FDA Releases Guidelines for Regulation of Therapeutic Pet Diets

The US Food and Drug Administration (FDA) has released guidelines for regulating dog and cat diets intended to treat diseases (for example, obesity and renal failure). The document contains nonbinding recommendations for FDA staff and is a response to the increase in therapeutic diets marketed directly to the general public.

Dog and cat diets that are marketed as able to diagnose, cure, mitigate, treat, or prevent diseases are classified as drugs, according to section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. Most dog and cat diets that are marketed as disease treatments do not comply with drug registration requirements. However, in the past the FDA has usually not pursued enforcement as long as the diets (1) provided most of an animal’s daily nutrient requirements, (2) did not include claims of disease treatment or prevention on labels or other materials available to the general public, and (3) were distributed for sale only through licensed veterinarians.

The number of dog and cat diets intended to treat disease has been increasing, as has the number being sold directly to pet owners. The FDA produced the compliance policy guide to ensure animal safety. “These products are commonly labeled or marketed for use in dogs or cats with diseases or conditions that cannot be accurately diagnosed by pet owners,” states the guide. “In addition, the labeling or other materials may lack sufficient information, particularly for pet owners, on the effectiveness, possible side effects, and contraindications for use.”

Pet diets intended to treat disease are considered adulterated and misbranded products unless they are approved as new animal drugs, produced in compliance with manufacturing requirements, and manufactured by a facility registered with the FDA. However, according to the guide, the FDA is “less likely to initiate enforcement action” when all of the following conditions are met:

• The product is available to the public only directly through veterinarians or via retail or internet sales under the direction of a veterinarian.
• The product presents no known safety risk when used according to label directions.
• The product label includes no representation that it can treat or prevent disease.
• Materials representing the product as intended to treat disease are available only to veterinary professionals.
• Electronic resources for information related to intended product use are secure and available only to veterinary professionals.
• The product labeling is not false or misleading.
• The product is not marketed as an alternative to approved animal drugs.
• The product manufacturer is registered under section 415 of the Food, Drug, and Cosmetic Act.
• Manufacture of the product complies with animal food manufacturing regulations.
• The product labeling complies with food labeling requirements.
• All ingredients are either (1) generally recognized as safe according to the Code of Federal Regulations, (2) approved food additives, or (3) food ingredients defined by the Association of American Feed Control Officials.

The guide recommends that staff consult the FDA Center for Veterinary Medicine before taking regulatory action. The guide also suggests that districts consider enforcement when 1 or more of these conditions is not met.