B2(6%) are less than 10% of the RDI for Vitamins A; B1; and B2. 12/20/05
Notes:Analysis determined that the product does not contain 10% of the RDI for Vitamin C as declared on the label. Therefore the product is misbranded under Section 403(r)(1) of the FFD&C Act because it bears the nutrient content claim ?enriched with Vitamins A; C; B1; B2;? however the label declaration for vitamins A (4%); B1(6%); and B2(6%) are less than 10% of the RDI for Vitamins A; B1; and B2. 12/20/05
21 K - - 03 Cherry, Juice, Pit Fruit Juices or Concentrates
Date Published: 11/12/2009
Desc:Pau Pau Cherry Juice Drink
Notes:Analysis determined that the product does not contain 10% of the RDI for Vitamin C as declared on the label. Therefore the product is misbranded under Section 403(r)(1) of the FFD&C Act because it bears the nutrient content claim ?enriched with Vitamins A; C; B1; B2;? however the label declaration for vitamins A (4%); B1(6%); and B2(6%) are less than 10% of the RDI for Vitamins A; B1; and B2. 12/20/05
Notes:Analysis determined that the product does not contain 10% of the RDI for Vitamin C as declared on the label. Therefore the product is misbranded under Section 403(r)(1) of the FFD&C Act because it bears the nutrient content claim ?enriched with Vitamins A; C; B1; B2;? however the label declaration for vitamins A (4%); B1(6%); and B2(6%) are less than 10% of the RDI for Vitamins A; B1; and B2. 12/20/05
22 K - - 99 Other Fruits and Fruit Products, Other Fruit Juices or Concentrates, N.E.C.
Date Published: 11/12/2009
Desc:Pau Pau Cherry Juice Drink
Notes:Analysis determined that the product does not contain 10% of the RDI for Vitamin C as declared on the label. Therefore the product is misbranded under Section 403(r)(1) of the FFD&C Act because it bears the nutrient content claim ?enriched with Vitamins A; C; B1; B2;? however the label declaration for vitamins A (4%); B1(6%); and B2(6%) are less than 10% of the RDI for Vitamins A; B1; and B2. 12/20/05
Notes:Analysis determined that the product does not contain 10% of the RDI for Vitamin C as declared on the label. Therefore the product is misbranded under Section 403(r)(1) of the FFD&C Act because it bears the nutrient content claim ?enriched with Vitamins A; C; B1; B2;? however the label declaration for vitamins A (4%); B1(6%); and B2(6%) are less than 10% of the RDI for Vitamins A; B1; and B2. 12/20/05
22 K - - 99 Other Fruits and Fruit Products, Other Fruit Juices or Concentrates, N.E.C.
Date Published: 11/12/2009
Desc:Jumex Blends Exotic Medley Juice Drink
Notes:Analysis determined that the product does not contain 10% of the RDI for Vitamin A & C as declared on the label. Therefore the product is misbranded under Section [403(r)(1)(A)] of the FFD&C Act. In addition the product appears to contain only a small percentage of the label-declared amount of iron [Misbranding;403(a)(1)] 6/26/07
Notes:Analysis determined that the product does not contain 10% of the RDI for Vitamin A & C as declared on the label. Therefore the product is misbranded under Section [403(r)(1)(A)] of the FFD&C Act. In addition the product appears to contain only a small percentage of the label-declared amount of iron [Misbranding;403(a)(1)] 6/26/07
40 E - - 40 Fruit Flavored Drink
Date Published: 11/12/2009
Desc:Jumex Blends Exotic Medley Juice Drink
Notes:Analysis determined that the product does not contain 10% of the RDI for Vitamin A & C as declared on the label. Therefore the product is misbranded under Section [403(r)(1)(A)] of the FFD&C Act. In addition the product appears to contain only a small percentage of the label-declared amount of iron [Misbranding;403(a)(1)] 6/26/07
Notes:Analysis determined that the product does not contain 10% of the RDI for Vitamin A & C as declared on the label. Therefore the product is misbranded under Section [403(r)(1)(A)] of the FFD&C Act. In addition the product appears to contain only a small percentage of the label-declared amount of iron [Misbranding;403(a)(1)] 6/26/07
40 E - - 40 Fruit Flavored Drink
Date Published: 11/12/2009
Desc:Pau Pau Cherry Juice Drink
Notes:Analysis determined that the product does not contain 10% of the RDI for Vitamin C as declared on the label. Therefore the product is misbranded under Section 403(r)(1) of the FFD&C Act because it bears the nutrient content claim ?enriched with Vitamins A; C; B1; B2;? however the label declaration for vitamins A (4%); B1(6%); and B2(6%) are less than 10% of the RDI for Vitamins A; B1; and B2. 12/20/05
Notes:Analysis determined that the product does not contain 10% of the RDI for Vitamin C as declared on the label. Therefore the product is misbranded under Section 403(r)(1) of the FFD&C Act because it bears the nutrient content claim ?enriched with Vitamins A; C; B1; B2;? however the label declaration for vitamins A (4%); B1(6%); and B2(6%) are less than 10% of the RDI for Vitamins A; B1; and B2. 12/20/05
LESLIE GAMINO FRANCO
Date Published : 10/28/2010
Milan , Guadalajara, MX-JAL MEXICO
33 H - - -- Soft Candy W/Coconut
Date Published: 10/28/2010
Desc:Rollo De Coco Soft Candy All Sizes (Coconut Candy Roll)
Notes:VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Nutrition Facts is provided in the linear format, however, the declared format is not as specified in 21 CFR 101.9(G)(13)(ii)(2). Specifically, the serving size is not declared in household measure, as required by 21 CFR 101.9(b)(7). The provided format does not distinguish the heading Nutrition Facts by presenting it in bold type. Note: The words Calories, Total Fat, Cholesterol, Sodium, Total Carbohydrates and Sodium may voluntarily be presented in bold type. The statement of identity is not presented in bold type on the principal display panel and is not parallel to the base on which the package rests as it is designed to be displayed, as required by 21 CFR 101.3(d), and the provided format does not include commas after each nutrient entry. Additionally, the product is further misbranded within the meaning of Section 403 (e) because it appears from the description of the sample that the submitted label is applied to a cellophane container. If this is the case, the net weight is not located on the Principal Display Panel (PDP) in accordance with the requirements of 21 CFR 101.105(f). The declaration of net weight for the submitted label is not in the lower 30% of the label. Note: The only time this placement provision does not apply is on products where the area of the Principal Display Panel (PDP) is 5 square inches or less.
Notes:VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Nutrition Facts is provided in the linear format, however, the declared format is not as specified in 21 CFR 101.9(G)(13)(ii)(2). Specifically, the serving size is not declared in household measure, as required by 21 CFR 101.9(b)(7). The provided format does not distinguish the heading Nutrition Facts by presenting it in bold type. Note: The words Calories, Total Fat, Cholesterol, Sodium, Total Carbohydrates and Sodium may voluntarily be presented in bold type. The statement of identity is not presented in bold type on the principal display panel and is not parallel to the base on which the package rests as it is designed to be displayed, as required by 21 CFR 101.3(d), and the provided format does not include commas after each nutrient entry. Additionally, the product is further misbranded within the meaning of Section 403 (e) because it appears from the description of the sample that the submitted label is applied to a cellophane container. If this is the case, the net weight is not located on the Principal Display Panel (PDP) in accordance with the requirements of 21 CFR 101.105(f). The declaration of net weight for the submitted label is not in the lower 30% of the label. Note: The only time this placement provision does not apply is on products where the area of the Principal Display Panel (PDP) is 5 square inches or less.
33 L - - -- Soft Candy W/O Nut/Fruit
Date Published: 10/28/2010
Desc:Rollo De Coco Soft Candy All Sizes (Coconut Candy Roll)
Notes:VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Nutrition Facts is provided in the linear format, however, the declared format is not as specified in 21 CFR 101.9(G)(13)(ii)(2). Specifically, the serving size is not declared in household measure, as required by 21 CFR 101.9(b)(7). The provided format does not distinguish the heading Nutrition Facts by presenting it in bold type. Note: The words Calories, Total Fat, Cholesterol, Sodium, Total Carbohydrates and Sodium may voluntarily be presented in bold type. The statement of identity is not presented in bold type on the principal display panel and is not parallel to the base on which the package rests as it is designed to be displayed, as required by 21 CFR 101.3(d), and the provided format does not include commas after each nutrient entry. Additionally, the product is further misbranded within the meaning of Section 403 (e) because it appears from the description of the sample that the submitted label is applied to a cellophane container. If this is the case, the net weight is not located on the Principal Display Panel (PDP) in accordance with the requirements of 21 CFR 101.105(f). The declaration of net weight for the submitted label is not in the lower 30% of the label. Note: The only time this placement provision does not apply is on products where the area of the Principal Display Panel (PDP) is 5 square inches or less.
Notes:VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Nutrition Facts is provided in the linear format, however, the declared format is not as specified in 21 CFR 101.9(G)(13)(ii)(2). Specifically, the serving size is not declared in household measure, as required by 21 CFR 101.9(b)(7). The provided format does not distinguish the heading Nutrition Facts by presenting it in bold type. Note: The words Calories, Total Fat, Cholesterol, Sodium, Total Carbohydrates and Sodium may voluntarily be presented in bold type. The statement of identity is not presented in bold type on the principal display panel and is not parallel to the base on which the package rests as it is designed to be displayed, as required by 21 CFR 101.3(d), and the provided format does not include commas after each nutrient entry. Additionally, the product is further misbranded within the meaning of Section 403 (e) because it appears from the description of the sample that the submitted label is applied to a cellophane container. If this is the case, the net weight is not located on the Principal Display Panel (PDP) in accordance with the requirements of 21 CFR 101.105(f). The declaration of net weight for the submitted label is not in the lower 30% of the label. Note: The only time this placement provision does not apply is on products where the area of the Principal Display Panel (PDP) is 5 square inches or less.
33 S - - -- Candy Specialties
Date Published: 10/28/2010
Desc:Rollo De Coco Soft Candy All Sizes (Coconut Candy Roll)
Notes:VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Nutrition Facts is provided in the linear format, however, the declared format is not as specified in 21 CFR 101.9(G)(13)(ii)(2). Specifically, the serving size is not declared in household measure, as required by 21 CFR 101.9(b)(7). The provided format does not distinguish the heading Nutrition Facts by presenting it in bold type. Note: The words Calories, Total Fat, Cholesterol, Sodium, Total Carbohydrates and Sodium may voluntarily be presented in bold type. The statement of identity is not presented in bold type on the principal display panel and is not parallel to the base on which the package rests as it is designed to be displayed, as required by 21 CFR 101.3(d), and the provided format does not include commas after each nutrient entry. Additionally, the product is further misbranded within the meaning of Section 403 (e) because it appears from the description of the sample that the submitted label is applied to a cellophane container. If this is the case, the net weight is not located on the Principal Display Panel (PDP) in accordance with the requirements of 21 CFR 101.105(f). The declaration of net weight for the submitted label is not in the lower 30% of the label. Note: The only time this placement provision does not apply is on products where the area of the Principal Display Panel (PDP) is 5 square inches or less.
Notes:VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Nutrition Facts is provided in the linear format, however, the declared format is not as specified in 21 CFR 101.9(G)(13)(ii)(2). Specifically, the serving size is not declared in household measure, as required by 21 CFR 101.9(b)(7). The provided format does not distinguish the heading Nutrition Facts by presenting it in bold type. Note: The words Calories, Total Fat, Cholesterol, Sodium, Total Carbohydrates and Sodium may voluntarily be presented in bold type. The statement of identity is not presented in bold type on the principal display panel and is not parallel to the base on which the package rests as it is designed to be displayed, as required by 21 CFR 101.3(d), and the provided format does not include commas after each nutrient entry. Additionally, the product is further misbranded within the meaning of Section 403 (e) because it appears from the description of the sample that the submitted label is applied to a cellophane container. If this is the case, the net weight is not located on the Principal Display Panel (PDP) in accordance with the requirements of 21 CFR 101.105(f). The declaration of net weight for the submitted label is not in the lower 30% of the label. Note: The only time this placement provision does not apply is on products where the area of the Principal Display Panel (PDP) is 5 square inches or less.
33 Y - - -- Candy Wo/Choc N.E.C.
Date Published: 10/28/2010
Desc:Rollo De Coco Soft Candy All Sizes (Coconut Candy Roll)
Notes:VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Nutrition Facts is provided in the linear format, however, the declared format is not as specified in 21 CFR 101.9(G)(13)(ii)(2). Specifically, the serving size is not declared in household measure, as required by 21 CFR 101.9(b)(7). The provided format does not distinguish the heading Nutrition Facts by presenting it in bold type. Note: The words Calories, Total Fat, Cholesterol, Sodium, Total Carbohydrates and Sodium may voluntarily be presented in bold type. The statement of identity is not presented in bold type on the principal display panel and is not parallel to the base on which the package rests as it is designed to be displayed, as required by 21 CFR 101.3(d), and the provided format does not include commas after each nutrient entry. Additionally, the product is further misbranded within the meaning of Section 403 (e) because it appears from the description of the sample that the submitted label is applied to a cellophane container. If this is the case, the net weight is not located on the Principal Display Panel (PDP) in accordance with the requirements of 21 CFR 101.105(f). The declaration of net weight for the submitted label is not in the lower 30% of the label. Note: The only time this placement provision does not apply is on products where the area of the Principal Display Panel (PDP) is 5 square inches or less.
Notes:VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Nutrition Facts is provided in the linear format, however, the declared format is not as specified in 21 CFR 101.9(G)(13)(ii)(2). Specifically, the serving size is not declared in household measure, as required by 21 CFR 101.9(b)(7). The provided format does not distinguish the heading Nutrition Facts by presenting it in bold type. Note: The words Calories, Total Fat, Cholesterol, Sodium, Total Carbohydrates and Sodium may voluntarily be presented in bold type. The statement of identity is not presented in bold type on the principal display panel and is not parallel to the base on which the package rests as it is designed to be displayed, as required by 21 CFR 101.3(d), and the provided format does not include commas after each nutrient entry. Additionally, the product is further misbranded within the meaning of Section 403 (e) because it appears from the description of the sample that the submitted label is applied to a cellophane container. If this is the case, the net weight is not located on the Principal Display Panel (PDP) in accordance with the requirements of 21 CFR 101.105(f). The declaration of net weight for the submitted label is not in the lower 30% of the label. Note: The only time this placement provision does not apply is on products where the area of the Principal Display Panel (PDP) is 5 square inches or less.
