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GUIDANCE DOCUMENT

CVM GFI #294 - Animal Food Ingredient Consultation (AFIC) January 2025

Final
Docket Number:
FDA-2024-D-2978
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the authority to regulate substances used in animal food, including substances that are food additives and substances that are generally recognized as safe (GRAS) for their intended uses in food.

The Association of American Feed Control Officials (AAFCO) maintains the AAFCO Official Publication, which contains, among other things, a comprehensive list of animal food ingredients, including FDA-approved animal food additives, substances that are GRAS for a use, and animal food ingredient definitions established through the AAFCO Ingredient Definition Request Process. In 2007, FDA entered into an MOU with AAFCO that outlined how FDA would provide its scientific and technical expertise to AAFCO in reviewing ingredient definitions requested by industry or AAFCO. This MOU was renewed and revised several times. The MOU 225-07-7001 expired on October 1, 2024.

FDA is evaluating its animal Food Additive Petition and GRAS Notification programs to determine if changes are needed to promote the efficient development and review of new animal food ingredients.  AFIC will provide an additional way for firms to consult with the FDA regarding animal food ingredients and for the FDA to review the safety of such ingredients to help support firms developing animal food ingredients which may have otherwise utilized the AAFCO ingredient definition process. The AFIC process will also allow for public awareness of and input on such ingredients. In addition, this guidance describes FDA’s enforcement policy for certain ingredients assessed using the AFIC process.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-2978.

Questions?

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CVM
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Food and Drug Administration
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Rockville, MD 20855
AskCVM@fda.hhs.gov
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