On October 2, 2012
FDA proposes guidelines for therapeutic petfoods
After decades of informal Food and Drug Administration policies for the marketing of these petfoods, the agency has now proposed formal guidance
["Marketing of this type of product presents unique challenges from a regulatory perspective.", "Most of these conditions of the FDA’s exercise of enforcement discretion are not new to the agency."] The concept of using diet in the management of disease in dogs and cats can be traced back to the 1940s, when Mark Morris Sr., DVM, first marketed a restricted protein product for the feeding of dogs with chronic kidney disease. Since that time, therapeutic petfoods (also known as veterinary medical foods) have shown themselves to be a vital component of the veterinary practitioner’s arsenal for managing a number of medical conditions.Marketing of this type of product presents unique challenges from a regulatory perspective, as the products blur the distinction between “food” and “drug” as defined by the US Federal Food, Drug and Cosmetic Act. While the Food and Drug Administration has had informal policies regarding the marketing of therapeutic petfoods for decades, for the first time the agency has proposed formal guidance on the matter. On September 10, 2012, the FDA announced the availability of a draft compliance policy guide entitled “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats.”The FDA considers these products to meet the statutory definition of drugs, and as such, they are subject to enforcement action as adulterated drugs because they have not been approved via new animal drug applications as required by law. However, in establishing regulatory priorities to address its most ...