FDA Issues Warning Against Iams Dry and Wet Foods

Eukanuba Weight ControlBad 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 Picolinate–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

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

13 Responses to “FDA Issues Warning Against Iams Dry and Wet Foods”

  1. Vicki T says:

    Another outrage! How dare they do this to our beloved animals! I quit using any Iams products many years ago when I found out they put their test animals through hell. Pet food should be a good thing, not something where people are worried everytime they try to provide nutrition to their “best friends”. P.S. Thanks itchmo for your very informative and timely Pet Safety Alerts. I really appreciate them very much.

  2. E wem says:

    I wish I had discovered itchmo a lot sooner. This is my first safety alert and it is worth a million to me.

    I am absolutely disillusioned about the pet food industry. I thought the cheaper brands using by-products were the main problem.

    I guess they think they can throw anything into a pet food because the pets can’t talk.

    All the hype in tv ads about the care and concern for our pets is just hype.

  3. susanUnPC says:

    I agree with you two — we cannot ever again trust most pet food companies or, for that matter, the government’s enforcement capabilities. Itchmo’s story here shows that Iams wasn’t responsive, and the FDA didn’t crack down.

    I hope you all saw the breaking news story — I first saw it on MSNBC, and here’s the AP account:

    Friday, March 30, 2007 · Last updated 7:43 a.m. PT
    FDA testing reveals chemical in pet food

    Recalled pet foods contained a chemical used to make plastics, but government tests failed to confirm the presence of rat poison, federal officials said Friday.

    The Food and Drug Administration said it found melamine in samples of the Menu Foods pet food, as well as in wheat gluten used as an ingredient. Cornell University scientists also have found the chemical, also used as a fertilizer, in the urine of sick cats, as well as in the kidney of one cat that died after eating the company’s wet food.

    […]

    The apparently melamine-contaminated wheat gluten also was shipped to an unnamed company that manufactures dry pet food. The FDA is attempting to determine if that product, imported from China, was used to make any pet food, Sundlof said.

    ALL
    http://seattlepi.nwsource.com/.....ource=mypi

    SO DRY FOOD CONTAINS THE HARMFUL CHEMICAL AS WELL. But which dry food? Why won’t the FDA announce the brand name? Who needs to be protected — the company or pets?

  4. Sheryl M. says:

    Thank you for timely, honest & informative information.

  5. JM Leong says:

    Is the FDA truly this incompetent or what? What’s going on here?

    We are just now hearing about a letter they issued to Iams more than 2 months ago? And they won’t tell us which DRY pet food manufacturer received the wheat gluten? What gives them the right not to release that information? And, remember that when they identified the rat poison (which, now, it turns out may or may not be the real contaminant or the sole contaminant), they were unable at that time to even say for sure that it was the wheat gluten that was contaminanted. I still have not seen any reports that they have conclusively proved it. This means that in fact there is possibly a different ingredient that is contaminated, one which might be in other foods that have not been recalled — since the recall was based entirely on the assumption that the wheat gluten was the toxic ingredient.

    I understand that proper testing takes time and is subject to repeated verifications. But I am infuriated that clearly neither Menu Foods nor the FDA are releasing all the information they have in a timely manner. And the big question in all of this is: Why not? Incompetence? Laziness? Bad leadership? Fear of inducing panic? Fear of “damaging” a company’s reputation? Reluctance to issue what could or could not turn out to be unnecessary recalls?

    Not one of those reasons for the failure to release all the information they have justifies the needless deaths of so many pets. I fully expect a company like Menu Foods to act out of their own self-interest and be tight-fisted with their information. But isn’t that one of the reasons we have regulatory bodies like the FDA? To oversee companies’ standards and hold companies responsible when acting in their own self-interest is resulting in damage to consumers?

    The FDA, instead, in this instance is an accomplice to keeping consumers in the dark. It’s wholly unacceptable! I want to know who distributed that wheat gluten, what other products they distribute, and who else besides Menu Foods receives it. If the FDA cannot or will not release information regarding a threat to the food supply — pets’ or humans’ — then the agency itself and its policies should be subject to investigation.

