Import Alert 99-29

(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 # 99-29
Published Date: 04/04/2022
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of All Vegetable Protein Products From China for Animal or Human Food Use Due to the Presence of Melamine and/or Melamine Analogs"

Reason for Alert:

NOTE: The revision to this import alert dated 12/21/2020 updates the reason for alert section, the guidance section and the contact information. Changes are bracketed by asterisks (***).

*** In April of 2007, FDA learned of an outbreak of cat and dog deaths and illness associated with pet food manufactured with vegetable proteins contaminated with melamine and melamine related compounds. The Agency worked with federal, state, and local governments, academia, and industry to assess the extent of the outbreak, better understand how melamine and melamine related compounds contributed to the pet deaths and illnesses, and to determine the underlying cause of the contamination. This outbreak resulted in over 17,000 complaints and 17 Class I and Class II recalls based on samples collected by FDA.

In 2007, FDA collected approximately 750 samples of wheat gluten and products made with wheat gluten and 330 were positive for melamine and/or melamine related compounds. FDA also collected approximately 85 samples of rice protein concentrate and products made with rice protein concentrate and 27 were positive for melamine and/or melamine related compounds. FDA's investigation traced all of these positive samples as having been imported from China.

As a result, the U.S. have been monitoring animal food for melamine. Melamine is a compound used primarily in commercial and industrial applications. There are no approved uses of melamine as a food additive in human or animal food in the U.S.***

Guidance:

Divisions may detain without physical examination, all vegetable protein derived ingredients identified in the attachment for this alert, except finished products and shipments from those firms listed in the Green List to this alert.

***Release of Articles Subject to Detention without Physical Examination under 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 melamine or cyanuric acid. Third-party laboratories may use any method that is found acceptable to FDA and which meets the method performance of the LC-MS/MS methods available at https://www.fda.gov/food/laboratory-methods-food/laboratory-information-bulletin-lib-4422-melamine-and-cyanuric-acid-residues-foods ***

***Removal from Detention without Physical Examination (ADDITION TO THE GREEN LIST):***
In order to adequately assess whether a manufacturer has the appropriate controls and processes in place to ensure the quality of the product being produced, the firm or shipper should provide the following information:

1. Documentation showing that a minimum of five (5) consecutive non-violative shipments have been released by FDA based on third party laboratory analyses using FDA recommended methods and that all shipments did not contain the presence of melamine and/or melamine analogs.

AND

2. Certificate, such as from AQSIQ, indicating that an inspection of the manufacturer was conducted and adequate controls are in place. Information should also include:

a. Copy of the inspectional report and compliance status of the firm (statement as to whether such inspection concluded that the firm has adequate controls in place to ensure that its products are free of melamine or its analogs).

b. If products were sampled during the course of the inspection, test results indicating that the products are free of melamine and/or melamine analogs.

All requests for removal (exemption) from DWPE will be forwarded by DIO to CVM or CFSAN for evaluation depending on the intended final use in animal or human food.

***If a firm and/or a representative thereof would like to petition for removal (exemption) 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 (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 oraorsprivatelabimportalerts@fda.hhs.gov

Questions or issues with regard to human food on policy, sample collection recommendations, or other any addition questions, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch, (HFS-607) at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov

Questions or issues with regard to animal food on policy, sample collection recommendations, or any other additional questions, should be addressed to Center for Veterinary Medicine (CVM), Division of Compliance, Animal Drug Program Team (HFV-233) at CVMImportRequests@fda.hhs.gov ***

Product Description:

Wheat Gluten, Rice Gluten, Rice Protein, Rice Protein Concentrate, Corn Gluten, Corn Gluten Meal, Corn Milled Protein, Soy Protein, Soy Gluten, Soy Meal, Mung Bean Protein

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) 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. Contains: " ***[Adulteration, 402(a)(1)]***

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, 402(a)(3)]

