FDA has issued a guidance for FDA staff intended to ensure animal safety related to direct-to-consumer or retail sales of dog and cat food products intended for use in treatment or prevention of disease. FDA has seen an increase of such products recently. The guidance summarizes FDA's concerns with the safety and effectiveness of these products, which are not evaluated by the FDA, and pet owners' misinterpretation of claims. For example, a pet owner might purchase a food that claims to treat obesity when in fact the product may not be formulated to meet the pet's daily nutrient requirements.
Although animal food products intended to diagnose, cure, mitigate, treat, or prevent diseases are regulated as drugs, and hence need to be registered and listed with and approved by the FDA, FDA has exercised enforcement discretion in the past when those products provided all or most of the nutrient in support of the animal's total required daily nutrient needs, did not claim to treat or prevent disease when made available to the general public, and were distributed only through licensed veterinarians, who know the health history of the pet and the nutrient, food, or drugs (if any) the pet needs to consume. FDA concludes that it will enforce applicable rules as to food manufacturers that sell these products directly to the consumer where the manufacturer makes health claims that are not scientifically substantiated or that could pose a health safety risk to the pet, where the product contains ingredients that are not generally recognized as safe or contain unapproved food additives, or where the product does not comply with food regulations, such as food labeling, establishment registration, or good manufacturing practices.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
