FDA Issues Warning Letter to Iams Pet Food - Chromium Tripicolinate

FDA - Center for Veterinary Medicine - FDA/Freedom of Information ^ | Thursday March 29, 2007 | Milwaukee_Guy

[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

[ClearBlueSky]

The baby food is something people should try!
I bought a maltepoo who would NOT eat dry food-no way. So I tried mixing the dry with strained meat baby food. It coated, and softened, the dry food and he loved it!
He still eats it sometimes( he's almost 2 now) but I alternate Lil Cesars food and food I cook for him- chicken and rice, turkey and rice, chicken liver and dry food.
Why pay big $ for 'human type' foods that are not only overpriced, but not what they claim to be, when you can just MAKE human food? It's more trouble, but safer!
I can see how it would be expensive if you have huge dogs or multiple pets, but if commercial pet food cannot be trusted their lives are worth it.

What a SCAM this has uncovered! Cheap dog food and expensive are the same thing! And what about prosecutions?
If my neighbor 'accidentally' poisoned my pet, or if someone 'put down' unwanted pets by poisoning there would be criminal charges! Mass poisoning should be prosecuted!
And people should have learned that 'gourmet' food is a rip-off!

[ClearBlueSky]

Sabotage...hmm, actually that was the first thing I thought.
First-ruin the trust in pet foods, then the trust in human foods. If one source can be contaminated, so can the other.

When I heard one of the factories was in New Jersey, bells went off. BIG Muslim community in N.J- weren't some of the 9-11 terrorists from there?
How hard would it be to take a bag of this poison and dump it into a batch of pet food?
We all know how much Muslims hate dogs- and that they know how much most Americans love their pets.
Kill dogs- make people paranoid about the safety of pet- and eventually- human food...sounds like motivation to me!
That's a possiblity, IMO. No apologies.

[Psalm 73]

"If this keeps up, Kitty is going to be eating Soylent Green."

You know that's what they think anyway - good thing humans are as large as we are - sometimes our cats get that "weird" look in their eyes, then a minute later they're back to being adult kittens.

[GovernmentShrinker]

I wouldn't get too worked up over scare words like "DNA disruptor". Chromium picolinate (same thing tripicolinate) tablets are readily available as a human dietary supplement without prescription, and the FDA has not seen fit to pull it off the market. http://en.wikipedia.org/wiki/Chromium_picolinate

[Ramius]

IMHO, the pet food scandal will broaden to include other pet food safety issues.

Of course it will. Panic is like that.

Pretty soon the media panic should make it all but impossible for anyone to figure out what's going on.

I read someplace that all of the dead animals were exposed to high doses of dihydrogen monoxide. Maybe thats it.

[NittanyLion]

I read someplace that all of the dead animals were exposed to high doses of dihydrogen monoxide. Maybe thats it.

Good Lord! I just ingested dihydrogen monoxide in my coffee this morning, and again with lunch. And last night after my 6 mile run...I don't even want to think about it. Am I at risk?

[Ramius]

OH man... sounds like potential trouble.

Maybe you could dilute it with something.

[Rembrandt]

"I'm glad that I don't use it, and I certainly never will now."

Well, all that aside, how are your Amway sales volumes doing?

[Rembrandt]

"You're faith may be misplaced!"

I won't bother to correct your grammar. I used to work for IAMS and they have never, would never, taint a product in an IAMS plant

Co-packers, well they are not the same company and I can't be real happy about this issue, but odd stuff does happen when you let things out of your corporate control.

[Nik Naym]

I just bought a box of instant dihydrogen monoxide and I can't figure out what to add!

[Milwaukee_Guy]

Dear Grammar Cop/Iams Booster,

What's your explanation for all of the recalled Iams product listed below? Where these all made by Menu foods or where some made by Iams?

