Updated Aug. 8, 2024
The U.S. Food and Drug Administration (FDA) and the Association of American Feed Control Officials (AAFCO) announced on Aug. 2 their Memorandum of Understanding (MOU) that outlines the two organizations’ responsibilities for defining animal feed ingredients will not be renewed when it expires on Oct. 1, 2024.
For the past 17 years through the MOU (and informally for decades before that time), FDA has provided scientific expertise related to the safety and utility of proposed feed ingredients submitted for approval within the AAFCO ingredient definition process.
In response to the end of the MOU, AAFCO is considering establishing a new ingredient definition process that would utilize an expert panel to provide the necessary scientific review of proposed ingredients. AAFCO voted to further explore this concept on Aug. 7 during its Annual Meeting in San Antonio, Texas.
On Aug. 8, FDA issued a CVM Update that announced the release of the following documents regarding the transition phase after the expiration of the MOU:
- Request for Comments (RFC) that asks stakeholders to address specific questions and requests for information about the FDA’s Food Additive Petition (FAP) and Generally Recognized as Safe (GRAS) Notification programs, to help the agency determine what changes, if any, may be needed to better serve public health and improve the path to market for new animal food ingredients.
- Draft Guidance for Industry (GFI) #293 that explains despite the expiration of the MOU FDA generally does not intend to initiate enforcement action in response to the interstate marketing of animal food ingredients that are listed in the ingredient definition chapter of the 2024 AAFCO Official Publication.
- Draft GFI #294 that describes an interim Animal Food Ingredient Consultation (AFIC) process for firms to engage with FDA regarding ingredients for which firms may have otherwise used the AAFCO ingredient definition process. The interim process could be utilized while FDA evaluates its current Food Additive Petition and GRAS Notification programs for animal food.
NGFA issued the following statement regarding the end of the MOU:
“NGFA has strongly supported the long-standing relationship between FDA and AAFCO to define animal feed ingredients. The FDA/AAFCO ingredient definition process utilized federal and state expertise, along with stakeholder input, to ensure the safety and utility of ingredients, thereby protecting animal health, the safety of animal-based foods consumed by humans, and public health. FDA’s participation within the AAFCO process has been effective and yielded a comprehensive list of ingredients that promote a common understanding and acceptance within the industry, FDA and state regulators, consumers, and global trade partners. The process also provided harmonization between state and federal regulatory authorities that is vital.
“NGFA is disappointed the Memorandum of Understanding (MOU) between FDA and AAFCO that facilitates their current partnership to define feed ingredients will not be renewed when it expires on Oct. 1, 2024. However, we look forward to engaging with both AAFCO and FDA regarding future ingredient approval processes that will support the U.S. animal food industry, facilitate innovation, ensure the safety and utility of ingredients, and protect public health.”