OASIS charge code: UNFIT4FOOD

Countries

CHINA

  • (02 G - - 08) Soybean Flour, Meal, or Powder
    Problems:MELAMINE (CYROMAZINE METABOLITE);
  • (18 E - - 03) Soybean Protein Powder (Meat Extender)
    Problems:MELAMINE (CYROMAZINE METABOLITE);
  • (71 L - - 07) Soybean Meal
    Problems:MELAMINE (CYROMAZINE METABOLITE);
  • (02 F - - 08) Gluten, Wheat
    Problems:MELAMINE (CYROMAZINE METABOLITE);
  • (02 E - - 06) Wheat Flour, Gluten
    Problems:MELAMINE (CYROMAZINE METABOLITE);
  • (71 M - - 01) Wheat Gluten
    Problems:MELAMINE (CYROMAZINE METABOLITE);
  • (02 D - - 12) Rice Protein
    Problems:MELAMINE (CYROMAZINE METABOLITE);
  • (02 D - - 13) Rice Gluten
    Problems:MELAMINE (CYROMAZINE METABOLITE);
  • (71 I - - 03) Rice Protein
    Problems:MELAMINE (CYROMAZINE METABOLITE);
  • (71 G - - 02) Corn Gluten
    Problems:MELAMINE (CYROMAZINE METABOLITE);
  • (02 B - - --) Milled Corn Product
    Problems:MELAMINE (CYROMAZINE METABOLITE);
  • (18 Y - - 99) Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
    Desc: Vegetable Protein Products N.E.C.
  • (02 G - - 12) Mung Bean Protein
    Desc: Mung Bean Protein
  • (70 A - - 09) Soybeans, Soybean Meal Ground Grains Animal
    Desc: Soy Bean Meal Whole/Ground Grains Animal

List of firms and their products that have met the criteria for exclusion from Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Green List)


CHINA


Anhui Shunxin Shengyuan Biological Food Co.,Ltd
Date Published : 11/07/2017
No. 28 Bangbu Road , Langye , Chuzhou, Anhui CHINA
02 D - - 12 Rice Protein
Date Published: 11/07/2017

Desc: Rice Protein

DALIAN FULL RICH CO.,LTD
Date Published : 03/25/2021
Ganjingzi District 116113 Dalian,Liaoning Province China , Dalian Wancun; Dalianwanzhen Jinzhousubdistrict , Dalian, Liaoning CHINA
70 A - - 09 Soybeans, Soybean Meal Ground Grains Animal
Date Published: 03/25/2021

Desc: Soybean Meal
Notes: 6/27/2018

DEZHOU RUIKANG BIO TECHNOLOGY CO.,LTD
Date Published : 10/30/2013
NO. 968 RUIKANG AVENUE , ECONOMIC DEVELOPMENT ZONE , Dezhou, SHANDONG CHINA
02 G - - 08 Soybean Flour, Meal, or Powder
Date Published: 10/30/2013

Desc: Soy Protein Isolate

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 10/30/2013

Desc: Soy Protein Isolate

Dalian Gindy oil & foodstuffs Co., Ltd.
Date Published : 09/28/2017
Dalianwan Town , GanJingzi district , Dalian, Liaoningsheng CHINA
70 A - - 09 Soybeans, Soybean Meal Ground Grains Animal
Date Published: 09/28/2017

Desc: Organic Soybean Meal

70 Y - - 99 Animal Feeds, N.E.C.
Date Published: 09/28/2017

Desc: Organic Soybean Meal

Dalian Xinglongken Organic Cereal & Oil Co., Ltd.
Date Published : 07/28/2016
Weiguo Community , Jinzhou , Dalian, Liaoning CHINA
70 A - - 09 Soybeans, Soybean Meal Ground Grains Animal
Date Published: 07/28/2016

Desc: Soybean Meal

71 L - - 07 Soybean Meal
Date Published: 07/28/2016

Desc: Soybean Meal

DuPont Shineway Luohe Food Company Limited
Date Published : 10/30/2020
Shuanghui Industrial Park , Economic Development Zone , Luohe, Henan CHINA
18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 10/30/2020

Desc: Pea Protein

Dunhua City Earth Beans Trade Organic Foodstuffs Co.,Ltd
Date Published : 11/13/2012
Dongdianzicun , Dunhua , Yanbianchaoxianzuzizhizhou, Jilin CHINA
71 L - - 07 Soybean Meal
Date Published: 11/13/2012

Desc: Soybean Meal for animal feed

Dunhua City Fuxing Agricultural Products Co., Ltd.
Date Published : 09/17/2015
Group , 1 Minzhujie; Dunhua , Yanbianchaoxianzuzizhizhou, Jilin CHINA
02 G - - 08 Soybean Flour, Meal, or Powder
Date Published: 09/17/2015

Desc: Organic Soybean Meal

Forest Foods Co., Ltd.
Date Published : 01/14/2021
Jilin Fengman Economic Development Zone , Jilin City, Jilin CHINA
02 B - - 01 Corn, Bolted Meal or Flour
Date Published: 01/14/2021