    Heckofajob, FDA.

  6. Carrie C says:

    This is an OUTRAGE!!!!! I fed my cats the Eukanuba restricted-calorie dry food for over a year and a half, and NOW they’re saying it’s genotoxic! On the MSNBC website, their article states they’ve known about this since 1996…what the HE!!!!!! If my cats end up with tumors or cancer b/c of eating this food, somebody’s butt is going to end up on a platter!!!

    For those interested, I’ve switched my cats to Pet Promise foods…check out their website at www.petpromiseinc.com. They really have a different philosophy regarding pet food.

  7. Diana M. Vacek says:

    I am appalled that the FDA will not release the the dry dog food or foods that may be or are contaminated. I would like to know like another person commented about, who are they protecting? It is the responsibility of the food companies and the FDA and any other agency, to make sure that the foods that we feed are pets are safe to feed them. I don’t care if it cost more for the food as long as I know that it is safe to feed my dogs and cats. I am fortunate that my pets weren’t poisioned, but I can tell you now that I will never again buy any of the commerical foods for my pets, because of this irresponsible attitude that Menu has taken in getting the ingredients from another country just so they can save money.

    Diana M. Vacek–Cleveland, Ohio

  8. Peggy Rhodes says:

    Please Keep Me In The Loop for all safety redcalls. Thank You

  9. Diana M. Vacek says:

    You go girlfriend! It was scary shopping for pet food this week. Wal-mart’s shelves were bare. Is pedigree and Alpo dog food still safe? I bought chicken legs today and baked them to feed my dogs. I realized it isn’t any more expensive than a can of “who knows what your getting,” with a list of ingredients, often desguised, that you would need a science degree to decipher. Add a little brown rice and you got a low-fat, filling meal that your dogs dive into every time. What does it say about our country when greedy, multi-million dollar industries put their employees out of work and take from our economy by buying inferior materials from other countries to save a few bucks. As Americans, we spend more on our pets than any other country in the world. Things can’t be all that bad. The Levi jeans company operates overseas with the excuse of the competion is too bad. Too Bad? Have you checked out the price on a pair recently. Try $50 or $60 bucks a pop. There is at least on pair in every American Household. Hershey’s recently followed suit. They can’t make a profit so they put thousands out of work. Hersey’s chocolate! It is an American Icon for God’s sake. I am with you Diana. These companies will never see my money again. Alpo,Nestles and Wranglers work good for me.
    Dee

  10. Kristen says:

    ALPO is on the list as of TODAY!!!!!!!!!!!!!!!! Please be careful my beagle was deathly ill two weekends ago and she eats (well ATE) ALPO and IAMS as dry food (neither anymore) Please Be Careful DEE!!!!!

  11. rita says:

    My dog was recently diagnosed with diabetes. He started developing symptoms after I switched his food to Eukanuba lamb and rice senior dry food 7+. Does anyone have similar experience with dogs getting sick after eating that food?

  12. Michelle says:

    My dog was deceased on 3-19-07. She was diagnosed with acute liver failure at 4 years old. I fed her Eukanuba dry and wet as well as Scince Diet dry and wet. I have no proof that the food caused it but I sure am suspicious. At the time I had no idea there was a problem with all of the pet foods. So I didn’t do an autpsy to find out the exact cause. I had 800.00 dollars in my dog with-in 2 weeks trying to save her life. It was devestating to our family and still is. I would only stick to Wellness dog food or Innova costs alittle more but those foods are so much healthier for sure!! Thanks for listening.

  13. ticocats says:

    Apologies to those who have to scroll through this long post, but this Eukanuba incident seems to demonstrate, at least as much as the ongoing recalls, the fundamental problems with the pet food industry and the alleged regulation of it.

    The FDA says that use of chromium tripicolinate in pet foods is “unsafe” and that pet foods containing this product are considered “adulterated” under the Federal Food, Drug, and Cosmetic Act. Sales of such adulterated products are prohibited under section 301(a) of the Act.

