FDA Announces Significant Changes for Pre-Market Animal Feed Ingredient Reviews

Under the MOU, FDA had historically provided scientific and technical review for animal food ingredients listed in the AAFCO Official Publication. Concurrent with this announcement, FDA issued draft guidance explaining that the agency will continue to exercise enforcement discretion over AAFCO-listed animal feed ingredients that are not the subject of a Food Additive Petition (FAP) or notice that the ingredient is generally recognized as safe (GRAS Notice).¹ FDA also announced through draft guidance an interim consultation process for reviewing new animal feed ingredients while the agency works on a broader assessment of its animal feed ingredient review processes.

Background

AAFCO is an independent organization that has been guiding state, federal, and international feed regulators with ingredient definitions, label standards, and laboratory standards. AAFCO’s members are regulators that are charged by their local, state, or federal laws to regulate the sale and distribution of animal feeds and animal drug remedies. FDA is a member of AAFCO. The AAFCO Official Publication, published annually, includes standard ingredient definitions for animal feeds (including pet foods) and a model law that many states have incorporated into their animal feed laws and regulations. The Official Publication includes 1) animal feed additives and GRAS substances listed in FDA’s regulations, 2) GRAS substances that have been reviewed by FDA through the GRAS Notice process but that are not listed in FDA’s regulations, and animal feed ingredient definitions established through the AAFCO definition request process. While this third category of ingredients are not approved food additives and have not gone through the FDA GRAS review process, the agency has historically not objected to the marketing of feed ingredients that have an AAFCO definition in interstate commerce, provided there are no safety concerns associated with the ingredient’s use.²

FDA-AAFCO MOU

Currently, animal feed manufacturers seeking to obtain a definition for a new animal feed ingredient in the Official Publication (or seeking to modify an existing definition) can submit a proposed ingredient definition to AAFCO for review.³ As part of this review, AAFCO has historically sought a letter of concurrence from FDA regarding the suitability of the feed ingredient before establishing a definition in the Official Publication. FDA’s role in the AAFCO review is outlined in the FDA-AAFCO MOU, first established in 2007, which provides among other things what materials FDA reviews as part of the consultation, how FDA and AAFCO will handle disagreements on existing definitions, and how AAFCO reviews requests by FDA to remove an ingredient definition.⁴ The MOU does not allocate any regulatory authority to AAFCO or otherwise state FDA will exercise enforcement discretion over AAFCO-listed ingredients.

The MOU is set to expire on October 1, 2024, and FDA has announced it does not plan to renew the MOU. In its announcement, FDA emphasizes that “[t]o be legally marketed, an ingredient used in animal food (including pet food) must be the subject of an FDA-approved animal food additive petition (FAP) or be generally recognized as safe (GRAS) for the intended use in animal food."⁵

While FDA does not provide an explanation for its decision, we suspect the agency is making these changes in light of the recent Supreme Court decision on the need for regulatory agencies to follow the mandates of Congress in the authorizing statutes.⁶ The FDA MOU could have been criticized, and subject to legal challenge, because FDA was actively engaged in a process that resulted in a food ingredient that does not meet the GRAS criteria, and that would technically be considered an unapproved food additive, being listed in the AAFCO publication and authorized for use by state regulators. While FDA is no longer participating in the AAFCO review process, the agency is establishing a new program for animal feed ingredient consultations that on its face may provide an opportunity to seek FDA review of new ingredients in animal feed that do not meet the technical criteria for GRAS.

Request for Comments (RFC)

FDA issued a Request for Comments (RFC) requesting input on FDA’s FAP process and GRAS Notification programs to help the agency determine whether any changes are required to its animal feed ingredient review programs.⁷ The agency poses the following six questions for stakeholder input:

1. What do you perceive as barriers and/or benefits to pursuing a Food Additive Petition or GRAS Notification?

2. Are there changes that could make the Food Additive Petition and GRAS Notification programs more feasible, such as regulatory changes, changes to guidance, or changes to FDA policy or processes?

3. Is there information that is currently required to be submitted in a Food Additive Petition or GRAS Notification that you do not think is necessary for evaluating the ingredient?

4. Is there information that is not currently required to be submitted in a Food Additive Petition or GRAS Notification, but should be to better enable FDA's evaluation?

5. What review process for proposed animal food ingredients would best enable FDA to review their safety?

6. If you have submitted a request for an ingredient definition through the AAFCO ingredient definition process, what was your reason for doing so instead of filing a Food Additive Petition or submitting a GRAS Notification with FDA?

Proposed Guidance Documents

In anticipation of the MOU’s expiration, FDA published two draft guidance documents to clarify its enforcement position on AAFCO-listed feed ingredients and establish an interim consultation process for animal feed reviews while FDA evaluates changes that may be required to its animal feed ingredient review programs, as noted above.