Desc: Corn Flour

02 B - - 01 Corn, Bolted Meal or Flour
Date Published: 01/14/2021

Desc: Corn Groats

02 B - - 06 Corn, Hominy Grits
Date Published: 01/14/2021

Desc: Corn Groats

02 B - - 06 Corn, Hominy Grits
Date Published: 01/14/2021

Desc: Corn Flour

02 B - - 99 Corn, Milled Product N.E.C.
Date Published: 01/14/2021

Desc: Corn Groats

02 B - - 99 Corn, Milled Product N.E.C.
Date Published: 01/14/2021

Desc: Corn Flour

GABIO CO., LTD
Date Published : 06/24/2021
Xiushui Industrial Park , Road Yushui , Jiujiang, Jiangxi CHINA
02 D - - 12 Rice Protein
Date Published: 06/24/2021

Desc: Rice Protein

Gushen Biological Technology Group CO.,Ltd.
Date Published : 04/12/2012
The Economic , The Middle Of Caiyuan Road; Gushen Industrial Zone , Dezhou, Shandong CHINA
02 G - - 08 Soybean Flour, Meal, or Powder
Date Published: 04/12/2012

Desc: Soy Protein Isolate

JIANGXI HENGDING FOOD CO., LTD
Date Published : 05/18/2021
Fengcheng High-Tech Industrial Park , No 2 Huideng Road , Fengcheng, Jiangxi CHINA
02 D - - 12 Rice Protein
Date Published: 05/18/2021

Desc: Rice Protein

Jiujiang Tiantai Food
Date Published : 04/04/2022
No. 669 E. Binjiang Road , Xingang Industrial Park, Laixi District , Jiujiang, Jiangxi CHINA
18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 04/04/2022

Desc: Pea Protein

54 Y - - 17 Vegetable Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 04/04/2022

Desc: Pea Protein

Linyi Shansong Biological Products Co., Ltd.
Date Published : 11/07/2014
Lanshan District , Bancheng Town , Linyi, Shandong CHINA
02 G - - 08 Soybean Flour, Meal, or Powder
Date Published: 11/07/2014

Desc: Soy Protein Isolate

Nantong Sun-Green Bio Tech Co., Ltd.
Date Published : 11/27/2012
Pingchao Industry Park , Nantong, Jiangsu CHINA
02 G - - 08 Soybean Flour, Meal, or Powder
Date Published: 11/27/2012

Desc: Soy Protein Isolate

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 11/27/2012

Desc: Soy Protein Isolate

Nehe Dingsheng Agricultural Products Co. Ltd
Date Published : 04/24/2018
Industry Zone , Nehe, CN-23 CHINA
70 A - - 09 Soybeans, Soybean Meal Ground Grains Animal
Date Published: 04/24/2018

Desc: Soybean Meal

71 L - - 07 Soybean Meal
Date Published: 04/24/2018

Desc: Soybean Meal

PUER YONGJI BIOLOGICAL TECHNIQUE CO.,LTD
Date Published : 01/21/2015
Ning'Er County , Yuhecun; Zhenyuanyizuhanizulahuzuzizhi Xian , Puer, Yunnan CHINA
02 D - - 12 Rice Protein
Date Published: 01/21/2015

Desc: Rice Protein

Panjin Hetian Food Co., Ltd.
Date Published : 04/10/2019
Ping'An , Habacun; Pinganxiang Dawaxian , Pan Jin, Liaoning CHINA
02 D - - 12 Rice Protein
Date Published: 04/10/2019

Desc: Brown Rice Protein Powder

Pingdingshan TianJing Plant Albumen Co.
Date Published : 10/17/2019
Yancheng Middle Road , Ye County , Pingdingshan, Henan CHINA
02 G - - 08 Soybean Flour, Meal, or Powder
Date Published: 10/17/2019

Desc: Soy Protein Isolate

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 10/17/2019

Desc: Soy Protein Isolate

Qinhuangdao Goldensea Foodstuff Industries Co., Ltd.
Date Published : 01/25/2022
No. 1 Jinhai Road East Zone Of Economic , & Technological Development Zone , Qinhuangdao, Hebeisheng CHINA
18 E - - 03 Soybean Protein Powder (Meat Extender)
Date Published: 01/25/2022

Desc: Soy protein

18 E - - 99 Vegetable Protein Meat Extenders, N.E.C.
Date Published: 01/25/2022

Desc: Soy protein

SHANDONG HUA-THAI FOODPRODUCTS CO.,LTD.
Date Published : 06/11/2021
Zhaoyuan City , Shiduitou Zhangxing Town , Zhaoyuan City, Shandong CHINA
18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 06/11/2021

Desc: Pea Protein

54 Y - - 17 Vegetable Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 06/11/2021

Desc: Pea Protein

SHANDONG WONDERFUL BIOTECH CO.,LTD.
Date Published : 09/17/2020
North Of Yihonghe , Kenli; Kenlixian , Dongying, Shandong CHINA
02 G - - 08 Soybean Flour, Meal, or Powder
Date Published: 09/17/2020