La Zagala de Los Altos SA de CV
Date Published : 10/28/2010
JOSE RUIZ #109 COL. LA ZAGALA , SAN JUAN DE LOS LAGOS, Mx-Jal MEXICO
33 B - - 99 Hard Candy with Coconut, N.E.C. (without Chocolate)
Date Published: 12/07/2010
Desc:Alfajor (Coconut Candy)
Notes:VIOLATION: Product is misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343 (q)] in that: the Servings Per Container is not declared as required by [21 CFR 101.9(d)(3)(ii)]; the Total Calorie content is not expressed to the nearest 10- calorie increment [21 CFR 101.9(c)(1)]; the Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1)(ii)]; the Sodium content is not expressed in accordance with 21 CFR 101.9(c)(4); the Trans fat content is not declared as required by [21 CFR 101.9(c)(2)(ii)]; the Vitamin and Minerals are not declared in accordance with 21 CFR 101.9(c)(8)(iii); the product label fails to include a footnote that states, "Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs... "as required by 21 CFR 101.9(d)(9); and, the Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d).
Notes:VIOLATION: Product is misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343 (q)] in that: the Servings Per Container is not declared as required by [21 CFR 101.9(d)(3)(ii)]; the Total Calorie content is not expressed to the nearest 10- calorie increment [21 CFR 101.9(c)(1)]; the Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1)(ii)]; the Sodium content is not expressed in accordance with 21 CFR 101.9(c)(4); the Trans fat content is not declared as required by [21 CFR 101.9(c)(2)(ii)]; the Vitamin and Minerals are not declared in accordance with 21 CFR 101.9(c)(8)(iii); the product label fails to include a footnote that states, "Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs... "as required by 21 CFR 101.9(d)(9); and, the Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d).
33 C - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Fruit (without Chocolate)
Date Published: 10/28/2010
Desc:Jamoncillo (Milk Candy Bar)
Notes:Violation: The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. Specifically, the serving size declaration for this product, "48grs" is not expressed in common Household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12(b). Also, the Servings Per Container is not declared as required by [21 CFR 101.9(d)(3)(ii)]. In addition, the Total Calorie content is not expressed to the nearest 10-calorie increment [21 CFR 101.9(c)(1)].
Notes:Violation: The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. Specifically, the serving size declaration for this product, "48grs" is not expressed in common Household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12(b). Also, the Servings Per Container is not declared as required by [21 CFR 101.9(d)(3)(ii)]. In addition, the Total Calorie content is not expressed to the nearest 10-calorie increment [21 CFR 101.9(c)(1)].
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 12/07/2010
Desc:Alfajor (Coconut Candy)
Notes:VIOLATION: Product is misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343 (q)] in that: the Servings Per Container is not declared as required by [21 CFR 101.9(d)(3)(ii)]; the Total Calorie content is not expressed to the nearest 10- calorie increment [21 CFR 101.9(c)(1)]; the Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1)(ii)]; the Sodium content is not expressed in accordance with 21 CFR 101.9(c)(4); the Trans fat content is not declared as required by [21 CFR 101.9(c)(2)(ii)]; the Vitamin and Minerals are not declared in accordance with 21 CFR 101.9(c)(8)(iii); the product label fails to include a footnote that states, "Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs... "as required by 21 CFR 101.9(d)(9); and, the Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d).
Notes:VIOLATION: Product is misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343 (q)] in that: the Servings Per Container is not declared as required by [21 CFR 101.9(d)(3)(ii)]; the Total Calorie content is not expressed to the nearest 10- calorie increment [21 CFR 101.9(c)(1)]; the Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1)(ii)]; the Sodium content is not expressed in accordance with 21 CFR 101.9(c)(4); the Trans fat content is not declared as required by [21 CFR 101.9(c)(2)(ii)]; the Vitamin and Minerals are not declared in accordance with 21 CFR 101.9(c)(8)(iii); the product label fails to include a footnote that states, "Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs... "as required by 21 CFR 101.9(d)(9); and, the Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d).
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 10/28/2010
Desc:Jamoncillo (Milk Candy Bar)
Notes:Violation: The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. Specifically, the serving size declaration for this product, "48grs" is not expressed in common Household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12(b). Also, the Servings Per Container is not declared as required by [21 CFR 101.9(d)(3)(ii)]. In addition, the Total Calorie content is not expressed to the nearest 10-calorie increment [21 CFR 101.9(c)(1)].
Notes:Violation: The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. Specifically, the serving size declaration for this product, "48grs" is not expressed in common Household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12(b). Also, the Servings Per Container is not declared as required by [21 CFR 101.9(d)(3)(ii)]. In addition, the Total Calorie content is not expressed to the nearest 10-calorie increment [21 CFR 101.9(c)(1)].
Manuel Gonzalez Blanco
Date Published : 09/16/2009
Ahuehuete No. 53 ( Juncos y Sauces ) , Fraccionamiento Floresta , Veracruz, MX-VER MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 11/12/2009
Desc:Corn Silk Blend Capsules (Cabellos de Elote Enebro)
Notes:Product is misbranded under 403(q)(5)(F) in that the nutrition label does not include adequate information; Product is further misbranded under 403(a)(1)in that the declared value for Vitamin E is false & misleading; Product is further misbranded under 403(i)(2) in that the label does not declare the capsule ingredient; and under 403(s)(2)(C)in that the label does not declare the plant parts used {21CFR 101.36; 101.3(g); and 101.4(h)} 8/13/07 MANUFACTURER: Plantas Medicinales Anahuac SA de CV; FEI #1000599639
Notes:Product is misbranded under 403(q)(5)(F) in that the nutrition label does not include adequate information; Product is further misbranded under 403(a)(1)in that the declared value for Vitamin E is false & misleading; Product is further misbranded under 403(i)(2) in that the label does not declare the capsule ingredient; and under 403(s)(2)(C)in that the label does not declare the plant parts used {21CFR 101.36; 101.3(g); and 101.4(h)} 8/13/07 MANUFACTURER: Plantas Medicinales Anahuac SA de CV; FEI #1000599639
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/12/2009
Desc:Su-K rofitina syrup
Notes:The nutritional information is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403(q)] 6/30/06 MANUFACTURER: Plantas Medicinales Anahuac SA de CV; FEI #1000599639
Notes:The nutritional information is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403(q)] 6/30/06 MANUFACTURER: Plantas Medicinales Anahuac SA de CV; FEI #1000599639
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/12/2009
Desc:Su-K rofitina syrup
Notes:The nutritional information is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403(q)] 6/30/06 MANUFACTURER: Plantas Medicinales Anahuac SA de CV; FEI #1000599639
Notes:The nutritional information is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403(q)] 6/30/06 MANUFACTURER: Plantas Medicinales Anahuac SA de CV; FEI #1000599639
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/12/2009
Desc:Corn Silk Blend Capsules (Cabellos de Elote Enebro)
Notes:Product is misbranded under 403(q)(5)(F) in that the nutrition label does not include adequate information; Product is further misbranded under 403(a)(1)in that the declared value for Vitamin E is false & misleading; Product is further misbranded under 403(i)(2) in that the label does not declare the capsule ingredient; and under 403(s)(2)(C)in that the label does not declare the plant parts used {21CFR 101.36; 101.3(g); and 101.4(h)} 8/13/07 MANUFACTURER: Plantas Medicinales Anahuac SA de CV; FEI #1000599639
Notes:Product is misbranded under 403(q)(5)(F) in that the nutrition label does not include adequate information; Product is further misbranded under 403(a)(1)in that the declared value for Vitamin E is false & misleading; Product is further misbranded under 403(i)(2) in that the label does not declare the capsule ingredient; and under 403(s)(2)(C)in that the label does not declare the plant parts used {21CFR 101.36; 101.3(g); and 101.4(h)} 8/13/07 MANUFACTURER: Plantas Medicinales Anahuac SA de CV; FEI #1000599639
NATURAL DE ALIMENTOS, S.A. DE C.V.
Date Published : 06/05/2012
LOMA LINDA CAMINO AL ROSARIO KM 2,5, , COLONIA LOMA LINDA , San Juan Del Rio, MX-QUE MEXICO
26 E - - 01 Oleomargarine
Date Published: 06/05/2012
Desc:Saborex Margarine
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the nutrition facts information does not meet the format requirements as required by 21 CFR 101.9. Specifically, the Nutrition Facts panel is not in the proper format, and the serving size does not appear to be based on the Reference Amount Customarily Consumed (RACC) for margarine specified in Table 2 of 21 CFR 101.12 (b). In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act in that the nutrition label is not in English as required by 21 CFR 101.15(c)(1). Lastly, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(g) of the Act because it appears to purport to be margarine; however, based on the nutrition information and ingredient list the product does not appear to meet the standard for margarine as required by 21 CFR 166.110. Specifically, in accordance with 21 CFR 166.110(a), margarine must contain not less than 80 percent fat; however, the nutrition label declares fat as 72 g per 100 g (72%). In addition, in accordance with 21 CFR 166.110(a)(3), margarine must contain at least 15,000 international units per pound of vitamin A. The nutrition label does not declare vitamin A and the ingredient list does not appear to contain any ingredient that is a source of vitamin A.
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the nutrition facts information does not meet the format requirements as required by 21 CFR 101.9. Specifically, the Nutrition Facts panel is not in the proper format, and the serving size does not appear to be based on the Reference Amount Customarily Consumed (RACC) for margarine specified in Table 2 of 21 CFR 101.12 (b). In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act in that the nutrition label is not in English as required by 21 CFR 101.15(c)(1). Lastly, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(g) of the Act because it appears to purport to be margarine; however, based on the nutrition information and ingredient list the product does not appear to meet the standard for margarine as required by 21 CFR 166.110. Specifically, in accordance with 21 CFR 166.110(a), margarine must contain not less than 80 percent fat; however, the nutrition label declares fat as 72 g per 100 g (72%). In addition, in accordance with 21 CFR 166.110(a)(3), margarine must contain at least 15,000 international units per pound of vitamin A. The nutrition label does not declare vitamin A and the ingredient list does not appear to contain any ingredient that is a source of vitamin A.
26 E - - 99 Oleomargarine, N.E.C.
Date Published: 06/05/2012
Desc:Saborex Margarine
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the nutrition facts information does not meet the format requirements as required by 21 CFR 101.9. Specifically, the Nutrition Facts panel is not in the proper format, and the serving size does not appear to be based on the Reference Amount Customarily Consumed (RACC) for margarine specified in Table 2 of 21 CFR 101.12 (b). In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act in that the nutrition label is not in English as required by 21 CFR 101.15(c)(1). Lastly, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(g) of the Act because it appears to purport to be margarine; however, based on the nutrition information and ingredient list the product does not appear to meet the standard for margarine as required by 21 CFR 166.110. Specifically, in accordance with 21 CFR 166.110(a), margarine must contain not less than 80 percent fat; however, the nutrition label declares fat as 72 g per 100 g (72%). In addition, in accordance with 21 CFR 166.110(a)(3), margarine must contain at least 15,000 international units per pound of vitamin A. The nutrition label does not declare vitamin A and the ingredient list does not appear to contain any ingredient that is a source of vitamin A.
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the nutrition facts information does not meet the format requirements as required by 21 CFR 101.9. Specifically, the Nutrition Facts panel is not in the proper format, and the serving size does not appear to be based on the Reference Amount Customarily Consumed (RACC) for margarine specified in Table 2 of 21 CFR 101.12 (b). In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act in that the nutrition label is not in English as required by 21 CFR 101.15(c)(1). Lastly, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(g) of the Act because it appears to purport to be margarine; however, based on the nutrition information and ingredient list the product does not appear to meet the standard for margarine as required by 21 CFR 166.110. Specifically, in accordance with 21 CFR 166.110(a), margarine must contain not less than 80 percent fat; however, the nutrition label declares fat as 72 g per 100 g (72%). In addition, in accordance with 21 CFR 166.110(a)(3), margarine must contain at least 15,000 international units per pound of vitamin A. The nutrition label does not declare vitamin A and the ingredient list does not appear to contain any ingredient that is a source of vitamin A.
PRODUCTOS DE HARINA SA DE CV
Date Published : 04/10/2012
calle # 32 231 x 21 y 28 , col garcia ginebres , Merida, MX-YUC MEXICO
04 A - - 05 Spaghetti
Date Published: 04/10/2012
Desc:Noodles Pasta Alimentes Fideos
Notes:VIOLATION: The following product Pasta Alimentes Fideos Noodles fails to declare iron as per 21 CFR 101.9(g)(4)(ii) ,in that, the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore, these articles are misbranded within the meaning of section 403(a) of the ACT, in that; the labels are false or misleading. The vitamins and minerals are not ordered in accordance with 21 CFR 101.9(c)(8)(iii). The Nutrition Facts Panel headings are not bolded nor are nutrients indented as required and hairlines are not used appropriately. [21 CFR 101.9(d)] Further more, the product is misbranded within the meaning of Section 403(q) of the Act in that the nutritional facts information is not declared in accordance with the requirements under 21 CFR 101.9. For example: The serving declaration, 25g is not in expressed in common household measure. The Total Calorie content is not expressed to the nearest 10-calorie increment [21 CFR 101.9(c)(1)] The Saturated Fat content should be expressed as zero when a serving contains less that 0.5-grams of saturated fat [ 21 CFR 101.9(c)(2)(i)] The Cholesterol content should be expressed to the nearest milligram [21 CFR 101.9(c)(3)] The Sodium content should be expressed in milligrams. In addition, when a serving contains less that 5-milligrams of sodium, it should be expressed as zero. [21 CFR 101.9(c)(4)] The Total carbohydrate content in a serving should be declared as Carbohydrate, total or Total carbohydrate and should be expressed in grams. [21 CFR 101.9(c)(6)] The Sugar content should be declared as Sugars. [21 CFR 101.9(c)(6)(ii)] The Protein should be expressed to the nearest gram. [21 CFR 101.9(c)(7)] Vitamins and minerals shall be expressed to the nearest 2% increment up to and including 10-percent level and the nearest 5% increment above 10% and including 50% level. [21 CFR 101.9(c)(8)(iii)]
Notes:VIOLATION: The following product Pasta Alimentes Fideos Noodles fails to declare iron as per 21 CFR 101.9(g)(4)(ii) ,in that, the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore, these articles are misbranded within the meaning of section 403(a) of the ACT, in that; the labels are false or misleading. The vitamins and minerals are not ordered in accordance with 21 CFR 101.9(c)(8)(iii). The Nutrition Facts Panel headings are not bolded nor are nutrients indented as required and hairlines are not used appropriately. [21 CFR 101.9(d)] Further more, the product is misbranded within the meaning of Section 403(q) of the Act in that the nutritional facts information is not declared in accordance with the requirements under 21 CFR 101.9. For example: The serving declaration, 25g is not in expressed in common household measure. The Total Calorie content is not expressed to the nearest 10-calorie increment [21 CFR 101.9(c)(1)] The Saturated Fat content should be expressed as zero when a serving contains less that 0.5-grams of saturated fat [ 21 CFR 101.9(c)(2)(i)] The Cholesterol content should be expressed to the nearest milligram [21 CFR 101.9(c)(3)] The Sodium content should be expressed in milligrams. In addition, when a serving contains less that 5-milligrams of sodium, it should be expressed as zero. [21 CFR 101.9(c)(4)] The Total carbohydrate content in a serving should be declared as Carbohydrate, total or Total carbohydrate and should be expressed in grams. [21 CFR 101.9(c)(6)] The Sugar content should be declared as Sugars. [21 CFR 101.9(c)(6)(ii)] The Protein should be expressed to the nearest gram. [21 CFR 101.9(c)(7)] Vitamins and minerals shall be expressed to the nearest 2% increment up to and including 10-percent level and the nearest 5% increment above 10% and including 50% level. [21 CFR 101.9(c)(8)(iii)]
Pablo Ignacio Michel Ontiveros
Date Published : 07/02/2012
Carretera Escuela De Agricultura 7620 , La Venta Del Astillero, MEXICO
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 07/02/2012
Desc:Botu 2 Lollipop with Chili Powder (Assort Fruit Flavors)
Notes:VIOLATION (IN NOTES): 1. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded product within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example: The Caloric content is not declared in accordance with 21 CFR 101.9(c)(l). Specifically, the caloric content should be declared as "Calories" and the units should be in calories, not "k" or "kcal." The "Energy Content" may be expressed in kilojoules units, added in parentheses immediately following the statement of caloric content. The Trans fat content is not declared as required by 21 CFR 101.9(c)(2)(ii). The Calcium and Iron content is not declared as required by 21 CFR 101.9(c)(8) (ii)..
