Posted on 04/01/2007 4:49:58 PM PDT by Milwaukee_Guy
IA #99-26, IMPORT ALERT #99-26, "DETENTION WITHOUT PHYSICAL EXAMINATION AND INTENSIFIED COVERAGE OF WHEAT GLUTEN DUE TO THE PRESENCE OF MELAMINE"
TYPE OF ALERT: Detention Without Physical Examination
(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).
PRODUCT: Wheat Gluten
PRODUCT CODES: 02F[][]08 Wheat gluten 02E[][]06 - Wheat flour gluten 71M[][]01 wheat gluten
PROBLEMS: Poisonous or deleterious substance Unsafe food additive
PAF: PES FAD
PAC FOR COLLECTION: 71003A 09006A
COUNTRY: See Attachment
MANUFACTURER/ FEI#: See Attachment
CHARGES: 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 it injurious to health [Adulteration, section 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 bear or contain a food additive that is unsafe within the meaning of section 409 [Adulteration, section 402(a)(2)(C)(i)]" (Oasis Charge Code: UNSAFE ADD)
RECOMMENDING OFFICE: Division of Compliance, CVM (HFV-230)
REASON FOR ALERT: In March 2007, FDA became aware of the illness and death of cats and dogs associated with certain pet food. Subsequently, samples of the implicated pet food were analyzed and found to contain melamine. The consumption of pet food containing melamine may be associated with acute renal failure in cats. Investigations have revealed that the sour ce of the melamine was wheat gluten which is an ingredient in the pet food. The attachment to this alert includes manufacturers whose wheat gluten products have been found to contain melamine. GUIDANCE: Districts may detain without physical examination, products offered for importation from manufacturers and shippers listed in the Attachment to this import alert. Report wheat gluten samples found positive for melamine to Cathie Marshall, CVM, Division of Compliance, HFV-232, at (240) 276-9217.
Appropriate screening criteria have been set for wheat gluten from China and the Netherlands, as a country through which transshipping of Chinese wheat gluten may occur. Sampling has been recommended. Recommendations for detention without physical examination of firms with violative product should be forwarded to DIOP, HFC- 170.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact Tom Savage, Division of Field Science, at 301-827-1026.
To enable the agency to assess whether the firm has identified the source of the problem, and has taken the appropriate steps to correct and prevent future occurrences, FDA recommends that a firm requesting removal from detention without physical examination provide the following information:
1. a. Results of the firm's investigation(s) into the problem of melamine contamination
b. Documentation showing corrective action(s)such as:
i. a description of the process(es) currently being used ii. verification that the process is adequate iii. measures that have been taken to prevent recontamination
c. Copies of three (3) production records showing the process, quantities processed, lot numbers and dates of processing.
AND
d. Documentation showing that a minimum of five (5) consecutive entries have been released by FDA based on third party laboratory analyses that show the shipments of wheat gluten do not contain melamine.
All requests for removal from DWPE should be forwarded to DIOP,(HFC-170) which in turn will forward the requests to CVM (HFV-230) for evaluation.
PRIORITIZATION GUIDANCE: I
FOI: No purging required
KEYWORDS: Feed, pet food, melamine, wheat gluten
PREPARED BY: Cathie Marshall, CVM, HFV-232, 240-276-9217 and Linda Wisniowski, DIOP, HFC-172, 301-443-6553
DATE LOADED INTO FIARS: March 30, 2007 ATTACHMENT 3/30/07
Firms and products currently under detention without physical examination
CHINA (CN)
Firm: Date DWPE Product /Code:
Xuzhou Anying Biologic Technology 3/30/07 Wheat gluten Development Company Ltd. 02F[][]08 Wangdian Industrial Zone, Peixian, CN-32, China 221623 FEI# 2000023594
FDA authorizes siezure without having to prove or inspect imported wheat gluten.
Sounds like dramatic action.
Why is some of the wheat gluten being trans shipped from Holland?
Whoa...
This is a bit startling, no?
Send your cards and letters of appreciation to,
I knew it all along. The Company at fault is named Kat Poi Son. I think it is in the Dog Chow province.
The page formatting didn't come through properly. The name of the company and the address:
Xuzhou Anying Biologic Technology Development Company Ltd.
Wangdian Industrial Zone,
Peixian, CN-32, China 221623
Pu Chi No Mo
My kids make fun of me because I won't buy anything from China that touches food (no pans, flatware, plates, small Chinese cooks, etc). The Chinese simply don't have to follow the same standards of safety which we have to follow.
Don't trust 'em. Guess I was right. Guess I need to to go tell my kids, "I told you so!"
"The full name of the company is: Xuzhou Anying Biologic Technology Development Company Ltd. This company also exports wheat flour, cornstarch, sweet potato starch, protein powder, zinc oxide, carrots, garlic, ginger, and other agricultural products."
LOL
Why the hell would the United States or Canada need to import any grain product from China?
Don't trust 'em. Guess I was right. Guess I need to to go tell my kids, "I told you so!"
I just -love- it when I can do that!
heh...
I'm wondering if some kind of transportation contamination occurred.
A Netherlands based company named DMS is the largest supplier of melamine in the world. China uses melamine as a fertilizer. There is another potential player here in the U.S.--an unnamed supplier/distributer of the imported wheat gluten.
Nice grab!
Sheesh--I know all this because I just read about it an hour ago. Why? Because I just about had an anxiety attack this afternoon while shopping for pet food.
Some pet food company is going to get sued flat for that saving.
"Vital Wheat Gluten
Brief Introdction:
wheat gluten meal is also named vital wheat gluten. The flour is used as its raw material, and from which extracts a light brown natural grain powder through intensively processing. It is a good solubles protein, containing fifteen amino acid essential for human body. After all, it can yet be regarded as a plant protein food looking good, smelling good and tasting good. It is the basic raw material of high-grade aquatic food.
Specification:
Protein≥75%
Moisture≤8%
Ash (lime)≤1%
The rate of absorbing water≥160%
The degree of thickness: 99% through 200 um tough silk sieve
Taste, smell: normal, with grain delicious
Outward ap: light yellow powder"
Emphasis added. Note that it looks like this is also used as a human food additive/supplement.
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