Center for Veterinary Medicine Releases New Guidance

The center makes no bones about dog and cat food health claims.

If you have been down a pet food aisle recently, you may have noticed dog and cat foods that claim to treat various conditions, such as claims to treat urinary tract disease in cats or “control blood glucose” in dogs. Products with these types of claims have been marketed for more than 50 years; however, because of the potential for consumers to misuse or misunderstand these products as effective treatments for disease conditions in pets, the US Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) recently outlined its policies for enforcement on the topic of disease claims in dog and cat foods.

On April 29, 2016, CVM released Compliance Policy Guide (CPG) 690.150: Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases.[1] The CPG describes situations when CVM intends to take enforcement action against dog and cat foods that are labeled as intended to treat a disease.

Dog and cat foods are unique in that they can be intended to be the animals’ sole source of nutrients or diet other than water. Because these products make claims intended to diagnose, cure, mitigate, treat, or prevent diseases (disease claims), they meet FDA’s statutory definition of a drug.[2] Additionally, these products meet the FDA’s statutory definition of food because they are articles used for food for animals.[3] Therefore, these products may be regulated as a food, drug, or both. A product is an animal drug if it makes disease claims, and otherwise is an animal food.

New animal drugs must have an Approved New Animal Drug Application (ANADA), a conditional approval, or an index listing.[4] Otherwise, they are misbranded pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act).[5] Manufacturers of ANADAs must comply with the requirements of the FD&C Act, including manufacturing the products in accordance with current good manufacturing processes (cGMPs) and registering and listing products with the FDA.

Most currently marketed dog and cat foods that make disease claims do not have an ANADA or conditional approval and thus cannot make disease claims.[6] Previously, however, FDA has exercised enforcement discretion (i.e., not pursued an enforcement action) with regard to dog and cat foods that make disease claims that do not have an ANADA or conditional approval when the products

• provide all or most of the nutrients in support of the animal’s total required daily nutrient needs,
• do not contain claims to treat or prevent disease in the labeling and/or manufacturer communications to the general public, and
• are distributed only through licensed veterinarians.

These factors mitigate consumer confusion with regard to the diagnosis and treatment of a disease. Under these factors, CVM did not take enforcement action when the distribution and use of foods that make disease claims was overseen by a licensed veterinarian who can properly diagnose and treat the disease in cats and dogs.

Recently, however, an increased number of dog and cat foods have made disease claims in labeling and manufacturer communications directly to the consumer. These products have not been evaluated by the CVM for safety, efficacy, or nutritional adequacy. CVM is concerned that many of these products are used by pet owners for conditions that cannot be accurately diagnosed by pet owners and that the labeling lacks information regarding side effects, effectiveness, and contraindications. CVM provides the example that owners of diabetic dogs and cats may interpret the disease claim “control blood glucose” to mean that the product is the sole treatment required for a diabetic cat or dog when the animal may require insulin therapy and other treatment from a licensed veterinarian to control blood glucose. Furthermore, foods intended to treat obesity in pets may provide inadequate nutrients for the pet.

The new CPG outlines factors that CVM will consider for dog and cat foods that make disease claims

• whether the product is made available to the public exclusively through licensed veterinarians or through retail or Internet sales to individuals purchasing the product under the direction of a veterinarian;
• whether the product is responsibly marketed and labeled (e.g., when a product is marketed as an alternative to approved new animal drugs, the FDA will take enforcement action); and
• whether the product complies with registration and listing requirements cGMPs and contains only proper ingredients as defined by the FD&C Act and the CPG.

Overall, products that make disease claims for dog and cat foods must not be marketed directly to consumers.

Contacts

If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:

Washington, DC
Gary L. Yingling