The Association of American Feed Control Officials (AAFCO) and the US Food and Drug Administration (FDA) announced on August 2, 2024 that their long-standing Memorandum of Understanding (MOU) governing the development and review of definitions of animal feed ingredients will not be renewed once it expires on October 1, 2024. FDA described AAFCO and its relationship as “evolving” rather than “ending” and noted in a Letter to Stakeholders that FDA will continue to work closely with AAFCO and state authorities “to help ensure the safety of the animal food supply.”
FDA-AAFCO Long-Standing Relationship
AAFCO maintains the AAFCO Official Publication, which contains a comprehensive list of animal food ingredients and includes definitions established through the AAFCO ingredient definition request process. Most states have adopted the ingredient definitions listed in the AAFCO Official Publication, and the AAFCO ingredient definition request process facilitates and expedites the marketing of animal food ingredients under state laws. MOU-225-07-7001 was signed by AAFCO and FDA in 2007, clarifying the organizations’ responsibilities with respect to AAFCO’s ingredient definition request process.
Under the MOU, the ingredient definition request process is operated by AAFCO with scientific and technical review and consultation from FDA. AAFCO provides the ingredient definition request process in order to identify the safety, utility, and identity of ingredients used in animal feed and established common or usual names for ingredients, which must be displayed on feed labels under federal and state laws. The MOU provides mechanisms for resolving disputes related to defining animal feed ingredients and for modifying the definitions when necessary.
Importantly, under the MOU, AAFCO agreed to seek advice and FDA concurrence regarding the suitability of a feed ingredient for its proposed use prior to adopting new feed ingredient definitions or amending existing definitions. The AAFCO process was seen as a faster path to FDA’s Generally Recognized as Safe (GRAS) process and often addressed product claims on which FDA would not opine (e.g., human-grade food).
What Is Changing?
With the expiring MOU, AAFCO will stop accepting new feed ingredient definition requests on September 1, 2024 in order to allow sufficient time to process and submit all requests to FDA prior to the MOU’s expiration on October 1.
FDA’s letter to end the MOU describes the expiration of the MOU as an opportunity for the agency to thoroughly evaluate its pre-market animal food review programs. As part of the upcoming transition, FDA issued a Request for Comments (RFC) seeking public input regarding the Food Additive Petition and GRAS Notification programs to determine if changes are needed to promote their efficiency. The agency also issued two draft guidance documents relating to FDA’s enforcement policy for AAFCO-defined animal feed ingredients and agency consultation for animal food ingredients.
In its draft guidance setting forth its enforcement policy for AAFCO-defined animal feed ingredients, FDA states that it does not intend to initiate enforcement action with respect to the food additive approval requirements of the Federal Food, Drug, and Cosmetic Act for the ingredients, or animal food containing the ingredients, that are listed in the Official Common or Usual Names and Definitions of Feed Ingredients section of the AAFCO 2024 Official Publication. The agency notes that it has reviewed many of these ingredients through its participation of the AAFCO ingredient definition request process.
Further, for ingredients listed in the 2024 AAFCO Official Publication that are not approved food additives or GRAS and that FDA did not review as part of the AAFCO ingredient definition request process, the agency notes that it is not aware of any safety concerns that would cause it to request that an ingredient be withdrawn from the AAFCO Official Publication.
As part of its evaluation of its animal Food Additive Petition and GRAS Notification programs, FDA is proposing to conduct consultations with firms developing animal food ingredients through the Animal Food Ingredient Consultation (AFIC) process. In its draft guidance on the AFIC process, FDA describes a process for firms to engage with the agency regarding ingredients for which firms may have otherwise used the AAFCO ingredient definition process. AFIC is intended to be an interim process that will begin sometime after the expiration of the FDA’s MOU with AAFCO. The AFIC process includes opportunities for public awareness of and input on the ingredients for which the FDA is providing consultation.
Looking Ahead
FDA’s decision to allow the MOU to expire is likely to draw industry criticism. According to a statement by the American Feed Industry Association, approvals for new feed ingredients have historically taken an average of three to five years and $600,000 per ingredient. FDA’s decision to change the approval process creates uncertainty as to how—and how fast—the agency intends to review new ingredients. It is also unclear how state regulators may approach changes to the approval process.
FDA will accept comments on its pre-market animal food ingredient review programs until December 9, 2024. FDA seeks input on the following questions:
- What do you perceive as barriers and/or benefits to pursuing a Food Additive Petition or GRAS Notification?
- 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?
- 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?
- 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?
- What review process for proposed animal food ingredients would best enable FDA to review their safety?
- 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?
Comments can be submitted through Docket No. FDA-2024-N-2979.