Notes:VIOLATION (IN NOTES): 1. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded product within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example: The Caloric content is not declared in accordance with 21 CFR 101.9(c)(l). Specifically, the caloric content should be declared as "Calories" and the units should be in calories, not "k" or "kcal." The "Energy Content" may be expressed in kilojoules units, added in parentheses immediately following the statement of caloric content. The Trans fat content is not declared as required by 21 CFR 101.9(c)(2)(ii). The Calcium and Iron content is not declared as required by 21 CFR 101.9(c)(8) (ii)..
Pablo Ignacio Michel Ontiveros Grupo Industrial Michel
Date Published : 07/02/2012
Quintana Roo 1611, Col. Guadalupana , Guadalajara, MX-JAL MEXICO
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 07/02/2012
Desc:Botu 2 Lollipop with Chili Powder (Assort Fruit Flavors)
Notes:VIOLATION (IN NOTES): 1. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded product within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example: The Caloric content is not declared in accordance with 21 CFR 101.9(c)(l). Specifically, the caloric content should be declared as "Calories" and the units should be in calories, not "k" or "kcal." The "Energy Content" may be expressed in kilojoules units, added in parentheses immediately following the statement of caloric content. The Trans fat content is not declared as required by 21 CFR 101.9(c)(2)(ii). The Calcium and Iron content is not declared as required by 21 CFR 101.9(c)(8) (ii)..
Notes:VIOLATION (IN NOTES): 1. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded product within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example: The Caloric content is not declared in accordance with 21 CFR 101.9(c)(l). Specifically, the caloric content should be declared as "Calories" and the units should be in calories, not "k" or "kcal." The "Energy Content" may be expressed in kilojoules units, added in parentheses immediately following the statement of caloric content. The Trans fat content is not declared as required by 21 CFR 101.9(c)(2)(ii). The Calcium and Iron content is not declared as required by 21 CFR 101.9(c)(8) (ii)..
Pastas Alimenticias Laziali Sa Cv
Date Published : 09/16/2009
Calle 4 Norte No. 301 Lote 17 , Toluca, Edo. De Mexico, MEXICO
04 C - - 02 Noodles, Enriched
Date Published: 11/12/2009
Desc:Stars Pasta (Faraon Brand)
Notes:Product?s label fails to bear required nutrition information in the format required by 21CFR 101.9; specifically; label print too small; incorrect bolding; no indentation. Serving size visual unit of measure not listed first; calories not expressed in 10 cal increment. [Misbranded; Section 403 (q)] NOTE; this product is also indicated for detention in that it does not meet the 21 CFR 139.115(a)(1) requirement for enriched macaroni products; laboratory analysis revealed the product contained less than 1.7mg/lb of riboflavin; 21 CFR 139.115(a)(1) requires between 1.7mg/lb and 2.2mg/lb of riboflavin for enriched macaroni products [Misbranded; section 403(g); use OASIS charge code STD IDENT] 7/20/05
Notes:Product?s label fails to bear required nutrition information in the format required by 21CFR 101.9; specifically; label print too small; incorrect bolding; no indentation. Serving size visual unit of measure not listed first; calories not expressed in 10 cal increment. [Misbranded; Section 403 (q)] NOTE; this product is also indicated for detention in that it does not meet the 21 CFR 139.115(a)(1) requirement for enriched macaroni products; laboratory analysis revealed the product contained less than 1.7mg/lb of riboflavin; 21 CFR 139.115(a)(1) requires between 1.7mg/lb and 2.2mg/lb of riboflavin for enriched macaroni products [Misbranded; section 403(g); use OASIS charge code STD IDENT] 7/20/05
04 C - - 02 Noodles, Enriched
Date Published: 11/12/2009
Desc:Alphabet Pasta (Faraon Brand)
Notes:Product?s label fails to bear required nutrition information in the format required by 21CFR 101.9; specifically; label print too small; incorrect bolding; no indentation. Serving size visual unit of measure not listed first; calories not expressed in 10 cal increment. [Misbranded; Section 403 (q)] 7/20/05
Notes:Product?s label fails to bear required nutrition information in the format required by 21CFR 101.9; specifically; label print too small; incorrect bolding; no indentation. Serving size visual unit of measure not listed first; calories not expressed in 10 cal increment. [Misbranded; Section 403 (q)] 7/20/05
04 C - - 99 Noodles And Noodle Products, N.E.C.
Date Published: 11/12/2009
Desc:Alphabet Pasta (Faraon Brand)
Notes:Product?s label fails to bear required nutrition information in the format required by 21CFR 101.9; specifically; label print too small; incorrect bolding; no indentation. Serving size visual unit of measure not listed first; calories not expressed in 10 cal increment. [Misbranded; Section 403 (q)] 7/20/05
Notes:Product?s label fails to bear required nutrition information in the format required by 21CFR 101.9; specifically; label print too small; incorrect bolding; no indentation. Serving size visual unit of measure not listed first; calories not expressed in 10 cal increment. [Misbranded; Section 403 (q)] 7/20/05
04 C - - 99 Noodles And Noodle Products, N.E.C.
Date Published: 11/12/2009
Desc:Stars Pasta (Faraon Brand)
Notes:Product?s label fails to bear required nutrition information in the format required by 21CFR 101.9; specifically; label print too small; incorrect bolding; no indentation. Serving size visual unit of measure not listed first; calories not expressed in 10 cal increment. [Misbranded; Section 403 (q)] NOTE; this product is also indicated for detention in that it does not meet the 21 CFR 139.115(a)(1) requirement for enriched macaroni products; laboratory analysis revealed the product contained less than 1.7mg/lb of riboflavin; 21 CFR 139.115(a)(1) requires between 1.7mg/lb and 2.2mg/lb of riboflavin for enriched macaroni products [Misbranded; section 403(g); use OASIS charge code STD IDENT] 7/20/05
Notes:Product?s label fails to bear required nutrition information in the format required by 21CFR 101.9; specifically; label print too small; incorrect bolding; no indentation. Serving size visual unit of measure not listed first; calories not expressed in 10 cal increment. [Misbranded; Section 403 (q)] NOTE; this product is also indicated for detention in that it does not meet the 21 CFR 139.115(a)(1) requirement for enriched macaroni products; laboratory analysis revealed the product contained less than 1.7mg/lb of riboflavin; 21 CFR 139.115(a)(1) requires between 1.7mg/lb and 2.2mg/lb of riboflavin for enriched macaroni products [Misbranded; section 403(g); use OASIS charge code STD IDENT] 7/20/05
Pastas y Galletas de Tijuana, S. A. de C.V.
Date Published : 09/16/2009
Calle Jose Gallego L. # 13250 , Col. 20 De Noviembre, La Mesa , Tijuana, MX-BCN MEXICO
04 A - - 01 Macaroni Enriched
Date Published: 11/12/2009
Desc:Pagasa Brand Macaroni Products;
Notes:Product?s label fails to bear required nutrition information in the format required by 21CFR 101.9; specifically; the label does not list trans fat as required in 21 CFR 101.9(c)(2)(ii) [Misbranded; Section 403 (q)] 12/20/07 NOTE: these products are also indicated for detention because their labeling fails to declare the presence of the major food allergen ¿wheat¿ as required by section 403(w)(1) of the Act. The products list semolina in the ingredient statement (semolina is wheat and wheat is a major food allergen). [Misbranded, section 403(w); use OASIS charge code ALLERGEN]
Notes:Product?s label fails to bear required nutrition information in the format required by 21CFR 101.9; specifically; the label does not list trans fat as required in 21 CFR 101.9(c)(2)(ii) [Misbranded; Section 403 (q)] 12/20/07 NOTE: these products are also indicated for detention because their labeling fails to declare the presence of the major food allergen ¿wheat¿ as required by section 403(w)(1) of the Act. The products list semolina in the ingredient statement (semolina is wheat and wheat is a major food allergen). [Misbranded, section 403(w); use OASIS charge code ALLERGEN]
Plantas Medicinales Anahuac, S.A. De C.V.
Date Published : 09/16/2009
Oriente 255, #57, Col. Agricola Oriental , Del. Iztacalco , Mexico City (Mexico, D.F.), MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 11/12/2009
Desc:Corn Silk Blend Capsules (Cabellos de Elote Enebro)
Notes:Product is misbranded under 403(q)(5)(F) in that the nutrition label does not include adequate information; Product is further misbranded under 403(a)(1)in that the declared value for Vitamin E is false & misleading; Product is further misbranded under 403(i)(2) in that the label does not declare the capsule ingredient; and under 403(s)(2)(C)in that the label does not declare the plant parts used {21CFR 101.36; 101.3(g); and 101.4(h)} 8/13/07 SHIPPER: Manuel Goknzalez Blanco, FEI #3004679342
Notes:Product is misbranded under 403(q)(5)(F) in that the nutrition label does not include adequate information; Product is further misbranded under 403(a)(1)in that the declared value for Vitamin E is false & misleading; Product is further misbranded under 403(i)(2) in that the label does not declare the capsule ingredient; and under 403(s)(2)(C)in that the label does not declare the plant parts used {21CFR 101.36; 101.3(g); and 101.4(h)} 8/13/07 SHIPPER: Manuel Goknzalez Blanco, FEI #3004679342
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/12/2009
Desc:Su-K rofitina syrup
Notes:The nutritional information is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403(q)] 6/30/06 SHIPPER: Manuel Goknzalez Blanco, FEI #3004679342
Notes:The nutritional information is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403(q)] 6/30/06 SHIPPER: Manuel Goknzalez Blanco, FEI #3004679342
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/12/2009
Desc:Su-K rofitina syrup
Notes:The nutritional information is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403(q)] 6/30/06 SHIPPER: Manuel Goknzalez Blanco, FEI #3004679342
Notes:The nutritional information is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403(q)] 6/30/06 SHIPPER: Manuel Goknzalez Blanco, FEI #3004679342
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/12/2009
Desc:Corn Silk Blend Capsules (Cabellos de Elote Enebro)
Notes:Product is misbranded under 403(q)(5)(F) in that the nutrition label does not include adequate information; Product is further misbranded under 403(a)(1)in that the declared value for Vitamin E is false & misleading; Product is further misbranded under 403(i)(2) in that the label does not declare the capsule ingredient; and under 403(s)(2)(C)in that the label does not declare the plant parts used {21CFR 101.36; 101.3(g); and 101.4(h)} 8/13/07 SHIPPER: Manuel Goknzalez Blanco, FEI #3004679342
Notes:Product is misbranded under 403(q)(5)(F) in that the nutrition label does not include adequate information; Product is further misbranded under 403(a)(1)in that the declared value for Vitamin E is false & misleading; Product is further misbranded under 403(i)(2) in that the label does not declare the capsule ingredient; and under 403(s)(2)(C)in that the label does not declare the plant parts used {21CFR 101.36; 101.3(g); and 101.4(h)} 8/13/07 SHIPPER: Manuel Goknzalez Blanco, FEI #3004679342
Productos Avila Sa De Cv
Date Published : 09/16/2009
Puerto Melaque 1379 Col Sta Maria , Guadalajara, JAL MEXICO
33 J - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Fruit (without Chocolate)
Date Published: 09/16/2009
Notes:Liquid (Liquid Chili Snack/Barril con Chili)
33 L - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, without Nuts and Fruit (without Chocolate)
Date Published: 09/16/2009
Notes:Liquid (Liquid Chili Snack/Barril con Chili)
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 09/16/2009
Notes:Liquid (Liquid Chili Snack/Barril con Chili)
Productos Bryanda
Date Published : 04/11/2011
Constituyentes No 268 Col Ley 57 , Hermosillo, MEXICO
03 J - - 10 Creme Filled/Iced Cookie,Biscuit,Wafer
Date Published: 04/11/2011
Desc:Filled Pastries (Coyotas)
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801 (a)(3) of the Act in that the label appears to be misbranded under section 403(i)(2) because the label fails to properly declare the ingredients of this product. The English translation of the Spanish ingredient declaration is incorrect. The English translation of the ingredient statement declares "milk candy", but the Spanish version declares "leche condensada" which translates as "condensed (concentrated) milk". In addition, the Spanish ingredient statement lists "aceite vegetal" (vegetable fat) and the English ingredient statement lists "vegetal fat", which both fail to include the source of the fat in accordance with 21 CFR 101.4(b) (14). The Spanish version of the ingredient statement also does not declare the "molasses" and "water" ingredients that are declared on the English version. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9: ¿ It does not appear that this product qualifies for the linear display as shown in the product label. We also question whether or not the nutrition label meets the minimum type size requirements as specified in 21 CFR 101.9(d)(l)(iii).
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801 (a)(3) of the Act in that the label appears to be misbranded under section 403(i)(2) because the label fails to properly declare the ingredients of this product. The English translation of the Spanish ingredient declaration is incorrect. The English translation of the ingredient statement declares "milk candy", but the Spanish version declares "leche condensada" which translates as "condensed (concentrated) milk". In addition, the Spanish ingredient statement lists "aceite vegetal" (vegetable fat) and the English ingredient statement lists "vegetal fat", which both fail to include the source of the fat in accordance with 21 CFR 101.4(b) (14). The Spanish version of the ingredient statement also does not declare the "molasses" and "water" ingredients that are declared on the English version. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9: ¿ It does not appear that this product qualifies for the linear display as shown in the product label. We also question whether or not the nutrition label meets the minimum type size requirements as specified in 21 CFR 101.9(d)(l)(iii).