IAMS CAT

1. Select Bites 3 oz Pouches

· Adult with Beef in Gravy

· Adult with Chicken and Wild Rice in Gravy

· Adult with Chicken in Gravy

· Adult with Turkey in Gravy

· Adult with Salmon in Sauce

· Adult with Tuna in Sauce

· Kitten with Chicken in Gravy

· Weight Control with Tuna in Sauce

· Active Maturity with Chicken in Gravy

· Variety Pack with Beef, Chicken & Turkey

· Variety Pack with Salmon and Tuna

· Variety Pack with Chicken and Turkey

2. Cat Slices and Flakes in Cans

· Slices with Turkey in Gravy 3/6 oz

· Slices with Beef in Gravy 3/6 oz

· Slices with Chicken in Gravy 3/6 oz

· Kitten Slices with Turkey in Gravy 3 oz

· Flakes with Tuna & Ocean White Fish in Sauce 3/6 oz

· Flakes with Salmon in Sauce 3/6 oz

· Variety Pack Slices with Chicken and Beef in Gravy 3 oz

· Variety Pack Flakes with Tuna & Ocean White Fish and Salmon in Sauce 3 oz

IAMS DOG

1. Select Bites 5.3 oz Pouches

· Puppy with Chicken in Gravy

· Adult with Beef in Gravy

· Adult with Beef, Potatoes and Carrots in Gravy

· Adult with Chicken in Gravy

· Adult with Turkey in Gravy

· Adult with Lamb and Wild Rice in Gravy

· Weight Control with Chicken in Gravy

· Active Maturity with Beef in Gravy

· Variety Pack with Beef, Chicken, Lamb & Rice

· Variety Pack with Beef and Chicken

2. Small Bites 6 oz Cans

· Puppy with Beef & Chicken in Gravy

· Small Dogs with Chicken in Gravy

· Small Dogs with Beef & Vegetables in Gravy

· Variety Pack for Small Dogs with Beef & Vegetables and Chicken in Gravy

3. Chunks 13.2 oz Cans

· Beef & Vegetables in Gravy

· Chicken in Gravy

· Active Maturity with Beef in Gravy

· Weight Control with Beef in Gravy

· Puppy with Beef & Chicken in Gravy

· Variety Pack for with Beef & Vegetables and Chicken in Gravy

· Multipack with Beef & Vegetables in Gravy

· Multipack with Beef & Chicken in Gravy

· Multipack with Chicken in Gravy

http://www.menufoods.com/recall/

[enviros_kill]

So when will the cowards in government and corporate leadership approve wide scale food irradiation for human and pet food? And when will the stupid masses get over their irrational fear of radiation so their pets don't have to die? Never? Well, stop your bitching then and I don't want to hear about lawsuits and elevating pets to a frickin' human (pain and suffering awards) either.

Food irradiation back on the table, Dec 2006
Third story down at this link
http://antigreen.blogspot.com/2006/12/has-new-ice-age-begun-post-below.html
EXCERPT
Irradiation disinfects food by damaging the DNA of microorganisms, rendering them unable to reproduce. The most common irradiation machines employ the high-energy gamma rays produced by radioactive cobalt. Newer alternatives use X-ray and electron acceleration techniques that do not require radioactive material. Units suitable for mass food processing cost between $4 million and $8 million, according to executives at two U.S. food irradiation firms. Irradiation was first identified as a food disinfectant in the 1920s. It does not make food radioactive, and its safety is supported by the results of nearly all studies of the technology performed over the past 50 years.

Radiation Myths Harming Public Health
Book Review by Jay Lehr
http://www.heartland.org/PrinterFriendly.cfm?theType=artId&theID=20823
EXCERPT
Let us first examine the Linear No-Threshold (LNT) theory, by which we have been held hostage for so long.

To take it to an absurd extreme so you will easily understand it, the theory basically says that if 100 percent of a given population will die from a fall from a 100 foot cliff, and 50 percent would die when falling from a height of 50 feet, then we can expect that one person of a hundred would die when falling from a height of one foot.

Silly as this seems, we use the same theory when studying the effects of chemicals and heavy metal intake by humans. Substances such as mercury, lead, tin, cadmium, oxygen, fluorine, arsenic, and selenium are toxic in large quantities, yet critical to our health in small quantities.

We call the phenomenon of harm at high doses and help at low doses "hormesis," derived from the Greek word "hormo," which means to excite. Thus, a substance that excites a positive bodily response at a low dose and is harmful at high doses is considered hormetic. Vitamins and trace minerals clearly show the difference a dose makes. The same is true of sunlight, noise, and stress.

[BagCamAddict]

My dog also had unexplained blood in her urine... started back in mid-October and lasted through mid-February. We also did 20 days of antibiotics, but there was no bacteria in her urinalysis, and after 17 days on the antibiotic I could still SEE blood in her urine. They recommended doing an ultrasound (over $500), but while I was weighing whether to do that or not, her symptoms appeared to disappear - AFTER we stopped the antibiotic.

She had been eating Iams, which is also made by the company that makes Eukanuba.

Even though her symptoms are gone, I'm going to do a urinalysis this week to confirm that the blood is gone. And in light of this pet food recall, I have now switched her off Iams and back to Abady brand.

[BagCamAddict]

You need to read more on this subject, because if you were fully informed or you wouldn't have that scepticism. That's not a slam, I'm just saying you honestly don't have all the info or you wouldn't be skeptical.

