On January 6, 2025, the FDA rolled out its final Guidance for Industry #294, which details the new Animal Food Ingredient Consultation (AFIC) process.
This initiative aims to enhance collaboration between the FDA and developers of animal food ingredients, following the recent lapse of a memorandum of understanding (MOU) with the Association of American Feed Control Officials (AAFCO).
Role of AAFCO
AAFCO is an influential voluntary organization that has long served as a resource for regulatory bodies, maintaining an extensive database of definitions and listings related to animal food ingredients.
Every U.S. state, apart from Alaska, has implemented regulations based on AAFCO’s model legislation.
Until just before the MOU expired in October 2024, the FDA played a significant role in AAFCO’s ingredient definition process, providing scientific and technical advice.
A formal partnership was established in 2007 to enhance this collaboration, but the agreement was not renewed once it lapsed.
AFIC Process Details
With the AFIC, the FDA introduces a temporary framework while it continues to assess the existing processes for Food Additive Petitions and GRAS Notifications.
While these systems will still be available, AFIC offers an additional route for ingredient developers to discuss their products and address any safety issues directly with the FDA.
Companies wishing to engage with AFIC must provide certain pieces of information, including:
- Company and contact details
- The proposed name and definition of the ingredient
- A summary of the consultation request
- A description of the ingredient
- Details about its manufacturing process
- The intended purpose, supported by relevant data
- An assessment of safety for both the target animal and human food
- Any pertinent literature and reports
- Proposed labeling
- Any other information that might be relevant
Enforcement Policy and Conclusion
The FDA will keep its website updated with the status of both pending and finalized AFIC submissions while adhering to its confidentiality guidelines.
Stakeholders are invited to contribute additional information or data during this process.
Once all consultations are wrapped up, the FDA will issue a letter summarizing the findings.
Additionally, the guidance clarifies the FDA’s enforcement policy for ingredients that have completed the AFIC review.
For those ingredients that receive a “consultation complete” letter, the FDA will not pursue enforcement actions related to food additive approval, as long as no outstanding safety concerns remain.
This marks a significant step in ensuring a smoother process for the approval of animal food ingredients while prioritizing safety and collaboration.
Source: Natlawreview