33 L - - 99 Soft Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 04/11/2011
Desc:Filled Pastries (Coyotas)
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801 (a)(3) of the Act in that the label appears to be misbranded under section 403(i)(2) because the label fails to properly declare the ingredients of this product. The English translation of the Spanish ingredient declaration is incorrect. The English translation of the ingredient statement declares "milk candy", but the Spanish version declares "leche condensada" which translates as "condensed (concentrated) milk". In addition, the Spanish ingredient statement lists "aceite vegetal" (vegetable fat) and the English ingredient statement lists "vegetal fat", which both fail to include the source of the fat in accordance with 21 CFR 101.4(b) (14). The Spanish version of the ingredient statement also does not declare the "molasses" and "water" ingredients that are declared on the English version. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9: ¿ It does not appear that this product qualifies for the linear display as shown in the product label. We also question whether or not the nutrition label meets the minimum type size requirements as specified in 21 CFR 101.9(d)(l)(iii).
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801 (a)(3) of the Act in that the label appears to be misbranded under section 403(i)(2) because the label fails to properly declare the ingredients of this product. The English translation of the Spanish ingredient declaration is incorrect. The English translation of the ingredient statement declares "milk candy", but the Spanish version declares "leche condensada" which translates as "condensed (concentrated) milk". In addition, the Spanish ingredient statement lists "aceite vegetal" (vegetable fat) and the English ingredient statement lists "vegetal fat", which both fail to include the source of the fat in accordance with 21 CFR 101.4(b) (14). The Spanish version of the ingredient statement also does not declare the "molasses" and "water" ingredients that are declared on the English version. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9: ¿ It does not appear that this product qualifies for the linear display as shown in the product label. We also question whether or not the nutrition label meets the minimum type size requirements as specified in 21 CFR 101.9(d)(l)(iii).
33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 04/11/2011
Desc:Filled Pastries (Coyotas)
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801 (a)(3) of the Act in that the label appears to be misbranded under section 403(i)(2) because the label fails to properly declare the ingredients of this product. The English translation of the Spanish ingredient declaration is incorrect. The English translation of the ingredient statement declares "milk candy", but the Spanish version declares "leche condensada" which translates as "condensed (concentrated) milk". In addition, the Spanish ingredient statement lists "aceite vegetal" (vegetable fat) and the English ingredient statement lists "vegetal fat", which both fail to include the source of the fat in accordance with 21 CFR 101.4(b) (14). The Spanish version of the ingredient statement also does not declare the "molasses" and "water" ingredients that are declared on the English version. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9: ¿ It does not appear that this product qualifies for the linear display as shown in the product label. We also question whether or not the nutrition label meets the minimum type size requirements as specified in 21 CFR 101.9(d)(l)(iii).
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801 (a)(3) of the Act in that the label appears to be misbranded under section 403(i)(2) because the label fails to properly declare the ingredients of this product. The English translation of the Spanish ingredient declaration is incorrect. The English translation of the ingredient statement declares "milk candy", but the Spanish version declares "leche condensada" which translates as "condensed (concentrated) milk". In addition, the Spanish ingredient statement lists "aceite vegetal" (vegetable fat) and the English ingredient statement lists "vegetal fat", which both fail to include the source of the fat in accordance with 21 CFR 101.4(b) (14). The Spanish version of the ingredient statement also does not declare the "molasses" and "water" ingredients that are declared on the English version. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9: ¿ It does not appear that this product qualifies for the linear display as shown in the product label. We also question whether or not the nutrition label meets the minimum type size requirements as specified in 21 CFR 101.9(d)(l)(iii).
Productos Cihuapilli
Date Published : 09/16/2009
Luis Cabrera No. 562 , Colinas de la Normal , Guadalajara, Jalisco MEXICO
33 H - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Coconut (without Chocolate)
Date Published: 09/16/2009
Notes:Coconut Candy Rolls
33 H - - 12 Mixed/Assorted Soft Candy with Coconut (without Chcocolate)
Date Published: 09/16/2009
Notes:Coconut Candy Rolls
33 H - - 99 Soft Candy with Coconut, N.E.C. (without Chocolate)
Date Published: 09/16/2009
Notes:Coconut Candy Rolls
33 S - - 05 Marzipan, Coconut Roll (without Chocolate)
Date Published: 09/16/2009
Notes:Coconut Candy Rolls
33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 09/16/2009
Notes:Coconut Candy Rolls
Productos De Leche Aldama S.A. De C.V
Date Published : 01/13/2011
Calzada De Guadalupe No. 2 , Guanajuato, Mexico, MEXICO
33 L - - 02 Caramel Candy Pieces, Soft, without Nuts and Fruit (without Chocolate)
Date Published: 01/13/2011
Desc:Caramel Wafers (Obleas Aldama Soft Candy)
Notes:VIOLATION; Product is misbranded within the meaning of section 403(q) of the Act because of major formatting deviations in the Nutrition Facts panel.
Notes:VIOLATION; Product is misbranded within the meaning of section 403(q) of the Act because of major formatting deviations in the Nutrition Facts panel.
33 T - - 02 Caramel Topping (Topping without Fruit, Nuts or Chocolate)
Date Published: 01/13/2011
Desc:Caramel Wafers (Obleas Aldama Soft Candy)
Notes:VIOLATION; Product is misbranded within the meaning of section 403(q) of the Act because of major formatting deviations in the Nutrition Facts panel.
Notes:VIOLATION; Product is misbranded within the meaning of section 403(q) of the Act because of major formatting deviations in the Nutrition Facts panel.
Productos Del Valle
Date Published : 06/08/2012
Av.Del Rayo #67 Col. San Clemente , Mexicali, B.C., Mexico, MEXICO
07 A - - 02 Corn Chips, Baked
Date Published: 06/08/2012
Desc:Corn Snacks (Churritos De Maiz Super 30)
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) in that the outer multi-pack label is fabricated from two or more ingredients, and the common or usual name of each such ingredient is not declared in accordance with 21 CFR 101.4. In addition, the article appears to be misbranded within the meaning of section 403 (q) in that the outer multi-pack label fails to bear nutrition information in accordance with 21 CFR 101.9. In addition, the article appears to be misbranded within the meaning of section 403 (i)(2) in that the inner individual bag label fails to declared corn and wheat flour collectively as required by 21 CFR 101.4(a) and the specific type of vegetable oil is not declared as required by 21 CFR 101.4(b)(14). Lastly, the article appears to be misbranded within the meaning of section 403(q) in that inner individual bag label fails to present the nutritional information as prescribed by 21 CFR 101.9(d). For example, the foreign language should follow English, and improper bolding, indentation, rounding, placement of headings and use of hairlines/bars. In addition, there is no percent daily value for trans fat.
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) in that the outer multi-pack label is fabricated from two or more ingredients, and the common or usual name of each such ingredient is not declared in accordance with 21 CFR 101.4. In addition, the article appears to be misbranded within the meaning of section 403 (q) in that the outer multi-pack label fails to bear nutrition information in accordance with 21 CFR 101.9. In addition, the article appears to be misbranded within the meaning of section 403 (i)(2) in that the inner individual bag label fails to declared corn and wheat flour collectively as required by 21 CFR 101.4(a) and the specific type of vegetable oil is not declared as required by 21 CFR 101.4(b)(14). Lastly, the article appears to be misbranded within the meaning of section 403(q) in that inner individual bag label fails to present the nutritional information as prescribed by 21 CFR 101.9(d). For example, the foreign language should follow English, and improper bolding, indentation, rounding, placement of headings and use of hairlines/bars. In addition, there is no percent daily value for trans fat.
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/08/2012
Desc:Corn Snacks (Churritos De Maiz Super 30)
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) in that the outer multi-pack label is fabricated from two or more ingredients, and the common or usual name of each such ingredient is not declared in accordance with 21 CFR 101.4. In addition, the article appears to be misbranded within the meaning of section 403 (q) in that the outer multi-pack label fails to bear nutrition information in accordance with 21 CFR 101.9. In addition, the article appears to be misbranded within the meaning of section 403 (i)(2) in that the inner individual bag label fails to declared corn and wheat flour collectively as required by 21 CFR 101.4(a) and the specific type of vegetable oil is not declared as required by 21 CFR 101.4(b)(14). Lastly, the article appears to be misbranded within the meaning of section 403(q) in that inner individual bag label fails to present the nutritional information as prescribed by 21 CFR 101.9(d). For example, the foreign language should follow English, and improper bolding, indentation, rounding, placement of headings and use of hairlines/bars. In addition, there is no percent daily value for trans fat.
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) in that the outer multi-pack label is fabricated from two or more ingredients, and the common or usual name of each such ingredient is not declared in accordance with 21 CFR 101.4. In addition, the article appears to be misbranded within the meaning of section 403 (q) in that the outer multi-pack label fails to bear nutrition information in accordance with 21 CFR 101.9. In addition, the article appears to be misbranded within the meaning of section 403 (i)(2) in that the inner individual bag label fails to declared corn and wheat flour collectively as required by 21 CFR 101.4(a) and the specific type of vegetable oil is not declared as required by 21 CFR 101.4(b)(14). Lastly, the article appears to be misbranded within the meaning of section 403(q) in that inner individual bag label fails to present the nutritional information as prescribed by 21 CFR 101.9(d). For example, the foreign language should follow English, and improper bolding, indentation, rounding, placement of headings and use of hairlines/bars. In addition, there is no percent daily value for trans fat.
07 B - - 02 Corn Chips, Fried
Date Published: 06/08/2012
Desc:Corn Snacks (Churritos De Maiz Super 30)
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) in that the outer multi-pack label is fabricated from two or more ingredients, and the common or usual name of each such ingredient is not declared in accordance with 21 CFR 101.4. In addition, the article appears to be misbranded within the meaning of section 403 (q) in that the outer multi-pack label fails to bear nutrition information in accordance with 21 CFR 101.9. In addition, the article appears to be misbranded within the meaning of section 403 (i)(2) in that the inner individual bag label fails to declared corn and wheat flour collectively as required by 21 CFR 101.4(a) and the specific type of vegetable oil is not declared as required by 21 CFR 101.4(b)(14). Lastly, the article appears to be misbranded within the meaning of section 403(q) in that inner individual bag label fails to present the nutritional information as prescribed by 21 CFR 101.9(d). For example, the foreign language should follow English, and improper bolding, indentation, rounding, placement of headings and use of hairlines/bars. In addition, there is no percent daily value for trans fat.
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) in that the outer multi-pack label is fabricated from two or more ingredients, and the common or usual name of each such ingredient is not declared in accordance with 21 CFR 101.4. In addition, the article appears to be misbranded within the meaning of section 403 (q) in that the outer multi-pack label fails to bear nutrition information in accordance with 21 CFR 101.9. In addition, the article appears to be misbranded within the meaning of section 403 (i)(2) in that the inner individual bag label fails to declared corn and wheat flour collectively as required by 21 CFR 101.4(a) and the specific type of vegetable oil is not declared as required by 21 CFR 101.4(b)(14). Lastly, the article appears to be misbranded within the meaning of section 403(q) in that inner individual bag label fails to present the nutritional information as prescribed by 21 CFR 101.9(d). For example, the foreign language should follow English, and improper bolding, indentation, rounding, placement of headings and use of hairlines/bars. In addition, there is no percent daily value for trans fat.
07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 06/08/2012
Desc:Corn Snacks (Churritos De Maiz Super 30)
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) in that the outer multi-pack label is fabricated from two or more ingredients, and the common or usual name of each such ingredient is not declared in accordance with 21 CFR 101.4. In addition, the article appears to be misbranded within the meaning of section 403 (q) in that the outer multi-pack label fails to bear nutrition information in accordance with 21 CFR 101.9. In addition, the article appears to be misbranded within the meaning of section 403 (i)(2) in that the inner individual bag label fails to declared corn and wheat flour collectively as required by 21 CFR 101.4(a) and the specific type of vegetable oil is not declared as required by 21 CFR 101.4(b)(14). Lastly, the article appears to be misbranded within the meaning of section 403(q) in that inner individual bag label fails to present the nutritional information as prescribed by 21 CFR 101.9(d). For example, the foreign language should follow English, and improper bolding, indentation, rounding, placement of headings and use of hairlines/bars. In addition, there is no percent daily value for trans fat.
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) in that the outer multi-pack label is fabricated from two or more ingredients, and the common or usual name of each such ingredient is not declared in accordance with 21 CFR 101.4. In addition, the article appears to be misbranded within the meaning of section 403 (q) in that the outer multi-pack label fails to bear nutrition information in accordance with 21 CFR 101.9. In addition, the article appears to be misbranded within the meaning of section 403 (i)(2) in that the inner individual bag label fails to declared corn and wheat flour collectively as required by 21 CFR 101.4(a) and the specific type of vegetable oil is not declared as required by 21 CFR 101.4(b)(14). Lastly, the article appears to be misbranded within the meaning of section 403(q) in that inner individual bag label fails to present the nutritional information as prescribed by 21 CFR 101.9(d). For example, the foreign language should follow English, and improper bolding, indentation, rounding, placement of headings and use of hairlines/bars. In addition, there is no percent daily value for trans fat.
07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 06/08/2012
Desc:Corn Snacks (Churritos De Maiz Super 30)
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) in that the outer multi-pack label is fabricated from two or more ingredients, and the common or usual name of each such ingredient is not declared in accordance with 21 CFR 101.4. In addition, the article appears to be misbranded within the meaning of section 403 (q) in that the outer multi-pack label fails to bear nutrition information in accordance with 21 CFR 101.9. In addition, the article appears to be misbranded within the meaning of section 403 (i)(2) in that the inner individual bag label fails to declared corn and wheat flour collectively as required by 21 CFR 101.4(a) and the specific type of vegetable oil is not declared as required by 21 CFR 101.4(b)(14). Lastly, the article appears to be misbranded within the meaning of section 403(q) in that inner individual bag label fails to present the nutritional information as prescribed by 21 CFR 101.9(d). For example, the foreign language should follow English, and improper bolding, indentation, rounding, placement of headings and use of hairlines/bars. In addition, there is no percent daily value for trans fat.
