Import Alert 99-31

(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 # 99-31
Published Date: 08/16/2019
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Food Products Due to the Presence of Melamine and/or Melamine Analogs"

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 11/19/2018 updates the reason for the alert, guidance (specifically, removal from DWPE), agency contacts, charge code language, PAF, and the product description section. Changes are bracketed by asterisks (***).

In September 2008, FDA became aware of thousands of infant illnesses in China associated with the consumption of infant formula suspected of containing melamine. As recently as October 1, 2008, reports indicated there have been over 53,000 illnesses, nearly 13,000 hospitalizations, 100 seriously ill cases and at least four infant deaths in China.

As a result, the U.S. and other countries have been sampling and testing infant formula, milk-derived ingredients, and finished food products containing milk. Information received from a number of sources, and from a number of different countries, indicates a wide range and variety of products, such as candies, desserts, and beverages, have been found to be contaminated with melamine.

Melamine is a compound used primarily in commercial and industrial applications. There is no approved melamine use in direct addition to human or animal food in the U.S.

Note: ORS contact information updated on 08/16/2019

Guidance:

***Divisions*** may detain without physical exam the identified products offered for importation from the manufacturers and/or shippers identified in the attachment for this import alert.

In order to secure release of an individual shipment detained pursuant to this Import Alert, the importer should provide results of a third-party laboratory analysis, of a representative sample of the lot, which verifies the product does not contain of melamine ***and its analogues (ammeline, ammelide and cyanuric acid).*** Third-party laboratories may use any method that is found acceptable to FDA and which meets the method performance. Methods are available at; http://www.fda.gov/AnimalVeterinary/ScienceResearch/ToolsResources/ucm135002.htm

***To remove a firms product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (i.e., the Act). For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE), available at: http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm179271.htm.

If a firm and/or a representative thereof wishes 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/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at ORAOISMDSSIMPCOMPLSYSBR@FDA.HHS.GOV.

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at (301) 796-6600 or oraorsprivatelabimportalerts@fda.hhs.gov.

Questions or issues concerning technical/scientific interpretation of documents provided at the time of entry, policy, sample collection recommendations, or any other additional questions, should be addressed to CFSAN/Division of Enforcement at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov.***

Product Description:

Various (see attachment)

Charge:

***"The article is subject to refusal of admission in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409. ***[Adulteration, Section 402(a)(2)(C)(i)]

OASIS charge code - MELAMINE

and/or

***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. [Adulteration, Section 402(a)(1)] Contains:***

OASIS charge code - POISONOUS

and/or

"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food. [Adulteration, ***Section*** 402(a)(3)]

OASIS charge code - UNFIT4FOOD

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


CHINA


Candy Manufacturer Inc
Date Published : 09/16/2009
H.K Office: Room A, 1st. Floor, 111 Pak , Kowloon, CHINA
34 - - - -- Choc/Cocoa Prod
Date Published: 09/16/2009

Notes: Cocoa Powder;Charge: 402(a)(2)(C)(i); 12/1/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

35 - - - -- Gelatin/Rennet/Pudding Mix/Pie Filling
Date Published: 09/16/2009

Notes: Cocoa Powder;Charge: 402(a)(2)(C)(i); 12/1/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

Candy Manufacturer Inc.
Date Published : 09/16/2009
Unit 103 , NO 17 Qiaoxing North Road , Jiangmen, Guangdong CHINA
34 - - - -- Choc/Cocoa Prod
Date Published: 09/16/2009

Notes: Cocoa Powder;Charge: 402(a)(2)(C)(i); 12/1/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

35 - - - -- Gelatin/Rennet/Pudding Mix/Pie Filling
Date Published: 09/16/2009

Notes: Cocoa Powder;Charge: 402(a)(2)(C)(i); 12/1/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

Inner Mongolia Yili Dairy Products Co. Ltd
Date Published : 09/16/2009
NO 8 Jichanglu , Saihan , Huhehaote, Neimengguzizhiqu CHINA
09 - - - -- Milk/Butter/Dried Milk Prod
Date Published: 09/16/2009

Notes: Yeast Flavored milk drink Yili Brand; Charge: 402(a)(2)(c)(i); 10/10/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated
Date Published: 09/16/2009

Notes: Yeast Flavored milk drink Yili Brand; Charge: 402(a)(2)(c)(i); 10/10/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 09/16/2009

Notes: Yeast Flavored milk drink Yili Brand; Charge: 402(a)(2)(c)(i); 10/10/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

29 B - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Carbonated
Date Published: 09/16/2009

Notes: Yeast Flavored milk drink Yili Brand; Charge: 402(a)(2)(c)(i); 10/10/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

29 B - - 99 Carbonated Soft Drink, N.E.C.
Date Published: 09/16/2009

Notes: Yeast Flavored milk drink Yili Brand; Charge: 402(a)(2)(c)(i); 10/10/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

QING DAO JIA NA COCOA PRODUCT CO., LTD
Date Published : 09/16/2009
Jiangshan , Town, Lai Xidao , Qingdao, Shandong CHINA
34 - - - -- Choc/Cocoa Prod
Date Published: 09/16/2009

