Animal Food Ingredient Consultation (AFIC)
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. During this evaluation, the FDA intends to conduct voluntary consultations with firms developing animal food ingredients through the Animal Food Ingredient Consultation (AFIC) process.
AFIC is an interim process providing an additional way for firms to consult with the FDA regarding animal food ingredients and for the FDA to identify potential safety concerns associated with such ingredients, to help support firms developing animal food ingredients for which they may have otherwise utilized the AAFCO ingredient definition process.
Information on AFIC is available in 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.
Interested Party Input
When the FDA accepts requests for AFIC, interested parties can 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.