FDA Finalizes Compliance Policy Guide: Pet Food Diets Intended for Sick Animals are Drugs but FDA will Exercise Enforcement Discretion under Limited Circumstances

May 5, 2016

By Riëtte van Laack & Wes Siegner

Under the FDC Act, dog and cat food products that are intended to treat or prevent disease and to provide nutrients in support of the animal’s daily nutrient needs can be regulated as drugs or foods or both. Drugs may be not be marketed without pre-market approval. Thus, according to FDA, pet food products intended to treat sick animals are illegal. Unlike human food products, where FDC Act provisions addressing health claims and food for special dietary use, and the Orphan Drug Act Amendments of 1988 defining “medical food” permit certain disease-related claims, there are no such provisions applicable to products intended for animals. However, as FDA explains in a new guidance, under limited specific circumstances, FDA will exercise enforcement discretion with regard to these products. The guidance identifies eleven factors FDA will consider.

Although the Agency considers these products drugs, it will exercise enforcement discretion if manufacturing and labeling complies with the regulations for animal feed; i.e., the manufacturing facility must be registered as an animal feed establishment, the product must be manufactured in accordance with cGMPS and preventive controls applicable to animal food manufacturing, and the product must contain only ingredients that are GRAS ingredients, approved food additives, or ingredients defined in the 2015 Official Publication of the Association of American Feed Control Officials. In addition, the product labeling must comply with all labeling requirements for animal food products.

The label of the product may not include representation regarding its effect on disease. Labeling and other marketing materials may reference the disease but only if the distribution of these materials is be limited so that the information is available for veterinary professionals only. In addition, the product may be made available to the public only through licensed veterinarians or through sales to individuals purchasing the product under the direction of a veterinarian.

The draft guidance was published in 2012. The Draft Guidance identified specific factors determining enforcement priorities. The Final Guidance is less specific and merely advises Districts to consider enforcement action when one of more of the factors listed by FDA is not present.

All in all, the final Guidance is substantially similar to the draft guidance. FDA does not explain whether it did consider any of the suggestions made in comments. For example, comments advised FDA that the type of foods at issue generally do not treat or prevent disease but instead “manage” disease in that they address the nutritional needs of animals with diseases. Similarities with medical foods for humans were noted.

Comments also recommended that FDA not include a date in the reference to the AAFCO Official Publication because this would create issues the moment that publication would be updated. Rather than removing the date, FDA updated it to refer to the 2015 version which has already been replaced by the 2016 edition.

This guidance does not apply to products intended for nutritional supplementation of foods for animals and products marketed as dietary supplements for animals. These are the subject of a different unpublished FDA enforcement discretion policy.