FDA CVM: Working With Stakeholders to Troubleshoot, Look to the Future

Written by: Victoria Broehm   |   May 25, 2023

Federal agencies, Ingredients

Last week, the American Feed Industry Association’s Board of Directors participated in a “fireside chat” with senior Food and Drug Administration officials about challenges facing the regulatory agency and steps it’s taking to work with stakeholders to solve problems and prepare for future innovation.

“I recognize, going forward, that we have to be nimble, and we have to be flexible, and one of the beauties of being a small center is that we can do that,” said Tracey Forfa, J.D., director of the FDA Center for Veterinary Medicine (CVM).

She said the CVM is “small” (by FDA standards), with roughly 700 staff covering a massive portfolio that includes everything from the regulation of animal food to animal drugs and veterinary devices. Unfortunately, the center is working with authorities based in the 1930s from the original Federal Food, Drug and Cosmetic Act, Forfa explained, which has proven to be a challenge for regulating novel feed products with non-nutritive benefits (e.g., reduced food safety pathogens or emissions) – an issue she is working “feverishly” with her staff to figure out.

“We have pushed very hard to recognize that there are a lot of novel feed ingredients coming down – that is the future,” said Forfa. “We recognize that, and so we have been really working very hard to figure out how to make the process for reviewing those keep up with the times.”

Part of moving the agency forward is improving FDA’s relationship with stakeholders, which has become more “collaborative and cooperative” over her 31-year tenure. She said that problem solving can’t happen “in a vacuum,” that the agency must have open communication with the industry it regulates so that the agency can answer questions and hear how regulations are or are not working.

Tim Schell, Ph.D., director of the FDA’s Office of Surveillance and Compliance, continued that the agency’s leadership team balances problem solving with doing its regulatory work, saying the agency continues to find instances of certain hazards showing up in animal food and urged industry representatives not to “overlook hazards you think are minor,” but to account for them in their animal food safety plans. He also provided examples of how the agency has listened to the animal food industry’s concerns over how label claims are regulated within the United States versus other jurisdictions and the speed and complexity of the Food Additive Petition (FAP) submission process.

The pair commented that state partners at the Association of American Feed Control Officials (AAFCO) are important for completing some of the agency’s regulatory work but recognized that there is room for “tweaks” and greater transparency in the FDA-AAFCO feed ingredient definition process, particularly coming out of the February public listening session. Schell recognized that AAFCO is important for the “stability” of the industry and wants to make sure the process works in a timely way.

Ensuring FDA is appropriately staffed to handle current ingredient reviews and the anticipated surge that could come as a new pathway is defined for regulating novel feed ingredients is also a priority for the duo. Schell said right now there are about 30 open CVM positions, out of 200, that are in some stage of being advertised or awarded, but it takes a while (upwards of a year) to hire new staff. Forfa said, however, that the quality and experience of candidates coming in is “impressive.”

Overall, the two agency leaders covered a lot of ground (even chatting complications with supply chain over recent years for a few minutes!) but kept with that forward-looking theme that given more resources, the FDA is dedicated to bringing in the right expertise and modernizing its processes to keep pace or slightly ahead of innovation.

“The future is not really like anything of my previous time at FDA. And I see it accelerating,” said Forfa. “It is not a slow march, it’s really just a full-out, and I think that’s critical.”