Author Topic: FDA Warns Hill's and Science Diet  (Read 3106 times)

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Offline Lola

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FDA Warns Hill's and Science Diet
« on: December 01, 2011, 09:46:04 PM »
Don't read just the snips posted here.  PLEASE read the entire letter!!!

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FDA Inspections, Compliance, Enforcement, and Criminal Investigations
November 23, 2011

WARNING LETTER
Ref. KAN 2012-02
 
Neil Thompson
President and CEO
Hill’s Pet Nutrition, Incorporated
400 SW 8th Street
Topeka, Kansas 66603
 
Dear Mr. Thompson:
 
This letter concerns Hill’s Pet Nutrition’s marketing of the Science Diet® Healthy MobilityTM Adult Dry Dog Food (“the Healthy Mobility Diet”)[1]. The Food and Drug Administration (FDA) reviewed the label and labeling of this product, including statements made on your website at the Internet addresses www.hillspet.com and www.sciencediet.com. Based on claims made by Hill’s Pet Nutrition for this product, the Healthy Mobility Diet is a drug under section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (“FD&C Act”), [21 U.S.C. § 321 (g)(1)(B)], as it is intended for use in the mitigation and treatment of joint disease in dogs.   As discussed below, this product is an unapproved new animal drug and your marketing of it violates the FD&C Act.

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Some structure/function claims, however, imply that the product has an impact on disease.

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The content on your website implies that the Healthy Mobility Diet has an effect on joint disease, including arthritis, by referring to identifiable characteristics of the disease.

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Audio/visual segments on the Healthy Mobility Diet product-specific webpage reinforce the implication that the Healthy Mobility Diet is intended for use in dogs with joint disease. For instance, one segment contains a dramatized testimonial from a veterinarian that shows a dog exhibiting signs and symptoms consistent with joint disease and seeking treatment from the veterinarian, who states that she recommends the Healthy Mobility Diet for dogs that are “starting to have trouble getting around.” The segment goes on to suggest that 30 days after the veterinarian recommends the Healthy Mobility Diet for the dog, the dog returns to the clinic with improved flexibility and mobility as evidenced by the dog running and jumping over another dog and jumping up on the veterinarian with its front legs on her shoulders.

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Because Science Diet® Healthy Mobility TM Adult Dry Dog Food is intended to mitigate or treat joint disease in dogs, it is a drug within the meaning of section 201(g)(1)(B) of the FD&C Act, [21 U.S.C. § 321 (g)(1)(B)]. The product is also a new animal drug under section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because it is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.

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This letter is not intended to be an all-inclusive review of Hill’s Pet Nutrition’s products and their promotion. FDA has significant concerns about the promotion of other pet foods marketed by your firm.

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You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm281270.htm


nonono
« Last Edit: December 01, 2011, 11:52:33 PM by Lola »
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Offline Amber

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Re: FDA Warns Hill's and Science Diet
« Reply #1 on: December 02, 2011, 01:21:21 AM »
Finally, someone is holding them accountable for promoting a (low quality food) as medicine.

Offline FurMonster Mom

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Re: FDA Warns Hill's and Science Diet
« Reply #2 on: December 02, 2011, 02:50:56 AM »
The only thing I anticipate resulting from this, is that Hills will change their marketing phrases to indicate that the food is not a "treatment".  Omega 3's and Glucosamine are considered "supplements" and can be described as such without changing anything else.

I don't think it will stop vets from "prescribing" all the SD products that have been on the market all these years.
meow meow meow meow meow meow? -woof!
Translation: "I can has my raw food? -please!"

Offline CarnivorousCritter

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Re: FDA Warns Hill's and Science Diet
« Reply #3 on: December 02, 2011, 07:41:25 AM »
This is very worrisome, bolded extremely scary!!     Have spent 5 years trying to convince people that there is NO medicine in that "prescription" food $cam and now this = the fda is, indeed, classifying that carp as "drug"?

 I smell   flamingturd (<---putting it nicely)    and inevitably "vets" charging MORE for this garbage becaue the FDA "says" it's a drug         :'( :'(

Is this the "opening"?   Are those joint supplements even drugs?    I bought them right off the shelf for my dog when he had arthritis.
It ALL stinks to high heaven.  How long until Hill's "is forced to" make it "prescription"??  This sets a precedent....

<<
Because Science Diet® Healthy Mobility TM Adult Dry Dog Food is intended to mitigate or treat joint disease in dogs, it is a drug within the meaning of section 201(g)(1)(B) of the FD&C Act, [21 U.S.C. § 321 (g)(1)(B)]. The product is also a new animal drug
under section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because it is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. It is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b,
« Last Edit: December 02, 2011, 07:43:34 AM by CarnivorousCritter »

Offline CarnivorousCritter

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Re: FDA Warns Hill's and Science Diet
« Reply #4 on: December 02, 2011, 07:53:03 AM »
The only thing I anticipate resulting from this, is that Hills will change their marketing phrases to indicate that the food is not a "treatment".  Omega 3's and Glucosamine are considered "supplements" and can be described as such without changing anything else.

