UPDATE 5:40pm Pacific: USAToday points out confusion among experts and consumers. Melamine toxicity is being disputed by many sources, leaving customers to wonder when the smoking gun will be found.
Also, the NY lab that found aminopterin is continuing to stand by its findings.
FDA just issued this warning against the import of specific wheat gluten from a maker in China. 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. (Web site)
This is the only known source of contamination identified by the FDA. Unfortunately, this was never released to the media from what we can gather.
If anyone else is using supplies from this company (for human or pet consumption), they should contact the FDA ASAP.
In the alert, the FDA has now authorized the quarantine or dentention of any wheat gluten from this specific company in China and passed through the Netherlands (a transit point) without the need to inspect it. Basically preventing the supply from getting into any food stream.
Judging by the date (3/30) we suspect that this definitive action labeling this supply wheat gluten as “poisonous” is what prompted many other makers from issuing their “voluntary recalls” last Friday. After all, legally speaking, their hands were now tied.
(Thanks to Gina at Pet Connection)
Full FDA alert after the jump.
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
CODES: 02F08 Wheat gluten
02E06 - Wheat flour gluten
71M01 wheat gluten
PROBLEMS: Poisonous or deleterious substance
Unsafe food additive
COUNTRY: See Attachment
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;
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)
OFFICE: Division of Compliance, CVM (HFV-230)
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 source
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
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-
For questions or issues concerning science, science policy, sample collection, analysis,
preparation, or analytical methodology, contact Tom Savage, Division of Field Science,
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
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.
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.
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
INTO FIARS: March 30, 2007
Firms and products currently under detention without physical examination
Firm: Date DWPE Product /Code:
Xuzhou Anying Biologic Technology 3/30/07 Wheat gluten
Development Company Ltd. 02F08
Wangdian Industrial Zone,
Peixian, CN-32, China 221623