Notes: Cocoa; Charge: 402(a)(2)(C)(i); 3/23/09
Problems: MELAMINE (CYROMAZINE METABOLITE);

WEIFANG GOURMET ART AND CRAFT CO., LTD.
Date Published : 09/16/2009
New-High Technology , Qimei Street; Dev. Zone , Weifang, Shandong CHINA
34 - - - -- Choc/Cocoa Prod
Date Published: 09/16/2009

Notes: Hot Chocolate Mix; Charge: 402(a)(2)(c)(i) & 402(a)(1); 11/18/08; update charge: 12/3/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

35 - - - -- Gelatin/Rennet/Pudding Mix/Pie Filling
Date Published: 09/16/2009

Notes: Hot Chocolate Mix; Charge: 402(a)(2)(c)(i) & 402(a)(1); 11/18/08; update charge: 12/3/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

Weifang Gourmet Art and Craft Co., Ltd
Date Published : 09/16/2009
No 598 Lanxiang Street , Kuiwen District Weifang , Shandong, CHINA
34 - - - -- Choc/Cocoa Prod
Date Published: 09/16/2009

Notes: Hot Chocolate Mix; Charge: 402(a)(2)(c)(i) & 402(a)(1); 11/18/08; update charge 12/3/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

35 - - - -- Gelatin/Rennet/Pudding Mix/Pie Filling
Date Published: 09/16/2009

Notes: Hot Chocolate Mix; Charge: 402(a)(2)(c)(i) & 402(a)(1); 11/18/08; update charge 12/3/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

Yikang Group Limited Company of Shandong
Date Published : 09/16/2009
NO. 68 of Yikang Road , Zaozhuang, Shandong CHINA
03 - - - -- Bakery Prod/Dough/Mix/Icing
Date Published: 09/16/2009

Notes: Chocolate chip Cookies; Charge: 402(a)(2)(C)(i); 3/30/09
Problems: MELAMINE (CYROMAZINE METABOLITE);

34 - - - -- Choc/Cocoa Prod
Date Published: 09/16/2009

Notes: Chocolate chip Cookies; Charge: 402(a)(2)(C)(i); 3/30/09
Problems: MELAMINE (CYROMAZINE METABOLITE);

Zhongshan Kunbo Foodstuff Import & Export Corp. Ltd.
Date Published : 09/16/2009
NO. 32 Changyi Road , Changmingshui Village, Wuguishan , Zhongshan, Guangdong CHINA
09 - - - -- Milk/Butter/Dried Milk Prod
Date Published: 09/16/2009

Notes: Milk based flavored drink Blue Cat;Charge:402(a)(2)(c)(i); 10/10/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated
Date Published: 09/16/2009

Notes: Milk based flavored drink Blue Cat;Charge:402(a)(2)(c)(i); 10/10/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 09/16/2009

Notes: Milk based flavored drink Blue Cat;Charge:402(a)(2)(c)(i); 10/10/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

29 B - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Carbonated
Date Published: 09/16/2009

Notes: Milk based flavored drink Blue Cat;Charge:402(a)(2)(c)(i); 10/10/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

29 B - - 99 Carbonated Soft Drink, N.E.C.
Date Published: 09/16/2009

Notes: Milk based flavored drink Blue Cat;Charge:402(a)(2)(c)(i); 10/10/08
Problems: MELAMINE (CYROMAZINE METABOLITE);

Zhongshan Lebang Chocolate Foods Co., Ltd
Date Published : 06/27/2018
No. 16 Yixian Rd , Torch Development Zone , Zhongshan, Guangdong CHINA
34 - - - -- Choc/Cocoa Prod
Date Published: 06/27/2018

Desc: All Chocolate products
Notes: Added to IA 10/23/2008


INDIA


Cadbury India Limited
Date Published : 09/16/2009
19 , Bhulabhi Desai Road , Mumbai, Maharashtra INDIA
09 - - - -- Milk/Butter/Dried Milk Prod
Date Published: 09/16/2009

Notes: Bourn vita with (super charges); Malt- milk beverage; dry power mix with cocoa; Charge: 402(a)(2)(C)(i); 3/23/09
Problems: MELAMINE (CYROMAZINE METABOLITE);

14 - - - -- Filled Milk/Imit Milk Prod
Date Published: 09/16/2009

Notes: Bourn vita with (super charges); Malt- milk beverage; dry power mix with cocoa; Charge: 402(a)(2)(C)(i); 3/23/09
Problems: MELAMINE (CYROMAZINE METABOLITE);

29 - - - -- Soft Drink/Water
Date Published: 09/16/2009

Notes: Bourn vita with (super charges); Malt- milk beverage; dry power mix with cocoa; Charge: 402(a)(2)(C)(i); 3/23/09
Problems: MELAMINE (CYROMAZINE METABOLITE);

34 - - - -- Choc/Cocoa Prod
Date Published: 09/16/2009

Notes: Bourn vita with (super charges); Malt- milk beverage; dry power mix with cocoa; Charge: 402(a)(2)(C)(i); 3/23/09
Problems: MELAMINE (CYROMAZINE METABOLITE);

