Import Alert 40-05

(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 # 40-05
Published Date: 04/03/2019
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Infant Formula Due to Failure to Meet Nutrient and Labeling Requirements"

Reason for Alert:

In June 2004, infant formula manufactured in China was found on the store shelves of an Asian retail store in the Chinatown section of Manhattan New York. On July 9, 2004, FDA warned consumers not to feed their infants infant formula from China because the safety and nutritional adequacy of infant formula from China is unknown.



In September 2005, CFSAN issued the "Unregistered Infant Formula at Ethnic Retail Establishments" field assignment. As a result of this assignment, samples of unregistered infant formulas from India and Israel were collected and based on the analyses, certain nutrients were inadequately declared on the label and there were also significant

labeling violations found on the product labels.



Domestic and foreign manufacturers of infant formula who intend to introduce new infant formula into interstate commerce must first provide CFSAN's Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) written notification at least 90 days prior to marketing the formula. The notification must contain the name of such

person, the place of business of such person, and all establishments at which such person intends to manufacture such new infant formula. (Refer to Section 412 of the FD&C Act for other provisions applicable to infant formula).



Districts should not detain infant formula products solely on the basis that the manufacturer has not provided this notification to FDA. The products listed on the Red List for this alert have either been analyzed by FDA and they do not meet the nutrient requirements applicable to infant formula as specified in 21 CFR 107.100 or were found to be misbranded due to labeling violations.

Guidance:

Districts may detain without physical examination the infant formula(s) from the identified manufacturers on the attachment for this import alert.



For questions or issues concerning science, science policy, or analytical methodology, contact the Division of Field Science at 301 796-6600.



Refer to the Infant Formula Compliance Program (7321.006) for guidance on product coverage, sample collection, sample preparation, and sample analysis.

Product Description:

Infant formula

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3)in that the infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.100 [Adulteration, Section 412(a)(1)]".



OASIS CHARGE CODE: NUTR DEF



and/or



"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to be misbranded within the meaning of Section 403 in that the labeling fails to use the proper units to declare the nutrients as specified in 21 CFR 107.10 [Misbranded, Section 403(f)]."



OASIS CHARGE CODE: NUTR UNIT



and/or



"The article is subject to refusal of admission pursuant to Section 801(a)(3)in that the infant formula appears to be misbranded within the meaning of Section 403 in that the label or labeling is false and misleading in any particular [Misbranded, Section 403(a)(1)]."



OASIS CHARGE CODE: FALSE



and/or



"The article is subject to refusal of admission pursuant to Section 801(a)(3)in that the infant formula appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to declare the name and place of business of manufacturer, packer, or distributor

[Misbranded, Section 403(e)(1)]."



OASIS CHARGE CODE: Lacks Firm



and/or



"The article is subject to refusal of admission pursuant to Section 801(a)(3)in that the infant formula appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to declare accurate statement of quantity of contents [Misbranded, Section 403(e)(2)]."



OASIS CHARGE CODE: Lacks N/C



and/or



"The article is subject to refusal of admission pursuant to Section 801(a)(3)in that the infant formula appears to be misbranded within the meaning of Section 403 in that the label does not declare the common or usual name [Misbranded, Section 403(i)(1)]."



OASIS CHARGE CODE: Usual Name



and/or



"The article is subject to refusal of admission pursuant to Section 801(a)(3)in that the infant formula appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to list ingredients by common or usual name [Misbranded, Section 403(i)(2)]."



OASIS CHARGE CODE: List Ingre



and/or



"The article is subject to refusal of admission pursuant to Section 801(a)(3)in that the infant formula appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to declare allergens [Misbranded, Section 403(w)]."



