Posted on 03/29/2007 8:53:15 PM PDT by Milwaukee_Guy
Department of Health and Human Services Public Health Service
Food and Drug Administration
Rockville, MD 20857
JAN 08 2007
CERTIFIED MAIL RETURN RECEIPT REQUESTED
In Reply refer to # CVM-06002V
Mr. Gerald G. May Director, Government and Trade Affairs Product Safety and Regulatory Affairs The lams Company 6571 State Route 503 North P. O. Box 189 Lewisburg, Ohio 45338-0189
WARNING LETTER
Dear Mr. May:
The Center for Veterinary Medicine (CVM) reviewed The Iams Company website with respect to several Eukanuba brand products containing chromium tripicolinate. Chromium tripicolinate when added to food is a food additive as defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act (the Act) [Title 21 United States Cod (U.S.C.) Section 321(s)(21 U.S.C. 321(s))]. The Iams Company stated in a letter dated January 6, 2006, and on The lams Company website as recently as November 17, 2006, that Eukanuba Veterinary Diets Optimum Weight Control/Canine dry, Optimum Weight Control/Feline dry, Restricted-Calorie/Canine dry and canned, and Restricted-Calorie/Feline dry an canned contain chromium tripicolinate. Because the food additive chromium tripicolinate is not the subject of a regulation prescribing the conditions under which it maybe safely used, it is unsafe under section 409 [21 U.S.C. 348] of the Act. Foods, including animal feed and the products listed above, that contain food additives that are unsafe within the meaning of section 409 [21 U.S.C.348] of the Act are adulterated under section 402(a)(2)(C)(i) [21 U.S.C. 342(a)(2)(C)(i)] of the Act. The introduction or delivery for introduction into interstate commerce of an adulterated food is a prohibited act as specified in section 301(a) [21 U.S.C. 331(a)] of the Act.
On January 11, 1996, CVM indicated it was not likely to take enforcement action with respect to the inclusion of chromium tripicolinate as a source of supplemental chromium in diets for swine at levels of 0.2 ppm (200 parts per billion (ppb)) or less, however, we did not make this statement with respect to the use of chromium tripicolinate in any other animal feed. In a July 9, 2004 letter, CVM denied The Iams Company's request to extend the exercise of its enforcement discretion to the use of chromium tripicolinate in dog food at amounts up to 150 ppb and in cat food at amounts up to 200 ppb. In a January 6, 2006 letter to CVM, The Iams Company submitted data purporting to demonstrate that chromium tripicolinate is non-genotoxic. CVM responded in an April 25, 2006, letter, informing The Iams Company that the data it submitted are inconclusive and not sufficient to address CVM 's target animal safety concerns. CVM reminded The Iams Company that we did not intend to exercise enforcement discretion with respect to the use of chromium tripicolinate in any animal feed products other than diets for swine.
This letter is not intended to be an all-inclusive review of the products The Iams Company manufactures and markets. It is The Iams Company's responsibility to ensure that its over all operation and the products it manufactures and markets are in compliance with the Act.
The lams Company should take prompt action to correct the above cited violations, and should establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice, including seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps The Iams Company has taken to correct the noted violations. Include an explanation of each step being taken to identify and to correct any underlying problems necessary to assure similar violations will not recur. You should include in your response copies of documents that support your corrective actions. If corrective action cannot be completed within fifteen (15) working days, state the reason for delay and the time within which the corrections will be completed.
Your written response should be sent to Mr. Kim Young, Deputy Director, Acting Director, Division of Compliance, HFV 230, FDA-Center for Veterinary Medicine, 7519 Standish Place, Rockville, Maryland 20855. If you have any questions about this letter, please contact Dr. Cathie Marshall by telephone at 240-276-9217 or by email at cathie.marshall@fda.hhs.gov.
Sincerely,
/S/
Kim R. Young Deputy Director Division of Compliance HFV-230 Center for Veterinary Medicine
Long story short,
Iams was specifically told in 2004, by the FDA, it could not use Chromium Tripicolinate in pet food. Iams went ahead and used it anyway. On 01-08-07 the FDA issued the warning letter posted above, after the FDA found Iams listing this ingredient on the Iams web site.
