SILVER SPRING, MD. — The US Food and Drug Administration (FDA) released its finalized Guidance for Industry (GFI) #293, called “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients,” on Oct. 23. 

This new guidance follows the expiration of the Memorandum of Understanding (MOU) between the FDA and the Association of American Feed Control Officials. At the beginning of August, the organizations announced the MOU would not be renewed upon its expiration on Oct. 1. Following this, the FDA released drafts of GFI #293 and #294, asking for stakeholder comments. 

GIF #293 describes how the FDA will handle enforcement action on ingredients that are not approved as food additives under the Federal Food, Drug, and Cosmetic Act (FD&C Act), but are included in the 2024 AAFCO Official Publication.

The FDA currently has authority under the FD&C Act to regulate substances in animal foods. Under the act, companies must submit an animal food petition to support premarket approval, allowing the additive to be legally marketed and used and considered safe. Otherwise, the animal food additive is considered unsafe. Additionally, the FDA has affirmed certain substances as generally recognized as safe (GRAS), which does not require premarket review and approval. 

The problem arises when considering ingredients that are not approved additives under the FD&C Act requirements nor are they GRAS, but they are included in the AAFCO Official Publication. GFI #293 seeks to address this potential issue. 

Under GFI #293, the FDA does not intend to initiate enforcement action regarding the food additive approval requirements under the FD&C Act for ingredients that are not approved food additives or GRAS, but are listed in the 2024 AAFCO Official Publication. 

“We have reviewed many of these ingredients through our participation in the AAFCO ingredient definition request process and recommended that the ingredient definitions, including specifications for use, be added to the AAFCO Official Publication,” the FDA stated. “For those ingredients listed in the 2024 AAFCO Official Publication that are not approved food additives or GRAS and that we did not review as part of the AAFCO ingredient definition request process, at this time, we are not aware of any safety concerns that would cause us to request that an ingredient be withdrawn from the AAFCO Official Publication, and many have a long history of use in animal food.”

Additionally, the FDA anticipates that GFI #293 may help minimize disruption or shortages of ingredients that have been commonly used in animal foods for years. 

“This approach would allow us to focus our resources on reviewing new ingredients before they are marketed and addressing unsafe ingredients in the marketplace,” the FDA stated.

The American Feed Industry Association (AFIA) thanked the FDA upon the release of the finalized policy. According to the AFIA, without the GFI #293, the use of hundreds of animal feed and pet food ingredients could have been at risk within the United States. 

“We are encouraged by the FDA Center for Veterinary Medicine’s (CVM) decision to formally recognize the safety of hundreds of AAFCO-defined animal food ingredients, ensuring there is no question about their ability to be used or marketed within the United States and internationally,” said Constance Cullman, president and chief executive officer of the AFIA. “This decision is crucial for maintaining stability and confidence in our regulatory system, especially after the FDA recently ended its longstanding partnership with AAFCO on the review of new animal food ingredients.

“Before moving forward, we will encourage the agency to accept the last ingredients completing their reviews under the prior FDA-AAFCO MOU, which will be listed in future editions of the AAFCO Official Publication,” she added. “Our members are also engaged in providing the FDA feedback on its additional efforts to modernize the existing and proposed regulatory review systems so that animal food ingredient innovators can not only bring their products to the US marketplace in a timely, efficient manner but compete with our competitors’ modernized regulatory systems.”

Read more about this policy in the FDA’s GFI #293. 

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