/>i- On January 6, 2025, FDA finalized its Guidance For Industry #294: Animal Food Ingredient Consultation (AFIC). The guidance describes FDA’s AFIC process, which is one way FDA intends to work with animal food ingredient developers following the expiration of the Agency’s memorandum of understanding (MOU) with the Association of American Feed Control Officials (AAFCO).
- AAFCO is a voluntary organization that guides regulators and has long maintained a list of animal food ingredients and definitions. Every state, except Alaska, has some version of the AAFCO model bill and regulations codified under their respective state laws. Historically, FDA participated in the AAFCO ingredient definition request process by providing scientific and technical assistance to AAFCO. In 2007, FDA and AAFCO entered into an MOU to collaborate on animal ingredient definitions to be listed in the AAFCO Official Publication. However, the MOU expired in October 2024 and was not renewed.
- According to the guidance, AFIC is intended to be an interim process while FDA reviews the animal Food Additive Petition and GRAS Notification processes. While these programs are still available, AFIC serves as an additional avenue for animal food ingredient developers to consult with FDA regarding the ingredients and their safety. Companies can participate in the AFIC process by submitting the following information:
- Firm and contact information;
- Proposed ingredient name and definition;
- Summary of the request;
- Ingredient description;
- Manufacturing information;
- Purpose of the ingredient, including data to support the intended use;
- A safety assessment, including target animal and human food safety;
- Copies of cited literature and reports;
- Proposed labeling; and
- Any other relevant information.
- Pending and completed AFICs will be posted on FDA’s website in accordance with the Agency’s confidentiality obligations. Interested parties will have an opportunity to provide input, including additional data or information, and FDA will complete the consultation process by issuing a “consultation complete” letter summarizing the Agency’s review of the ingredient.
- The guidance also describes FDA’s enforcement policy for ingredients reviewed using the AFIC policy. FDA does not intend to initiate enforcement action with respect to the food additive approval requirements of ingredients reviewed under the AFIC and subject to a “consultation complete” letter, as long as there continue to be no questions regarding the safety of the ingredient.
FDA Releases Final Guidance on Animal Food Ingredient Consultation Process
Wednesday, January 8, 2025
Current Public Notices
Published: 6 January, 2025
Published: 6 January, 2025
Published: 26 December, 2024
Published: 9 December, 2024
