The U.S. Food and Drug Administration on Thursday released long-anticipated draft guidance outlining expanded disclosure requirements for dietary supplement manufacturers, a move that signals the agency's most significant regulatory push in the sector in over a decade. The guidance, published in the Federal Register, would require companies to provide more detailed evidence of ingredient safety before products reach store shelves, and would mandate clearer labelling of synthetic compounds and novel botanical extracts.

The announcement follows reporting earlier this week that the FDA was actively weighing changes to what ingredients can legally appear in supplements — a $60 billion annual industry in the United States. Consumer advocacy organisations including the Center for Science in the Public Interest and the Natural Products Association had both submitted competing comment letters to the agency earlier this year, reflecting deep divisions over how aggressively Washington should regulate the sector.

Under the proposed framework, supplement makers would face a 90-day pre-market notification window for any ingredient not already listed in the FDA's New Dietary Ingredient database. Companies would also be required to disclose third-party testing results for heavy metal contamination and microbial safety, a standard that currently applies only voluntarily. The FDA estimated that up to 40 percent of supplements currently on the market contain ingredients that have never been independently reviewed by the agency.

Industry trade groups including the Council for Responsible Nutrition said they were reviewing the guidance and expressed concern that overly burdensome requirements could stifle innovation and disadvantage smaller domestic manufacturers. Meanwhile, several Democratic senators, including those on the Senate HELP Committee, issued statements welcoming the draft as a necessary step toward protecting consumers, particularly older adults and children who are disproportionate users of supplement products.

The draft guidance opens a 60-day public comment period, with a final rule expected no sooner than early 2027. Analysts at Bernstein Research noted that large supplement companies such as Herbalife, Nature's Sunshine, and Church & Dwight's Vitafusion brand would likely absorb compliance costs more easily than smaller competitors, potentially accelerating industry consolidation. The FDA is expected to hold a public stakeholder meeting in May to address questions from manufacturers and healthcare providers.