Two New Regulatory Pathways for Approval of Innovative Feed Ingredients

In October 2024, we wrote about the end of the memorandum of understanding (MOU) between the Food and Drug Administration (FDA) and the Association of American Feed Control Officials (AAFCO) in regard to their review of new animal food ingredients. At the time, the American Feed Industry Association (AFIA) was concerned that the end of the relationship between the FDA and AAFCO could raise costs and delay the approval of new animal food ingredients, making the U.S. market less attractive for innovators. However, the recent FDA release of a final guidance for industry and a new AAFCO regulatory pathway currently under scientific review have addressed some of those concerns.

Three Pathways for FDA Review of Animal Food Ingredients

According to the FDA guidance, the new process entitled “Animal Food Ingredient Consultation (AFIC)” provides an additional way for ingredient innovators to work with the FDA for ingredients that may have otherwise used the AAFCO Ingredient Definition Request process. The FDA is also evaluating the Food Additive Petition and Generally Recognized As Safe (GRAS) Notification programs to determine if changes are needed to improve the efficiency of new animal food ingredient development and review.

AFIA was pleased to see the establishment of the AFIC framework and provision of an alternative pathway for ingredient innovators — especially since the FDA-AAFCO pathway was the one most used by innovators for bringing safe ingredients to market.

The final FDA guidance provides instructions for companies who would like to participate in the AFIC process. The guidance details that the AFIC process will:

• Help the FDA be aware of new ingredients that are marketed in interstate commerce and any potential safety concerns associated with them
• Provide a baseline of safety information available about an ingredient
• Give the FDA an opportunity to discuss any potential safety concerns
• Allow for public awareness of and input on ingredients for which the FDA is providing consultation

AAFCO Proposes a Replacement to the Ingredient Definition Request Pathway

AAFCO membership recently approved a proposal from Kansas State University’s Olathe Innovation Campus to provide scientific review for a new animal food ingredient submission pathway after the Ingredient Definition Request ended when the FDA MOU ended.

The new pathway will include scientific review by a panel of subject matter experts from U.S. universities as well as independent consultants who will evaluate potential ingredient submissions and provide recommendations to AAFCO membership for approval. According to the AAFCO press release, the new pathway is intended to complement the FDA’s current GRAS Notice program and is another option for bringing new and innovative products to market.

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