This regulatory change will replace the decades-long FDA-AAFCO pathway, which ended Oct. 1, 2024, removing one of the industry’s three primary regulatory pathways—and the one most used by ingredient innovators—for bringing safe ingredients to market. FDA’s purported 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.
The final GFI 294 offers a structured pathway for ingredient innovators to consult with the FDA, ensuring that ingredient safety standards are met prior to market entry. Through the AFIC program, animal food innovators will have the opportunity to engage with the FDA to provide data demonstrating ingredient safety. This guidance also clearly specifies submission requirements, including the type of data needed for FDA evaluation, and details the FDA’s role in assessing this information, addressing industry’s concerns. |