Import Alert 99-47

(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 # 99-47
Published Date: 07/15/2024
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Human Food Products That Appear to be Adulterated for Economic Gain"

Reason for Alert:

Economically motivated adulteration (EMA) includes the substitution, addition, or omission of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production for economic gain.

Examples of EMA can include the addition of corn or cane syrup to honey, citric acid to a product labeled 100% lemon juice, or hydrolyzed inulin syrup to apple juice; the substitution for olive oil of another edible oil; offering a less expensive seafood species for sale as a more expensive-species; the addition of unapproved colors in bright colored spices to give the appearance of high quality; or the addition of filler material in blended spices.

EMA can not only affect economic conditions but may cause food safety hazards to be overlooked or misidentified. For example, species substitution in seafood may cause potential food safety hazards to be overlooked or misidentified by processors or end users.

Products may be adulterated if they are found to contain a substituted or added substance which renders the product adulterated under section 402(b) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C § 342(b)]. Under section 402(b) of the Act, a product shall be deemed adulterated: (1) if any valuable constituent has been in whole or in part omitted or abstracted therefrom; (2) if any substance has been substituted wholly or in part therefor; (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater values than it is.

Note – for medical foods, see also IA 41-03.

Guidance:

Divisions may detain without physical examination, the specified product(s) from the firms listed in the Red List of this import alert.

Recommendations for addition to the Red List should be forwarded to the Division of Import Operations (DIO). DIO and the FDA's Center for Food Safety and Applied Nutrition (CFSAN) will evaluate regulatory evidence on a case-by-case basis.

Release of Articles Subject to Detention Without Physical Examination under this Import Alert:
In order to secure release of an individual shipment subject to detention without physical examination (DWPE) under this import alert, the owner, consignee and/or other responsible party to the shipment should provide all relevant information supporting the request for release to the appropriate FDA Division compliance office. Relevant information should pertain to the nature of the original violation and may include evidence such as results of a third-party laboratory analysis, which verifies the violation has been overcome, or revised labeling. Resources for private laboratory testing are available at https://www.fda.gov/science-research/field-science-and-laboratories/private-laboratory-testing. Refer to the notes of the individual firm listing for the original violation.

Import Divisions should submit testimony provided to overcome the detention by the responsible party to CFSAN's Office of Compliance Dietary Supplement Labeling Assessment Branch (HFS-608) for Center concurrence.

Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List, information should be provided to the Agency that adequately demonstrates that the food producer has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the FD&C Act. For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or, be sent via email to: Importalerts2@fda.hhs.gov.

Questions or issues involving import operations should be addressed to ORA Division of Import Operations (DIO) at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov.

Questions or issues on policy, sample collection recommendations, or any other additional questions, should be addressed to CFSAN/Dietary Supplement and Labeling Assessment Branch (HFS-608) at CFSANEnforcement@fda.hhs.gov.

                                                                                                                                                                

Product Description:

Various Food Products (conventional foods or dietary supplements)

Charge:

The article is subject to refusal of admission pursuant Section 801(a)(3) of the FD&C Act in that it appears that a
valuable constituent of the article has been in whole or in part omitted or abstracted from the article. [Adulteration,
Section 402(b)(1)] OASIS charge code – OMITTED

And/or

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that a substance has
been substituted wholly or in part for one or more of the article's ingredients. [Adulteration, Section 402(b)(2)]
OASIS charge code - SUBSTITUTE

And/or

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be food which has
damage or inferiority concealed in any manner. [Adulteration, Section 402(b)(3)]
OASIS charge code - CONCEALED

And/or

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the food appears to have a
substance added to, mixed or packed with it so as to increase its bulk or weight, or reduce its quality or
strength, or make it appear better or of greater value than it is. [Adulteration, Section 402(b)(4)]
OASIS charge code - ADDED BULK

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


AFGHANISTAN


Talay Sorkh Afghan Ltd
Date Published : 10/19/2023
Jade Mahbas Ibnesina 18 , Herat, AFGHANISTAN
28 A - - 40 Saffron, Whole (Spice)
Date Published: 10/19/2023

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears that a valuable constituent of the article has been in whole or in part omitted or abstracted from the article. [Adulteration, section 402(b)(1)]. No saffron found. Published 10/19/2023

