The Food and Drug Administration is considering a change to its rules requiring dietary supplements to display health disclaimers on packaging, a move that could reduce how frequently the warnings appear and make them easier for consumers to miss.
Currently, a 1994 federal law requires supplement makers to include a bold disclaimer alongside any health claims, such as “supports immune health” or “promotes heart health,” stating: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” Unlike prescription drugs, dietary supplements are not reviewed by the FDA for safety or effectiveness before hitting the market.
In a letter to supplement companies, Kyle Diamantas, head of the FDA’s food division, said the proposed change would still require the disclaimer to appear on products at least once, but it would no longer need to be repeated with every health claim. Diamantas said the agency has rarely enforced the current rule and that the adjustment would reduce label clutter and production costs. While no timeline was provided, the FDA will not enforce the existing rule while reviewing the potential change.
Dietary supplements are widely used, with more than three-quarters of Americans taking at least one botanical, vitamin, or mineral product. As many as 100,000 supplement products are sold in stores or online across the U.S. Critics warn that the change could weaken already limited consumer protections. Dr. Pieter Cohen of Harvard Medical School said reducing the prominence of disclaimers could make it easier for people to overlook potential risks, noting that supplements can contain inaccurate ingredient amounts or even undeclared ingredients. His research found nearly 9 out of 10 melatonin gummy brands were inaccurately labeled.
Supporters of the change argue it will simplify packaging without compromising consumer awareness. Andrew Nixon, a spokesperson for the Department of Health and Human Services, which oversees the FDA, said the adjustment would not make it harder for consumers to notice warnings, emphasizing that more Americans are paying closer attention to product labels. Steve Mister, president of the Council for Responsible Nutrition, a supplement industry trade group, welcomed the clarification, noting that a single disclaimer linked to health claims is sufficient to meet federal law requirements.
Former FDA Commissioner Scott Gottlieb acknowledged that the change could reduce the visibility of disclaimers, potentially making them easier to overlook, while critics point out that this could further obscure the true health effects of dietary supplements.