The US Food and Drug Administration (FDA) has introduced new guidance, GFI #294, providing a structured framework for animal food ingredient innovators to consult with the agency. This initiative aims to ensure ingredient safety standards are met prior to market entry, according to the American Feed Industry Association (AFIA).
The guidance marks a significant shift in regulatory pathways, replacing the decades-long FDA-Association of American Feed Control Officials (AAFCO) process, which officially ended on October 1, 2024. This pathway had been one of the three primary regulatory routes for bringing safe ingredients to market, and the most utilized by ingredient suppliers.
“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,” said the AFIA.
Under the new Animal Food Ingredient Consultation (AFIC) process described in GFI #294, the FDA plans to conduct voluntary consultations with firms developing animal food ingredients. This initiative will be in place while the agency evaluates its existing Food Additive Petition (FAP) and Generally Recognized as Safe (GRAS) Notification programs.
The AFIC process is designed to accommodate animal food ingredient producers that 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,” the AFIA reported.
AFIA CEO Constance Cullman praised the guidance as “a step forward,” highlighting that it reflects several of the trade association’s recommendations.
“We will work 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 our members’ input, 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 faster,” Cullman added.
The new guidance, GFI #294, introduced by the US Food and Drug Administration (FDA), represents a significant shift in regulatory pathways for animal food ingredient innovators. This initiative, known as the Animal Food Ingredient Consultation (AFIC) process, aims to streamline the process of bringing safe ingredients to market and ensure that ingredient safety standards are met prior to entry into the market.
The AFIC program provides a structured framework for firms developing animal food ingredients to voluntarily consult with the FDA. This program replaces the previous FDA-Association of American Feed Control Officials (AAFCO) process, which officially ended on October 1, 2024. The AFIC process is designed to minimize delays, reduce potential gaps in ingredient reviews, and establish consistent standards to prevent market disruptions.
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. This new approach reflects several recommendations made by the American Feed Industry Association (AFIA) and is seen as a positive step forward by AFIA CEO Constance Cullman.
In conclusion, the introduction of the AFIC program and GFI #294 by the FDA represents a proactive approach to ensuring the safety and quality of animal food ingredients in the market. By providing a structured framework for consultation and data submission, the FDA aims to streamline the process of bringing safe ingredients to market and prevent potential disruptions. This new guidance is a positive development for the animal food industry and demonstrates the FDA’s commitment to ensuring the safety and quality of animal food ingredients.