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The AFIA expressed its concern with the FDA and AAFCO's announcements today to end their longstanding relationship for the review of new animal food ingredients.
The AFIA is concerned that the end of this partnership could lead to increased uncertainty in regulatory review processes, potentially raising the time and costs for approving new animal food ingredients, making the U.S. market less attractive for innovators.
The AFIA emphasized its commitment to working with both the FDA and AAFCO to ensure that any changes to the review processes provide clear requirements and timely, consistent reviews across state and federal jurisdictions.
Today, the American Feed Industry Association (AFIA) expressed its disappointment over the Food and Drug Administration and Association of American Feed Control Officials’ (AAFCO) announcements that they will be ending their longstanding relationship for the review of new animal food ingredients on Oct. 1, abolishing a system that has worked well for decades. The AFIA believes this relationship has been vital for building and maintaining confidence across the food chain that U.S. animal food products are safe – the ultimate goal of the industry’s customers at home and abroad.
Upon learning of the news, AFIA’s President and Chief Executive Officer Constance Cullman issued the following statement:
“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 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 association 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.