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) in that the outer multi-pack label is fabricated from two or more ingredients, and the common or usual name of each such ingredient is not declared in accordance with 21 CFR 101.4. In addition, the article appears to be misbranded within the meaning of section 403 (q) in that the outer multi-pack label fails to bear nutrition information in accordance with 21 CFR 101.9. In addition, the article appears to be misbranded within the meaning of section 403 (i)(2) in that the inner individual bag label fails to declared corn and wheat flour collectively as required by 21 CFR 101.4(a) and the specific type of vegetable oil is not declared as required by 21 CFR 101.4(b)(14). Lastly, the article appears to be misbranded within the meaning of section 403(q) in that inner individual bag label fails to present the nutritional information as prescribed by 21 CFR 101.9(d). For example, the foreign language should follow English, and improper bolding, indentation, rounding, placement of headings and use of hairlines/bars. In addition, there is no percent daily value for trans fat.
Productos de Trigo SA de CV
Date Published : 09/16/2009
Quetzal No. 1132 Col Morelos , Guadalajara, Jalisco MEXICO
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/15/2010
Desc:Rancheritas Cookies
Notes:5/1/06
Notes:5/1/06
03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C.
Date Published: 09/16/2009
Notes:Rancheritas Cookies; 5/1/06
SABRITAS, S.de R.L. de C.V.
Date Published : 08/29/2012
Norte 45 #740 , Colonia Industrial Vallejo , Mexico City, MX-DIF MEXICO
07 B - - 02 Corn Chips, Fried
Date Published: 08/29/2012
Desc:Tostitos Salsa Verde Corn Chips Cheetos Horneados Bolitas Chips
Notes:VIOLATION (IN NOTES): 1. 403(1)(r)(A); 2. 403(i)(2); 3. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(l)(A) for the following reasons: -- The Cheetos Horneados Bolitas product declares Low in Saturated Fat and 25% less saturated fat, but fails to meet the requirements of21 CFR 101.62(c)(2) and 21 CFR 101.130). -- The Tostitos Salsa Verde product declares "Og trans fat on the PDP, but fails to declare the disclosure statement required under 21 CFR 101.13(h); this statement is required because it contains 5g of saturated fat per 50g (based on the label declaration);2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i) (2) for failing to declare the common or usual name for each ingredient in accordance with 21 CFR lOl A. -- The Cheetos Horneados Bolitas product declares the ingredient mixed cheeses which is not the common or usual name of an ingredient. In addition the sub- ingredients of mixed cheeses, corn flakes and chili mix are not declared. -- The Tostitos Salsa Verde Chip product declares hydrolyzed protein meat, which is not the common or usual name of the ingredient in accordance with 21 CFR lOlA. -- The Tostitos Salsa Verde and Cheetos Horneados Bolitas, products fail to declare "flavorings" in accordance with 21 CFR 101.22; and vegetable oil is not declared in accordance with 21 CFR 101.4(b)(l4);3. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) for the following reasons:
Notes:VIOLATION (IN NOTES): 1. 403(1)(r)(A); 2. 403(i)(2); 3. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(l)(A) for the following reasons: -- The Cheetos Horneados Bolitas product declares Low in Saturated Fat and 25% less saturated fat, but fails to meet the requirements of21 CFR 101.62(c)(2) and 21 CFR 101.130). -- The Tostitos Salsa Verde product declares "Og trans fat on the PDP, but fails to declare the disclosure statement required under 21 CFR 101.13(h); this statement is required because it contains 5g of saturated fat per 50g (based on the label declaration);2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i) (2) for failing to declare the common or usual name for each ingredient in accordance with 21 CFR lOl A. -- The Cheetos Horneados Bolitas product declares the ingredient mixed cheeses which is not the common or usual name of an ingredient. In addition the sub- ingredients of mixed cheeses, corn flakes and chili mix are not declared. -- The Tostitos Salsa Verde Chip product declares hydrolyzed protein meat, which is not the common or usual name of the ingredient in accordance with 21 CFR lOlA. -- The Tostitos Salsa Verde and Cheetos Horneados Bolitas, products fail to declare "flavorings" in accordance with 21 CFR 101.22; and vegetable oil is not declared in accordance with 21 CFR 101.4(b)(l4);3. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) for the following reasons:
07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 08/29/2012
Desc:Tostitos Salsa Verde Corn Chips Cheetos Horneados Bolitas Chips
Notes:VIOLATION (IN NOTES): 1. 403(1)(r)(A); 2. 403(i)(2); 3. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(l)(A) for the following reasons: -- The Cheetos Horneados Bolitas product declares Low in Saturated Fat and 25% less saturated fat, but fails to meet the requirements of21 CFR 101.62(c) (2) and 21 CFR 101.130). -- The Tostitos Salsa Verde product declares "Og trans fat on the PDP, but fails to declare the disclosure statement required under 21 CFR 101.13(h); this statement is required because it contains 5g of saturated fat per 50g (based on the label declaration);2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i) (2) for failing to declare the common or usual name for each ingredient in accordance with 21 CFR lOl A. -- The Cheetos Horneados Bolitas product declares the ingredient mixed cheeses which is not the common or usual name of an ingredient. In addition the sub- ingredients of mixed cheeses, corn flakes and chili mix are not declared. -- The Tostitos Salsa Verde Chip product declares hydrolyzed protein meat, which is not the common or usual name of the ingredient in accordance with 21 CFR lOlA. -- The Tostitos Salsa Verde and Cheetos Horneados Bolitas, products fail to declare "flavorings" in accordance with 21 CFR 101.22; and vegetable oil is not declared in accordance with 21 CFR 101.4 (b)(l4);3. The article is subject to refusal of admission pursuant to Section 801(a) (3) in that it appears to be misbranded within the meaning of 403(q) for the following reasons: ;
Notes:VIOLATION (IN NOTES): 1. 403(1)(r)(A); 2. 403(i)(2); 3. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(l)(A) for the following reasons: -- The Cheetos Horneados Bolitas product declares Low in Saturated Fat and 25% less saturated fat, but fails to meet the requirements of21 CFR 101.62(c) (2) and 21 CFR 101.130). -- The Tostitos Salsa Verde product declares "Og trans fat on the PDP, but fails to declare the disclosure statement required under 21 CFR 101.13(h); this statement is required because it contains 5g of saturated fat per 50g (based on the label declaration);2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i) (2) for failing to declare the common or usual name for each ingredient in accordance with 21 CFR lOl A. -- The Cheetos Horneados Bolitas product declares the ingredient mixed cheeses which is not the common or usual name of an ingredient. In addition the sub- ingredients of mixed cheeses, corn flakes and chili mix are not declared. -- The Tostitos Salsa Verde Chip product declares hydrolyzed protein meat, which is not the common or usual name of the ingredient in accordance with 21 CFR lOlA. -- The Tostitos Salsa Verde and Cheetos Horneados Bolitas, products fail to declare "flavorings" in accordance with 21 CFR 101.22; and vegetable oil is not declared in accordance with 21 CFR 101.4 (b)(l4);3. The article is subject to refusal of admission pursuant to Section 801(a) (3) in that it appears to be misbranded within the meaning of 403(q) for the following reasons: ;
Salud Natural Mexicana SA de CV
Date Published : 09/16/2009
Av. Inglaterra 3109 , Col. Arcos Sur , Guadalajara, Jalisco MEXICO
54 A - - 99 Vitamin, N.E.C.
Date Published: 09/16/2009
Notes:ActiKrol Brand Glutamic Acid Syrup for Children
54 B - - 01 Calcium (Mineral)
Date Published: 09/16/2009
Notes:Caltron 600 D calcium supplent
54 C - - 07 L-Glutamic Acid (Protein)
Date Published: 09/16/2009
Notes:ActiKrol Brand Glutamic Acid Syrup for Children
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/16/2009
Notes:Dinamax Jr. a liquid vitamin supplement
Toma Products, S.A. de C.V. (Planta)
Date Published : 09/16/2009
Carretera Los Pinos Km 1.5 , Ramos Arizpe, MX-COA MEXICO
22 D - - 01 Cantaloupe, Juice, Vine Fruit Juices or Concentrates
Date Published: 09/16/2009
Notes:Agua Fruta Melon(Cantaloupe) Fruit Drink
Unilever de Mexico, S. de R.L de C.V
Date Published : 08/14/2012
Temascalapa No 2 , Col. Rancho Sto. Domingo , Tultitlan, Mx-Mex MEXICO
26 E - - 01 Oleomargarine
Date Published: 08/14/2012
Desc:Flex Margarine Blue
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. For example: The Sugar content is not declared as required by [21 CFR 101.9(c)(6)(ii)]. The Vitamin and Mineral content is not declared as required by [21 CFR 101.9(c) (8)]. The product label fails to include a footnote that states, Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs as required by 21 CFR 101.9(d)(9). The Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d). The serving size declaration for this product, "5g" is not expressed in common household measure in accordance with 21 CFR101.9(b)(5) and 21 CFR 101.12(b). For example, a sample serving size statement is "1 tbsp (_ g)"; or "1 tbsp (15mL). The Caloric content is not declared in accordance with 21 CFR 101.9(c)(1). Specifically, the caloric content units should be in calories, not KJ KCAL. The Energy Content may be expressed in kilojoule units, added in parentheses immediately following the statement of caloric content. The Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1) (ii)]. The Total Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2). The Polyunsaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iii). The Monosaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iv). The Dietary Fiber content is not declared as required by [21 CFR 101.9(c)(6)(i)].
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. For example: The Sugar content is not declared as required by [21 CFR 101.9(c)(6)(ii)]. The Vitamin and Mineral content is not declared as required by [21 CFR 101.9(c) (8)]. The product label fails to include a footnote that states, Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs as required by 21 CFR 101.9(d)(9). The Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d). The serving size declaration for this product, "5g" is not expressed in common household measure in accordance with 21 CFR101.9(b)(5) and 21 CFR 101.12(b). For example, a sample serving size statement is "1 tbsp (_ g)"; or "1 tbsp (15mL). The Caloric content is not declared in accordance with 21 CFR 101.9(c)(1). Specifically, the caloric content units should be in calories, not KJ KCAL. The Energy Content may be expressed in kilojoule units, added in parentheses immediately following the statement of caloric content. The Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1) (ii)]. The Total Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2). The Polyunsaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iii). The Monosaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iv). The Dietary Fiber content is not declared as required by [21 CFR 101.9(c)(6)(i)].
26 E - - 01 Oleomargarine
Date Published: 08/14/2012
Desc:Flex Margarine Red
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. For example: The Sugar content is not declared as required by [21 CFR 101.9(c)(6)(ii)]. The Vitamin and Mineral content is not declared as required by [21 CFR 101.9(c) (8)]. The product label fails to include a footnote that states, Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs as required by 21 CFR 101.9(d)(9). The Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d). The serving size declaration for this product, "5g" is not expressed in common household measure in accordance with 21 CFR101.9(b)(5) and 21 CFR 101.12(b). For example, a sample serving size statement is "1 tbsp (_ g)"; or "1 tbsp (15mL). The Caloric content is not declared in accordance with 21 CFR 101.9(c)(1). Specifically, the caloric content units should be in calories, not KJ KCAL. The Energy Content may be expressed in kilojoule units, added in parentheses immediately following the statement of caloric content. The Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1) (ii)]. The Total Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2). The Polyunsaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iii). The Monosaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iv). The Dietary Fiber content is not declared as required by [21 CFR 101.9(c)(6)(i)].
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. For example: The Sugar content is not declared as required by [21 CFR 101.9(c)(6)(ii)]. The Vitamin and Mineral content is not declared as required by [21 CFR 101.9(c) (8)]. The product label fails to include a footnote that states, Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs as required by 21 CFR 101.9(d)(9). The Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d). The serving size declaration for this product, "5g" is not expressed in common household measure in accordance with 21 CFR101.9(b)(5) and 21 CFR 101.12(b). For example, a sample serving size statement is "1 tbsp (_ g)"; or "1 tbsp (15mL). The Caloric content is not declared in accordance with 21 CFR 101.9(c)(1). Specifically, the caloric content units should be in calories, not KJ KCAL. The Energy Content may be expressed in kilojoule units, added in parentheses immediately following the statement of caloric content. The Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1) (ii)]. The Total Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2). The Polyunsaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iii). The Monosaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iv). The Dietary Fiber content is not declared as required by [21 CFR 101.9(c)(6)(i)].
26 E - - 99 Oleomargarine, N.E.C.
Date Published: 08/14/2012
Desc:Flex Margarine Red
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. For example: The Sugar content is not declared as required by [21 CFR 101.9(c)(6)(ii)]. The Vitamin and Mineral content is not declared as required by [21 CFR 101.9(c) (8)]. The product label fails to include a footnote that states, Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs as required by 21 CFR 101.9(d)(9). The Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d). The serving size declaration for this product, "5g" is not expressed in common household measure in accordance with 21 CFR101.9(b)(5) and 21 CFR 101.12(b). For example, a sample serving size statement is "1 tbsp (_ g)"; or "1 tbsp (15mL). The Caloric content is not declared in accordance with 21 CFR 101.9(c)(1). Specifically, the caloric content units should be in calories, not KJ KCAL. The Energy Content may be expressed in kilojoule units, added in parentheses immediately following the statement of caloric content. The Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1) (ii)]. The Total Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2). The Polyunsaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iii). The Monosaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iv). The Dietary Fiber content is not declared as required by [21 CFR 101.9(c)(6)(i)]. ;
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. For example: The Sugar content is not declared as required by [21 CFR 101.9(c)(6)(ii)]. The Vitamin and Mineral content is not declared as required by [21 CFR 101.9(c) (8)]. The product label fails to include a footnote that states, Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs as required by 21 CFR 101.9(d)(9). The Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d). The serving size declaration for this product, "5g" is not expressed in common household measure in accordance with 21 CFR101.9(b)(5) and 21 CFR 101.12(b). For example, a sample serving size statement is "1 tbsp (_ g)"; or "1 tbsp (15mL). The Caloric content is not declared in accordance with 21 CFR 101.9(c)(1). Specifically, the caloric content units should be in calories, not KJ KCAL. The Energy Content may be expressed in kilojoule units, added in parentheses immediately following the statement of caloric content. The Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1) (ii)]. The Total Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2). The Polyunsaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iii). The Monosaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iv). The Dietary Fiber content is not declared as required by [21 CFR 101.9(c)(6)(i)]. ;
26 E - - 99 Oleomargarine, N.E.C.
Date Published: 08/14/2012
Desc:Flex Margarine Blue
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. For example: The Sugar content is not declared as required by [21 CFR 101.9(c)(6)(ii)]. The Vitamin and Mineral content is not declared as required by [21 CFR 101.9(c) (8)]. The product label fails to include a footnote that states, Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs as required by 21 CFR 101.9(d)(9). The Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d). The serving size declaration for this product, "5g" is not expressed in common household measure in accordance with 21 CFR101.9(b)(5) and 21 CFR 101.12(b). For example, a sample serving size statement is "1 tbsp (_ g)"; or "1 tbsp (15mL). The Caloric content is not declared in accordance with 21 CFR 101.9(c)(1). Specifically, the caloric content units should be in calories, not KJ KCAL. The Energy Content may be expressed in kilojoule units, added in parentheses immediately following the statement of caloric content. The Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1) (ii)]. The Total Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2). The Polyunsaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iii). The Monosaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iv). The Dietary Fiber content is not declared as required by [21 CFR 101.9(c)(6)(i)].
