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

The federal Food and Drug Administration (FDA) announced 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. For example, two of these factors are: whether the nutritional supplements company only makes its products available to licensed veterinarians, and whether the products are or are not intended as substitutes for corresponding animal drugs.

In its draft guidance, the FDA notes that nutritional products that make disease claims are in fact to be regulated as drugs under the federal Food, Drug & Cosmetic Act. However, in the past, such products were marketed to veterinarians, whereas now they are widely marketed to laypeople through the Internet. The FDA points out that, for example, claims to “control blood sugar” could be misleading to pet owners, and could lead them to miss symptoms of diabetes.

In this respect, FDA’s new enforcement posture with respect to pet food claims is similar to its posture under the DSHEA with respect to claims about dietary supplements.

Pet food manufacturers and distributors should consult FDA legal counsel regarding their marketing activities. Contact the Cohen Healthcare Law Group for a legal consultation regarding your FDA legal and regulatory needs today, whether they involve human or pet nutritional products, dietary supplements, cosmetics, or drugs.