FDA Ofc of Regulatory Affairs supposedly has a fiars

[kestrel91316]

order out on the Chinese gluten but it's NOT posted on their website. Some vet at VIN managed to get a link to it and i saaw it with my own eyes, but can't link to the vet page with it. I am gonna try again...

http://www.fda.gov/ora/fiars/ora_import_40cn.html

[DCKit]

1. Just in case it "disappears"

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 " (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
"
(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 [phone].

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

[formercia]

2. FOI: No purging required?

don't you think the material should be purged?

[kestrel91316]

4. Lol, that refers to FREEDOM OF INFORMATION ACT, I bet.

Not purging the product. That would be referred to as destruction anyway.

[kestrel91316]

3. Here's the FDA link:

http://www.fda.gov/ora/fiars/ora_import_ia9926.html