Expired US pet ingredient review creates uncertainty – and opportunity

The US has recognized for the past 17 years a list of ingredient definitions maintained by the Association of American Feed Control Officials (AAFCO) as a means of determining what may be included in commercial pet food products sold nationwide.

End of understanding

Under the terms of this agreement, the US Food and Drug Administration (FDA) provided AAFCO with the scientific expertise to review the safety and efficacy of new ingredients, and AAFCO’s membership would vote to decide which ingredients ultimately passed muster.

That Memorandum of Understanding (MOU) formally ended on 1 October 2024 and the FDA has implemented an interim food ingredient consultation process that will continue to recognize existing AAFCO- approved ingredient definitions in the meantime.

But the agency’s long-term plans remain unsettled pending a broader public review of its animal food rules.

Possible new pathways

In the meantime, AAFCO has issued its own proposal with the scientific support of Kansas State University (KSU) that may or may not be recognized by the FDA, but could nonetheless hold legal sway. So, the US could end up with 2 new, legally binding pathways for ingredient review within the next 6-9 months.

AAFCO’s Executive Director Austin Therrell believes the new process could cut the length of new ingredient reviews in half. But unlike the FDA process, it will require AAFCO to charge applicants a service fee. If approved by the general membership in January 2025, AAFCO could have the new process up and running by the second quarter of the year.

Comprehensive review

The FDA, meanwhile, has initiated a comprehensive review of its remaining ingredient approval pathways, the animal food additive petition process and the Generally Recognized as Safe (GRAS) process.

An FDA official admits to PETS International that it is still too early to speculate on possible outcomes of the agency’s broader animal food rules review, so it remains unclear what the regulatory landscape might look like in the long term.

AAFCO is hopeful that the federal agency will recognize ingredient definitions created under its own revised process, given that the association intends to abide by the criteria required for ingredients to be GRAS approved.

With the federal agency’s recent announcement that it will not take action against ingredients listed in the 2024 AAFCO Official Publication, the FDA seems to have kept that door open.

Even if the FDA decides not to recognize the AAFCO process, the feed industry believes that determinations by AAFCO may still be legally binding. That’s because state governments also have authority to regulate sales of animal food, and all 50 US states continue to recognize AAFCO’s ingredient definitions.

Industry reactions

The American Feed Industry Association (AFIA) has also called on the agency to adopt AAFCO’s newer definitions, including those that were already under review when the MOU expired, on an annual basis.

Although it’s created some confusion for the time being, AFIA’s Vice President of Public Policy and Education Leah Wilkinson says she’s hopeful all this could work in the pet food industry’s favor in the long run.

This could be true even if AAFCO and the FDA end up going their own ways and running 2 separate approval processes, because it could allow pet food companies to choose the pathway that is best suited to their new ingredient, Wilkinson says.

“If the review processes are done correctly, and they can help bring products to market in a timely, predictable manner, I think it will be good for the animal food industry,” she says. “We’re behind the rest of the world right now in our ingredient reviews and we know it, so we need to do things differently. And this is a good opportunity for that to happen.”

AFIA’s member companies have already adopted a varied approach to the interim review processes, Wilkinson points out, with some choosing to pivot to the GRAS or feed additive applications, and others opting to wait for a new process to be set up.