In a sweet effort at CYA during the course of the current national pet food scandal, the FDA finally got around to posting, with little fanfare, their warning letter to Iams, only today!
Chromium Tripicolinate is a known genotoxin (DNA disrupter).
IMHO, the pet food scandal will broaden to include other pet food safety issues.
I should certainly hope so. I'd really like someone to tell me just what the hell a DNA disruptor is doing in food anyfood, at all.
Ping - Another pet food toxin!
B4L8r
"In a sweet effort at CYA during the course of the current national pet food scandal, the FDA finally got around to posting, with little fanfare, their warning letter to Iams, only today!
Chromium Tripicolinate is a known genotoxin (DNA disrupter).
IMHO, the pet food scandal will broaden to include other pet food safety issues."
~~~
This sounds, seems and feels like a hit piece by a competitor, or an energetic employee of one.
I know, categorically, that IAMS would not continue to use an ingredient which the FDA has identified as a problem, certainly not for 3 years.
National Toxicology Program - Executive Summary: Chromium Picolinate
http://ntp.niehs.nih.gov/index.cfm?objectid=6F5E980E-F1F6-975E-7CA23E823F2CB959
Never, ever buy food products from China. They treat people like dogs over there and we are just dogs to them.
More from CNN/Reuters
Genotoxic compounds can cause genetic mutations or tumors, according to the FDA Web site.
Chromium tripicolinate is known to boost metabolism in both humans and animals, Iverson said.
"The FDA wanted additional studies to prove certain things but those would require us to go beyond our animal welfare policy, so we've chosen to take that ingredient out," he said.
However, Iverson did not have a date by which time the compound - which continues to be listed as an ingredient on the Iams Web site - would be removed.
http://money.cnn.com/2007/03/29/news/iam_pet_food.reut/?postversion=2007032916
This is getting huge and unreal.
Very sad for those of us who have lost pets and others who's pets are sick.
You might be interested in this.
Thank goodness my 5 dogs eat no commercial food at all. They are on the Biologically Appropriate Raw Foods diet or as it is widely known the BARF diet.
If I was unable to prepare their food I would feed them Dick Van Patten's Natural Choice foods. Anyone interested in this food can get info from it at www.1800.jeffers.com
I feel very sad for those who's pets have died or been sickened by the food contamination. I hope pet owners realize there are alternatives to mass produced commercial foods.
Our male cat got nailed by the Aldi's canned food. The vet has me giving him a subcutaneous Ringer's Lactate solution for the last week and a half.
He seems to be responding well. I am worried about his next blood test though. I hope there is no permanent damage.
The female cat stopped eating the Aldi's sliced cuts in gravy style food three weeks ago. She is fussy but had eaten it for two years before, twice a day! The male cat stopped eating it and got sick about a week and a half before the recall. For him to lose his appetite is remarkable.
I'm worried that the male cat gets good "clean" food while he (hopefully) recovers. I am going to get a bag of the dry food you recommend and see how they like it.
The chemical came in wheat gluten from China, if I received the correct information. Is our US Government moving to assure that in the future, our pet foods come directly from China?
I have no idea why we pay billions in subsidies to US farmers and then allow tainted wheat product from China to be imported.
Makes no sense at all......
OBJECTIVE: To report a case of acute tubular necrosis associated with the use of a chromium picolinate–containing dietary supplement.
CASE SUMMARY: A 24-year-old white male who had been ingesting a dietary supplement (Arsenal X) for 2 weeks during his workout sessions developed acute renal failure. Radiologic investigation showed the presence of a solitary right kidney, and an open renal biopsy confirmed features of acute tubular necrosis. He developed significant renal impairment that required hemodialysis. He was also treated with plasmapheresis and steroids, as a diagnosis of pulmonary–renal syndrome was entertained early in the disease course, which was subsequently ruled out. The patient ultimately recovered and, on outpatient visits, was noted to have normal renal function
Link, http://www.theannals.com/cgi/content/abstract/40/3/563
A couple of weeks of antibiotics from our terrific vet appeared to alleviate the problem.
She's been fed Eukanuba dry for her entire 18-month-old life. We switched two weeks ago to Innova...I hope she hasn't suffered any lasting effects from a previously unreported problem.
Pings
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