CVM GFI #293 - FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients October 2024

GUIDANCE DOCUMENT

• Docket Number: FDA-2024-D-2977
• Issued by: Center for Veterinary Medicine

The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the authority to regulate substances used in animal food. The FD&C Act defines a food additive, in part, as any substance whose intended use results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food . . . if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety . . . to be safe under the conditions of its intended use. Substances that are “generally recognized as safe” (GRAS) for their intended uses in food are not food additives.

The FD&C Act and FDA regulations describe the animal food additive petition process and the data and information that must be submitted to FDA as part of an animal food additive petition to support premarket approval. In general, to be legally marketed and used, a food additive must be approved, covered by an FDA regulation, and used as described in the FDA regulation. Otherwise, the food additive is considered unsafe under section 409(a)(2) of the FD&C Act, and the food additive and any food that bears or contains it is adulterated under section 402(a)(2)(C)(i) of the FD&C Act. Approved food additives for animal food use are found in 21 CFR parts 573 and 579.  

FDA has affirmed certain substances as GRAS for their intended use in animal food and these are listed in 21 CFR parts 582 and 584. Importantly, these lists are not all-inclusive. Because the GRAS use of a substance is not subject to premarket review and approval by FDA, it is impracticable to list all substances that are used in food on the basis of a conclusion of GRAS status. However, FDA encourages any person who intends to market a food substance on the basis of a conclusion of GRAS status to submit a GRAS notice to FDA.

The Association of American Feed Control Officials (AAFCO) is a voluntary membership association of State and Federal regulatory officials in the United States as well as officials from government agencies in other countries, that are responsible for the execution of laws, including regulations, in their jurisdictions pertaining to the production, labeling, distribution, use, or sale of animal food (including ingredients).  

Since 1920, AAFCO has maintained the AAFCO Official Publication (OP), which contains, among other things, a comprehensive list of animal food ingredients, many of which include definitions established through the AAFCO Ingredient Definition Request Process. Because most States adopt the ingredient definitions listed in the AAFCO OP under their State laws, the AAFCO ingredient definition request process facilitates the marketing of animal food ingredients under those State laws. In 2007, FDA entered into an MOU, 225-07-7001, with AAFCO that outlines how FDA would provide its scientific and technical expertise to AAFCO in reviewing requested ingredient definitions. This MOU has been renewed and revised several times. The current MOU expired in October 2024, and the MOU was not renewed.

This guidance describes our policy that FDA generally does not intend to initiate enforcement action with respect to the food additive approval requirements of the FD&C Act for the ingredient, or animal food containing the ingredient, that is listed in the Official Common or Usual Names and Definitions of Feed Ingredients section of chapter six of the AAFCO 2024 OP. We have reviewed many of these ingredients through our participation in the AAFCO ingredient definition request process and recommended that the ingredient definitions, including specifications for use, be added to the AAFCO OP. For those ingredients listed in the 2024 AAFCO OP that are not approved food additives or GRAS and that we did not review as part of the AAFCO ingredient definition request process, at this time, we are not aware of any safety concerns that would cause us to request that an ingredient be withdrawn from the AAFCO OP, and many have a long history of use in animal food. In addition, the guidance describes FDA’s policy with respect to the use of certain ingredient names listed in chapter six of the AAFCO 2024 OP on animal food labels.
 

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