OASIS CHARGE CODE: Allergen

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


GERMANY


Hipp GmbH & CO Vertrieb KG
Date Published : 04/03/2019
Georg-Hipp-Str. 7 , Pfaffenhofen a.d.Ilm, Bavaria GERMANY
40 N - - 01 Milk Base Formula Product, Ready to Feed
Date Published: 04/03/2019

Desc: HiPP Combiotic PRE Infant Milk
Notes: The product appears to be misbranded within the meaning of: (1)Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically, (1) the translation indicates that the product label contains the statements 'Anfangsmilch' which translates to 'Infant Formula' and 'Anfangsmilch von Geburt' which translates to 'Beginning milk from birth'; (2) the product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

40 N - - 99 Other Formula Products, N.E.C., Ready to Feed
Date Published: 04/03/2019

Desc: HiPP Combiotic PRE Infant Milk
Notes: The product appears to be misbranded within the meaning of: (1)Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically, (1) the translation indicates that the product label contains the statements 'Anfangsmilch' which translates to 'Infant Formula' and 'Anfangsmilch von Geburt' which translates to 'Beginning milk from birth'; (2) the product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

40 Y - - 99 Baby and Junior Food N.E.C.
Date Published: 04/03/2019

Desc: HiPP Combiotic PRE Infant Milk
Notes: The product appears to be misbranded within the meaning of: (1)Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically, (1) the translation indicates that the product label contains the statements 'Anfangsmilch' which translates to 'Infant Formula' and 'Anfangsmilch von Geburt' which translates to 'Beginning milk from birth'; (2) the product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).


INDIA


Nestle India Ltd
Date Published : 09/18/2009
M-5a Connaught circus , New Delhi , New Delhi, Delhi INDIA
40 C - - -- Formula Prod (Baby)
Date Published: 09/18/2009


IRELAND


Nutricia
Date Published : 05/10/2017
Castleforbes Business Park , Sheriff Street Upper , Dublin 1, Co. DUBLIN IRELAND
40 N - - -- Ready To Feed Formula Products
Date Published: 05/10/2017

Desc: First Infant Milk
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Section 403(i)(2) of the FD&C Act in that the ingredients do not appear to be declared in accordance with 21 CFR 101.4. Section 403(3)(1) of the FD&C Act in that the business association of the products is not declared as required by 21 CFR 101.5. Section 403€(2) of the FD&C Act in that the label or labeling fails to declare accurate statement of quantity or contents in avoirdupois pound in accordance with 21 CFR 101.7.


ISRAEL


Materna Industries, Limited Partnership
Date Published : 09/18/2009
Kibbutz Maabarot , Ma'abarot, IL-NOTA ISRAEL
40 C - - -- Formula Prod (Baby)
Date Published: 09/18/2009

Notes: Materna Infant Formula

40 N - - -- Ready To Feed Formula Products
Date Published: 01/18/2012

40 O - - -- Liquid Concentrate Formula Products
Date Published: 01/18/2012

40 P - - -- Powder Formula Products
Date Published: 01/18/2012


NETHERLANDS


JOANNUSMOLEN
Date Published : 09/20/2018
Hulsbos 3 , Cuijk, Noord-Brabant NETHERLANDS
40 M - - -- Infant Formula Raw Material
Date Published: 09/20/2018

Desc: EkoBaby Zuigelingenmelk 1
Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

40 M - - -- Infant Formula Raw Material
Date Published: 09/20/2018

Desc: EkoBaby Groeimelk 3
Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

40 M - - -- Infant Formula Raw Material
Date Published: 09/20/2018

Desc: EkoBaby Opvolgmelk 2
Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

40 N - - -- Ready To Feed Formula Products
Date Published: 09/20/2018

Desc: EkoBaby Opvolgmelk 2
Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

40 N - - -- Ready To Feed Formula Products
Date Published: 09/20/2018

Desc: EkoBaby Groeimelk 3
Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

40 N - - -- Ready To Feed Formula Products
Date Published: 09/20/2018

Desc: EkoBaby Zuigelingenmelk 1
Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

40 O - - -- Liquid Concentrate Formula Products
Date Published: 09/20/2018

Desc: EkoBaby Zuigelingenmelk 1
Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

40 O - - -- Liquid Concentrate Formula Products
Date Published: 09/20/2018

Desc: EkoBaby Opvolgmelk 2
Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

40 O - - -- Liquid Concentrate Formula Products
Date Published: 09/20/2018

Desc: EkoBaby Groeimelk 3
Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

40 P - - -- Powder Formula Products
Date Published: 09/20/2018

Desc: EkoBaby Groeimelk 3
Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

40 P - - -- Powder Formula Products
Date Published: 09/20/2018

Desc: EkoBaby Zuigelingenmelk 1
Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

40 P - - -- Powder Formula Products
Date Published: 09/20/2018

Desc: EkoBaby Opvolgmelk 2
Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).


