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,
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