Notes:The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. For example: The Sugar content is not declared as required by [21 CFR 101.9(c)(6)(ii)]. The Vitamin and Mineral content is not declared as required by [21 CFR 101.9(c) (8)]. The product label fails to include a footnote that states, Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs as required by 21 CFR 101.9(d)(9). The Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d). The serving size declaration for this product, "5g" is not expressed in common household measure in accordance with 21 CFR101.9(b)(5) and 21 CFR 101.12(b). For example, a sample serving size statement is "1 tbsp (_ g)"; or "1 tbsp (15mL). The Caloric content is not declared in accordance with 21 CFR 101.9(c)(1). Specifically, the caloric content units should be in calories, not KJ KCAL. The Energy Content may be expressed in kilojoule units, added in parentheses immediately following the statement of caloric content. The Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1) (ii)]. The Total Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2). The Polyunsaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iii). The Monosaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iv). The Dietary Fiber content is not declared as required by [21 CFR 101.9(c)(6)(i)].
NETHERLANDS
Visser Kaashandel BV
Date Published : 06/02/2010
Nijverheidsweg 20 , Huizen, Noord-holland NETHERLANDS
12 A - - 12 Cheese, Edam
Date Published: 06/02/2010
Desc:Edam Cheese
Notes:Product is misbranded within the meaning of section 403(i)(2) in that the label does not declare the product ingredients by the common or usual name as required by 21 CFR 101.4; Also; the product label does not declare the name and place of business of the manufacturer; packer or distributor in accordance with 21 CFR 101.5; Also; the product label does not declare the major food allergen properly using the word ¿contains¿; followed by the name of the food source from which the major food allergen is derived; Also; the product label does not declare the color additive(s) as required by 21 CFR 101.22.
Notes:Product is misbranded within the meaning of section 403(i)(2) in that the label does not declare the product ingredients by the common or usual name as required by 21 CFR 101.4; Also; the product label does not declare the name and place of business of the manufacturer; packer or distributor in accordance with 21 CFR 101.5; Also; the product label does not declare the major food allergen properly using the word ¿contains¿; followed by the name of the food source from which the major food allergen is derived; Also; the product label does not declare the color additive(s) as required by 21 CFR 101.22.
PAKISTAN
Unilever Pakistan Foods Limited
Date Published : 10/04/2010
52-km Lathore-multan Road , Bhai Pheru, PAKISTAN
04 C - - 07 Noodles, Instant
Date Published: 10/04/2010
Desc:Chatt Patta Instant Noodles
Notes:VIOLATION; Product is misbranded within the meaning of section 403(q)(1) of the Act because the serving size declaration does not include the common household measure [21 CFR 101.9(b)(7)] and the serving size does not represent the product as packaged [21 CFR 101.9(a)(1)]; Product is further misbranded within the meaning of section 403(i) of the Act because the ingredients declared on the label are not all declared by their common or usual name; including; "noodle cake;" "vegetable oil;" "refined salt;" "maize starch;" "carbonates;" "permitted food color;" and "antioxidant" [21 CFR 101.4] and the label does not indicate the function for the preservatives sodium and potassium phosphates [21 CFR 101.4(a)(I)]; Product is further misbranded within the meaning of section 403(g) because the product purports to be a "noodle" product; which is defined under 21 CFR 139.150; but fails to contain any egg ingredient(s).; Product is further misbranded within the meaning of section 403(f) because the net quantity of contents statement is on the product label; but it is not prominent and conspicuous since it is incorrectly placed below the ingredient statement on the information panel; rather than on the principal display panel [21 CFR 101.105(f)]; the net quantity of contents statement is not declared in terms of avoirdupois pounds and ounces [21 CFR 101.105(b)]; and the term "Net weight" is not included in the declaration of the weight of the product [21 CFR 101.105(u)(3)].;
Notes:VIOLATION; Product is misbranded within the meaning of section 403(q)(1) of the Act because the serving size declaration does not include the common household measure [21 CFR 101.9(b)(7)] and the serving size does not represent the product as packaged [21 CFR 101.9(a)(1)]; Product is further misbranded within the meaning of section 403(i) of the Act because the ingredients declared on the label are not all declared by their common or usual name; including; "noodle cake;" "vegetable oil;" "refined salt;" "maize starch;" "carbonates;" "permitted food color;" and "antioxidant" [21 CFR 101.4] and the label does not indicate the function for the preservatives sodium and potassium phosphates [21 CFR 101.4(a)(I)]; Product is further misbranded within the meaning of section 403(g) because the product purports to be a "noodle" product; which is defined under 21 CFR 139.150; but fails to contain any egg ingredient(s).; Product is further misbranded within the meaning of section 403(f) because the net quantity of contents statement is on the product label; but it is not prominent and conspicuous since it is incorrectly placed below the ingredient statement on the information panel; rather than on the principal display panel [21 CFR 101.105(f)]; the net quantity of contents statement is not declared in terms of avoirdupois pounds and ounces [21 CFR 101.105(b)]; and the term "Net weight" is not included in the declaration of the weight of the product [21 CFR 101.105(u)(3)].;
PHILIPPINES
EXTREME XCIENCE, INC.
Date Published : 07/19/2012
UNIT 1010 ANTEL GLOBAL CORPORATE CENTER , # 3 JULIA VARGAS ST., ORTIGAS CENTER , Metro Manila, National Capital Region PHILIPPINES
25 G - - 99 Mixed Vegetables, Juice or Drink, N.E.C.
Date Published: 07/19/2012
Desc:Greenlife Veggie Plus Health Drink
Notes:NOTE; SRL analyzed the protein content of these products (sample #728571; #728624). Their findings indicate that these products were violative for protein content; as percent label declared amount. The lab?s review of the labels also found that the products do not comply with NLEA or DSHEA labeling requirements.
Notes:NOTE; SRL analyzed the protein content of these products (sample #728571; #728624). Their findings indicate that these products were violative for protein content; as percent label declared amount. The lab?s review of the labels also found that the products do not comply with NLEA or DSHEA labeling requirements.
50 L - - 32 Vegetable Juice
Date Published: 07/19/2012
Desc:Greenlife Veggie Plus Health Drink
Notes:NOTE; SRL analyzed the protein content of these products (sample #728571; #728624). Their findings indicate that these products were violative for protein content; as percent label declared amount. The lab?s review of the labels also found that the products do not comply with NLEA or DSHEA labeling requirements.
Notes:NOTE; SRL analyzed the protein content of these products (sample #728571; #728624). Their findings indicate that these products were violative for protein content; as percent label declared amount. The lab?s review of the labels also found that the products do not comply with NLEA or DSHEA labeling requirements.
Edlou Enterprises
Date Published : 09/16/2009
341 Cristobal Street, Samapaloc, Manila , Manila, PH-ILS PHILIPPINES
16 J - H 05 Shrimp & Prawns
Date Published: 09/16/2009
Notes:Dried Shrimp Fry
16 X - H 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 09/16/2009
Notes:Dried Shrimp Fry
JOY TABLE SAUCE
Date Published : 04/12/2013
P-4, Km 13 Los Angeles, , Butuan City , PHILIPPINES
53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 04/12/2013
Notes:Desc; Hydrosol; Joy Tanglad Distilled Lemongrass (Hydrosol-Yellow Colored Label);Note; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear nutrition information enclosed in a box using hairlines with the title ?Supplement Facts?; in accordance with 21 CFR 101.36.
In addition; the article is misbranded within the meaning of sections 403(s)(2)(B) of the Act in that the label fails to identify the products using the term ?dietary supplement? in accordance with 21 CFR 101.3(g) as part of the product's statement of identity; except that the word
53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 04/12/2013
Desc:Hydrosol Joy Tanglad Distilled Lemongrass
Notes:Desc: Hydrosol; Joy Tanglad DNote: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear nutrition information enclosed in a box using hairlines with the title Supplement Facts , in accordance with 21 CFR 101.36;In addition, the article is misbranded within the meaning of section 403(s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g) as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product; In addition, the article is misbranded within the meaning of section 403(e)(1) of the Act in that the product fails to bear a label with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5 istilled Lemongrass (Orange Colored Label);
Notes:Desc: Hydrosol; Joy Tanglad DNote: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear nutrition information enclosed in a box using hairlines with the title Supplement Facts , in accordance with 21 CFR 101.36;In addition, the article is misbranded within the meaning of section 403(s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g) as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product; In addition, the article is misbranded within the meaning of section 403(e)(1) of the Act in that the product fails to bear a label with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5 istilled Lemongrass (Orange Colored Label);
53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 04/12/2013
Desc:Hydrosol Arapal Livelihood Distilled Lemongrass*
Notes:Desc; Hydrosol; Arapal Livelihood Distilled Lemongrass (Hydrosol-Lime Green/Yellow Gradient Label);Note: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear supplement facts information in accordance with 21 CFR 101.36. In addition, the article is misbranded within the meaning of sections 403 (s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g) as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product. In addition, the article is misbranded within the meaning of section 403(e) (1) of the Act in that the product fails to bear a label with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
Notes:Desc; Hydrosol; Arapal Livelihood Distilled Lemongrass (Hydrosol-Lime Green/Yellow Gradient Label);Note: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear supplement facts information in accordance with 21 CFR 101.36. In addition, the article is misbranded within the meaning of sections 403 (s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g) as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product. In addition, the article is misbranded within the meaning of section 403(e) (1) of the Act in that the product fails to bear a label with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/12/2013
Desc:Hydrosol Joy Tanglad Distilled Lemongrass
Notes:Desc: Hydrosol; Joy Tanglad DNote: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear nutrition information enclosed in a box using hairlines with the title Supplement Facts , in accordance with 21 CFR 101.36;In addition, the article is misbranded within the meaning of section 403(s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g) as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product; In addition, the article is misbranded within the meaning of section 403(e)(1) of the Act in that the product fails to bear a label with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5 istilled Lemongrass (Orange Colored Label); ;
Notes:Desc: Hydrosol; Joy Tanglad DNote: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear nutrition information enclosed in a box using hairlines with the title Supplement Facts , in accordance with 21 CFR 101.36;In addition, the article is misbranded within the meaning of section 403(s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g) as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product; In addition, the article is misbranded within the meaning of section 403(e)(1) of the Act in that the product fails to bear a label with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5 istilled Lemongrass (Orange Colored Label); ;
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/12/2013
Desc:Hydrosol Joy Tanglad Distilled Lemongrass*
Notes:Desc: Hydrosol; Joy Tanglad Distilled Lemongrass (Hydrosol-Yellow Colored Label) Note: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear nutrition information enclosed in a box using hairlines with the title Supplement Facts , in accordance with 21 CFR 101.36. In addition, the article is misbranded within the meaning of sections 403 (s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g) as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product. In addition, the article is misbranded within the meaning of section 403 (y) of the Act in that the label fails to include a domestic address or phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
Notes:Desc: Hydrosol; Joy Tanglad Distilled Lemongrass (Hydrosol-Yellow Colored Label) Note: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear nutrition information enclosed in a box using hairlines with the title Supplement Facts , in accordance with 21 CFR 101.36. In addition, the article is misbranded within the meaning of sections 403 (s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g) as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product. In addition, the article is misbranded within the meaning of section 403 (y) of the Act in that the label fails to include a domestic address or phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/12/2013
Desc:Hydrosol Arapal Livelihood Distilled Lemongrass*
Notes:Desc; Hydrosol; Arapal Livelihood Distilled Lemongrass (Hydrosol-Lime Green/Yellow Gradient Label)Note: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear supplement facts information in accordance with 21 CFR 101.36. In addition, the article is misbranded within the meaning of sections 403 (s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g) as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product. In addition, the article is misbranded within the meaning of section 403(e) (1) of the Act in that the product fails to bear a label with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
Notes:Desc; Hydrosol; Arapal Livelihood Distilled Lemongrass (Hydrosol-Lime Green/Yellow Gradient Label)Note: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear supplement facts information in accordance with 21 CFR 101.36. In addition, the article is misbranded within the meaning of sections 403 (s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g) as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product. In addition, the article is misbranded within the meaning of section 403(e) (1) of the Act in that the product fails to bear a label with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
Total Nature's Great Value, Inc.