28 B - - 40 Saffron, Ground, Cracked (Spice)
Date Published: 02/12/2024

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears that a valuable constituent of the article has been in whole or in part omitted or abstracted from the article. [Adulteration, section 402(b)(1)]. No saffron found. Published 10/19/2023


CHINA


Yantai Ruihe Foods Co., Ltd.
Date Published : 06/05/2023
NO. 0002 Xingyuan West Road , Yantai, CHINA
16 M - - 03 Squid, Other Aquatic Species
Date Published: 06/05/2023

Desc: Frozen Squid
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it is adulterated within the meaning of section 402(b)(4) of the FD&C Act (21 U.S.C. § 342(b)(4)) because a substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight. Violation 402(b)(4): net weight.


DOMINICAN REPUBLIC (THE)


Procesadora Vizcaya, C por A
Date Published : 05/02/2023
Barrio San Miguel , Calle Hatillo Sampana No. 364 , Santo Domingo, Distrito Nacional (Santo Domin DOMINICAN REPUBLIC (THE)
36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 11/26/2021. Firm previously listed on deactivated Import Alert 36-01.


ECUADOR


Sanchez Obando Alexander Ricardo
Date Published : 06/03/2024
Gregorio Bobadilla N37-108 Y Jose Villalengua , Quito, ECUADOR
28 B - - 13 Cinnamon, Cassia, Ground, Cracked (Spice)
Date Published: 06/03/2024

Desc: Ground Cinnamon
Notes: Sanchez Obando Alexander Ricardo d.b.a. Negasmart S.A. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be adulterated within the meaning of section 402(b)(4) of the Act because a substance, lead chromate, has been added there to or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.


EL SALVADOR


ACOPIDECHA DE R.L.
Date Published : 05/02/2023
Km 59.5 carretera Longitudinal del Norte , Canton Chilamates , Nueva Concepcion, Chalatenango EL SALVADOR
36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Natural Honey without Honeycomb (in barrels)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 10/22/2018. Firm previously listed on deactivated Import Alert 36-01.

ASOCIACION COOPERATIVA DE COMMERCIALIZACION
Date Published : 05/02/2023
Km I Carretera Longitudinal Del , Chalatenango, Chalatenango EL SALVADOR
36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Natural Honey without Honeycomb (in barrels)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 10/22/2018. Firm previously listed on deactivated Import Alert 36-01.


GREECE


Crysoula Tsiakanika Xalimourda
Date Published : 05/02/2023
Spolaita , Agrinio, Aitoloakarnanias GREECE
36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 12/07/2021. Firm previously listed on deactivated Import Alert 36-01.


INDIA


AmulFed Dairy (Previously known as Mother Dairy) - A Unit of GCMMF Ltd
Date Published : 05/09/2023
Near Indira Bridge , Gandhi Nagar, Gujarat INDIA
09 A - - 01 Butter (Plain or Whipped)
Date Published: 05/09/2023

Desc: Amul Pure Ghee
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. DWPE date: 06/20/2013. Firm previously listed on deactivated Import Alert 09-01.

09 A - - 02 Butter Oil
Date Published: 05/09/2023

Desc: Amul Pure Ghee
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. DWPE date: 06/20/2013. Firm previously listed on deactivated Import Alert 09-01.

09 A - - 99 Butter And Butter Products, N.E.C.
Date Published: 05/09/2023

Desc: Amul Pure Ghee
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. DWPE date: 06/20/2013. Firm previously listed on deactivated Import Alert 09-01.

Elmac Foods
Date Published : 04/26/2023
National Highway 6 , Haora, West Bengal INDIA
20 K - - 04 Lemon, Citrus Fruit Juices or Concentrates
Date Published: 04/26/2023

Desc: LEMON JUICE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): isocitric acid levels, carbon SIRA value. DWPE date: 03/13/2023. Firm previously listed on deactivated Import Alert 22-04.


