FDA Issues Warning Letter to Iams Pet Food

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

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.

Kim R. Young Deputy Director Division of Compliance HFV-230 Center for Veterinary Medicine

As you've heard in the news, they apparently don't know what toxin is causing the ARF. One lab found aminopterin, another found melanine... FDA says melanine isn't known to cause ARF in dogs but they don't have many mammalian studies, and they don't have any studies done on cats so they aren't sure, but they do know that cats react adversely to a variety of substances at significantly lower concentrations than other mammalian species do, etc. In other words, the-powers-that-be don't apparently know what toxin, exactly, is causing the ARF.

One of the reasons Vets haven't published the cause is because they probably didn't recognize there even was a spike in ARF cases until after the recall when they were asked to look at their records. Each individual vet may have seen only 1-2 cases more than normal, so it didn't seem like a spike to that individual vet, so they didn't do any more extensive laboratory testing (of blood, urine, or necropsy, etc.) on the individual animals in their practice that died. They probably presumed it was another case of antifreeze poisoning and closed the case when the animal died.

Then the recall happened... and someone asked Banfield Pet Hospitals about their records. Banfield reviewed their records for 600 hospitals and compared the number of cases of ARF to similar time periods and notices a spike in cases. But as I said, this all happened after the fact, so they didn't notice it as it was happening. (They don't have a person dedicated to reviewing all veterinary cases to look for spikes in certain symptoms.)

Banfield has 600 hospitals and they are linked by a database/computer. Most Vets are not linked to a central database. The Veterinary Information Network has about 30,000 members. They are currently conducting a survey of their members on this topic. As of a few days ago, about 10-20% of their members had responded to the survey, and they had (I'm going from memory here) about 471 total cases and about 104 deaths reported. If that's 10-20% of their Vets reporting, that extrapolates to about 520-1040 deaths. Statistically, that's not a significant number relative to the millions of dogs/cats in the country. But each death is significant to the pet owner.

Your premise about 60 million dogs/cats isn't quite accurate though, because (a) you are counting all pets, whereas Menu Foods has said they feed about 5 million pets a day, and (b) if 2,000 more animals die than normal, that's only 0.04% higher than normal for that 5 million pets, or 0.0017% of the 120 million pet population, so it would be very hard to notice this spike on a statistical basis unless you were specifically looking for it (which Banfield did after they were asked to review their records). In other words, the spike wouldn't be statistically "substantial" at all, but the actual number of deaths (if it's 2000) is obviously substantial to 2000 pet owners. And in Oregon, approximately 2 out of 3 pets sickened by the food have survived (so far), so double the number of deaths to get the number of sick.

I guess I'm confused what your skepticism is about. Are you not believing there is a recall? Are you not believing there is a contaminant in the food? Are you not believing that pets are dying from eating the food? Are you not believing individual humans reporting, because it's not the FDA or some other "official" source who is making the report? What exactly are you in disbelief about? Just because they haven't identified the toxin doesn't mean pets aren't dying. So what is the skepticism about/regarding? Are you believing Menu Foods when they say 16 animals have died and they refuse to update the number?

Please visit the Oregon Veterinary Medical Association's website for some "official" information if you are looking for official confirmation of dead pets, with last count 32 dead in Oregon alone, and those are numbers reported by Veterinarians to the State Vet (i.e., not alarmist individual pet owners):

http://www.oregonvma.org/

Well I have to agree with you on that. Since they don't know what is causing these deaths/illnesses, then naturally they can't make the appropriately directed recall. I assume you mean you think the recall is way bigger and broader than it needs to be? I agree with that from a logical perspective, because it isn't logical to recall foods that are not contaminated.

But since they don't know, with certainty:
(a) what the toxin is,
(b) what ingredient(s) are contaminated with the toxin,
(c) where/who produced the contaminated food,
(d) during what timeframe the contaminated food was produced, and
(e) what specific lot numbers are contaminated,

then by default the recall(s) are much broader and less-appropriately-directed than they should/could be.

I'm a scientist too, and I agree there are PLENTY of questions yet to ask and be answered. But just because the mystery hasn't been solved yet doesn't make it any less real. There's a good deal of over-reacting, panic, confusion, and so forth happening right now due to the unknowns. The same thing happens every time there is an e-coli outbreak before they determine the cause and the source. It doesn't usually take quite this long when it's an e-coli outbreak in humans though. So the uncertainty here is allowing a bit of a snowball effect to occur. Once they identify, with certainty, the toxin, the source ingredient, the supplier, the product manufacturers, the dates of production, and the product codes, then we'll have some definitive info and a specific and more refined course of action.

For now, I'm of the opinion that it's better to be safe than sorry. Certainly if this was the human food supply, most everyone would be acting on that same premise (better safe than sorry). And we might have quicker answers if it was the human food supply that was affected.

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