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Animal Food Ingredient Consultations (AFICs)

Overview

As announced on August 8, 2024, the FDA is evaluating its animal Food Additive Petition (FAP) and Generally Recognized As Safe (GRAS) Notification programs to determine if changes are needed to better serve public health and improve the path to market for new animal food ingredients. While it conducts this evaluation, the FDA is proposing to conduct consultations with firms developing animal food ingredients through the Animal Food Ingredient Consultation (AFIC) process. 

AFIC would be an interim process available after draft GFI #294 is finalized. AFIC would 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. AFIC could be used for ingredients such as those that make up a significant proportion of an animal’s diet, including plant materials, grains, or human food by-products.

Information on AFIC is available in Draft Guidance for Industry #294: Animal Food Ingredient Consultation (AFIC). Answers to common questions about the transition period post-AAFCO MOU can be found in the “Questions & Answers” section of Evaluation of FDA Pre-market Animal Food Programs and Plan for Consultations.

Firms are encouraged to contact the FDA at Animalfood-premarket@fda.hhs.gov prior to developing an animal food ingredient submission to discuss the available options.

Stakeholder Input

When the FDA begins accepting requests for AFICs, stakeholders would be able to provide additional data or information regarding the safety of ingredients posted on the AFIC webpage, by submitting them to the AFIC docket (FDA-2024-N-2979) on Regulations.gov. 

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