INDONESIA


Bumi Pangan Utama PT
Date Published : 06/27/2024
Jln. Millenium 2a No. 1 , Blok L 1 , Tangerang, Banten INDONESIA
16 J - - 05 Shrimp & Prawns
Date Published: 06/27/2024

Desc: Shrimp

16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 06/27/2024

Desc: Shrimp

Mega Marine Pride
Date Published : 06/10/2024
Desa Wonokoyo , Kecamatan Beji , Pasuruan, Jawa Timur INDONESIA
16 J - - 05 Shrimp & Prawns
Date Published: 06/10/2024

Desc: Shrimp
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it is adulterated within the meaning of section 402(b)(4) of the FD&C Act (21 U.S.C. § 342(b)(4)) because a substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight.

16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 06/10/2024

Desc: Shrimp
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it is adulterated within the meaning of section 402(b)(4) of the FD&C Act (21 U.S.C. § 342(b)(4)) because a substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight.


IRAN


Orum Narin Ltd
Date Published : 04/26/2023
6 Km Gahre Aghaj Road , Orumia, IR-02 IRAN
22 K - - 01 Pomegranate, Juice, Other Fruit Juices or Concentrates
Date Published: 04/26/2023

Desc: Pomegranate Juice
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): anthocyanin level; tartaric acid level. DWPE date: 12/07/2012. Firm previously listed on deactivated Import Alert 22-04.


ITALY


SOC. AGR. ARTEMIDE SNC
Date Published : 05/02/2023
Via Dell' Industria 1 , Pietradefusi, Avellino ITALY
36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Truffle Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 10/14/2021. Firm previously listed on deactivated Import Alert 36-01.


LEBANON


Maalouf Industry & Trading S.A.L
Date Published : 05/02/2023
Bziza Main Road 2km Amouin , Lib`A, LEBANON
36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Thistle Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 12/14/2021. Firm previously listed on deactivated Import Alert 36-01.


MALAYSIA


EMINENT FOOD INDUSTRIES SDN BHD
Date Published : 05/02/2023
42 Jalan Bk 1 11 , Taman Perindustri Puchong, Jalan Puchong , Puchong, Selangor MALAYSIA
36 C - - -- Honey
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 10/02/2012. Firm previously listed on deactivated Import Alert 36-01.


MEXICO


BLANCA ZAMORA JACOBO
Date Published : 05/02/2023
Calle Juan S. Millan # 12 , Pueblo Villa Union, Mazatlan , Villa Union, Sinaloa MEXICO
36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 08/14/2018. Firm previously listed on deactivated Import Alert 36-01.

36 C - - 99 Honey, N.E.C.
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 08/14/2018. Firm previously listed on deactivated Import Alert 36-01.

EMPACADORA DE MIEL GDL
Date Published : 06/10/2024
Calle Volcan Kenia No 5640 , Col. Panoramica De Huentitan, Guadalajara , Guadalajara, Jalisco MEXICO
36 C - - 01 Comb Honey
Date Published: 06/10/2024

Desc: Natural Honey Bee with Honeycomb (Miel de Abeja con Penca)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level.

36 C - - 04 Honey
Date Published: 06/10/2024

Desc: Natural Honey Bee with Honeycomb (Miel de Abeja con Penca)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level.

36 C - - 99 Honey, N.E.C.
Date Published: 06/10/2024

Desc: Natural Honey Bee with Honeycomb (Miel de Abeja con Penca)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level.


NEW ZEALAND


Claridges Organic Limited
Date Published : 05/02/2023
2 Ivan Jamieson Place , Christchurch Airport , Christchurch, Canterbury NEW ZEALAND
36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 06/12/2012. Firm previously listed on deactivated Import Alert 36-01.

36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 06/12/2012. Firm previously listed on deactivated Import Alert 36-01.

36 C - - 99 Honey, N.E.C.
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 06/12/2012. Firm previously listed on deactivated Import Alert 36-01.

36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C.
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 06/12/2012. Firm previously listed on deactivated Import Alert 36-01.


PHILIPPINES


Heir Deli Foods Corporation
Date Published : 12/27/2023
Bagumbong, Brgy 171 , 1081-A Congressional Road; Ext. , Caloocan City North, National Capital Region PHILIPPINES
28 A - - 40 Saffron, Whole (Spice)
Date Published: 12/27/2023

Desc: Saffron (kasubha)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it is adulterated within the meaning of section 402(b)(1) of the FD&C Act (21 U.S.C. § 342(b)(1)) 402(c) of the Act [21 U.S.C. 342(b)(1), 342(c)]. FDA sample concluded the presence of 0% saffron (saffron spice, saffron spice with attached styles), and 100% non-saffron matter, including safflower material and other unidentified material. See Import Alert 45-02 for adulteration/misbranding of this product with non-permitted and undeclared colors.