A national Vet chain (Banfield Pet Hospitals) has reported that there is a SPIKE in cases of acute renal failure (ARF), estimated to be "hundreds per week" during the recall period, that is OVER AND ABOVE the NORMAL number of cases of ARF for the same time period in previous years.

Additionally, ARF is not the same thing as chronic renal failure, which is what your post (rightfully) refers to: "dying of renal failure on a daily basis, mostly due to old age, diabetes"... those are chronic (slow or long-term) kidney failures... "and antifreeze" - that is ARF which comes on suddenly and is due to poison.

(I'm posting a day late, so perhaps you have heard more info by now and are no longer skeptical... if so, disregard this post. :-)

[dforest]

I am really po'ed at the Iams company. They sent me a survey email that cannot be completed. I will NEVER buy their product again.

If they can't keep out of buying their product from China, then they will never get a dime more from me.

I guess we made the mistake that they would test their high priced product for purity.

Makes you wonder what we humans are getting served.

[sweetiepiezer]

Another

http://www.delmonte.com/petfoodrecall.html

[beardiethor]

Thank God my stray dog "Thor" has been on the b.a.r.f diet for over 12 years. (He's close to 19 now). When I found him he was nearly dead. A vet friend brought him back to live and I adopted him feeding him only the highest quality dog food. He fell ill again, this time, at age 12, the diagnose looked grim. I researched nonstop until I found Dr. Ian Billinghurst,
www.drianbillingurst.com in austrailia. I was a real skeptic.
Feed your dog nothing but raw meaty bones (mostly) and a bit of pureed veggies? Would he even eat it. Weren't chicken bones out of the question? All these questions were answered and thor lives on to almost age 20 without one single vet bill in 10 years.

If someone really thinks there was poison in the dog and cat food, well they are absolutely right; it is the pet food itself (which I found nearly killed my dog twice). Thor and I were lucky. He gladly eats his raw regiment daily.

I didn't fall off a turnip truck yesterday. Rat poison is probably about the healthiest thing in processed pet foods.

The question is, now that we know it has caught up with this very corrupt industry with a very powerful lobby (and salespersons who "educate" the vets as most vets have little or no nutritional training in food; for instance there is no known minimum requirements for grains in a dogs diet. NOT ANY. Ever heard a vet tell you that?

Dogs and cats need raw enzymes just like we do. Only raw foods gives that.

Yes I will be crucified, ridiculed, called crazy, etc etc. Used to it now and I don't blink and eye. I simply ask how
long their pets have lived and then show them "Thor", still at almost 19 actively playing like a pup, walked 3 miles a day with me until last year, and still walks 1/3 a mile at his age, plays on the floor with his toys with me, has complete control over his elimination and "tells" me when its ready to go out.

The media of course will not showcase studies on the b.a.r.f. diet. Too much advertising dollars in the pet food industry.

But if you want your dog or cat to have a VERY HIGH quality of life (sorry if your vet cannot buy a mercedes and boat this year); try the b.a.r.f diet.

You (and particular your loved four legged creature will be forever grateful).

[EBH]

What is really fightening is some of what is being reported is confusing. I am thinking about the report I read yesterday that talked about a dry cat kibble being recalled, yet now the updated report makes no mention of it. The information regarding the particular product is gone and the manufacture website has no mention of it either?

I have switched to a product called Pet Promise, which at least they are seemingly open and honest about how their product is made. All natural, no byproducts, no rendered meats, no wheat gluten etc. It is a little more expensive, but at this point when information is so garbled...at least I can have the confidence in the food I have now chosen to feed my four-footed friend.

[Neoliberalnot]

OK, what is the toxicant causing the ARF? With 60 million dogs and a similar number of cats, the "spike data" should be substantial. Show me the numbers please. To date, the toxicants reported do not cause ARF.

[Milwaukee_Guy]

I have no problem with the irradiation of foods. Actually makes sense considering the recent spinach recall which proved the inability or willingness of the FDA or corporate farming to actually inspect produce.

IIRC,

- Saudi Arabia irradiates milk. Freshness dates go out to a couple of three months! Makes sense given the hot climate.

- Ever eat a military MRE? Quite the little secret that they are irradiated.

I would start by mandating irradiation of all imported produce to compensate for the third world hygiene encountered with imports.

BTW - You are very correct about hormesis. Nobody is ready for that reality however.

Don't presume I am a health food nut or an animal activist.

I'm PO'd about my sick cat and the $500.00 in vet bills I've acquired during the ongoing pet food scandal. My biggest concern is that this will soon become an issue in the human food chain.