FDA regulates foods and substances added to food under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Many substances added to foods are food additives. Section 201(s) of the FD&C Act (21 U.S.C. § 321(s)) defines a “food additive” as “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.” Section 201(s) excludes from this definition any substance that is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or that qualifies for any of the other exemptions from the food additive definition (e.g., new animal drug, color additive, etc.). 

Food additives require premarket approval based on data demonstrating safety. FDA issues food additive regulations specifying the conditions under which an additive has been demonstrated to be safe and, therefore, may be lawfully used. (See Section 409(a)(2) of the FD&C Act (21 U.S.C. § 348(a)(2)). A food that contains an unapproved food additive is deemed to be unsafe under section 409(a) of the FD&C Act and adulterated under section 402(a)(2)(C)(i) of the FD&C Act. Adulterated foods cannot be legally imported or marketed in the United States. Therefore, to use a food additive in animal food, FDA must issue a food additive regulation prescribing the conditions under which the additive may be safely used. Section 409(b) through (g) of the FD&C Act provides for a petition process to establish that a use of a food additive is safe.

This guidance describes the types of information that the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) recommends for inclusion in food additive petitions (FAPs) for food additives used in animal food. This guidance only applies to food additives for use in animal food. It is intended to help the petitioner (you) submit FAP information in a consistent and appropriate manner.

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