28 B - - 40 Saffron, Ground, Cracked (Spice)
Date Published: 12/27/2023

Desc: Saffron (kasubha)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it is adulterated within the meaning of section 402(b)(1) of the FD&C Act (21 U.S.C. § 342(b)(1)) 402(c) of the Act [21 U.S.C. 342(b)(1), 342(c)]. FDA sample concluded the presence of 0% saffron (saffron spice, saffron spice with attached styles), and 100% non-saffron matter, including safflower material and other unidentified material. See Import Alert 45-02 for adulteration/misbranding of this product with non-permitted and undeclared colors.

L. Dometita & Sons Food Industries
Date Published : 11/20/2023
15 L. Rivera Street Project 4 , Quezon City, National Capital Region (Manil PHILIPPINES
28 A - - 40 Saffron, Whole (Spice)
Date Published: 11/20/2023

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears that a valuable constituent of the article has been in whole or in part omitted or abstracted from the article. [Adulteration, section 402(b)(1)].


SAUDI ARABIA


Hamil Al Musk
Date Published : 05/02/2023
Phase 4, Industrial Area , Jeddah, SAUDI ARABIA
36 C - - -- Honey
Date Published: 05/02/2023

Desc: All Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 02/06/2013. Firm previously listed on deactivated Import Alert 36-01.


SPAIN


Apicola Cuartero Navarro S.L.
Date Published : 05/02/2023
Fuendejalon , Calle De La Posada 14 , Fuendejalon, Zaragoza SPAIN
36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Acacia Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 05/23/2019. Firm previously listed on deactivated Import Alert 36-01.

36 C - - 99 Honey, N.E.C.
Date Published: 05/02/2023

Desc: Acacia Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 05/23/2019. Firm previously listed on deactivated Import Alert 36-01.

Luis Penalva, S.L.
Date Published : 11/21/2023
Plaza De La Magdalena 13 , Novelda, Alicante SPAIN
28 A - - 40 Saffron, Whole (Spice)
Date Published: 11/21/2023

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears that a valuable constituent of the article has been in whole or in part omitted or abstracted from the article. [Adulteration, section 402(b)(1)].

MANUEL ROMERO DE AVILA RAMIREZ
Date Published : 07/15/2024
A Nave 12 , Avenida 5poligono Ind Campollano , Albacete, SPAIN
28 A - - 40 Saffron, Whole (Spice)
Date Published: 07/15/2024

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears that a valuable constituent of the article has been in whole or in part omitted or abstracted from the article. Based on the amount of floral waste found, the product is adulterated under section 402(b)(1) of the Federal Food, Drug, and Cosmetic Act.

28 B - - 40 Saffron, Ground, Cracked (Spice)
Date Published: 07/15/2024

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears that a valuable constituent of the article has been in whole or in part omitted or abstracted from the article. Based on the amount of floral waste found, the product is adulterated under section 402(b)(1) of the Federal Food, Drug, and Cosmetic Act.

28 C - - 40 Saffron, Natural Extract or Flavor (Spice)
Date Published: 07/15/2024

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears that a valuable constituent of the article has been in whole or in part omitted or abstracted from the article. Based on the amount of floral waste found, the product is adulterated under section 402(b)(1) of the Federal Food, Drug, and Cosmetic Act.

28 C - - 84 Safflower, Natural Extract or Flavor (Spice)
Date Published: 07/15/2024

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears that a valuable constituent of the article has been in whole or in part omitted or abstracted from the article. Based on the amount of floral waste found, the product is adulterated under section 402(b)(1) of the Federal Food, Drug, and Cosmetic Act.

The Harvest Of Saffron, S.L.
Date Published : 01/08/2024
Plaza Don Diego 6 , La Solana, Ciudad Real SPAIN
28 A - - 40 Saffron, Whole (Spice)
Date Published: 01/08/2024

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of Section 402(b)(1) of the Act because it appears that a valuable consistent of the article has been in whole or in part omitted or abstracted from the article.

