FDA Finalizes Animal Feed Ingredients Enforcement Policy Guide

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FDA Finalizes New Enforcement Policy for Animal Feed Ingredients; AAFCO Proposes Expert Panel Ingredient Review Process at K-State Olathe

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Thursday, October 31, 2024

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On October 23, 2024, The US Food and Drug Administration (FDA) finalized its guidance document on its enforcement policy for animal feed ingredients, following the sunsetting of FDA’s longstanding Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) addressing the review of animal food definitions listed in AAFCO’s Official Publication (OP).
The Association of American Feed Control Officials (AAFCO) is a voluntary organization that guides regulators and has long maintained a list of animal food ingredients and definitions. Every state, except Alaska, has some version of the AAFCO model bill and regulations codified under their respective state laws. Historically, FDA participated in the AAFCO ingredient definition request process by providing scientific and technical assistance to AAFCO. In 2007, FDA and AAFCO entered into an MOU to collaborate on animal ingredient definitions to be listed in the AAFCO Official Publication. However, the MOU expired in October 2024 and was not renewed.
FDA’s guidance document states that the agency does not plan to initiate enforcement actions related to feed ingredients listed in AAFCO’s official Common or Usual Names and Definitions of Feed Ingredients section of chapter six of the AAFCO 2024 OP. FDA does not plan to initiate action if the ingredient is not an approved animal food additive or GRAS, so long as the ingredient:
- (1) Is included in the Official Common or Usual Names and Definitions of Feed Ingredients section of chapter six of the 2024 AAFCO OP;
- (2) Is used according to its intended use, specifications, and limitations listed in the 2024 AAFO OP; and
- (3) FDA has no questions or concerns about the safety of the ingredients.
The agency is currently accepting comments on the guidance submitted to the docket. Please reach out to Keller and Heckman if you would like assistance in submitting a comment to the Agency
Separately, AAFCO announced that it is considering a proposal from Kansas State University’s K-State Olathe Innovation Campus (K-State Olathe) to provide the scientific review for its new animal food ingredient submission pathway. This proposed pathway would replace AAFCO’s former Ingredient Definition Request process that sunset on October 1, 2024, following the expiration of AAFCO’s MOU with FDA.