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: 02/21/2025
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
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; https://www.fda.gov/food/laboratory-methods-food/laboratory-information-bulletin-lib-4422-melamine-and-cyanuric-acid-residues-foods
***To remove a firm's 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 FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE)," available at: https://www.fda.gov/food/laboratory-methods-food/laboratory-information-bulletin-lib-4422-melamine-and-cyanuric-acid-residues-foods
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 OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov
Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov
******
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; https://www.fda.gov/food/laboratory-methods-food/laboratory-information-bulletin-lib-4422-melamine-and-cyanuric-acid-residues-foods
***To remove a firm's 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 FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE)," available at: https://www.fda.gov/food/laboratory-methods-food/laboratory-information-bulletin-lib-4422-melamine-and-cyanuric-acid-residues-foods
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 OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov
Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@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
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 - - - -- Chocolate/Cocoa Products/Cocoa beans
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 Mixes/Pie Fillings
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 - - - -- Chocolate/Cocoa Products/Cocoa beans
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 Mixes/Pie Fillings
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 Products
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);
JINJIANG QIMEI GIFTS AND FAVOURITE
Date Published : 02/05/2020
DONG CHEN
, FUJIAN,
CN-35 CHINA
72 - - - -- Pet/Laboratory Animal Food
Date Published: 02/05/2020
Desc: Fish Food
Notes: Original DWPE date; 2/25/2008
Jiang Su Peidi Brand Food Products Co., Ltd.
Date Published : 02/05/2020
No. 8 Zhen Bei Road , Gao Gang Area
, Taizhou,
Jiangsu CHINA
72 - - - -- Pet/Laboratory Animal Food
Date Published: 02/05/2020
Desc: Animal Food
Notes: Original DWPE date: 2/25/2008; *NOTE: While the physical location and personnel have not changed, as a result of a change in China's corporate law, JiangSu Peidi was required to change their legal name and address structure.
JiangSu Compet Pet Food Products Co., Ltd.
Date Published : 02/05/2020
Xuzhuang Street , Gaogang
, Taizhou,
Jiangsu CHINA
72 - - - -- Pet/Laboratory Animal Food
Date Published: 02/05/2020
Desc: Pet/Laboratory Animal Food
Notes: Original DWPE date: 3/18/2011. *NOTE; While the physical location and personnel have not changed; as a result of a change in China's corporate law; JiangSu Peidi was required to change their legal name and address structure.
QING DAO JIA NA COCOA PRODUCT CO., LTD
Date Published : 09/16/2009
Jiangshan , Town, Lai Xidao
, Qingdao,
Shandong CHINA
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 09/16/2009
Notes: Cocoa; Charge: 402(a)(2)(C)(i); 3/23/09
Problems:
MELAMINE (CYROMAZINE METABOLITE);
SHANDONG XIANTONG FOODSTUFF CO.,LTD
Date Published : 02/05/2020
Muping , NO. 98 Xiantanstreet Qinshuiindustrialzo
, Yantai,
Shandong CHINA
72 B - - 02 Poultry Prod Pet Dog Food
Date Published: 02/05/2020
Desc: Duck Sausage (Rawhide Dog Chews)
Notes: Original DWPE date; 11/28/2010. Manufacturer and shipper
WEIFANG GOURMET ART AND CRAFT CO., LTD.
Date Published : 09/16/2009
New-High Technology , Qimei Street; Dev. Zone
, Weifang,
Shandong CHINA
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
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 Mixes/Pie Fillings
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 - - - -- Chocolate/Cocoa Products/Cocoa beans
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 Mixes/Pie Fillings
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 Products/Dough/Mixes/Icings
Date Published: 09/16/2009
Notes: Chocolate chip Cookies; Charge: 402(a)(2)(C)(i); 3/30/09
Problems:
MELAMINE (CYROMAZINE METABOLITE);
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
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 Products
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 - - - -- Chocolate/Cocoa Products/Cocoa beans
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 Products
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/Imitation Milk Products
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 - - - -- Drinks, Soft Drinks, and Waters
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 - - - -- Chocolate/Cocoa Products/Cocoa beans
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 - - - -- Chocolate/Cocoa Products/Cocoa beans
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 JAPAN INC KASUMIGAURA FAC
Date Published : 09/16/2009
Azamukaeyama 1751 , Jinguji
, Inashiki,
Ibaraki JAPAN
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 09/16/2009
Notes: Mocha Drink Mix; Charge: 402(a)(2)(C)(i); 1/27/09
Problems:
MELAMINE (CYROMAZINE METABOLITE);
KOREA (THE REPUBLIC OF)
Erom Co., LTD
Date Published : 09/16/2009
111 Toegyenonggong-Ro
, Chuncheon,
Gangwon KOREA (THE REPUBLIC OF)
40 - - - -- Baby Food Products
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 (THE REPUBLIC OF)
13 - - - -- Ice Cream and related Products
Date Published: 09/16/2009
Notes: Chocolate Flavored Ice Tubes; Charge: 402(a)(2)(C)(i); 1/16/09
Problems:
MELAMINE (CYROMAZINE METABOLITE);
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
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 (THE REPUBLIC OF)
13 - - - -- Ice Cream and related Products
Date Published: 09/16/2009
Notes: Chocolate Flavored Ice Tubes; Charge: 402(a)(2)(C)(i); 1/16/09
Problems:
MELAMINE (CYROMAZINE METABOLITE);
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
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 (THE REPUBLIC OF)
04 - - - -- Macaroni/Noodle Products
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 (THE REPUBLIC OF)
04 - - - -- Macaroni/Noodle Products
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 Products/Dough/Mixes/Icings
Date Published: 09/16/2009
Notes: Crackers and Biscuits; Charge: 402(a)(2)(C)(i); 1/14/09
Problems:
MELAMINE (CYROMAZINE METABOLITE);
TAIWAN
Five Eels Industry Corp
Date Published : 02/05/2020
Lane 74 , NO. 44 Sanchun St
, Taipei,
TAIWAN
72 - - - -- Pet/Laboratory Animal Food
Date Published: 02/05/2020
Desc: Fish Food
Notes: Original DWPE date; 2/25/2008
JC-Sunny International Co., Ltd.
Date Published : 02/05/2020
No.23, Sec.2 , 4f-3; Keelung Road
, Taipei,
Tw-Tpe TAIWAN
72 - - - -- Pet/Laboratory Animal Food
Date Published: 02/05/2020
Desc: Fish Food
Notes: Original DWPE date; 2/25/2008
UNITED KINGDOM
Boxer Ltd
Date Published : 09/16/2009
63 Norwood Avenue
, Shipley,
West Yorkshire UNITED KINGDOM
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 09/16/2009
Notes: All Chocolate Products from Zhongshan Lebang; Charge: 402(a)(1); 10/23/08
Problems:
MELAMINE (CYROMAZINE METABOLITE);