Date Published : 09/16/2009
Balite I , Silang, Cavite PHILIPPINES
21 D - - 13 Berries and Subtropica/Tropical Fruits, Mixed, Juices or Concentrates
Date Published: 09/16/2009
Notes:Bio Enzyme Plus Natural Fruit Juice
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/16/2009
Notes:Bio Enzyme Plus Natural Fruit Juice
RUSSIA
"Market Plus" Co.Ltd
Date Published : 06/03/2010
11/1 Hlopina Str. Lit B , Sankt-Petersburg, RU-SPE RUSSIA
16 A - - 21 Herring
Date Published: 06/03/2010
Desc:Herring w/olives
Notes:This Product is misbranded within the meaning of 403(i)(2) The label declares the Ingredients ?E211? and ?E202? instead of using the common or usual names sodium benzoate and potassium sorbate and a seperate description of their functions [21CFR 101.22(j)]
Notes:This Product is misbranded within the meaning of 403(i)(2) The label declares the Ingredients ?E211? and ?E202? instead of using the common or usual names sodium benzoate and potassium sorbate and a seperate description of their functions [21CFR 101.22(j)]
16 A - - 21 Herring
Date Published: 06/03/2010
Desc:Tsar's Cuisine Herring in Oil w/Smoke flavor
Notes:These Product(s) are misbranded within the meaning of 403(f). The words; statements; and other required information does not appear to be in English on the label [21 CFR 101.15(c)(1)]
Notes:These Product(s) are misbranded within the meaning of 403(f). The words; statements; and other required information does not appear to be in English on the label [21 CFR 101.15(c)(1)]
16 A - - 21 Herring
Date Published: 06/03/2010
Desc:Herring Salted
Notes:These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
Notes:These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
16 - - - -- Fishery/Seafood Prod
Date Published: 06/03/2010
Desc:Kilka of Baltic Salted Small Fish
Notes:These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
Notes:These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
Baltic Shore Organization
Date Published : 06/03/2010
Paper Street , Division 17 Room 256 , Saint Petersburg, RUSSIA
16 A - - 21 Herring
Date Published: 06/03/2010
Desc:Herring w/olives
Notes:This Product is misbranded within the meaning of 403(i)(2) The label declares the Ingredients ¿E211¿ and ¿E202¿ instead of using the common or usual names sodium benzoate and potassium sorbate and a seperate description of their functions [21CFR 101.22(j)]
Notes:This Product is misbranded within the meaning of 403(i)(2) The label declares the Ingredients ¿E211¿ and ¿E202¿ instead of using the common or usual names sodium benzoate and potassium sorbate and a seperate description of their functions [21CFR 101.22(j)]
16 A - - 21 Herring
Date Published: 06/03/2010
Desc:Herring Salted
Notes:These Product(s) are misbranded within the meaning of 403(i)(2). The label declares an ingredient as ¿E211¿ instead of using the common or usual name sodium benzoate.[21CFR 101.22(j)] These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
Notes:These Product(s) are misbranded within the meaning of 403(i)(2). The label declares an ingredient as ¿E211¿ instead of using the common or usual name sodium benzoate.[21CFR 101.22(j)] These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
16 A - - 21 Herring
Date Published: 06/03/2010
Desc:Tsar's Cuisine Herring in Oil w/Smoke flavor
Notes:These Product(s) are misbranded within the meaning of 403(f). The words; statements; and other required information does not appear to be in English on the label [21 CFR 101.15(c)(1)]
Notes:These Product(s) are misbranded within the meaning of 403(f). The words; statements; and other required information does not appear to be in English on the label [21 CFR 101.15(c)(1)]
16 - - - -- Fishery/Seafood Prod
Date Published: 06/03/2010
Desc:Kilka of Baltic Salted Small Fish
Notes:These Product(s) are misbranded within the meaning of 403(i)(2). The label declares an ingredient as ¿E211¿ instead of using the common or usual name sodium benzoate.[21CFR 101.22(j)] These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
Notes:These Product(s) are misbranded within the meaning of 403(i)(2). The label declares an ingredient as ¿E211¿ instead of using the common or usual name sodium benzoate.[21CFR 101.22(j)] These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
Galan Oao
Date Published : 09/16/2009
158 Kommunisticheskaya St , Kurganinsk, RUSSIA
34 F - - 07 Mixed or Assorted Chocolate Candies (Bars, Boxes, Loose Form), without Nuts and Fruit
Date Published: 09/16/2009
Notes:Chocolate Egg Toy inside
34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 09/16/2009
Notes:Chocolate Egg Toy inside
Iriada International Limited
Date Published : 07/15/2011
Ul Novorybinskaya 19 21 , Building 529 , Sankt-peterburg, RU-LEN RUSSIA
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 07/15/2011
Desc:Soft Candy (Marmalade)
Notes:VIOLATION (IN NOTES): 1. 403(q) and 2. 403(i)(2) 1. The product fails to properly declare the serving size as specified by 21 CFR 101.9(b) and 101.12(b). Specifically, the product declares the serving size as 3.50z (l00 gr); however the established Reference Amount Customarily Consumed (RACC) for All other candies [21 CFR 101.12(b), Table 2, under Sugars and Sweets] is 40 g. Therefore, the nutrition information is not correct because it is not based on the established RACC provided for this product; The serving size is not expressed in a common household measure as required by 21 CFR 101.9(b)(5) and the "Servings Per Container" is not consistent with the requirements under 21 CFR 101.9(b)(8); The product fails to meet the requirements of 21 CFR 101.9(c) for the declaration of the required nutrients, the level of those nutrients, and the specified order of those nutrients. Specifically, the nutrition label fails to declare: calories from fat, saturated fat, trans fat, cholesterol, sodium, dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron. "Organic acid" is not permitted to be declared in the nutrition label. Also, protein must be declared after carbohydrate on the nutrition label. "Carbohydrate" must be declared as "Carbohydrate, total" or "Total carbohydrate"; The quantitative amounts of the declared nutrients are not rounded in accordance with 21 CFR 101.9(c) and the amounts are declared using commas instead of decimal points;¿ The nutrition information is not provided in the format specified by 21 CFR 101.9. For example, the full footnote is not provided in accordance with 21 CFR 101.9(d)(9)(i). Also, the nutrition label declares "gr" rather than the appropriate abbreviation, "g", for grams [21 CFR 101.9(d)(7)(i)]. In addition, the nutrition label fails to list the numerical percent of the DRV in a column aligned under the heading "% DV" as required per 21 CFR 101.9(d)(7)(ii).
Notes:VIOLATION (IN NOTES): 1. 403(q) and 2. 403(i)(2) 1. The product fails to properly declare the serving size as specified by 21 CFR 101.9(b) and 101.12(b). Specifically, the product declares the serving size as 3.50z (l00 gr); however the established Reference Amount Customarily Consumed (RACC) for All other candies [21 CFR 101.12(b), Table 2, under Sugars and Sweets] is 40 g. Therefore, the nutrition information is not correct because it is not based on the established RACC provided for this product; The serving size is not expressed in a common household measure as required by 21 CFR 101.9(b)(5) and the "Servings Per Container" is not consistent with the requirements under 21 CFR 101.9(b)(8); The product fails to meet the requirements of 21 CFR 101.9(c) for the declaration of the required nutrients, the level of those nutrients, and the specified order of those nutrients. Specifically, the nutrition label fails to declare: calories from fat, saturated fat, trans fat, cholesterol, sodium, dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron. "Organic acid" is not permitted to be declared in the nutrition label. Also, protein must be declared after carbohydrate on the nutrition label. "Carbohydrate" must be declared as "Carbohydrate, total" or "Total carbohydrate"; The quantitative amounts of the declared nutrients are not rounded in accordance with 21 CFR 101.9(c) and the amounts are declared using commas instead of decimal points;¿ The nutrition information is not provided in the format specified by 21 CFR 101.9. For example, the full footnote is not provided in accordance with 21 CFR 101.9(d)(9)(i). Also, the nutrition label declares "gr" rather than the appropriate abbreviation, "g", for grams [21 CFR 101.9(d)(7)(i)]. In addition, the nutrition label fails to list the numerical percent of the DRV in a column aligned under the heading "% DV" as required per 21 CFR 101.9(d)(7)(ii).
MARKET PLUS
Date Published : 06/03/2010
16 Uchitelskaya St , LIT B , ST PETERSBURG, RU-SPE RUSSIA
16 A - - 21 Herring
Date Published: 06/03/2010
Desc:Herring w/olives
Notes:This Product is misbranded within the meaning of 403(i)(2) The label declares the Ingredients ?E211? and ?E202? instead of using the common or usual names sodium benzoate and potassium sorbate and a seperate description of their functions [21CFR 101.22(j)]
Notes:This Product is misbranded within the meaning of 403(i)(2) The label declares the Ingredients ?E211? and ?E202? instead of using the common or usual names sodium benzoate and potassium sorbate and a seperate description of their functions [21CFR 101.22(j)]
16 A - - 21 Herring
Date Published: 06/03/2010
Desc:Tsar's Cuisine Herring in Oil w/smoke flavor
Notes:These Product(s) are misbranded within the meaning of 403(f). The words; statements; and other required information does not appear to be in English on the label [21 CFR 101.15(c)(1)]
Notes:These Product(s) are misbranded within the meaning of 403(f). The words; statements; and other required information does not appear to be in English on the label [21 CFR 101.15(c)(1)]
16 A - - 21 Herring
Date Published: 06/03/2010
Desc:Herring Salted
Notes:These Product(s) are misbranded within the meaning of 403(i)(2). The label declares an ingredient as ¿E211¿ instead of using the common or usual name sodium benzoate.[21CFR 101.22(j)] These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
Notes:These Product(s) are misbranded within the meaning of 403(i)(2). The label declares an ingredient as ¿E211¿ instead of using the common or usual name sodium benzoate.[21CFR 101.22(j)] These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
16 - - - -- Fishery/Seafood Prod
Date Published: 06/03/2010
Desc:Kilka of Baltic Salted Small Fish
Notes:These Product(s) are misbranded within the meaning of 403(i)(2). The label declares an ingredient as ¿E211¿ instead of using the common or usual name sodium benzoate.[21CFR 101.22(j)] These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
Notes:These Product(s) are misbranded within the meaning of 403(i)(2). The label declares an ingredient as ¿E211¿ instead of using the common or usual name sodium benzoate.[21CFR 101.22(j)] These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
Market Plus, LLC
Date Published : 06/03/2010
Uchitelskay 16, Lit B, Suite 1N , St. Petersburg, RU-LEN RUSSIA
16 A - - 21 Herring
Date Published: 06/03/2010
Desc:Herring w/olives
Notes:This Product is misbranded within the meaning of 403(i)(2) The label declares the Ingredients ?E211? and ?E202? instead of using the common or usual names sodium benzoate and potassium sorbate and a seperate description of their functions [21CFR 101.22(j)]
Notes:This Product is misbranded within the meaning of 403(i)(2) The label declares the Ingredients ?E211? and ?E202? instead of using the common or usual names sodium benzoate and potassium sorbate and a seperate description of their functions [21CFR 101.22(j)]
16 A - - 21 Herring
Date Published: 06/03/2010
Desc:Tsar's Cuisine Herring in Oil w/smoke flavor
Notes:These Product(s) are misbranded within the meaning of 403(f). The words; statements; and other required information does not appear to be in English on the label [21 CFR 101.15(c)(1)]
Notes:These Product(s) are misbranded within the meaning of 403(f). The words; statements; and other required information does not appear to be in English on the label [21 CFR 101.15(c)(1)]
16 A - - 21 Herring
Date Published: 06/03/2010
Desc:Herring Salted
Notes:These Product(s) are misbranded within the meaning of 403(i)(2). The label declares an ingredient as ¿E211¿ instead of using the common or usual name sodium benzoate.[21CFR 101.22(j)] These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
Notes:These Product(s) are misbranded within the meaning of 403(i)(2). The label declares an ingredient as ¿E211¿ instead of using the common or usual name sodium benzoate.[21CFR 101.22(j)] These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
16 - - - -- Fishery/Seafood Prod
Date Published: 06/03/2010
Desc:Kilka of Baltic Salted Small Fish
Notes:These Product(s) are misbranded within the meaning of 403(i)(2). The label declares an ingredient as ¿E211¿ instead of using the common or usual name sodium benzoate.[21CFR 101.22(j)] These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
Notes:These Product(s) are misbranded within the meaning of 403(i)(2). The label declares an ingredient as ¿E211¿ instead of using the common or usual name sodium benzoate.[21CFR 101.22(j)] These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading ¿Servings Per Container¿; ¿Amount Per Serving¿; ¿Calories from Fat¿; and ¿% Daily Value*¿ [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]
NAR LTD
Date Published : 06/20/2012
7A TCHAIKOVSKY STREET , Slantses, RU-LEN RUSSIA
22 K - - 01 Pomegranate, Juice, Other Fruit Juices or Concentrates
Date Published: 06/20/2012
Desc:Pomegranate Juice
Notes:VIOLATION (IN NOTES); 1. 403(q); 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.9 (e.g.; rounding of calories; indenting; holding; footnote not complete; and Nutrition Facts information is not set of in a box by the use of hairlines). 2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that the label or labeling fails to bear a percent juice declaration as required by 21 CFR 101.30.
Notes:VIOLATION (IN NOTES); 1. 403(q); 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.9 (e.g.; rounding of calories; indenting; holding; footnote not complete; and Nutrition Facts information is not set of in a box by the use of hairlines). 2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that the label or labeling fails to bear a percent juice declaration as required by 21 CFR 101.30.
NAR LTD
Date Published : 06/20/2012
7A TCHAIKOVSKY STREET , Slantses, RU-LEN RUSSIA
22 K - - 01 Pomegranate, Juice, Other Fruit Juices or Concentrates
Date Published: 06/20/2012
Desc:Pomegranate Juice
Notes:VIOLATION (IN NOTES); 1. 403(q); 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.9 (e.g.; rounding of calories; indenting; holding; footnote not complete; and Nutrition Facts information is not set of in a box by the use of hairlines). 2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that the label or labeling fails to bear a percent juice declaration as required by 21 CFR 101.30.
Notes:VIOLATION (IN NOTES); 1. 403(q); 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.9 (e.g.; rounding of calories; indenting; holding; footnote not complete; and Nutrition Facts information is not set of in a box by the use of hairlines). 2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that the label or labeling fails to bear a percent juice declaration as required by 21 CFR 101.30.
SOUTH AFRICA
Hersol Manufacturing Laboratories cc
Date Published : 10/06/2011
36 Maddison Street , Jeppestown , Johannesburg, ZA-GT SOUTH AFRICA
54 A - - 99 Vitamin, N.E.C.
Date Published: 10/06/2011
Desc:Antagolin (Dietary Supplement)
Notes:VIOLATION (IN NOTES): 403(q)(5)(F) Specifically, the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Supplement Facts panel) [Misbranded, Section 403 (q)(5)(F)]".
Notes:VIOLATION (IN NOTES): 403(q)(5)(F) Specifically, the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Supplement Facts panel) [Misbranded, Section 403 (q)(5)(F)]".
54 A - - 99 Vitamin, N.E.C.
Date Published: 10/06/2011
Desc:Nuerovance (Dietary Supplement)
Notes:VIOLATION (IN NOTES): 403(q)(5)(F) Specifically, the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Supplement Facts panel) [Misbranded, Section 403 (q)(5)(F)]".
Notes:VIOLATION (IN NOTES): 403(q)(5)(F) Specifically, the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Supplement Facts panel) [Misbranded, Section 403 (q)(5)(F)]".
Hersol Manufacturing Laboratories cc
Date Published : 10/06/2011
36 Maddison Street , Jeppestown , Johannesburg, ZA-GT SOUTH AFRICA
54 A - - 99 Vitamin, N.E.C.
Date Published: 10/06/2011
Desc:Nuerovance (Dietary Supplement)
Notes:VIOLATION (IN NOTES): 403(q)(5)(F) Specifically, the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Supplement Facts panel) [Misbranded, Section 403 (q)(5)(F)]".
Notes:VIOLATION (IN NOTES): 403(q)(5)(F) Specifically, the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Supplement Facts panel) [Misbranded, Section 403 (q)(5)(F)]".
54 A - - 99 Vitamin, N.E.C.
Date Published: 10/06/2011
Desc:Antagolin (Dietary Supplement)
Notes:VIOLATION (IN NOTES): 403(q)(5)(F) Specifically, the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Supplement Facts panel) [Misbranded, Section 403 (q)(5)(F)]".
Notes:VIOLATION (IN NOTES): 403(q)(5)(F) Specifically, the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Supplement Facts panel) [Misbranded, Section 403 (q)(5)(F)]".
