Food and Drug Administration Animal Food Ingredient Consultation; Guidance for Industry; Availability
Published Date: 1/7/2025
Notice
Summary
The FDA just rolled out a new way for companies making animal food ingredients to check in with them, called the Animal Food Ingredient Consultation (AFIC). This replaces the old process with AAFCO, which ended in October 2024, and helps spot safety issues early while keeping the public in the loop. If you’re in the animal feed business, this means new steps to follow, but no extra fees—just smarter safety checks starting now!
Analyzed Economic Effects
5 provisions identified: 2 benefits, 2 costs, 1 mixed.
AFIC replaces AAFCO engagement
If you make animal food ingredients, FDA is using a new Animal Food Ingredient Consultation (AFIC) process now that the AAFCO Memorandum of Understanding expired on October 1, 2024. AFIC provides an additional way to engage with FDA for any ingredient you might previously have used the AAFCO ingredient definition process for.
Enforcement policy for AFIC-assessed ingredients
The guidance describes FDA's enforcement policy for certain ingredients that are assessed using the AFIC process. If you develop ingredients evaluated via AFIC, FDA's described enforcement approach will apply to those ingredients.
Public awareness and comment opportunity
AFIC consultations let the public see and comment on proposed animal food ingredients through the docket system. FDA says AFIC will allow public awareness of and input on such ingredients and provides docket instructions for submitting comments.
Paperwork and OMB approval for AFIC
FDA says AFIC includes information collection recommendations that are subject to Office of Management and Budget (OMB) approval and that FDA will implement those recommendations only after OMB approval and after announcing that approval in the Federal Register. FDA published a separate PRA notice on December 19, 2024, inviting comment on revising information collections to explicitly discuss AFIC.
What to include in AFIC submissions
FDA revised the guidance to say you should include a proposed ingredient name and definition in AFIC consultations, that firms should not resubmit information already provided to FDA, and that FDA removed a prior recommendation to submit a statement of environmental risk. The guidance also clarifies what information commenters should include when commenting on pending AFICs through the docket.
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