Evaluation of FDA Pre-market Animal Food Programs and Plan for Consultations
At a glance
- FDA Issues Final GFI #294 [updated January 6, 2025]
- FDA Issues Final GFI #293 [updated October 23, 2024]
- Notice of Availability: Request for Comments: FDA Pre-Market Animal Food Ingredient Review Programs [posted August 8, 2024]
- Guidance for Industry (GFI) #293: FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients [finalized October 23, 2024]
- Guidance for Industry (GFI) #294: Animal Food Ingredient Consultation (AFIC) [finalized January 6, 2025]
Recent News
January 6, 2025: The FDA has finalized GFI #294: Animal Food Ingredient Consultation (AFIC).
October 23, 2024: The FDA has finalized GFI #293: FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients.
On August 8, 2024, the FDA announced that it is evaluating its current pre-market animal food review programs, specifically the animal Food Additive Petition 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. The agency accepted public comments on these programs until December 9, 2024.
Transition
While the FDA conducts its program evaluation, the agency intends to conduct voluntary consultations with firms developing animal food ingredients through the new Animal Food Ingredient Consultation (AFIC) process, which is described in GFI #294.
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.
For more information on the AFIC process, see Animal Food Ingredient Consultations (AFIC).
Public Input
To solicit public input, the FDA issued a Request for Comments (RFC) asking interested parties to address specific questions and requests for information about the FDA’s animal Food Additive Petition and GRAS Notification programs to help the FDA determine what changes, if any, may be needed to better serve public health and improve the path to market for new animal food ingredients.
In addition to establishing the RFC docket to accept electronic/written comments, the FDA held multiple virtual listening sessions focused on the FDA’s pre-market animal food review programs and the questions laid out in the RFC.
The FDA accepted public comments on “Request for Comments: FDA Pre-Market Animal Food Ingredient Review Programs,” in docket FDA-2024-N-2979 until December 9, 2024.
Questions & Answers
There is a small number of animal food ingredients for which the FDA provided scientific and technical assistance (consultation) to AAFCO under the then existing MOU and that the FDA has recommended for inclusion in the AAFCO OP, but for which AAFCO has not completed the Feed Ingredient Definition request process. The FDA is considering extending enforcement discretion to these ingredients and intends to describe any such enforcement policy in future guidance.
The FDA will continue to provide consultation on AAFCO Feed Ingredient Definition requests it had in house on October 1, 2024, under the AAFCO Feed Ingredient Definition request process. For AAFCO Feed Ingredient Definition requests that were in house as of October 1, 2024, but for which the FDA provided a letter requesting more information, the agency looks forward to discussing use of FDA processes to continue review of these substances. Please contact animalfood-premarket@fda.hhs.gov if you would like a meeting to discuss potential options.
For new requests that were not submitted before the MOU expired on October 1, 2024, please contact animalfood-premarket@fda.hhs.gov if you would like a meeting to discuss potential options.
To promote transparency in the AFIC process, the FDA intends to publish on its website an inventory of all pending and completed AFICs, along with a link to a docket (FDA-2024-D-2978).
The docket is a place for the public to provide scientific data and information that may support the identity and safety of a proposed ingredient or identify concerns. If information is submitted to the docket, it will be assigned to an FDA scientist for review. However, the agency generally does not intend to respond to docket submissions directly.
The FDA also intends to make an inventory of completed consultations available on its website.
Once the FDA receives its first AFIC, the agency intends to create a table on its AFIC web page to display an inventory of pending AFICs and completed AFICs.
When the agency has received adequate information to engage in an AFIC, it intends to update the online AFIC inventory to identify the submitter, the substance, the intended use, intended animal species, and date of the submission. This information will inform interested parties about ingredients under consultation and will facilitate the public’s ability to provide data and information to the docket while the FDA conducts the consultation. The inventory will have a link to the standing docket.
When an AFIC is completed, the agency intends to update the AFIC webpage with the AFIC number, the submitter, the substance, the intended use, intended animal species, date of the submission, and a “consultation complete” letter that will summarize information the FDA reviewed in order to conclude whether the agency has questions about the safe use of the proposed ingredient.
The FDA intends for the AFIC inventory of pending submissions to identify the submitter, the substance, the intended use, the intended animal species, and date of submission. This is similar to what is published in the Federal Register for an animal Food Additive Petition. For added transparency, the agency also intends to post consultation complete letters that summarize the information the FDA reviewed in order to conclude whether the agency has questions about the safe use of the proposed ingredient.
Firms that would like to participate in this process are encouraged to reach out to the FDA at Animalfood-premarket@fda.hhs.gov to engage in pre-submission conversations (see Guidance for Industry #262). These conversations will be an opportunity to help identify ingredients that would be within scope of the AFIC process and address any questions regarding the process.
Once the AFIC process is active, information to support an AFIC request may be submitted on paper or CD by mail to:
Center for Veterinary Medicine
Division of Animal Food Ingredients
U.S. Food and Drug Administration
MPN 2, Room E436
12225 Wilkins Avenue
Rockville, MD 20852
Alternatively, information may be emailed as a searchable PDF to Animalfood-premarket@fda.hhs.gov.
The FDA is considering an AFIC process like the following:
- The FDA would conduct a cursory review for all submissions under the AFIC process.
- Within 30 calendar days of receipt, a scientist in the FDA’s Center for Veterinary Medicine (CVM) would determine if the submission is appropriate for the AFIC process and if there is sufficient information to facilitate a consultation.
- If the submission is incomplete, CVM would notify the submitter of the missing information.
- If a substance is not appropriate for the AFIC process, CVM would notify the submitter.
- Upon receipt of sufficient information, CVM would accept the consultation, provide the submitter with the assigned AFIC number, and post details of the submission to the “pending inventory” list on the AFIC web page.