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Did FDA make a special deal with Hill’s Science Diet?

FDA Warning Letters are a big deal…that is unless you have friends at FDA that can make everything good for you.

FDA Warning Letters are a big deal…that is unless you have friends at FDA that can make everything good for you.

In late November of 2011, the FDA issued a warning letter to Hill’s Pet Nutrition regarding health claims on the label and marketing of Science Diet Healthy Mobility Adult Dry Dog Food. The FDA warning letter stated: “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”), as it is intended for use in the mitigation and treatment of joint disease in dogs.”

In the 2011 warning letter, the FDA told Hill’s Science Diet these label claims were drug claims and they were not allowed on a pet food:

“Tested nutrition to enhance active mobility in just 30 days”
“Improves joint flexibility in just 30 days”

In no uncertain terms, the FDA told Hill’s Science Diet the pet food marketing claims on this pet food and other Hill’s pet foods were in violation of federal law:

this product is an unapproved new animal drug and your marketing of it violates the FD&C Act. FDA has significant concerns about the promotion of other pet foods marketed by your firm. We strongly encourage you to contact Eric Nelson, Director of the Division of Compliance, at the FDA’s Center for Veterinary Medicine to arrange a meeting to discuss these concerns. It is your responsibility to ensure that all of your products are in compliance with the FD&C Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.

So…why is Hill’s Science Diet allowed to make the exact same health claims in 2019 it was warned about in 2011? This is the Hill’s Mobility pet food webpage today (9/15/2019) – making the exact same health claims it did in 2011:

And on the current pet food label:

In fact, even though FDA issued Hill’s Science Diet a warning letter calling them out on drug-like marketing claims of a pet food – Hill’s never changed their marketing claims of this dog food as the 2011 FDA warning letter required.

Thanks to the Wayback Machine website, we find in March 2012 – four months after the FDA warning letter – the Hill’s Science Diet website continued to make the same marketing claims for their Healthy Mobility dog food:

In 2013, the same marketing claims continued:

And the very same drug marketing claims that FDA warned Hill’s about have continued on the Hill’s website and on product labels to present day.

FDA and Hill’s did not come to any agreement on the drug marketing claims of the Mobility Dog Food, at least not a formal public agreement as evidenced by the FDA website still classifying this Warning Letter as open (a close-out letter date would be issued if the case had been officially resolved). Note the Warning Letter states a close-out of the warning has not been issued:

Why? Why did FDA issue a warning letter to Hill’s Science Diet and then allow the company to continue to make the exact same drug marketing claims?

Was a deal made with Hill’s Science Diet that FDA never made public?

Members of the Pet Food Institute (trade association Hill’s Science Diet is a member of) met with top brass of FDA a couple weeks after the Hill’s Warning Letter – on 12/8/2011. The Pet Food Institute not only met with the director of FDA’s Center for Veterinary Medicine Bernadette Dunham, they also had a face to face meeting with Michael Taylor Deputy Commissioner of Foods and Dr. Dan McChesney Director of CVM’s Office of Surveillance and Compliance.

Another suspicious meeting with FDA took place 3 1/2 months after the FDA Warning Letter to Hill’s Science Diet on March 8, 2012. This meeting was with Mars Petcare representatives (also members of the Pet Food Institute) who might have also had a stake in drug-like marketing claims of pet food (such as Royal Canin prescription pet foods). The FDA representatives included in this meeting was again Michael Taylor Deputy Commissioner of Foods, a representative of FDA’s Office of Nutrition and Labeling, and an FDA attorney Senior Advisor for Policy. Mars Petcare attendees included three of their own corporate attorneys and one Washington DC attorney specializing in helping companies with FDA issues.

And then guess what happened?

Ten months after the 2011 FDA Warning Letter to Hill’s Science Diet, six months after the lawyer filled meeting in March 2012, the FDA introduced a new policy regarding drug claims of pet foods on September 10, 2012. The new FDA policy just happened to allow pet food the ONLY opportunity of any food to make a drug claim without having to go through clinical trials. An organic apple farmer cannot market his apples with the statement ‘An apple a day keeps the doctor away’ – but pet feed is allowed to claim “improve joint flexibility in just 30 days“. That is…the 2012 FDA policy allows a feed grade pet food to make a drug marketing claim when the pet food is sold only through veterinarians.

Interestingly, the Hill’s Science Diet Healthy Mobility Adult Dry Dog Food that was the foundation of the FDA warning letter of November 2011 – is NOT a pet food sold only through veterinarians. Yet, the FDA has still allowed the pet food to make drug marketing claims each and every year since.

Perhaps there was a special deal made with FDA regarding the Healthy Mobility dog food…maybe it was grandfathered into the 2012 FDA policy. Or maybe FDA just agreed to look the other way.

It’s beyond criminal that FDA is allowed to bend the law to meet any want or need of Big Pet Feed. All while pet owners are forced to become private detectives to determine if their pet’s food marketing claims are even close to truthful. Criminal.

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
TruthaboutPetFood.com
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17 Comments

17 Comments

  1. Judith Linden

    September 16, 2019 at 10:56 am

    Thanks for the information. My vet sells science diet and includes it in prescriptions for our animals. Fortunately, for us and our pets, none of our 8 animals will eat Hills food! I get human grade food when I can find it, and I cook for the furries when I can.

    • Teresa Heckel

      September 16, 2019 at 5:55 pm

      This all makes me sick. Several years ago my vet “””prescribed””” Science Diet prescription cat food for my cat and when I opened the first can it smelled like feces, I kid you not. She wouldn’t go near it and I couldn’t stand to be near it either. It went into the garbage.

