FDA WARNING_LETTER - Hill's Pet Nutrition Inc - November 23, 2011

The FDA issued a Warning Letter to Hill's Pet Nutrition Inc. on November 23, 2011, regarding their Science Diet® Healthy MobilityTM Adult Dry Dog Food. The FDA determined that the product is an unapproved new animal drug under section 201(g)(1)(B) of the FD&C Act, as its labeling and website claims (e.g., "Improves joint flexibility in just 30 days," "Tested nutrition to enhance active mobility in just 30 days") indicate intent for use in the mitigation and treatment of joint disease in dogs.

The FDA cited website content that describes "early signs of joint health issues" (e.g., "Slow to get up or down," "Lagging behind while walking"), which are indistinguishable from symptoms of arthritis. The use of terms like "problems" and "issues" for joint conditions, and references to "early detection" or "warning signs," further imply the product targets disease. An audio/visual segment on the website also features a veterinarian recommending the product for dogs "starting to have trouble getting around," reinforcing its drug intent.

Because the product is intended to mitigate or treat disease, it is classified as a new animal drug under section 201(v) of the FD&C Act and is not generally recognized as safe and effective. It lacks an approved new animal drug application, making it unsafe under section 512(a