FDA to End MOU with AAFCO – Impact on Animal Food Ingredient Review

The Food and Drug Administration (FDA) is ending its 17-year memorandum of understanding (MOU) with the Association of American Feed Control Officials (AAFCO). The MOU, which memorialized the collaboration between FDA and AAFCO for the review and publication of definitions for animal food and feed ingredients, will expire on October 1, 2024, and will not be renewed.

Under the MOU, FDA’s Center for Veterinary Medicine (CVM) provided scientific and technical assistance by reviewing feed ingredients for safety and suitability prior to AAFCO adopting new feed ingredient definitions or amending existing definitions in its Official Publication (OP). When the MOU expires, FDA will no longer provide this scientific review. However, FDA has stated that it is working with industry and state regulators to ensure a smooth transition and will continue to participate in AAFCO meetings, with the ultimate goal of achieving an effective animal food regulatory system.

Draft Guidance Documents

On August 8, 2024, FDA released two draft guidance documents, described below, setting forth the Agency’s enforcement policy related to existing AAFCO ingredient definitions and an interim Animal Food Ingredient Consultation (AFIC) process.

Guidance for Industry (GFI) #293: FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients

• Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA has authority to regulate substances used in animal food. These substances must be either an approved animal food additive or generally recognized as safe (GRAS). 
• Approved animal food additives are listed in 21 CFR Parts 573 and 579. In addition, substances that FDA has affirmed as GRAS for their intended use in animal food are listed in 21 CFR Parts 582 and 584. Further, GRAS positions can also be submitted to FDA CVM’s GRAS Notification program.  
• AAFCO has maintained in its OP a comprehensive list of animal food ingredients, including:
  • FDA-approved additives and substances affirmed as GRAS; 
  • Substances subject to GRAS notices that have received “no objection letters” from FDA; and 
  • Definitions established through the AAFCO ingredient definition request process outlined in the MOU.
• Because FDA has reviewed many of the ingredients under the MOU, FDA intends to exercise enforcement discretion with respect to ingredients listed in the 2024 AAFCO OP that are not approved animal food additives. Specifically, FDA does not intend to initiate enforcement if:
  • The ingredient has an established common or usual name and definition in the 2024 AAFCO OP; 
  • The ingredient is used according to the intended use, specifications, and limitations listed in the 2024 AAFCO OP or in accordance with good manufacturing practices (GMPs) if the definition contains no specifications or limitations; and 
  • FDA has no questions or concerns about the safety of the ingredient. 
• FDA CVM also acknowledges in this draft guidance that the names of ingredients defined by AAFCO and listed in its OP may be considered common usage names, which is a basis for a common or usual name. FDA generally does not intend to initiate enforcement action with respect to use of the name for an ingredient included in the “Official Common or Usual Names and Definitions of Feed Ingredients” section of chapter six of the 2024 AAFCO OP on an animal food label unless use of the name causes the label to be false or misleading. 

GFI #294: Animal Food Ingredient Consultation (AFIC) 

• AFIC is FDA’s interim process for the assessment of animal food ingredients while the Agency evaluates the Food Additive Petition and GRAS Notification programs. 
• Firms may use the interim AFIC when developing animal food ingredients for which they previously would have used the AAFCO ingredient definition process. 
• Firms should submit the following information about the ingredient to FDA:
  • firm and contact person 
  • summary of the request (explain purpose of request, summarize rationale) 
  • description of the ingredient (chemical/botanical name, composition, physical/biological/chemical properties) 
  • manufacturing information (description of manufacturing, formulations, batch analysis, stability information, methods) 
  • purpose of the ingredient (describe intended use and intended target species), including data to support intended use 
  • safety assessment (narrative summarizing cited safety studies and exposure assessment), including: target animal safety (including use limitation, if applicable) and human food safety (if applicable) 
  • statement of environmental risk
  • copies of cited literature and reports 
  • proposed labeling
  • any other information considered relevant by the firm.
• The Agency will then post inventories of pending and completed AFICs in an inventory on its website, allow stakeholder input, and issue a letter summarizing whether FDA has questions about the ingredient’s safe use. 
• FDA will exercise enforcement discretion with respect to ingredients that have been reviewed and received a “consultation complete” letter. 
• We note that the interim AFIC consultation program bears some resemblance to the consultations and letters of opinion that were used prior to the implementation of the Animal GRAS Notification Program at CVM.  

AAFCO Response

In response to FDA’s announcement of the end of the MOU, AAFCO issued a statement that it will continue its “work to provide standardization to the food industry.” At AAFCO’s 2024 Annual Meeting, the Association passed two resolutions to review ingredients recommended under AFIC for inclusion in the OP, potentially recognize an “alternate” expert panel for scientific review of new animal food ingredients, and continue to lead new ingredient definitions through the Ingredient Definitions Committee. AAFCO is exploring these options and how to implement them; for example, the new scientific review panel could be a university. AAFCO Feed Definitions in Chapter 6 of the OP are available to the public on its website to “advance transparency and encourage consumer education.”

Next Steps

Keller and Heckman is closely monitoring this transition. FDA is accepting electronic and written comments on the two draft guidance documents until September 9, 2024, and will host listening sessions to hear from stakeholders about the pre-market animal food review programs.

In addition, FDA has issued a Request for Comments (RFC) on FDA’s pre-market animal food review programs, with comments due by December 9, 2024. FDA is asking for comments on the following questions: 

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?

Given the significant shift in the regulatory review of a broad range of feed ingredients and inputs following the sunsetting of the MOU, we strongly encourage industry to participate in the notice and comment procedure to help shape a risk-based and efficient animal food ingredient review program at FDA. In addition to monitoring, we are available to assist in preparing and submitting comments.