On September 11, 2013, FDA issued a draft Guidance entitled, “Recommendations for Preparation and Submission of Animal Food Additive Petitions.” This Guidance provides the Center for Veterinary Medicine’s (“CVM’s”) recommendations regarding information to be included in food additive petitions (“FAPs”) for animal foods. FDA regulates food and substances added to food, some of which are “food additives.”
A food additive is:
any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component of or otherwise affecting the characteristics of any food, unless the substance in Generally Recognized as Safe (GRAS) among qualified experts under the conditions of its intended use, or meets one of the other exemptions to the food additive definition (e.g., new animal drug, color additive, etc.).
To use a food additive in animal food, the additive must first be approved by FDA for such use. The Federal Food, Drug, and Cosmetic Act (“FD&C Act”) sets forth a petition process to ensure that the use of a food additive in animal food is safe. The process is set forth in section 409 of the FD&C Act. Prior to initiating a petition, applicants should verify whether the additive is already approved, i.e., there is a regulation in place for the intended use of the substance in animal food.