The Association of American Feed Control Officials (AAFCO) announced that its Memorandum of Understanding (MOU) with the U.S. Food and Drug Administration (FDA) will not be renewed when it expires on Oct. 1, 2024. The MOU, which outlines the two organizations’ responsibilities for defining animal feed ingredients, has been in place for 17 years.

“AAFCO believes that its ingredient definition process has been a shining example of successful collaboration and partnership between states and the federal government,” said Austin Therrell, executive director of AAFCO. “Although we are disappointed that the MOU is not being renewed, we are committed to being a conduit between the FDA and state regulatory programs, and to our work to provide standardization to the animal food industry.”

The FDA will continue to accept AAFCO Feed Ingredient Definition requests until the MOU expires. AAFCO investigators require roughly 30 days to prepare ingredient definition requests for the FDA, so AAFCO will stop accepting requests on September 1 in order to submit all definition requests prior to the October 1 expiration.

AAFCO and the FDA are independently working on plans that will provide a seamless transition and continue to support the U.S. animal food industry. The FDA is also evaluating its animal food ingredient review authorities and processes to determine if changes are needed to better serve public health and ensure that new ingredients have a predictable path to market. Further details about the transition will be shared by both organizations in the coming weeks.

“This decision opens the doors for AAFCO to look at new and innovative solutions in the ingredient space, and to seek out additional partners that can provide strong, science-based guidance to our state officials,” added Therrell.

Following the announcement, the American Feed Industry Association (AFIA) expressed disappointment, saying the partnership has been vital for building and maintaining confidence across the food chain that U.S. animal food products are safe.

AFIA's President and Chief Executive Officer Constance Cullman commented: “AFIA’s members are disheartened that the FDA will end its partnership with AAFCO, which for decades has ensured the regulatory review of animal food products is efficient, predictable and functional. In the United States, it takes an average three to five years and $600,000 per ingredient before animal food innovators gain the approvals they need to sell and use their products in diets for domestic livestock and pets. Our members are concerned that uncertainty in the regulatory review processes brought about by today’s announcements will only increase those figures, making the U.S. animal ingredient marketplace an unattractive place to do business.”

The AFIA said it will continue working with the FDA and AAFCO on next steps to ensure any proposed changes to the current review processes bring about clear requirements for members and some sense that new ingredients will be reviewed in a timely and consistent manner across state and federal jurisdictions.

Since the AFIA began in 1909, states have been developing their own feed laws. AAFCO was formed to harmonize and unify feed legislation and regulations between the states and work with federal officials who regulate feeds shipped in interstate commerce.

In the 1950s, the FDA and AAFCO began working together on reviewing new ingredients, a process which evolved over the years into a formal memorandum of understanding in 2007, when the agencies reiterated their respective roles and responsibilities, removing confusion between state and federal regulations for ingredient innovators. Since then, AAFCO has been responsible for providing one of three regulatory pathways ingredient innovators could pursue, with FDA involvement, on the safety and efficacy review of new ingredients.

The AFIA has publicly supported its position that should one of the three regulatory pathways be stopped, as was the case in 2010 when the two agencies briefly ended the mutual agreement, it puts undue pressure on the other pathways to fill the void. The AFIA plans to work with the FDA and AAFCO to avoid such unintended consequences, as additional costs and time spent caught in the regulatory process disincentivizes animal food ingredient innovators from doing business in the U.S. market.