Tiger Food Brands Limited
Date Published : 09/16/2009
3 Bayete Road , Maitland , Cape Town, ZA-WC SOUTH AFRICA
40 B - - 06 Wheat Cereal (Baby)
Date Published: 09/16/2009
Notes:Baby Cereal; wheat with bananas
40 B - - 20 Mixed Cereal, with Fruit (Baby)
Date Published: 09/16/2009
Notes:Baby Cereal; mix with strawberries
Tiger Food Brands Ltd - Culinary
Date Published : 09/16/2009
54 Oxford Street , Oxford Gate , Durbanville, SOUTH AFRICA
40 B - - 06 Wheat Cereal (Baby)
Date Published: 09/16/2009
Notes:Baby Cereal; wheat with bananas
40 B - - 20 Mixed Cereal, with Fruit (Baby)
Date Published: 09/16/2009
Notes:Baby Cereal; mix with strawberries
TAIWAN
Taiwan Wachine Co., Ltd
Date Published : 09/16/2009
2F., No.83, Ningbo W. St., , Zhongzheng Dist., Taipei City, Taiwan , Taipei City, Taipei - District TAIWAN
24 T - - 03 Bamboo Shoots (Leaf & Stem Vegetable)
Date Published: 09/16/2009
Notes:Bamboo shoots; cooked This bamboo product is also indicated for detention in
that a chemical
preservative (sulfite) is an ingredient in the product and is not identified
as a preservative [FFD&CA Section 403(k); 21 CFR 101.22(j)].
THAILAND
European Food Public Company Limited
Date Published : 12/06/2010
140 Moo 4 Raboapai Road, Nongprong , Si Maha Phot, Prachin Buri THAILAND
33 G - - 06 Flavored Candy, Soft (Live Savers, Etc.), with Nuts or Nut Products (without Chocolate)
Date Published: 12/06/2010
Desc:Assorted Jelly Candy (Pipo Brand)
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
33 G - - 07 Jellied Candies, Soft (Jelly Beans, Gum Drops, Etc.), with Nuts or Nut Products (without Chocolate)
Date Published: 12/06/2010
Desc:Assorted Jelly Candy (Pipo Brand)
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
33 J - - 06 Flavored Candy, Soft (Live Savers, Etc.), with Fruit (without Chocolate)
Date Published: 12/06/2010
Desc:Assorted Jelly Candy (Pipo Brand)
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 12/06/2010
Desc:Assorted Jelly Candy (Pipo Brand)
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
33 K - - 06 Flavored Candy, Soft (Live Savers, Etc.), with Nuts and Fruit (without Chocolate)
Date Published: 12/06/2010
Desc:Assorted Jelly Candy (Pipo Brand)
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
33 K - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Nuts and Fruit (without Chocolate)
Date Published: 12/06/2010
Desc:Assorted Jelly Candy (Pipo Brand)
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
33 M - - 01 Gel Cups, Fruit Flavored
Date Published: 12/06/2010
Desc:Assorted Jelly Candy (Pipo Brand)
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
33 M - - 03 Gel Cups, Fruit Flavored w/Fruit Candy
Date Published: 12/06/2010
Desc:Assorted Jelly Candy (Pipo Brand)
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
33 M - - 05 Gel Cups Candy
Date Published: 12/06/2010
Desc:Assorted Jelly Candy (Pipo Brand)
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
33 M - - 07 Gel Candy on a Stick Candy
Date Published: 12/06/2010
Desc:Assorted Jelly Candy (Pipo Brand)
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
Notes:VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.
The Union Frozen Products Co., Ltd.
Date Published : 08/06/2010
1259, 1094/10 Wichianchodok Road, , Ampur Muang , Samutsakorn, THAILAND
16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.
Date Published: 08/06/2010
Desc:Frozen Seafood Mix
Notes:This product is misbranded within the meaning of section 403(i)(2)because the label or labeling fails to bear the required information. Specifically, The ingredients in the product are not identified according to 21 CFR101.4(b) The principal display panel and the ingredients statement declare: ¿Cooked Clams or Mussels." Also, the product bears a ¿contains¿ statement that Reads ¿Allergen Warning: Contains shrimp and Shellfish ingredients.¿ ¿Shellfish ingredients¿ is not a major food allergen; therefore, according to 403(w) of the Act, it should not be in the ¿contains¿ statement. The UPC code and the Statement ¿Allergen Warning¿ is intervening material according to 21 CFR 101.2(e)
Notes:This product is misbranded within the meaning of section 403(i)(2)because the label or labeling fails to bear the required information. Specifically, The ingredients in the product are not identified according to 21 CFR101.4(b) The principal display panel and the ingredients statement declare: ¿Cooked Clams or Mussels." Also, the product bears a ¿contains¿ statement that Reads ¿Allergen Warning: Contains shrimp and Shellfish ingredients.¿ ¿Shellfish ingredients¿ is not a major food allergen; therefore, according to 403(w) of the Act, it should not be in the ¿contains¿ statement. The UPC code and the Statement ¿Allergen Warning¿ is intervening material according to 21 CFR 101.2(e)
TURKEY
Bumin Gida Sanayi Ve Ticaret Ltd
Date Published : 10/11/2011
Organize Sanayi Bolgasi , Turgutlu / Manisa, TURKEY
27 V - - 01 Cider Vinegar (Apple)
Date Published: 10/11/2011
Desc:Apple Cider Vinegar
Notes:VIOLATION (IN NOTES); 403(i)(2) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(i)(2) because the labels fails to declare E223 by the common or usual name; sodium metabisulphite; in accordance with 21 CFR 101.4.
Notes:VIOLATION (IN NOTES); 403(i)(2) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(i)(2) because the labels fails to declare E223 by the common or usual name; sodium metabisulphite; in accordance with 21 CFR 101.4.
27 V - - 03 Wine Vinegar
Date Published: 10/11/2011
Desc:Grape Wine Vinegar
Notes:VIOLATION (IN NOTES); 403(i)(2) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(i)(2) because the labels fails to declare E223 by the common or usual name; sodium metabisulphite; in accordance with 21 CFR 101.4.
Notes:VIOLATION (IN NOTES); 403(i)(2) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(i)(2) because the labels fails to declare E223 by the common or usual name; sodium metabisulphite; in accordance with 21 CFR 101.4.
Simsek Biskuvi ve gida sanayii A.s.
Date Published : 09/16/2009
Organize Sanayii Bolgesi , KARAMAN, Tr-70 TURKEY
34 C - - 07 Mixed or Assorted Chocolate Candies (Bars, Boxes, Loose Form), with Nuts or Nut Products (not Coconu
Date Published: 09/16/2009
Notes:Simsek Milky Kid Milk Chocolate Covered Suprprised Egg Candy. The product fails to properly declare the Organize serving size and fails to provide
UNITED KINGDOM
Metabolics Ltd
Date Published : 08/07/2012
5 Eastcott Common , Devizes, Wiltshire UNITED KINGDOM
54 A - - 04 Vitamin B6 (Pyridoxine)
Date Published: 08/20/2012
Desc:Vitamin B6 P-5-P
Notes:VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and zero amounts of nutrients are listed in the Supplement Facts" panel); 8/7/2012
Notes:VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and zero amounts of nutrients are listed in the Supplement Facts" panel); 8/7/2012
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 08/20/2012
Desc:Metabolics Multiple W/O (90)
Notes:VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and zero amounts of nutrients are listed in the Supplement Facts" panel); 8/7/2012
Notes:VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and zero amounts of nutrients are listed in the Supplement Facts" panel); 8/7/2012
Panesar Foods Ltd
Date Published : 09/16/2009
Black Lake House , Blacklake , West Bromwich, West Midlands UNITED KINGDOM
37 K - - 99 Pastes, n.e.c.
Date Published: 09/16/2009
Desc:Harissa Hot Chile Paste
UNITED STATES
Ferrero USA Inc.
Date Published : 01/05/2012
600 Cottontail Ln , Somerset, NJ 08873-1233 UNITED STATES
34 C - - 99 Chocolate and Chocolate Covered Candy, with Nuts or Nut Products, N.E.C. (not Coconut)
Date Published: 01/05/2012
Desc:Christmas Bell and Easter Hazelnut Chocolates
Notes:Reason: Nutrition label is on a hang tag and not on the product
Notes:Reason: Nutrition label is on a hang tag and not on the product
34 G - - 99 Chocolate and Chocolate Covered Candy, with Nuts and Fruit, N.E.C.
Date Published: 01/05/2012
Desc:Christmas Bell and Easter Hazelnut Chocolates
Notes:Reason; Nutrition label is on a hang tag and not on the product
Notes:Reason; Nutrition label is on a hang tag and not on the product
URUGUAY
Cooperativa Nacional De Productores De Leche
Date Published : 05/17/2012
Magallanes 1871 , Montevideo, URUGUAY
12 A - - 42 Cheese, Parmesan
Date Published: 05/17/2012
Desc:Parmesan cheese queso dolce
Notes:VIOLATION (IN NOTES); 1. 801(a)(3); 403(i)(2); 403(q) 1. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated within the meaning of section 402(a)(2)(c) of the Act in that the product contains a food additive which is unsafe within the meaning of Section 409. 2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts panel) in the proper format. 3. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food; Drug and Cosmetic Act (the Act) because the product fails to bear the specific common or usual name of each ingredient as required by 21 CFR 101.22(k)(3). Specifically; the product is labeled to contain; ?colouring agent INS 140(i)?? The INS number is not an appropriate common or usual name for a color additive not subject to certification.
Notes:VIOLATION (IN NOTES); 1. 801(a)(3); 403(i)(2); 403(q) 1. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated within the meaning of section 402(a)(2)(c) of the Act in that the product contains a food additive which is unsafe within the meaning of Section 409. 2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts panel) in the proper format. 3. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food; Drug and Cosmetic Act (the Act) because the product fails to bear the specific common or usual name of each ingredient as required by 21 CFR 101.22(k)(3). Specifically; the product is labeled to contain; ?colouring agent INS 140(i)?? The INS number is not an appropriate common or usual name for a color additive not subject to certification.
VIETNAM
Huong Vinh Co.,LTD
Date Published : 03/09/2010
404/1 AuCo Street,Ward 10,Tan Binh Dist , 404/1 AuCo Street,Ward 10,Tan Binh Dist , Ho Chi Minh, VN-65 VIETNAM
33 G - - 06 Flavored Candy, Soft (Live Savers, Etc.), with Nuts or Nut Products (without Chocolate)
Date Published: 03/09/2010
Desc:Black and White Sesame Candy
Notes:Product is misbranded within the meaning of Sec. 403(w)(1) of the Act because the label fails to declare the presence of the major food allergen peanuts? Product is further misbranded in that the information required by the Act must appear in both English and the foreign language (21 CFR 101.15(c)).
Notes:Product is misbranded within the meaning of Sec. 403(w)(1) of the Act because the label fails to declare the presence of the major food allergen peanuts? Product is further misbranded in that the information required by the Act must appear in both English and the foreign language (21 CFR 101.15(c)).
33 K - - 06 Flavored Candy, Soft (Live Savers, Etc.), with Nuts and Fruit (without Chocolate)
Date Published: 03/09/2010
Desc:Black and White Sesame Candy
Notes:Product is misbranded within the meaning of Sec. 403(w)(1) of the Act because the label fails to declare the presence of the major food allergen peanuts¿ Product is further misbranded in that the information required by the Act must appear in both English and the foreign language (21 CFR 101.15(c)).
Notes:Product is misbranded within the meaning of Sec. 403(w)(1) of the Act because the label fails to declare the presence of the major food allergen peanuts¿ Product is further misbranded in that the information required by the Act must appear in both English and the foreign language (21 CFR 101.15(c)).
33 L - - 03 Fondant Candy Bar, Soft, without Nuts and Fruit (without Chocolate)
Date Published: 03/09/2010
Desc:Black and White Sesame Candy
Notes:Product is misbranded within the meaning of Sec. 403(w)(1) of the Act because the label fails to declare the presence of the major food allergen peanuts? Product is further misbranded in that the information required by the Act must appear in both English and the foreign language (21 CFR 101.15(c)).
Notes:Product is misbranded within the meaning of Sec. 403(w)(1) of the Act because the label fails to declare the presence of the major food allergen peanuts? Product is further misbranded in that the information required by the Act must appear in both English and the foreign language (21 CFR 101.15(c)).
INTERFOOD SHAREHOLDING COMPANY
Date Published : 03/09/2010
No.9 Road 5 , Tan Tien Sub-district , BIEN HOA, VN-39 VIETNAM
21 V - - 99 Sutropical and Tropical Fruit, Juice, Milk, Creme, Drink or Nectar, N.E.C.
Date Published: 03/09/2010
Desc:Coconut Water w/Pulp (meat)
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15(c)(2); all required information must appear in these languages.
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15(c)(2); all required information must appear in these languages.
30 Y - - 02 Coconut Milk Beverage Base
Date Published: 03/09/2010
Desc:Coconut Water w/Pulp (meat)
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15 (c)(2); all required information must appear in these languages.
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15 (c)(2); all required information must appear in these languages.
Interfood Processing Industry Ltd.
Date Published : 03/09/2010
No. 9, Rd 5, Tan May Street , Tan Tien , Bien Hoa City, Fn VIETNAM
21 V - - 99 Sutropical and Tropical Fruit, Juice, Milk, Creme, Drink or Nectar, N.E.C.
Date Published: 03/09/2010
Desc:Coconut water w/pulp (meat)
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15(c)(2); all required information must appear in these languages.
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15(c)(2); all required information must appear in these languages.
30 Y - - 02 Coconut Milk Beverage Base
Date Published: 03/09/2010
Desc:Coconut water w/pulp (meat)
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15 (c)(2); all required information must appear in these languages.
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15 (c)(2); all required information must appear in these languages.
Interfood Shareholding Company
Date Published : 03/09/2010
lot 13 Tam Puhoc Industrial Zone , Long Thanh District,, VN-39 VIETNAM
21 V - - 99 Sutropical and Tropical Fruit, Juice, Milk, Creme, Drink or Nectar, N.E.C.
Date Published: 03/09/2010
Desc:Coconut water w/pulp (meat)
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15(c)(2); all required information must appear in these languages.
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15(c)(2); all required information must appear in these languages.
30 Y - - 02 Coconut Milk Beverage Base
Date Published: 03/09/2010
Desc:Coconut water w/pulp (meat)
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15 (c)(2); all required information must appear in these languages.
Notes:Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15 (c)(2); all required information must appear in these languages.
South Kinh Do Corporation
Date Published : 09/16/2009
6/134 13th National Road,Hiep Binh Phuoc , Hochiminh, VIETNAM
03 F - - 02 Flavored or Party Crackers
Date Published: 09/16/2009
Notes:Round Crackers; Mini Round Crackers; Cr3eatures of the Sea Crackers; Mini butter-Cheese Crackers
03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 09/16/2009
Notes:Round Crackers; Mini Round Crackers; Cr3eatures of the Sea Crackers; Mini butter-Cheese Crackers
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