FDA Announces Draft Compliance Policy Guide on Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats

September 10, 2012

Today, FDA is announcing the availability of a draft compliance policy guide (CPG) entitled, “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats.” The CPG provides guidance to FDA staff and industry on how FDA intends to use its enforcement discretion with regard to the labeling and marketing of these therapeutic diets.

These nutritional products or therapeutic diets are pet foods that are specially formulated to address specific disease conditions (for example urinary tract disease in cats). The products were originally sold through and used under the direction of licensed veterinarians.

Recently, FDA has observed an increase in marketing directly to pet owners over the internet and in supermarkets or pet stores. This shift in marketing directly to pet owners without veterinary direction, concerns FDA because these products are formulated for specific needs and may not be tolerated by all animals.

The draft CPG sets out the factors FDA will consider when determining whether or not to initiate enforcement action if the products are sold or marketed inappropriately.