FDA Issues Final Guidance on Its Interim Animal Food Ingredient Consultation Process

On January 6, 2025, the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) announced that it has finalized Guidance for Industry (GFI) #294, Animal Food Ingredient Consultation (AFIC) (Final Guidance). The Final Guidance replaces CVM’s draft guidance issued in August 2024 and provides several points of clarification, including those relating to the information that should be included in an AFIC submission or in a comment to a pending AFIC.

Background

As we previously reported, in August 2024 FDA announced that it would not renew the longstanding Memorandum of Understanding (MOU) between it 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 was set to expire on October 1, 2024. FDA also announced that it will evaluate its animal Food Additive Petition (FAP) and GRAS Notification programs to determine if changes are needed to better serve public health and stakeholder needs, and that it would issue draft guidance relevant to the upcoming transition phase. A few days later, CVM issued a draft guidance (Draft Guidance) on its AFIC program, which is intended to serve as an interim process after the expiration of the MOU and while FDA evaluates its FAP and GRAS Notification programs. The AFIC process provides an additional pathway for companies to engage with CVM regarding animal food ingredients for which they may have otherwise used the AAFCO ingredient definition process. The Draft Guidance also described CVM’s enforcement policy for certain ingredients reviewed using the AFIC process.

Key Revisions Made in the Final Guidance

FDA received 28 comments on the Draft Guidance. Based upon these comments, FDA removed the recommendation that an AFIC submission include a statement of environmental risk.[1] In addition, FDA made changes to clarify the following:

• The FAP and GRAS Notification programs remain available.
• The materials submitted to FDA as part of the AFIC process should include a proposed ingredient name and definition.
• Firms participating in the AFIC process should not resubmit information they have already provided to FDA.
• The confidentiality of information received in connection with the AFIC process will be handled in accordance with FDA’s obligations under 21 C.F.R. Part 20, “Public Information,” including regulations that preclude the public disclosure of a firm’s trade secrets or confidential commercial information (see, e.g., 21 C.F.R. 20.61).

The Final Guidance also includes specific recommendations regarding the submission of comments by interested parties on pending AFICs, including on timing and information to include.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Animal Food and Drug practice.