FDA Issues Final Guidance on Its Enforcement Policy for AAFCO-Defined Animal Feed Ingredients

FDA Issues Final Guidance on Its Enforcement Policy for AAFCO-Defined Animal Feed Ingredients

October 24, 2024, Covington Alert

On October 23, 2024, the Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) announced that it has finalized Guidance for Industry (GFI) #293, FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients (Final Guidance). The Final Guidance replaces CVM's draft guidance issued in August 2024 as well as Compliance Policy Guide Sec. 665.100, Common or Usual Names for Animal Feed Ingredients. The Final Guidance includes editorial changes to clarify the scope of CVM's enforcement policy, but otherwise is largely the same as the draft version.

Background

In August 2024, FDA announced that it would not renew the longstanding Memorandum of Understanding (MOU) between FDA and the Association of American Feed Control Officials (AAFCO), which outlined FDA's and AAFCO's respective roles in the AAFCO Ingredient Definition Request process, and which was set to expire on October 1, 2024.

As we previously reported, shortly after the announcement, CVM published a draft guidance (Draft Guidance) describing its proposed policy regarding the marketing in interstate commerce of unapproved food additives that were intended for use in animal feed and defined in chapter six of the 2024 print version of the AAFCO Official Publication (OP), and the marketing of animal feeds containing those food additives. The Draft Guidance also described CVM's proposed policy with respect to animal feed labels that identify ingredients by names defined in the AAFCO OP.

Revisions Made in the Final Guidance

In the Final Guidance, CVM clarified that its enforcement policy applies to unapproved food additives and animal feeds containing those food additives, and more specifically includes Generally Recognized as Safe (GRAS) substances and animal feeds containing those substances, where such food additives and GRAS substances are intended for use in animal feed and defined in the AAFCO OP.

In addition, the Final Guidance includes alink to the ingredient definitions in the AAFCO OP.

Looking Ahead

As we previously reported, simultaneously with the publication of the Draft Guidance in August 2024, FDA announced that it is evaluating its animal Food Additive Petition and GRAS Notification programs to determine if changes are needed to better serve public health and improve the path to market for new animal food ingredients. FDA requested comments from the public to assist with the agency's evaluation. Interested stakeholders can submit comments to the docket by December 9, 2024.

In the meantime, to provide an additional pathway for feed ingredient developers to engage with CVM regarding animal food ingredients for which firms may have otherwise used the AAFCO ingredient definition process, FDA issued a draft guidance in August 2024 on its new animal food ingredient consultation (AFIC) process.

Covington will closely monitor related developments, including any final guidance on FDA's AFIC process. If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drug, and Device practice.