J. D. Corporation
Date Published : 09/16/2009
305 Mahinder Chembers 619/28th W.T. , Patil Marg, Chembur, Mumbia , Maharashtra, INDIA
29 A - - -- Noncarb Soft Drink
Date Published: 09/16/2009

Notes: Bournvita with Sugar Chargers Nutritional Chocolate Drink; Charge: 402(a)(2)(C) (i); 2/18/09
Problems: MELAMINE (CYROMAZINE METABOLITE);

34 - - - -- Choc/Cocoa Prod
Date Published: 09/16/2009

Notes: Bournvita with Sugar Chargers Nutritional Chocolate Drink; Charge: 402(a)(2)(C) (i); 2/18/09
Problems: MELAMINE (CYROMAZINE METABOLITE);

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 09/16/2009

Notes: Bournvita with Sugar Chargers Nutritional Chocolate Drink; Charge: 402(a)(2)(C) (i); 2/18/09
Problems: MELAMINE (CYROMAZINE METABOLITE);


JAPAN


NESTLE CO.,LTD. KASUMIGAURA FACTORY
Date Published : 09/16/2009
Mukaeyama 1751 , Jinguji , Inashiki, Ibaraki JAPAN
34 - - - -- Choc/Cocoa Prod
Date Published: 09/16/2009

Notes: Mocha Drink Mix; Charge: 402(a)(2)(C)(i); 1/27/09
Problems: MELAMINE (CYROMAZINE METABOLITE);


KOREA, REPUBLIC OF (SOUTH)


Erom Co., LTD
Date Published : 09/16/2009
111 Toegyenonggong-Ro , Chuncheon, Gangwon KOREA, REPUBLIC OF (SOUTH)
40 - - - -- Baby Food Prod
Date Published: 09/16/2009

Notes: Kid's Natural raw Meal (Instant Cereal/Meal Replacement) 3/16/09; Charge: 402(a)(2)(C)(i);
Problems: MELAMINE (CYROMAZINE METABOLITE);

Lotte Samkang CO.,LTD
Date Published : 09/16/2009
Chaamdong 54 3 , Chonan, Chungnam KOREA, REPUBLIC OF (SOUTH)
13 - - - -- Ice Cream Prod
Date Published: 09/16/2009

Notes: Chocolate Flavored Ice Tubes; Charge: 402(a)(2)(C)(i); 1/16/09
Problems: MELAMINE (CYROMAZINE METABOLITE);

34 - - - -- Choc/Cocoa Prod
Date Published: 09/16/2009

Notes: Chocolate Flavored Ice Tubes; Charge: 402(a)(2)(C)(i); 1/16/09
Problems: MELAMINE (CYROMAZINE METABOLITE);

Lotte Samkang Co., Ltd.
Date Published : 09/16/2009
#21 6ga, Munrae-dong , Youngdeungpo-gu , Seoul, KR-NOTA KOREA, REPUBLIC OF (SOUTH)
13 - - - -- Ice Cream Prod
Date Published: 09/16/2009

Notes: Chocolate Flavored Ice Tubes; Charge: 402(a)(2)(C)(i); 1/16/09
Problems: MELAMINE (CYROMAZINE METABOLITE);

34 - - - -- Choc/Cocoa Prod
Date Published: 09/16/2009

Notes: Chocolate Flavored Ice Tubes; Charge: 402(a)(2)(C)(i); 1/16/09
Problems: MELAMINE (CYROMAZINE METABOLITE);

NONGSHIM ASAN FACTORY
Date Published : 09/16/2009
Tangjeong-Myun , 177-1 Dongsan-Ri , Asan, Chungnam KOREA, REPUBLIC OF (SOUTH)
04 - - - -- Macaroni/Noodle Prod
Date Published: 11/01/2010

Desc: Korean Noodle Soup (Hooroorook)
Problems: MELAMINE (CYROMAZINE METABOLITE);

Nongshim Co., Foods Co.,Ltd
Date Published : 11/01/2010
370 Sindaebang 2-dong Dongjak-gu , Seoul, Kr-11 KOREA, REPUBLIC OF (SOUTH)
04 - - - -- Macaroni/Noodle Prod
Date Published: 11/01/2010

Desc: Korean Noodle Soup (Hooroorook)
Problems: MELAMINE (CYROMAZINE METABOLITE);


PHILIPPINES


La Noceda Food Products
Date Published : 09/16/2009
78 General Luna Street , Mendez, PH-CAV PHILIPPINES
03 - - - -- Bakery Prod/Dough/Mix/Icing
Date Published: 09/16/2009

Notes: Crackers and Biscuits; Charge: 402(a)(2)(C)(i); 1/14/09
Problems: MELAMINE (CYROMAZINE METABOLITE);


UNITED KINGDOM


Boxer Ltd
Date Published : 09/16/2009
63 Norwood Ave , Shipley, UNITED KINGDOM
34 - - - -- Choc/Cocoa Prod
Date Published: 09/16/2009

Notes: All Chocolate Products from Zhongshan Lebang; Charge: 402(a)(1); 10/23/08
Problems: MELAMINE (CYROMAZINE METABOLITE);