The FDA recently held a pivotal public meeting on how innovative dietary supplement ingredients are regulated, signaling a renewed focus on modernizing oversight. New technologies like precision fermentation, synthesis, cell culture, and recombinant production are challenging whether current rules under DSHEA still fit today’s market.
This theme guided the March 27 meeting “Exploring the Scope of Dietary Supplement Ingredients,” where the FDA sought input on ingredient definitions, new production methods, and emerging categories such as peptides, proteins, enzymes, and microbials. Comments are open through April 27.
FDA Deputy Commissioner for Human Foods, Kyle Diamantas, noted that more than three-quarters of U.S. adults now use supplements. The market has grown from an estimated $2-4 billion in 1994 to over $60 billion today, with far more products and ingredients. Diamantas said this growth reflects perceived benefits but also raises new safety and classification questions for regulators. He emphasized that the FDA is working to maintain appropriate oversight within the limits of its authority as the market evolves.
DSHEA aimed to balance consumer access and public health protection, but that balance is harder to maintain as science and the marketplace advance. Diamantas said the FDA must be “nimble and adaptable” even though the regulatory framework has changed little since 1994. He called for closing gaps that allow bad actors to operate while supporting companies that follow the law. Modernization, he stressed, is intended to support a safe, thriving marketplace rather than restrict innovation or consumer choice. He framed improvements to the system as a shared responsibility between the FDA and industry.
A key issue was how companies bring new ingredients to market: through New Dietary Ingredient Notifications (NDINs) or the Generally Recognized As Safe (GRAS) pathway. Use of GRAS for supplements has drawn scrutiny from policymakers, including HHS Secretary Robert F. Kennedy Jr., who has raised transparency concerns. At the same time, the FDA’s NDI guidance remains incomplete, and issues like drug preclusion complicate launches. The FDA is asking how companies decide between GRAS and NDIN pathways and what challenges they encounter.
On potential GRAS reforms, Diamantas said the FDA’s goal is to keep safe ingredients available for both foods and supplements. He argued that strong oversight and reduced unnecessary burdens can coexist and help innovation that benefits consumer health. The FDA is looking for specific ideas to streamline processes while protecting public health.
What Comes Next?
Input from the March 27 meeting and public comments will guide the FDA’s ongoing work to update how it evaluates dietary supplement ingredients. The agency signaled that continued collaboration with industry will shape future oversight of novel ingredients.
