On August 2, 2024, the Association of American Feed Control Officials (“AAFCO”) announced that its Memorandum of Understanding 225-07-7001 (the “MOU”) with the U.S. Food and Drug Administration (“FDA”) outlining the AAFCO ingredient review process would not be renewed on October 1, 2024 when the MOU is set to expire. The MOU, which has been in effect for the last 17 years, established guidelines by which AAFCO reviews the safety and efficacy of new animal feed ingredients under the guidance of FDA.
Under federal regulations, the FDA maintains primary authority for the regulation of animal foods and feeds. The federal Food, Drug, and Cosmetic Act (“FDCA”) provides FDA with the authority to regulate all ingredients or additives used in animal feed. AAFCO, a non-profit, voluntary, industry organization, was originally established to create uniform standards and enforcement mechanisms across the animal food industry that would regulate the manufacture, labeling and sale of animal food products. AAFCO membership is largely comprised of federal government agencies, states in the U.S., and governments from other countries that enforce all aspects of the production and sale of animal food products. As part of its mission to guide industry actors to provide health and safety standards for animal feed products, AAFCO provides “model laws” for feed control programs that have been adopted by nearly every state.
Additionally, AAFCO also provides a process whereby the organization will review the safety, utility, and identity of novel ingredients used in animal feed (the “AAFCO Ingredient Definition Request Process”). If an ingredient is determined to be safe and effective during this review, AAFCO will include a definition of the ingredient in its Official Publication (the “AAFCO OP”). This definition includes the common ingredient name, description, and any appropriate limitations for its use so that both the production and labeling of the product are standardized across the industry. While AAFCO does operate and administer this program, FDA remains involved in the process providing scientific and technical assistance in the review of the ingredients and approving of AAFCO’s final determinations through a letter of concurrence.
Currently, there are three primary regulatory pathways in the U.S. to introduce a novel feed ingredient in animal foods in the U.S.:
- The food additive must be provided a definition through an AAFCO Ingredient Definition Request;
- The ingredient must be submitted and approved by FDA through a food additive petition; or
- The ingredient must be submitted through FDA’s voluntary generally recognized as safe (“GRAS”) notification.
FDA has stated that it will continue to accept AAFCO Feed Ingredient Definition requests until the MOU expires on October 1. However, AAFCO investigators require at least thirty days to prepare ingredient definition requests for the FDA. Thus, any industry groups intending to submit an animal food ingredient though this process will need to submit their request to AAFCO by September 1.
In FDA’s Letter to Stakeholders, FDA stated that it intends to publish a Request for Comments (“RFC” ) for industry to solicit comments to help FDA re-evaluate its pre-market programs for animal foods. Additionally, FDA confirmed that the agency intends to issue two draft guidance documents to aid in the transition phase: Draft GFI #293: FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients; and Draft GFI #294: Animal Food Ingredient Consultation (AFIC).
While FDA appears to be considering many options as it reformulates its pre-market approval processes, industry as a whole will be facing a prolonged lapse in regulatory approvals for novel animal feed ingredients come October 1. Without the AAFCO Ingredient Definition Request Process, industry will be required to pursue the more costly and time-consuming process of applying for a food additive petition with the FDA or submitting a GRAS notification. Ultimately, manufacturers and producers of animal food and feed products may see a decline in innovation given the now increased timeline for bringing a new food ingredient to market.
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Husch Blackwell has significant experience advising animal feed manufacturers on FDA regulations, including those involving product labeling, formulation, and manufacturing requirements. Our FDA lawyers have the required scientific and technical backgrounds to assist companies with understanding requirements for product labeling and proposing changes that will be advantageous for their business. Contact Emily Lyons or your Husch Blackwell attorney for more details.