28 B - - 40 Saffron, Ground, Cracked (Spice)
Date Published: 01/08/2024

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of Section 402(b)(1) of the Act because it appears that a valuable consistent of the article has been in whole or in part omitted or abstracted from the article.

28 C - - 40 Saffron, Natural Extract or Flavor (Spice)
Date Published: 01/08/2024

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of Section 402(b)(1) of the Act because it appears that a valuable consistent of the article has been in whole or in part omitted or abstracted from the article.

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 01/08/2024

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of Section 402(b)(1) of the Act because it appears that a valuable consistent of the article has been in whole or in part omitted or abstracted from the article.

28 C - - 84 Safflower, Natural Extract or Flavor (Spice)
Date Published: 01/08/2024

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of Section 402(b)(1) of the Act because it appears that a valuable consistent of the article has been in whole or in part omitted or abstracted from the article.

45 K - - 99 Flavor Enhancers (Food Additives for Human Use)
Date Published: 01/29/2024

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of Section 402(b)(1) of the Act because it appears that a valuable consistent of the article has been in whole or in part omitted or abstracted from the article.

50 L - - 25 Saffron
Date Published: 01/08/2024

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of Section 402(b)(1) of the Act because it appears that a valuable consistent of the article has been in whole or in part omitted or abstracted from the article.

VERDU CANTO SAFFRON SPAIN, S.L.
Date Published : 11/15/2023
C/ Sargento Navarro n 7 , Novelda, Alicante SPAIN
28 A - - 40 Saffron, Whole (Spice)
Date Published: 11/15/2023

Desc: Saffron
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears that a valuable constituent of the article has been in whole or in part omitted or abstracted from the article. [Adulteration, section 402(b)(1)].


TAIWAN


KINGLIKE CATERING TRADE INT'L COLTD
Date Published : 02/02/2024
Zhongyuan St , No 89 Sanmin Dist , Kaohsiung, TAIWAN
20 K - - 04 Lemon, Citrus Fruit Juices or Concentrates
Date Published: 02/02/2024

Desc: Lemon Juice
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated as defined in section 402(b)(2) of the Federal Food, Drug, and Cosmetic Act because it appears that a substance has been substituted wholly or in part for one or more of the article’s ingredients. Violation 402(b)(2): isocitric acid levels, carbon SIRA value.


THAILAND


Jirapha Bee Farm
Date Published : 05/02/2023
46 Kaoklang Road, Nonghoi , Muang, TH-50 THAILAND
36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Lychee Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 06/22/2021. Firm previously listed on deactivated Import Alert 36-01.

36 C - - 99 Honey, N.E.C.
Date Published: 05/02/2023

Desc: Lychee Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 06/22/2021. Firm previously listed on deactivated Import Alert 36-01.


TURKEY


Alhatoglu Gida Ltd. Sti.
Date Published : 04/26/2023
Inonu Mah. , Nuri Giyik Sanayi Sitesi.4 Blok Sok. 3 Tobb Akhisar Tic. Bor. Onder Yamanel , Akhisar, Manisa TURKEY
20 K - - 04 Lemon, Citrus Fruit Juices or Concentrates
Date Published: 04/26/2023

Desc: Lemon Juice
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): Brix, formol value, citric acid concentration, citrate carbon SIRA value. DWPE date: 04/15/2014. Firm previously listed on deactivated Import Alert 22-04.

Baloglu Gida Tarim Urun. Akar. Mot. Arac.
Date Published : 02/12/2024
302 Cad. No 1. , Salihli, Manisa TURKEY
20 K - - 04 Lemon, Citrus Fruit Juices or Concentrates
Date Published: 02/12/2024

Desc: Lemon Juice
Notes: The product 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 adulterated within the meaning of section 402(b)(2) of the Act [21 U.S.C. §342(b)(2)], because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients.

DEMTAT
Date Published : 05/02/2023
Fevzicakmak Mah. , 10732 Sok. No 6 , Karatay, Konya TURKEY
36 C - - -- Honey
Date Published: 05/02/2023

Desc: All Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 03/30/2013. Firm previously listed on deactivated Import Alert 36-01.

