USA – The U.S. Food and Drug Administration (FDA) has unveiled a comprehensive set of documents outlining the transition process after the expiration of its long-standing Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO). 

The MOU, which has governed the definition of animal feed ingredients for the past 17 years, will expire on October 1, marking the end of an era of close collaboration between the two organizations.

The agreement had been instrumental in facilitating the FDA’s provision of scientific and technical assistance to AAFCO, particularly in including ingredients in the AAFCO Official Publication (OP). 

Despite the expiration of the MOU, the FDA emphasized that AAFCO remains a vital partner in the agency’s ongoing efforts to ensure the safety of the animal food supply. 

“Although the MOU is expiring, AAFCO remains an important partner to the FDA. The FDA will continue to work closely with AAFCO and state regulatory partners to help ensure the safety of the animal food supply,”  the agency stated in an August 8 press release. 

Call for public comments and new guidance drafts

In preparation for the post-MOU era, the FDA has requested public comments on two draft guidance documents, GFI #293 and GFI #294, which outline the FDA’s enforcement policies and consultation processes for animal food ingredients. 

The agency seeks stakeholder input to help determine what changes, if any, may be necessary to improve the regulatory pathway for new animal food ingredients and better serve public health.

The FDA will accept comments on these drafts until September 9, starting on August 9. Given the time-sensitive nature of the guidance, the agency has indicated that it does not plan to extend the 30-day comment period, underscoring the urgency of the transition.

Draft GFI #293 clarifies the FDA’s enforcement policy following the expiration of the MOU. 

The document states that the FDA generally does not intend to initiate enforcement actions against the interstate marketing of animal food ingredients that are not approved as food additives or recognized as safe (GRAS) for their intended use, provided these ingredients are listed in the 2024 AAFCO OP and do not raise safety concerns.

Additionally, the draft guidance notes that the FDA would not take enforcement action against using animal food ingredient names that are not common or usual but are defined in the AAFCO OP, provided that using these names does not result in false or misleading labelling.

On the other hand, draft GFI #294 introduces an interim Animal Food Ingredient Consultation (AFIC) process, offering an alternative route for firms to engage with the FDA regarding new animal food ingredients. 

This process is designed to fill the gap left by the MOU’s expiration, allowing the FDA to review information from developers and the public about new ingredients and related safety concerns. 

Under this process, the FDA would generally refrain from taking enforcement action against an ingredient that has received a “consultation complete” letter as long as the ingredient is used per the terms specified in the letter and there are no ongoing safety issues.

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