close
close

FDA seeks comments on draft guidance for ingredient review procedures


FDA seeks comments on draft guidance for ingredient review procedures

SILVER SPRING, MD. — Following news that the Memorandum of Understanding (MOU) between the U.S. Food and Drug Administration (FDA) and the Association of American Feed Control Officials (AAFCO) will not be renewed after its expiration in October of this year, the FDA released a series of documents on August 8 regarding its transition plans.

Under the MOU, FDA has provided scientific and technical assistance to AAFCO in reviewing animal feed and pet food ingredients and has helped AAFCO determine whether certain ingredients should be included in AAFCO’s official publication. Although FDA has decided not to renew the MOU, the agency plans to continue working closely with AAFCO and state regulators to ensure the food safety of pet food, according to the agency.

With the MOU soon expiring and the ingredient review process pending, FDA has created guidance and is seeking public input on its premarket pet food review procedures.

Currently, to be legally marketed, an ingredient in animal feed must be the subject of an FDA-approved application for approval as an animal feed additive (FAP) or be generally recognized as safe (GRAS). The agency is now seeking industry input on the FAP and GRAS programs to determine if changes are needed to ensure food safety and improve the ingredients’ path to market. Stakeholders can submit their comments until December 9.

In addition, the agency has issued two draft Guidance for Industry (GFIs) on animal feed ingredients: GFI No. 293, entitled “FDA Enforcement Guidance on AAFCO-Defined Animal Feed Ingredients,” and GFI No. 294, entitled “Advisory on Animal Food Ingredient (AFIC).”

GFI #293 explains that FDA does not intend to take enforcement action against the interstate marketing of pet food ingredients that are not approved as additives or under GRAS but are listed in the ingredient definitions chapter of the official AAFCO publication in 2024. The agency also does not intend to enforce the use of ingredient names that are not common or customary but are defined in the official AAFCO publication unless the name is false or misleading.

GFI #294 describes an interim AFIC process that would allow companies to consult with FDA about an ingredient review process that might otherwise have been used with AAFCO. In addition to the FAP and GRAS programs, this AFIC process would provide another opportunity for companies to consult with FDA about new ingredients and would allow FDA to review information from developers and the public about any safety concerns with the ingredients. The AFIC would also provide the public with an opportunity to provide comments on the consulted ingredients.

The FDA is currently accepting comments from stakeholders on these GFIs through September 9.

Learn more about FDA guidance on animal feed ingredient review programs.

More informationregulatory news affecting the pet food marketvisit our Regulation page.

Leave a Reply

Your email address will not be published. Required fields are marked *