Meybuz Gida Enerji Sanayi Ve Ticaret A.S.
Date Published : 04/26/2023
Ankara Asfalti 9 Km 38070 , Melikgazi-Kaysery , Ankara, Kayseri TURKEY
22 K - - 01 Pomegranate, Juice, Other Fruit Juices or Concentrates
Date Published: 04/26/2023

Desc: Pomegranate Juice
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): Additional anthocyanin peaks vs authentic juice; artifical color detected; sucrose level; carbon SIRA value. DWPE date: 02/05/2013. Firm previously listed on deactivated Import Alert 22-04.

OMRAT LTD.CO.
Date Published : 05/02/2023
85.Yilcumhuriyet Mah. , Sanayi Cad. No 108 , Kemalpasa, Izmir TURKEY
36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 10/03/2011. Firm previously listed on deactivated Import Alert 36-01.

36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 10/03/2011. Firm previously listed on deactivated Import Alert 36-01.

36 C - - 99 Honey, N.E.C.
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 10/03/2011. Firm previously listed on deactivated Import Alert 36-01.

36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C.
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 10/03/2011. Firm previously listed on deactivated Import Alert 36-01.


VIETNAM


Hai Phong Company Ltd.
Date Published : 05/02/2023
No. 37, 407th Street, Phuoc Vinh An Ward, Cu Chi District , Buu Cuc Trung Tam Thanh Pho Ho Chi Minh, Ho Chi Minh VIETNAM
36 C - - -- Honey
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 12/15/2021. Firm previously listed on deactivated Import Alert 36-01.

Hai Phong Honeybee
Date Published : 05/02/2023
Binh Tan District , 49, No.10B Street, Binh Hung Hoa B Ward , Ho Chi Minh, VN-65 VIETNAM
36 C - - -- Honey
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 12/15/2021. Firm previously listed on deactivated Import Alert 36-01.

TANG MINH IMP. & EXP. TRADING CO.LTD
Date Published : 05/02/2023
DongNai Province , 061 , Dong Nai, Dong Nai VIETNAM
36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 09/12/2012. Firm previously listed on deactivated Import Alert 36-01.

36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 09/12/2012. Firm previously listed on deactivated Import Alert 36-01.

36 C - - 99 Honey, N.E.C.
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 09/12/2012. Firm previously listed on deactivated Import Alert 36-01.

36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C.
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 09/12/2012. Firm previously listed on deactivated Import Alert 36-01.

Thanh Hao Seafood Co., Ltd
Date Published : 04/02/2024
Concentrated Seafood Processing Zone, An Hai Hamlet, , Loc An Ward, , Dat Do District, Ba Ria-Vung Tau VIETNAM
16 M - - 03 Squid, Other Aquatic Species
Date Published: 04/02/2024

Desc: Squid
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 is adulterated within the meaning of section 402(b)(4) of the Act [21 U.S.C. § 342(b)(4)] because a substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight.


YEMEN


Al-Ragawi Trading Est.
Date Published : 05/02/2023
755, Sheraton Street , Sanaa, YEMEN
36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 11/24/2021. Firm previously listed on deactivated Import Alert 36-01.

Ali B. Ali G, Trading
Date Published : 05/02/2023
13, Khawlan Road , Sanaa, Sana [city] YEMEN
36 C - - 01 Comb Honey
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 08/30/2021. Firm previously listed on deactivated Import Alert 36-01.

Green City Export & Import
Date Published : 05/02/2023
05, Bait Baws , Sanaa, Sana [city] YEMEN
36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 06/14/2022. Firm previously listed on deactivated Import Alert 36-01.

MOKHA STORY
Date Published : 05/02/2023
Faj Attan Near Alkamel Gas Stati , 1 Al, Hayat St , Sanaa, YEMEN
36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 10/14/2021. Firm previously listed on deactivated Import Alert 36-01.

36 C - - 99 Honey, N.E.C.
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 10/14/2021. Firm previously listed on deactivated Import Alert 36-01.

MUGAHED MOHAMMED AHMED AL-HASBANI
Date Published : 05/02/2023
Sawann St , Sanaa, SANA YEMEN
36 C - - 04 Honey
Date Published: 05/02/2023

Desc: Honey
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be adulterated within the meaning of: Section 402(b)(2) of the Act because it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. Violation 402(b)(2): C4 sugar level. DWPE Published Date: 11/30/2021. Firm previously listed on deactivated Import Alert 36-01.