The US Food and Drug Administration (FDA) has recently introduced new guidance, GFI #294, aimed at providing a structured framework for animal food ingredient innovators to consult with the agency. This initiative is designed to ensure that ingredient safety standards are met prior to market entry, according to the American Feed Industry Association (AFIA).

This new guidance represents a significant shift in regulatory pathways, as it replaces the long-standing FDA-Association of American Feed Control Officials (AAFCO) process, which officially came to an end on October 1, 2024. The FDA-AAFCO process had been one of the primary regulatory routes for bringing safe ingredients to market, and was the most commonly utilized by ingredient suppliers.

The AFIA stated, “FDA’s goal for the AFIC program is to minimize delays in bringing safe ingredients to market, reduce potential gaps in ingredient reviews, and establish consistent standards to prevent market disruptions.”

Under the new Animal Food Ingredient Consultation (AFIC) process outlined in GFI #294, the FDA will conduct voluntary consultations with firms that are developing animal food ingredients. This program will operate alongside the agency’s evaluation of its existing Food Additive Petition (FAP) and Generally Recognized as Safe (GRAS) Notification programs.

The AFIC process is specifically designed to accommodate animal food ingredient producers who would have previously gone through the AAFCO ingredient definition process before the expiration of the FDA-AAFCO Memorandum of Understanding (MOU).

“Through the AFIC program, animal food innovators will have the opportunity to engage with the FDA to provide data demonstrating ingredient safety. The guidance outlines submission requirements, detailing the type of data needed for FDA evaluation and clarifying the FDA’s role in assessing this information,” reported the AFIA.

AFIA CEO Constance Cullman commended the guidance as “a step forward,” noting that it aligns with several of the trade association’s recommendations.

“We will collaborate closely with the FDA to ensure that this program is efficient, inclusive, and capable of accommodating the diversity of ingredients essential to animal nutrition. With input from our members, we will continue to advocate for a streamlined and adaptable approach, allowing the industry to innovate and bring safe, high-quality ingredients to the market more quickly,” Cullman added.

In conclusion, the introduction of the new guidance, GFI #294, by the FDA represents a significant development in the regulation of animal food ingredients. This structured framework aims to ensure that ingredient safety standards are met before market entry, providing a more efficient and consistent process for bringing safe ingredients to market. The AFIA and its members are committed to working closely with the FDA to support the implementation of this program and advocate for a streamlined and adaptable approach that promotes innovation and the availability of safe, high-quality ingredients for animal nutrition.