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
We've made our cats' food for a few years, and have a recipe down pat. If anyone wants it, freepmail me. Plus I have a link to a place that sells supplements to add to home made cat/dog food (cats need it more than dogs). We got some and add it to our cats' food and they really love it.
We just make a big pot full about every four days, for four cats.
They do the engineering and IT jobs Americans "just won't do".
I guess I didn't realize you were writing about someone losing their animal. Sad.
I was also puzzled by the comment: "Knowing they knew must be even more awful."
I now realize you were talking about the company. I'm S-L-O-W.
Man, that looks good. Just need some bacon and sausage and a couple of eggs, over-medium.
Looks like this is a good time to be a Celiac. 8-)
Son was telling me how his dog wasn't eating great and kind of sicky, but on Costco food.
He found this article
http://www.vetmed.wsu.edu/whatsNew/aflatoxin.aspWhy wasn't the FDA on this for a long time.
Then the other day he bought the dog Alpo, guess what, after he fed it to him, they recalled it. His cans are on recall list.
I am cooking for his dog tomorrow.
What is going on?
And Mr. Nixon, who NORMALIZED relations with the the murderous little, yellow-belly bastards.
That is why the FDA has the CDC on alert for kiney failure in humans.
So why is no-one talking about suing the Chi-Coms .................... Hmmmmmm?
...
They roll little Cindy, with her sad little puppy-dog eyes and her Golden Retriever Portable Dialysis Unit humming on its battery, up to the front of the courtroom.
As Mr. Horowitz was fond of saying, "Read the label!"
Some tuna is caught &/or canned in China, and worse, I tossed some whole salmon filets back into the store freezer last week.
Those salmon were labeled, "Farm raised in China"!
I could hardly believe my eyes when I saw that. Chinese imported farmed salmon.
God alone knows what they feed them; the Godless Commies almost certainly don't even, nor want to, know.
LOL!!!
Oh, thank you so much. This is beautiful and I have never seen it.
LOL!!!
You freepers are soooo fast!
My head is twisting like the Excorcist girl's!
Whaaaat is going on in this country?
Guess its those dynamic twins: Greed and Avarice.
You are not alone nor paranoid in your thinking. It could also be a trial run by the terrorists...lets see how they respond and then watch where their security is and how it works.
they can't sue Chinese...but they will sue the local companies who used this stuff...Yipes.
I wonder if it is too late for me to get into law school.
If John Edwards goes back to being an attorney HE WILL BE CHANNELING FLUFFY AND SPOT!!!
I would be shocked!!! /S off
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.