I don't think it will stop vets from "prescribing" all the SD products that have been on the market all these years.


What's really scary, FurMonster Mom, is that they are already legally "prescribing" combinations of salt, corn, sawdust,  soy, animal digest and by-products as such under the pretense that it's medicine/treatment.  :'(

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I've been wondering for a few years now, where are the Consumer Fraud attorneys? None of them have companion carnivores?????? Are they just too busy with frivilous lawsuits these days?  There's NO burden of proof regardless of drugs (or not) because our pets are carnivorous mammals!!  throwfit soapboxgif censoredgif flamingangry
NO burden of proof there ^   bangshead
« Last Edit: December 02, 2011, 07:57:50 AM by CarnivorousCritter »

Offline FurMonster Mom

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Re: FDA Warns Hill's and Science Diet
« Reply #5 on: December 03, 2011, 01:55:55 PM »
What I see here, is that the FDA is "warning" Hills that the way they've presented their food is as if it is a "drug" for "treatment". 

The FDA is telling Hill's that they have crossed the line between a "food that benefits healthy animals" and "a treatment for animals with problems". 

As such, the FDA will begin to treat Hill's food as a "drug", which will mean more rigorous testing, licensing and fines, UNLESS Hill's changes their presentation to fit the "food" description.

If Hills wants to argue that their food IS a "drug", they will have to present arguments that Glucosamine and Omegas are "drugs"... which would stir up one hell of a shit storm involving the supplement industry.

The path of least resistance for Hills is to simply bring their presentation into compliance with the FDA's "food" description.
Whereas, if they fight for the "drug" classification, it will be more expensive all around (for them initially, and the consumers in the long run).

And CC, you are right.  Hill's looses nothing by changing their presentation/description, because they already have Vets in their pockets.
However, if they go forward with the fight, the cost of the product will go up and, in this economy, they are more likely to lose customers.

.
meow meow meow meow meow meow? -woof!
Translation: "I can has my raw food? -please!"

Offline Lola

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Re: FDA Warns Hill's and Science Diet
« Reply #6 on: December 04, 2011, 08:38:40 PM »
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To explain a little further, the FDA does not consider food as healing; that food could cure or improve a disease or illness.  I disagree with this belief, but that aside, it is the FDA’s position that anything that cures or heals a disease or ailment would be considered a drug.  Thus, if it is a drug, the drug must go through FDA approval process.  As an example, with Science Diet’s claim of “improve joint flexibility in just 30 days!” – the FDA considers this to be a drug claim – thus it is not allowed for a food to make such a claim.

Science Diet should have known better.  They have been in the pet food business for too long now not to understand FDA’s perspective on health claims.

As of today 12/2, it does not appear that Science Diet has removed any of the marketing statements the FDA addressed in the Warning Letter.  Per the Warning Letter, Science Diet has 15 working days to respond.  It will be interesting to see if Science Diet will remove these marketing terms or if the FDA will cave to Science Diet.  We’ll see.

http://www.dogsnaturallymagazine.com/science-diet-gets-fda-warning-letter/
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Offline Lola

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Re: FDA Warns Hill's and Science Diet
« Reply #7 on: December 04, 2011, 08:44:46 PM »
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Hill's Science Diet and Hill's Prescription Diets are brands featuring a range of dog food products which are supposed to be the only right food we should feed our dogs.

They convinced the majority of veterinary professionals that the Hill's way is the only way. There are theories out there on the subject; I'm not going to get into that.

Now, there are a number of people whom I love and respect that believe in Hill's nutrition. I'm sure they have their good reasons.

Clearly, Hill's feels that the end consumers needed more convincing. So they came out with this miracle mobility formula and pulled out all the stops to promote it.

Judging by the FDA's reaction it seems that they really overshot the runway this time … by a mile.

So how does one formulate such a magical formula?

Here is how. You take any old run-of-the-mill formula and add some miracle ingredients. And voila.

What are those miracle ingredients?

Omega-3 fatty acids, Glucosamine and Chondroitin Sulfate (in optimal levels, of course)

I do believe these are great supplements and we use them as well.

Not much of a breakthrough, though, is it?

These supplements have been used for arthritis since I can remember.  A number of dog food formulas include them; and many of them don't even make a big deal out of it. Well, of course, nobody else is using them in optimal levels, I guess.

Well, I am glad that these supplements get the scientific stamp of approval.

http://dawgbusiness.blogspot.com/2011/12/hills-overshot-runway.html
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