Bad news continues to filter out. FDA has warned the Iams company in January against using an untested “dietary supplement” in its cat and dog weight control formula wet and dry foods. “The FDA considers chromium tripicolinate to be genotoxic, meaning it can damage DNA and cause mutations and tumors.” Amazingly, the FDA posted the letter only today.
No word yet if Iams has complied with the warning to remove the ingredient chromium tripicolinate. We’ve read several posts concerning the removal of weight control formulas from stores.
IMPORTANT: We have several articles that suggest a link between this substance and chronic as well as acute renal failure below.
And oh, FDA, how long does it take to post a letter?
UPDATE: Howl911 found some articles that link renal failure to this substance. Here’s one you can read: Acute Tubular Necrosis Associated with Chromium Picolinateâ€“Containing Dietary Supplement
UPDATE 2: There’s more links that connect this with renal failure: NTP: Executive Summary Chromium Picolinate
UPDATE 3: List of brands affected:
- Eukanuba Veterinary Diets Optimum Weight Control/Canine dry,
- Optimum Weight Control/Feline dry,
- Restricted-Calorie/Canine dry and canned, and
- Restricted-Calorie/Feline dry and canned
Complete FDA letter and more after the jump.
The letter, dated Jan. 8, 2007, and posted on the FDA Web site Thursday, said that several Eukanuba-brand dry and canned pet food products made by The Iams Company, a unit of Procter & Gamble Co., contain chromium tripicolinate, which is only allowed as a source of supplemental chromium in swine feed.
The company will take chromium tripicolinate out of future formulations of its Eukanuba Veterinary Diets Optimum Weight Control and Restricted-Calorie dry and canned products for obese dogs or cats, spokesman Kurt Iverson said.
He pointed out that the FDA had not ordered a recall of the products now in pet owners’ homes or on store shelves.
It’s not a recall, but clearly the FDA is not happy about Iams sneaking in a new untested ingredient.
The letter issued by the FDA’s Center for Veterinary Medicine also said Iams had earlier tried to demonstrate that chromium tripicolinate is non-genotoxic, but the agency determined that data submitted by the company did not sufficiently address its safety concerns.
Genotoxic compounds can cause genetic mutations or tumors, according to the FDA Web site.
FDA Warning Letter
JAN 08 2007
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
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 firstname.lastname@example.org.
Kim R. Young
Division of Compliance HFV-230
Center for Veterinary Medicine