• Draft Guidance #293: FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients⁸

  • This draft guidance states that despite the MOU’s expiration, FDA does not intend to initiate enforcement action against ingredients that are not approved animal food additives or GRAS for their intended use, but that do have definitions in the AAFCO Official Publication (Chapter 6, Official Common or Usual Names and Definitions of Feed Ingredients), when used according their intended use and for which FDA has no safety concerns. The draft guidance notes that FDA was involved in the AAFCO review for the vast majority of the AAFCO-defined ingredients, and FDA does not have safety concerns with the ingredients listed in the 2024 AAFCO Official Publication for which FDA was not involved in the review.

  • The draft guidance also states FDA does not intend to initiate enforcement action against animal food ingredient names that are not common or usual names but that are defined in the AAFCO Official Publication, unless the name is false or misleading.

  • Draft Guidance #294: Animal Food Ingredient Consultation (AFIC)9

    • Overview: This draft guidance establishes an interim process that will begin after the MOU expires on October 1 and is intended to provide a forum for FDA to review the safety of new animal feed ingredients.

    • AFIC Submission: The draft guidance says that a firm interested in consulting with FDA on a new animal feed ingredient should submit a packet of materials that includes information such as a description of the ingredient and its intended use, manufacturing information, a safety assessment with a narrative summarizing the cited safety studies and exposure assessment (to encompass both animal safety, and human food safety when applicable), supporting literature, and proposed labeling. FDA will post inventories of pending and completed AFICs on CVM’s website identifying the substance, intended use and species, and submitter.  The draft guidance is silent on the interplay between the AFIC process and the existing GRAS notification program. To the extent an entity is interested in commercializing a new animal feed ingredient but the ingredient fails to meet the GRAS criteria (e.g., because the studies that support the safe use of the ingredient have not been published), it is possible the AFIC program would provide such an opportunity. The draft guidance, however, requires the safety narrative to include “cited safety studies,” indicating FDA may require the key studies to be published. It would seem prudent to engage with FDA in advance of a submission to get guidance on whether the AFIC or GRAS notification process would be the more efficient pathway for seeking FDA review of new animal feed ingredients.

    • Stakeholder Input: FDA has opened a docket (FDA-2024-D-2978) that stakeholders may use to comment or provide additional data on ingredients undergoing AFIC review.

    • FDA Response: Upon completion of an AFIC, FDA will issue a “consultation complete” letter to the submitter concluding whether the agency has questions about the safe use of the proposed ingredient and summarizing the information that FDA reviewed to reach its conclusion. The letter will be published on FDA’s website along with the information on the submission noted above.

    • Enforcement Discretion: The draft guidance emphasizes that receipt of a favorable “consultation complete” letter does not mean the product is lawfully marketed, though FDA intends to exercise enforcement discretion over such ingredients so long as there are no safety concerns with the ingredient’s use. This outcome is similar to ingredients that have been reviewed by FDA under its GRAS Notification program.

Next steps

Comments on the two guidance documents are due on September 9, 2024. Comments responding to FDA’s Request for Comments on its pre-market animal food review programs are due December 9, 2024. FDA also plans to hold stakeholder listening sessions regarding the questions raised in the Request for Comments. We will continue to monitor these changes to FDA’s animal feed ingredient review processes. Please reach out to us with any questions.

Authored by Martin Hahn, Maile Gradison, and Connie Potter.

References

1 See FDA, FDA Releases Two Draft Guidances, Seeks Public Comment on Pre-market Animal Food Ingredient Review Programs (Aug. 8, 2024).

2 See FDA, Ingredients & Additives (accessed August 14, 2024), (“[M]any of the ingredients in the AAFCO Official Publication are not approved food additives and may not meet the criteria needed to be recognized as GRAS for a use (21 CFR 570.30). Nevertheless, FDA has accepted the listing of ingredients in the AAFCO Official Publication for their marketing in interstate commerce, provided there are no apparent safety concerns about the use or composition of the ingredient.”).

3 See AAFCO, Guide to Submitting New or Modified Ingredient Definitions to AAFCO (Jan. 21, 2020).

4 See FDA,  MOU 225-07-7001, “Memorandum of Understanding between the United States Food and Drug Administration and the Association of American Feed Control Officials” (June 2019).

5 FDA, FDA Releases Two Draft Guidances, Seeks Public Comment on Pre-market Animal Food Ingredient Review Programs (Aug. 8, 2024).

6 See Loper Bright Enterprises v. Secretary of Commerce, No. 22-451, slip op. (U.S. 2024).

7 FDA, Pre-Market Animal Food Ingredient Review Programs; Request for Comments, 89 Fed. Reg. 65363 (Aug. 9, 2024).

8 See FDA, FDA Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Draft Guidance for Industry, 89 Fed. Reg. 65294 (Aug. 9, 2024).

9 See FDA, Animal Food Ingredient Consultation; Draft Guidance for Industry; Availability, 89 Fed. Reg. 65368 (Aug. 9, 2024).