FDA considers regulatory action against therapeutic pet food manufacturers

The U.S. Food and Drug Administration (FDA) recently released draft guidelines on how it plans to regulate compliance with federal requirements for the labeling and distribution of therapeutic dog and cat foods--and potentially take action against manufacturers. The FDA’s Center for Veterinary Medicine (CVM) says pet foods with disease-related claims are increasingly being sold outside veterinary practices, and it intends to bring therapeutic nutrition back under the direction and oversight of veterinarians.

According to the FDA, the guide will be a strategy for enforcing the animal drug provisions of the federal Food, Drug and Cosmetic Act. “Since 1988, the Center for Veterinary Medicine (CVM) has observed an increase in the number of dog and cat food products making such claims that are sold with, or without, the direction of a licensed veterinarian,” the FDA states in a notice. “Because of this increase, and to help ensure animal safety, CVM is issuing this draft compliance policy guide to set out its current thinking with respect to factors it will consider before determining whether to take regulatory action against dog and cat food products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”

Within the policy guide, the FDA makes the following recommendations for manufacturers of therapeutic dog and cat foods:

• The product should be made available to the public only through licensed veterinarians or through retail or Internet sales to individuals purchasing the product under the direction of a veterinarian.

• The product should not be marketed as an alternative to approved new animal drugs.

• The manufacturer must be registered under section 415 of the Food, Drug and Cosmetic Act.

• The product’s labeling must comply with all food labeling requirements.

• The product should not include indications for a disease claim (e.g., obesity, renal failure) on the label.

• Distribution of labeling and promotional materials with any disease claims should be limited to veterinary professionals.

• Electronic resources that disseminate labeling information and promotional materials should be secured so that they are available only to veterinary professionals.

• The product must contain only ingredients that are generally recognized as safe, approved food additives or feed ingredients defined in the 2012 Official Publication of the Association of American Feed Control Officials (AAFCO).

• The labeling of the product should not be false or misleading in other respects.

The FDA encourages comments on the compliance policy guide. Comment can be made through the federal register online at federalregister.gov/articles/2012/09/10/2012-22231/draft-compliance-policy-guide-sec-690150-on-labeling-and-marketing-of-nutritional-products-intended#h-4 until Nov. 9. To view the compliance policy guide online, go to gpo.gov/fdsys/pkg/FR-2012-09-10/pdf/2012-22231.pdf.