If you have been down a pet food aisle recently, you may have noticed dog and cat foods that claim to treat various conditions, making 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 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 diagnose, cure, mitigate, treat, or prevent diseases (disease claims). 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.
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 and current good manufacturing practice 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. Our team at Morgan Lewis is happy to provide counsel regarding regulatory compliance in this area. For a detailed review of this topic, see our LawFlash: Center of Veterinary Medicine Releases New Guidance.
1http://www.fda.gov/downloads/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/UCM318761.pdf