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
That is what I have been wondering. I thought ag products were the one place where we were supposed to have a competitive advantage.
Why the hell would the United States or Canada need to import H1-B professionals from China?
BIG PING!
As you say.
Yeh...like 'Whatever happened to Kansas' (wheat)
sounds like a liberal book title.
While I suspected as much, this is quite unsettling!
"This company also exports wheat flour, cornstarch, sweet potato starch, protein powder, zinc oxide, carrots, garlic, ginger, and other agricultural products."
This story is going to go ballistic.
Nahhh.
Nothing to see here, move along...™
"Why the hell would the United States or Canada need to import any grain product from China?"
Its probably US products shipped back after the addition of the extenders.
Yes they do...which in itself is an eye-opener. Getting a federal agency to move at ALL is something of a miracle.
"The heat is on"
I also think the heat should be on MENU products. That company has been totally unsympathetic towards the pet owners who have had animals that died. People should be writing to the companies that used them as a manufacturer and told that they will boycott until a new(hopefully, American company) takes over.
Well, now it's $1.50 a pound when you include the cost of the recalls and the law suits. That cheap wheat doesn't look so cheap now does it?
How many people will never trust them again and will never buy their products?
__________________________________________________________
I have been having attacks since my dog got sick and more so since we had to put him down a week after the recall, even though menu foods and the AVMA knew about something very wrong in June
Go to the AVMA website and see where it says they had suspicions of it on June first.
Makes my blood run cold.
Thanks M_guy.
Some people will do anyting for money. Putting plastic as filler in the wheat gluten so it weighs more.that is low down dirty rotten nasty lying cheating stealing and beyond the pale. May they rot in hail.
"Some pet food company is going to get sued flat for that saving."
Man can you see the laywers around the US just drooling to get one of these cases and maybe make it a class-action.
You can see the court room drama ...
"Call little Cindy to the witness stand."
Little Cindy walks up with pictures of here dearly departed little Fluffy kitty, crying all the way to the stand.
Key Lay and all the other Enron scumbags would be saints compared to the "Big cat/dog Food" company executives.
This would turn into a capital murder case by the end of the day.
Imported foods need to go through the same rigor as US companies' foods.
I wonder if anyone was paid off to benefit our good trading partner friends and debt holders, the red Chinese? Now that's something the Dims should investigate, if they're in the investigating mood-- rather than the non-crimes.
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