USA – The US Food and Drug Administration (FDA) and the Association of American Feed Control Officials (AAFCO) have terminated their longstanding relationship for the review of new animal food ingredients.
The 17-year-old Memorandum of Understanding (MOU) between the two organizations will expire on October 1, 2024, and will not be renewed.
The MOU was established to delineate the responsibilities of both the FDA and AAFCO during the feed ingredient definition request process, providing mechanisms for resolving disputes and modifying definitions when necessary.
Despite the end of this formal agreement, the FDA has stated that its relationship with AAFCO will continue to evolve.
The agency will remain active in AAFCO committees and meetings, working closely with AAFCO and state authorities to ensure the safety of the animal food supply.
The expiration of the MOU is seen as an opportunity for the FDA to thoroughly evaluate and adapt its pre-market animal food review programs to serve public health and stakeholders’ needs better.
Austin Therrell, executive director of AAFCO, indicated that the FDA decided not to renew the MOU. Post-October 1, US feed ingredient manufacturers interested in gaining approval for new ingredients will need to use the existing food additive petition process, the GRAS notice program, or the FDA’s new interim animal food process, bypassing the AAFCO ingredient definition committee (IDC) process.
Therrell noted that AAFCO had been aware of the FDA’s ongoing evaluation of its programs and practices. He emphasized that both organizations develop plans to ensure a seamless transition and avoid unintended consequences.
The American Feed Industry Association (AFIA) expressed disappointment over the MOU’s dissolution, highlighting its efficiency, predictability, and functionality.
Feed associations express disapproval
AFIA’s CEO, Constance Cullman, voiced concerns that the increased uncertainty in regulatory review processes could make the US animal ingredient marketplace less attractive for innovators.
The current approval process, which averages three to five years and costs around US$600,000 per ingredient, could face further delays and increased costs.
The National Grain and Feed Association (NGFA) and AFIA have strongly supported the FDA/AAFCO partnership.
David Fairfield, senior vice president of feed at NGFA, emphasized that the ingredient definition process utilized federal and state expertise along with stakeholder input to ensure the safety and utility of ingredients.
“FDA’s participation within the AAFCO process has been effective and yielded a comprehensive list of ingredients that promote a common understanding and acceptance within the industry, FDA and state regulators, consumers, and global trade partners. The process also provided harmonization between state and federal regulatory authorities, which is vital,” Fairfield said.
Nevertheless, both the FDA and AAFCO assured stakeholders of a smooth transition. As details are finalized in the coming weeks, further updates on the transition plan will be released.
Therrell reaffirmed AAFCO’s commitment to working closely with the FDA and state regulatory bodies to streamline the approval process for new products while maintaining standardization and safety in the animal food industry.
AAFCO will cease accepting new feed ingredient definition requests on September 1 to allow sufficient time for processing final submissions to the FDA before the October expiration.
The AFIA and NGFA remain dedicated to working with both AAFCO and the FDA to ensure that any changes to the review processes are clear, timely, and consistent across state and federal jurisdictions, supporting the continued innovation and safety of the US animal food industry.
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