Desc: Soy Protein Isolate

18 E - - 03 Soybean Protein Powder (Meat Extender)
Date Published: 09/17/2020

Desc: Soy Protein Isolate

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 09/17/2020

Desc: Soy Protein Isolate

SHANDONG YUXIN BIO-TECH CO.,LTD
Date Published : 09/16/2020
Boxing , Economic Development Zone , Binzhou, Shandong CHINA
02 G - - 08 Soybean Flour, Meal, or Powder
Date Published: 09/16/2020

Desc: Soy Protein Isolate

54 Y - - 14 Soy Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 09/16/2020

Desc: Soy Protein Isolate

Shandong Yuwang Ecological Food Industry Co., Ltd.
Date Published : 01/31/2014
High , Fuhua Road; Tech Development Zone , Yucheng, Shandong CHINA
02 G - - 08 Soybean Flour, Meal, or Powder
Date Published: 01/31/2014

Desc: Soy Protein Isolate
Notes: 5/2/12

02 G - - 08 Soybean Flour, Meal, or Powder
Date Published: 01/31/2014

Desc: Soy Protein Concentrate
Notes: 5/2/12

Shandong Jianyuan Bioengineering
Date Published : 12/12/2012
NO. 100 Shengtai Road , Zhaoyuan, Shandong CHINA
18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 12/12/2012

Desc: Pea Protein

Shandong Jindu Talin Foods Co.,Ltd
Date Published : 07/21/2017
Zhaoyuan Economic And , No. 2 Xinhui Road; Technology Zone , Yantai, Shandong CHINA
18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 07/21/2017

Desc: Pea protein

Shandong Sinoglory Health Food Co.,Ltd
Date Published : 08/14/2012
No 19 Hongtu Street , Shen County , Liaocheng, Shandong CHINA
02 G - - 08 Soybean Flour, Meal, or Powder
Date Published: 08/14/2012

Desc: Soy Protein Isolate

18 E - - 03 Soybean Protein Powder (Meat Extender)
Date Published: 08/14/2012

Desc: Soy Protein Isolate

Solbar Ningbo Protein Technology Co., Ltd.
Date Published : 01/27/2020
No. 12 Xingye Road , Free Trade Zone , Ningbo, Zhejiang CHINA
02 G - - 08 Soybean Flour, Meal, or Powder
Date Published: 01/27/2020

Desc: Soy Protein Isolate

Wuxi Jinnong Biotechnology Co. Ltd. Shanggao Branch
Date Published : 02/28/2014
No. 115 Shang Gao Avenue , Shanggaoxian , Yichun, Jiangxi CHINA
02 D - - 12 Rice Protein
Date Published: 02/28/2014

Desc: Rice Protein

Wuxi Jinnong Biotechnology Co.,Ltd
Date Published : 03/25/2021
No. 1 Yanqiao Street Yansheng Road , Huishan , Wuxi, Jiangsu CHINA
02 D - - 12 Rice Protein
Date Published: 03/25/2021

Desc: Rice Protein
Notes: 1/4/2018

YIWU HIGHSTAR BIOTECHNOLOGY CO L
Date Published : 10/07/2020
No 2288 Lotus South Str , Yiwu City, CHINA
02 D - - 12 Rice Protein
Date Published: 10/07/2020

Desc: Rice Protein

YanTai T.Full Biotech Co., Ltd.
Date Published : 10/02/2015
Shi Dui Toucun , Zhangxingzhen Zhaoyuan , Yantai, Shandong CHINA
02 G - - 12 Mung Bean Protein
Date Published: 03/22/2021

Desc: Mung Bean Protein

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 10/02/2015

Desc: Pea Protein Isolate

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 03/22/2021

Desc: Mung Bean Protein

Yantai Oriental Protein Tech Co. Ltd
Date Published : 06/03/2013
668 Jincheng Guangchang Jiashulou , Zhaoyuan , Yantai, Shandong CHINA
18 E - - 99 Vegetable Protein Meat Extenders, N.E.C.
Date Published: 06/03/2013

Desc: Pea Protein

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 06/03/2013

Desc: Pea Protein

Yantai Shuangta Food Co., LTD.
Date Published : 11/20/2013
Jinling Town , Zhaoyuan City, Shandong CHINA
18 E - - 99 Vegetable Protein Meat Extenders, N.E.C.
Date Published: 11/20/2013

Desc: Pea Protein Isolates

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 11/20/2013

Desc: Pea Protein Isolates

Yantai Yiyuan Bioengineering Co., Ltd.
Date Published : 03/21/2020
North Of Exit Coastal New Region Weiwu Highway , Zhaoyuan, Shandong CHINA
18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 03/21/2020

Desc: Pea Protein