SWITZERLAND


HOLLE FOOD
Date Published : 02/13/2017
Baselstrasse 11 , Riehen, Basel Stadt SWITZERLAND
40 P - - 01 Milk Base Formula Product, Powder Formula
Date Published: 02/13/2017

Desc: Holle Organic Infant Formula Bio-Folgemilch 2
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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, according to the English translation, this product is intended for infants after 6 months of age; therefore, it appears to be an infant formula intended for infants less than 12 month old. The product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

HOLLE FOOD
Date Published : 04/14/2017
Lorracherstrasse 50 , Riehen, Basel Stadt SWITZERLAND
40 P - - 01 Milk Base Formula Product, Powder Formula
Date Published: 04/14/2017

Desc: Holle Organic Infant Follow-On Formula 2
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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107.


UNITED KINGDOM


Britsuperstore
Date Published : 06/06/2017
122 Elms Vale Road , Dover, UNITED KINGDOM
40 P - - 01 Milk Base Formula Product, Powder Formula
Date Published: 06/06/2017

Desc: HiPP Organic Good Night Milk
Notes:                                                                                                                                                                                                                 

40 P - - 01 Milk Base Formula Product, Powder Formula
Date Published: 06/06/2017

Desc: HiPP Organic Combiotic Anti-Reflux Milk Powder
Notes:                                                                                                                                                                                                                 

HIPP UK Ltd
Date Published : 06/06/2017
He Stable Block , Hurst Grove , Sandford, Berkshire,United Kingdom RG10, UNITED KINGDOM
40 P - - 01 Milk Base Formula Product, Powder Formula
Date Published: 06/06/2017

Desc: HiPP Organic Good Night milk
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however; the product is not labeled as required by 21 CFR 107.; Section 403(e)(2) of the FD&C Act in that the label or labeling fails to declare accurate statement of quantity or contents in avoirdupois pound in accordance with 21 CFR 101.7.

40 P - - 01 Milk Base Formula Product, Powder Formula
Date Published: 06/06/2017

Desc: HiPP Organic Combiotic anti-reflux milk powder
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however; the product is not labeled as required by 21 CFR 107.

Hipp
Date Published : 05/10/2017
The Stable Block , Standford Lane , Hurst Grove, UNITED KINGDOM
40 N - - -- Ready To Feed Formula Products
Date Published: 05/10/2017

Desc: Combiotic First Infant Milk
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however; the product is not labeled as required by 21 CFR 107. Section 403(e)(2) of the FD&C Act in that the label or labeling fails to declare accurate statement of quantity or contents in avoirdupois pound in accordance with 21 CFR 101.7.

Hipp Uk Ltd
Date Published : 04/05/2016
New Greenham Park , Berkshire, UNITED KINGDOM
40 N - - 99 Other Formula Products, N.E.C., Ready to Feed
Date Published: 04/07/2016

Desc: HiPP Organic Combiotic First Infant Milk
Notes: The product appears to be misbranded within the meaning of: (1)Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107; (2) Section 403 (e)(1) of the Act in that the business associated to the product (address provided on product label is located in U.K. but product label also states the product is from Germany) is not declared as required by 21CFR101.5(c); (3)Section 403(w) of the Act in that the product label fails to declare all major food allergens present in the product as required by 403(w)(1) of the Act (specifically, the product contains an ingredient that is derived from fish but the species of the fish is not declared as required by FALCPA).

40 N - - 99 Other Formula Products, N.E.C., Ready to Feed
Date Published: 04/05/2016

Desc: HiPP Organic Combiotic Hungry Infant Milk
Notes: The product appears to be misbranded within the meaning of: (1)Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107; (2) Section 403 (e)(1) of the Act in that the business associated to the product (address provided on product label is located in U.K. but product label also states the product is from Germany) is not declared as required by 21CFR101.5(c); (3)Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label as required by 21CFR101.4 (specifically, (1)‘LCP oils (fish…)’ is declared on the product label, which is not in accordance with 21CFR101.4, as ‘LCP’ is not an appropriate common or usual name of an ingredient; (2)the ingredient declaration fails to name the common or usual name of the marine fat source(s) as required by 21CFR101.4 – note: if the fish oil is not highly refined, then the product would be required to declare the species of the fish in accordance with FALCPA).

