Evaluation of FDA Pre-market Animal Food Programs and Plan for Consultations
At a glance
- FDA Releases Two Draft Guidances, Seeks Public Comment on Pre-market Animal Food Ingredient Review Programs
- Notice of Availability: Request for Comments: FDA Pre-Market Animal Food Ingredient Review Programs
- Draft Guidance for Industry (GFI) #293: FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients
- Draft Guidance for Industry (GFI) #294: Animal Food Ingredient Consultation (AFIC)
Recent News
The FDA recently 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.
Transition
While the FDA conducts its evaluation, the agency proposes to make the new Animal Food Ingredient Consultation (AFIC) process available to firms developing animal food ingredients.
The AFIC process, as introduced in Draft GFI #294, is intended be an interim process that begins after the expiration of the FDA’s MOU with AAFCO on October 1, 2024. 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 GFI #294: Animal Food Ingredient Consultation (AFIC).
Stakeholder Input
To solicit public input, the FDA has issued a Request for Comments (RFC) asking stakeholders 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. Instructions on how to comment are provided below.
In addition to establishing the RFC docket to accept electronic/written comments, the FDA also intends to hold multiple virtual stakeholder listening sessions focused on the FDA’s pre-market animal food review programs and the questions laid out in the RFC. Interested attendees will be grouped based on the sectors they represent. Those interested in participating in a listening session should email AnimalFoodIngredientRFC@fda.hhs.gov by no later than September 1, 2024, with their first and last name, email address, phone number, and organization/affiliation.
Comments on Request for Comments
Starting August 9, 2024, the FDA is accepting public comments on “Request for Comments: FDA Pre-Market Animal Food Ingredient Review Programs,” in docket FDA-2024-N-2979 until December 9, 2024. For instructions on commenting, please refer to the Federal Register Notice of Availability.
The FDA is also seeking comments on Draft GFI #293 and Draft GFI #294. Instructions on how to comment on each are provided below.
Comments on Draft GFI #293
Starting August 9, 2024, the FDA is accepting public comments on Draft GFI #293, “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients,” in docket FDA-2024-D-2977 until September 9, 2024. Due to the time-sensitive nature of the documents, the FDA does not intend to extend the 30-day comment period before it begins work on the final version of the guidance. For instructions on commenting, please refer to the Federal Register Notice of Availability.
Comments on Draft GFI #294
Starting August 9, 2024, the FDA is accepting public comments on Draft GFI #294, “Animal Food Ingredient Consultation (AFIC),” in docket FDA-2024-D-2978 until September 9, 2024. Due to the time-sensitive nature of the guidance, the FDA does not intend to extend the 30-day comment period before it begins work on the final version of the guidance. For instructions on commenting, refer to the Federal Register Notice of Availability.
Questions & Answers
There is a small number of animal food ingredients for which the FDA has provided scientific and technical assistance (consultation) to AAFCO in accordance with the procedures described in the 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 an enforcement policy similar to that described in Draft GFI #293 for these ingredients and is seeking public comment on this issue in the docket for draft GFI #293. The FDA intends to describe any such enforcement policy in future guidance.
The FDA will continue to accept AAFCO Feed Ingredient Definition requests for consultation from AAFCO’s investigators until the MOU expires on October 1, 2024. Although the FDA will accept these requests until October 1, the AAFCO investigators need time to prepare them for the FDA. Accordingly, in order to meet the October 1 deadline, AAFCO has stated that its investigators will only be able to accept feed ingredient definition requests until September 1, 2024. All requests for an ingredient definition, including questions about deadlines, must be made to AAFCO investigators; the FDA does not take such requests.
For new requests that cannot meet this deadline, the FDA encourages firms to consider submitting an animal Food Additive Petition or GRAS Notice or participating in the Animal Food Ingredient Consultation (AFIC) process (once the process is available). Please contact animalfood-premarket@fda.hhs.gov if you would like a meeting to discuss potential options.
The FDA will continue to provide consultation on AAFCO Feed Ingredient Definition requests it had in house on August 1, 2024, under the AAFCO Feed Ingredient Definition request process.
For AAFCO Feed Ingredient Definition requests that were in house as of August 1, 2024, but for which the FDA provides 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.
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.
The FDA intends to post an inventory of pending AFICs and completed AFICs on its AFIC web page.
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 stakeholders 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 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, 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 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.
Stakeholders interested in participating in this process are encouraged to reach out to the FDA at Animalfood-premarket@fda.hhs.gov to participate in pre-submission conversations (see Guidance for Industry #262). These conversations will be an opportunity to help identify ingredients that are 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 II, Room E474
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.