I was getting some information from folks about the FDA possibly holding out on who the wheat gluten supplier to Menu Foods was (we already know that Menu Foods, Nestle Purina PetCare Co. were holding out the info), and wouldn’t you know that when I did a search on the FDA site with the terms “wheat gluten” to verify the information being given to me, THIS popped up (will copy below)! If it was dated 3/30/07 WHY WASN’T IT RELEASED TO THE PUBLIC SOONER???

Mind you, the supplier mentioned at the bottom of the FDA document, Xuzhou Anying Biologic Technology Development Co. Ltd, may in fact NOT be the one who supplied the wheat gluten to Menu Foods (sorry, but the notice gets a tad confusing…will refer to those of you with more knowledge on this subject to offer up some insight, please!), but it is, at the very least, one which has tainted wheat gluten. And this information posted by the FDA is a somewhat good sign that they seem to be checking supplies at some point. I would like to hear, though, why the FDA didn’t bother putting a link to this information on the page they’ve been posting all other pet food recall press releases. Oh wait, silly me, a press release means RELEASE (publicly) of information through the press and that is NOT what it seems they wanted to do with THIS particular information.

I’m sure I’ll be adding more to this entry as information comes along, and I sure as heck hope main media sources are working on this development, too. If you’d like to read more about the conversation we’ve been having here about wheat gluten, click here. Some great information by some fabulous posters in the comment section…many thanks to them! Please note that I had to adjust some formatting of the FDA notice below so that it would fit, but HOPEFULLY I didn’t delete anything except a bunch of spaces. For the EXACT document, click the link here. Also, I could NOT find the attachments mentioned in the document anywhere on the site. That, of course, does not mean they weren’t right in front of me. 😉

Added 4/2/07: Just found this page on the FDA site that shows the process of their “Pet Food Contamination Response” and have to say the typos on that page astounded me. 😉

From the US Food and Drug Administration, Office of Regulatory Affairs: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 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

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 3/30/07 DWPE Wheat gluten

Product /Code: 02F[][]08

Xuzhou Anying Biologic Technology

Development Company Ltd.

Wangdian Industrial Zone,

Peixian, CN-32, China 221623

FEI# 2000023594

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