  2. Sharon M Abbott

    September 16, 2019 at 11:22 am

    I so luv big business…..not

  3. Harry Giarratana

    September 16, 2019 at 11:49 am

    Susan, thank-you for a very important and informative article. I also want to thank-you, from my heart for Sadie’s sweet picture.
    God Bless.

  4. Fred St Clair

    September 16, 2019 at 1:40 pm

    We really have the worst government that money can and does buy on a regular basis.

  5. Mollie Morrissette

    September 16, 2019 at 1:41 pm

    Good call out! I would report this to the FTC who is in charge of advertising, not labeling, for what it’s worth.

  6. Mitch

    September 16, 2019 at 2:38 pm

    Just a Briefcase of cash in a parking garage. Nothing to see here, move along. The same kind of Briefcases that Hill’s gives to Vet clinics. Utter worthless garbage.

  7. Cannoliamo

    September 16, 2019 at 3:36 pm

    Thanks Susan,

    Although I certainly don’t support ANY shady backroom “compliance” agreements between FDA and the pet food companies, I suspect that the original FDA warning letter may have overstated the implication that this food is a drug “intended for use in the mitigation and treatment of joint disease in dogs.”

    The use of human nutriceutical / OTC formulations containing EPA from fish oil and glucosamine and chondroitin sulfate for the “treatment” (symptom relief) of osteoarthritis in humans has gained considerable popularity

    https://www.verywellhealth.com/glucosamine-and-chondroitin-2548847
    https://www.verywellhealth.com/side-effects-of-glucosamine-88199

    and I’m guessing (correct me if I’m wrong) that Hills is simply advertising that this “Healthy Mobility” dog food contains natural sources for these ingredients that may (or may not) be helpful for dogs suffering from joint pain

    https://www.proplanveterinarydiets.com/media/1193/canine_ha.pdf
    https://www.rheumatoidarthritis.org/dogs-best-glucosamine/

    It may be that the “30 day” improvement claim has offended some FDA staff bureaucrat and he/she wanted Hills to provide the results of their feeding trials to verify their claim.

    Without knowing additional details, I suspect FDA has backed off of their original drug warning since it was issued and should have resolved or withdrawn their claim publicly. I don’t see any reason to require drug testing of the labelled ingredients at this point unless there are reported adverse side effects from pet owners. I didn’t notice any claim by Hills that “if your dog fails to show improvement in 30 days return the product for a full refund.”

    IMHO, we have bigger fish to fry with CVM with respect to their collusion with manufacturers and their neglectful regulatory disregard of FSMA.

    Please advise if you think I’m missing something here.

    Thanks.

    • Susan Thixton

      September 16, 2019 at 9:55 pm

      The legal definition of a drug is any product meant to treat, cure, or mitigate disease (not a direct quote). So to me, the Warning Letter was pointing out that Hill’s claims were to mitigate disease. And I’m confident before the Warning Letter went out to Hill’s, it was validated and cleared through FDA’s legal department. In other words, the FDA had a reason to issue it. At least that is my understanding of Warning Letters.

  8. Stephanie

    September 16, 2019 at 4:22 pm

    The FDA is corrupt? Who knew! *sarc*

    Here’s a blatant example of the FDA’s intentionally ignoring a plea from the manufacturer:

    Valisure, the manufacturer of Zantac and it’s generic counterparts, filed a petition with the FDA on Friday, September 13 asking the agency to recall Zantact and its generic that contain NDMA (a cancer causing ingredient.)

    The FDA said the NDMA levels in the drugs are low, while Valisure’s petition called them excessive. The FDA said, “We don’t think this poses an immediate hazard to human health so we’ll have an ongoing process to determine whether recalls are needed.”

    The manufacturer reports the levels as excessive asks for a recall, but the FDA doesn’t?! It makes me so angry. I don’t understand…

    • Mark Morton

      September 16, 2019 at 6:18 pm

      “FDA” is the perfect acronym for this bunch!

  9. nikki Boar

    September 16, 2019 at 8:40 pm

    Of course there was a payoff and I might add that the reason Vets sell Hills Science Diet all over the Nation is because the profit and payoffs to the Vets are superior to any other pet food company. The stuff is garbage and I know many families who had their pet get sick from the stuff from vomiting to more serious conditions. My pets never touched the stuff.

  10. Linda J Chiolero

    September 16, 2019 at 8:49 pm

    I truly hate SD food and all of their pretense, it is expensive crap IMO. Back in 1998, when I got my first dog as an adult, even the regular SD food was ONLY available at the Vet’s office, sending a false message to consumers. I stupidly and blindly fell for their marketing ploy. I will never be able to prove it, but I strongly suspect that SD food played a part with my Cocker Spaniel getting Cushing’s Disease and repeated UTI’s which culminated in struvite crystals. It was and still is expensive food, and I now know that you can purchase a much better quality food for the same price or less. I hope the FDA gets revamped soon, it needs a full make over, to say the least.

  11. Pingback: Vet Your Pet Food - Oliver Pet Care

  12. Richard Stone

    September 17, 2019 at 6:55 pm

    I don’t understand something, doesn’t the FDA have to report to a higher authority? Can we contact our congressman to help out in these situations?

    • Susan Thixton

      September 18, 2019 at 8:11 am

      Hi Richard – Yes, Congress is sort of the ‘boss’ of FDA. However on many issues pet owners have written their representatives in Congress and they have done nothing to regulate the agency.

      • Gdoggie Stone

        September 18, 2019 at 4:29 pm

        Can someone prepare a letter or a petition that can be forwarded to congress, would that help? There has to be thousands of pet lovers out there that would be more than happy to sign a petition

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