40 P - - 01 Milk Base Formula Product, Powder Formula
Date Published: 04/05/2016

Desc: HiPP Organic Combiotic Hungry Infant Milk
Notes: The product appears to be misbranded within the meaning of: (1)Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107; (2) Section 403 (e)(1) of the Act in that the business associated to the product (address provided on product label is located in U.K. but product label also states the product is from Germany) is not declared as required by 21CFR101.5(c); (3)Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label as required by 21CFR101.4 (specifically, (1)‘LCP oils (fish…)’ is declared on the product label, which is not in accordance with 21CFR101.4, as ‘LCP’ is not an appropriate common or usual name of an ingredient; (2)the ingredient declaration fails to name the common or usual name of the marine fat source(s) as required by 21CFR101.4 – note: if the fish oil is not highly refined, then the product would be required to declare the species of the fish in accordance with FALCPA).

40 P - - 01 Milk Base Formula Product, Powder Formula
Date Published: 04/25/2016

Desc: Combiotic Follow On Milk

40 P - - 01 Milk Base Formula Product, Powder Formula
Date Published: 04/07/2016

Desc: HiPP Organic Combiotic First Infant Milk
Notes: The product appears to be misbranded within the meaning of: (1)Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107; (2) Section 403 (e)(1) of the Act in that the business associated to the product (address provided on product label is located in U.K. but product label also states the product is from Germany) is not declared as required by 21CFR101.5(c); (3)Section 403(w) of the Act in that the product label fails to declare all major food allergens present in the product as required by 403(w)(1) of the Act (specifically, the product contains an ingredient that is derived from fish but the species of the fish is not declared as required by FALCPA).

Kendal Nutricare Ltd.
Date Published : 12/15/2017
Mint Bridge Road , CUMBRIA , Kendal, Cumbria UNITED KINGDOM
40 P - - 01 Milk Base Formula Product, Powder Formula
Date Published: 12/15/2017

Desc: First Infant Milk
Notes: Section 403 (a)(1) of the FD&C Act in that the label or labeling is false and misleading in any particular

Nannycare
Date Published : 05/09/2017
22-24 Kingsford Street , London, UNITED KINGDOM
09 F - - -- Goat Milk
Date Published: 05/09/2017

Desc: Follow on Milk
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular; Section 403(e)(2) of the FD&C Act in that the label or labeling fails to declare accurate statement of quantity of contents; Section 403(i)(1) of the FD&C Act in that the label does not declare the common or usual name; Section 403(i)(2) of the FD&C Act in that the label or labeling fails to list ingredients by common or usual name.

40 - - - -- Baby Food Prod
Date Published: 05/09/2017

Desc: Follow on Milk
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular; Section 403(e)(2) of the FD&C Act in that the label or labeling fails to declare accurate statement of quantity of contents; Section 403(i)(1) of the FD&C Act in that the label does not declare the common or usual name; Section 403(i)(2) of the FD&C Act in that the label or labeling fails to list ingredients by common or usual name.

Nutricia
Date Published : 09/15/2015
White Horse Business Park , Wilshire, UNITED KINGDOM
40 Y - - 99 Baby and Junior Food N.E.C.
Date Published: 09/15/2015

Desc: Aptamil Breast Milk Substitute
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(a)(1) of the Act in that the label is false or misleading because the product is marketed specifically for children under two years of age and the label bears the claim ?Now with increased levels of LCPs (Omega 3 & Omega 6)?. This claim is not specifically permitted for use on products intended for children under two years of age. Nutrient content claims may only be made on food intended for use by infants and children less than 2 years of age if the claim is specifically provided for in Parts 101; 105; or 107 of the regulations [21 CFR 101.13(b)(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(e)(2) of the Act because the label fails to declare accurate statement of quantity of contents statement as required in 21 CFR 101.105