    This is the chronology of events described in the FDA’s recent “warning letter” to The Iams Company, parent of Eukanuba:

    On July 9, 2004, the FDA denied Iams’ request to use chromium tripicolinate in dog and cat food. Nevertheless, the company added this ingredient in four of its Eukanuba cat and dog foods, as it admitted in a letter dated January 6, 2006 which again (a bit late, it seems) asked the FDA to approve this use. On April 25, 2006, the FDA again rejected Iams’ request, stating that data submitted by the company did not change the FDA’s view that chromium tripicolinate is genotoxic and unsafe in pet foods. At least as recently as November 17, 2006, the company’s web site continued to list chromium tripicolinate as an ingredient in the four Eukanuba pet foods. On January 8, 2007, the FDA issued the warning letter to Iams. Four months later, the FDA informed the public by posting the letter on its website.

    It seems clear that, with the FDA’s full knowledge, Iams distributed “adulterated” Eukanuba pet foods for at least two years after the FDA had specifically told the company that use of this additive was prohibited, and that Eukanuba products continued to be made with chromium tripicolinate even after a second FDA letter to Iams refusing to approve its use.

    The FDA’s recent letter declares that the Eukanuba products are “unsafe” and “adulterated” under the federal act, and that section 301(a) of the act prohibits distribution of such products. In fact, that section states that persons (corporations included) who distribute adulterated products “shall be imprisoned for not more than one year or fined not more than $1,000, or both,” with much more severe penalties if the violation was committed with the intent to defraud or mislead.

    Our FDA guardians’ response: a letter to Iams, telling them to (please) stop violating this law. No recall, no penalty, no effective public notice that the FDA is permitting continued sales of pet food that the agency has pronouced to be unsafe, adulterated and illegal.

    As for Iams . . . it will give you a free bag of Eukanuba food, adulterated varieties included, if you purchase one! (Offer valid only for purchases made between April 1 and June 30, 2007 so you’d better hurry if you want to induce DNA mutations and tumors in your pets.)

    It gets even better. The FDA recall list includes 29 Eukanuba products, all either can or pouch varieties, which actually were manufactured by Menu Foods.

    The company’s home page doesn’t mention the recall — and certainly doesn’t mention the FDA’s pronouncement that some of its products are adulterated but haven’t been recalled — but prominently states:

    “FEED WITH CONFIDENCE - Read Eukanuba’s Promise to you and your pets.”

    And this is the “Eukanuba Promise” (I’ve added the bracketed words and the emphasis on the word “dry”):

    “You can feed Eukanuba products with confidence.

    “Eukanuba dog and cat DRY foods and biscuits were not affected by the Menu Foods recall. [Let’s just ignore those 29 Eukanuba can/pouch products which were part of the recall.]

    “Eukanuba dog and cat DRY foods DO NOT include wheat gluten, corn gluten or rice protein concentrate..

    “All Eukanuba dog and cat DRY foods are manufactured in our own facilities in Nebraska, Ohio and North Carolina. [Again, let’s just ignore those 29 Eukanuba recalled products which were manufactured by Menu Foods.]

    “Eukanuba dog and cat foods are made with our own exclusive formulas, unique recipes and high-quality ingredients. [Yes, as far as we know, the illegal use of chromium tripicolinate was unique to Eukanuba.]

    “Eukanuba diets are natural with added vitamins and minerals and DO NOT contain fillers or artificial preservatives.

    “All Eukanuba dog and cat DRY foods are made with natural chicken, lamb or ocean fish.

    “Veterinarians and Breeders recommend Eukanuba dog and cat DRY foods.

    “We stand behind the quality of all Eukanuba DRY foods.

    “Feed with confidence and get a coupon for a free bag.”

    http://www.eukanubapromise.com

    Wow, I certainly feel confident about this company and about the FDA’s enforcement of the Food, Drug, and Cosmetic Act.


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