Speaking to NutraIngredients, Welch said the agency is committed to modernization and wants to work with industry on new approaches.
“Three out of four Americans rely on dietary supplements as part of their self-care routines, and they deserve an oversight approach that keeps pace with a dynamic and evolving marketplace,” Welch said.
“If there’s one thing we’d want every dietary supplement company to walk away from the conference understanding, it is that the FDA is committed to modernizing our approach to dietary supplement oversight, and meaningful engagement with regulated industry is central to accomplishing that goal.
“We welcome opportunities to engage with industry and other interested parties on new and innovative approaches to dietary supplement oversight. We’re also interested in collaborating on topics that may fall outside our typical programmatic agenda, exploring new and modernized regulatory approaches that protect public health while supporting a responsible dietary supplement industry.”
What does modernization look like?
Speaking to NI at CHPA’s Regulatory, Scientific and Quality Conference in Bethesda, Maryland, Greg Smith, senior director of regulatory affairs, Kenvue, said greater standardization could help create a more consistent regulatory environment. He advocated a systematic, phased approach rather than sweeping reform, noting that companies do not always follow the same standards.
“I think standardizing the requirements for dietary supplements would be a way to modernize the whole playing field,” Smith said.
Asa Waldstein, founder of Apex Compliance, said technology could help FDA identify problematic claims on websites and social media, as well as speed up the removal of products when safety concerns arise.
“I think the FDA should use more technological tools to help identify companies that are making over-the-top claims on websites and social media.”
Duffy MacKay, senior vice president of dietary supplements, CHPA, said innovation requires a more predictable new dietary ingredient (NDI) framework, including greater clarity on when notifications are required, how manufacturing changes affect notification requirements and which ingredients qualify for use in supplements.
“For innovation to be effective, we really need to see a modernized NDI framework,” he added.
MacKay also pointed to investigational new drug (IND) preclusion and the potential for qualified third-party audit data to help FDA better target its inspection resources.
Emerging technologies and ingredients, including peptides, add urgency to the discussion, MacKay said, as FDA must determine whether new ingredients fit within the scope of dietary supplements and are safe for consumers.
Watch the full video to hear Smith, Waldstein and MacKay further explain what they want FDA’s modernization efforts to look like in practice.