[Britster]

Hill's Pet Nutrition Inc 11/23/11

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 Hill's Pet Nutrition Home | Select a Location and Science Diet: Healthy Pet Food for Cats and Dogs | Hill's Pet Nutrition. 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.

The Healthy Mobility Diet bears the following claims on its label:
“Tested nutrition to enhance active mobility in just 30 days”
“Improves joint flexibility in just 30 days”
“Enhance active mobility in just 30 days
Vital fatty acids
Optimal levels of Omega-3 fatty acids to enhance overall mobility”
“Improve joint flexibility in just 30 days
Omega-3 fatty acids plus Glucosamine & Chondroitin Sulfate
Natural key building blocks of healthy cartilage and joint function”

The product’s label also bears the statement, “For more information about our precisely balanced nutrition and about other Hill’s® Science Diet® pet foods visit www.sciencediet.com.” This link takes a consumer who accesses it to a page on the hillspet.com website: Science Diet: Healthy Pet Food for Cats and Dogs | Hill's Pet Nutrition.

FDA acknowledges that the claims on the Hill’s Healthy Mobility Diet label – “enhance active mobility” and “improves joint flexibility” – appear to be claims that the product affects the structure or function of the body (“structure/function claims”), and the FD&C Act permits foods to make appropriate structure/function claims.

Some structure/function claims, however, imply that the product has an impact on disease. Although a food may make claims that refer to the product’s ability to maintain healthy structure or function, structure/function claims that imply the product is intended to diagnose, cure, mitigate, treat, or prevent disease are classified as “disease claims” and the product for which the claims are made is regulated as a drug.[2] FDA evaluates the context in which a structure/function claim is made to determine whether it is a disease claim. See 21 C.F.R. §101.93(g).[3]

The Hill's Pet Nutrition website provides ample context showing that the Healthy Mobility Diet is intended to treat or mitigate joint disease in dogs. 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. Reference to a characteristic set of signs or symptoms of a disease, even in the absence of the name of the disease, can be understood as a reference to the disease. See 21 C.F.R. 101.93(g)(2)(ii). The following lay terminology is used on your website to describe the “early signs of joint health issues”:
“Slow to get up or down”
“Lagging behind while walking”
“Longer recovery time after play or exercise”
“Less playful, running less or less active in general”
These signs are consistent with and indistinguishable from the characteristic signs and symptoms of arthritis, a broad spectrum of joint diseases with numerous etiologies. For instance, a page on your website entitled “Arthritis and Joint Pain” states that “If your dog has arthritis, the first thing you'll notice is that he or she finds movement difficult and is reluctant to walk, run and jump.”

Read more: Hill's Pet Nutrition Inc 11/23/11