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
I just switched my two kitties to Natural Balance kibble yesterday. They had eaten Science Diet all their lives, with a topping of canned 9-Lives or similar wet food. Although there haven't been problems with 9-Lives, I'm replacing the wet food with Natural Balance or Petguard canned foods. The ingredients are less processed and appear much more nutritious.
When I gave them the new food, one cat dove into her dish and would nearly have eaten the plastic right along with her dinner. She ate like she'd been waiting all her life for this meal. I had to remove her from the room to keep her from pushing her sister aside to eat both dinners. (This morning she's hanging around the kitchen looking for more . . . )
Kitty number two is typically more cautious (also much smarter). She sniffed the new stuff and initially was pretty suspicious. She kept looking over at her sister and saw her devouring something with gusto. After a bit, she also started eating, and kept going. She removed some of the kibble from her dish and put it on the floor beside her. After finishing everything in her bowl, she ate it up too. She took about 3x as long as usual to eat, but licked the bowl clean.
Long story, but I was very pleasantly surprised at how quickly my girls accepted the new food. I'd certainly recommend you give it a try with your little buddy. I don't usually sniff cat food, but I did this time. The kibble smells fresher and less oily than the Science Diet, and the canned food smells like, well, cat food - but good cat food. Good luck.
I find it interesting that, in the previous recall, all of the other brands were mostly "cheap house labels".
This indicates to me, that Iams has always been nothing more than a "cheap house brand" + marketing.
I'm glad that I don't use it, and I certainly never will now.
Did you actually -read- the FDA Warning Letter to Iams?
You're faith may be misplaced!
We all had faith in the quality of our pet food.
Over the last two weeks, that faith is rapidly being eroded.
Can anyone speak to the science of this? Does Iams have a legitimate point regarding the safety of this compound at such small exposure levels?
Based on the limited evidence, chromium picolinate should be avoided, at least until we know more about the potential side effects.
Other forms of chromium are a much better choice and make the choice of chromium picolinate by Iams highly questionable.
http://altmedicine.about.com/od/herbsupplementguide/a/chromiumsideeff.htm
Press Conference @ 10:00 AM EDT
"Testing by the FDA and at least one lab independent of the agency found melamine, a chemical used in plastics and household textiles, in samples of the recalled pet food and in one of its ingredients -- wheat gluten -- said an FDA official and another source close to the investigation. Neither wanted to be identified prior to the FDA's formal announcement this morning."
"The FDA has not determined how melamine got into the pet food. Melamine is used as a fertilizer in Asia and has several commercial and industrial uses."
http://pittsburghlive.com/x/pittsburghtrib/news/rss/s_500296.html
This is an interesting editorial.
http://www.thenewstribune.com/opinion/story/6437657p-5736267c.html
'The selfish spirit of commerce ... knows no country, and feels no passion or principle but that of gain.'
-Thomas Jefferson (1743-1826
I hope all your cats will do ok.It is such a worry for you, I know. Hugz to them from me.
What the heck is "Arsenal X?"
I have yet to see definitive evidence linking a toxicant in a dogfood at toxic levels with kidney failure in a dog. Until I see the proof I remain a skeptic. There are 120 million dogs and cats in the U.S. with 100s to 1000s dying of renal failure on a daily basis, mostly due to old age, diabetes, and antifreeze.
Read the links!
Evidence is already pouring in. Give it another two weeks and you'll see a firestorm brewing in this country over food quality.
I couldn't believe myself until our cat was affected. Now I'm a convert.
New thread on Breaking News concerning the new toxin found by the FDA,
http://www.freerepublic.com/focus/news/1809221/posts?page=6
"What the heck is "Arsenal X?"
Some kind of quack "nutritional supplement" used by bodybuilders.
Would you ingest anything called Arsenal X? :-O
How do you know your cat was affected. Did you find a toxic level in the food she was eating?
Sounds too much like arsenic. Actually organic arsenicals have been used as growth promotants and disease control in swine and poultry for decades.
The cat ate the recalled pet food, displayed all the symptoms, diagnosed with kidney dysfunction, too young to have this condition.
I don't know exactly what is going on and neither does the manufacturer, the Federal Government, State Governments, the UN, the aliens and whomever.
In only two weeks -three- toxins have been discovered in pet foods once owners like me started taking our sick and dying pets to the vet.
The fact that nobody has a handle on this situation is the point of our concern.
Or you could take your cat to the pet store and let him pick a mouse out from the mouse tank. I mean that is what the mouse tank is for right? People really don't buy them as pets do they??
Try giving your cat sardines. They are high in calcium, iron and fish oils. Cats need higher protien levels than dogs so on the BARF diet that is taken into account. Since most cats hunt most already have a bit of the BARF diet in their rations.
Here is some basic information on Natural Balance (sorry I got the name wrong late last night)Ultra premium dry cat food
Contains fresh chicken, duck, carrots, & potatoes, glucosamine, cranberry powder, brown rice, grape seed oil, flax seed and oatmeal. Vitamin & mineral packed with vitamins A & E, beta carotene, potassium, omegas 3 & 6, lecithin, linoleic acid, & biotin. Also is taurine fortified & has added yucca to help control waste odors. Free of artificial flavors, colors and chemical preservatives. Has 34% Protein, 18% Fat & 3% Fiber.
The full label can be found at 1800jeffers.com Jeffers is also a great source for pet medicines, toys, treats and supplies. If you do vaccinate your own pet find out what your State law is regarding rabies vaccine. Most States require certification from a vet. But you can buy wormer, prescription meds ( with script) and other medical supplies at a much lower cost.
Some of the possibilities include - sabotage a competitor, short a stock, experiment with a food supply to see how you could use the food supply chain as an instrument of terror?
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