The U.S. Food and Drug Administration is considering a regulatory change that could reduce how often warning disclaimers must appear on dietary supplement packaging, a move that has drawn mixed reactions from consumer advocates and industry groups.
Under current federal law, dietary supplements are not reviewed by the FDA for safety or effectiveness before being sold. However, since 1994, manufacturers have been required to include a prominent disclaimer whenever they make health-related claims such as “supports immune health” or “promotes heart health.” That disclaimer states that the claim has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent disease.
What Could Change
In a letter sent to supplement manufacturers last week, FDA food division head Kyle Diamantas said the agency is considering revising the rule so that the disclaimer would only need to appear once on a product’s label, rather than every time a health claim is mentioned.
According to Diamantas, the FDA has rarely enforced the existing repetition requirement. He said the potential change would reduce label clutter and lower compliance costs for companies. While the review is underway, the agency will not enforce the current rule, he added.
“If FDA does not identify significant concerns as we continue our review of the available data and information regarding this request, we are likely to propose a rule to amend this requirement,” Diamantas wrote.
No timeline has been given for when a formal rule proposal might be issued.
Concerns From Health Experts
Some medical experts warn that scaling back disclaimer requirements could make already-limited consumer protections even weaker. Dr. Pieter Cohen, an associate professor of medicine at Harvard Medical School, said the move could set a precedent for further reducing the visibility of warnings.
“Once you say it only needs to appear once, it becomes easier to push it to less noticeable locations or make it less prominent,” Cohen said.
Cohen has also raised broader concerns about supplement accuracy. Because supplements are not evaluated before reaching consumers, products may contain ingredient amounts that differ from what is listed — or substances not listed at all. A 2023 study he authored in The Journal of the American Medical Association found that nearly 90% of melatonin gummy products tested were inaccurately labeled.
Industry and Government Response
The dietary supplement industry has largely welcomed the FDA’s position. Steve Mister, president and CEO of the Council for Responsible Nutrition, said a single, clearly referenced disclaimer is sufficient to inform consumers and aligns with the intent of the law.
The Department of Health and Human Services, which oversees the FDA, downplayed concerns about consumer awareness. Spokesperson Andrew Nixon said the change would not make warnings harder to find, noting that many Americans are paying closer attention to product labels.
A Growing Market With Limited Oversight
More than three-quarters of U.S. adults use at least one supplement, vitamin, mineral, or botanical, according to the FDA. An estimated 100,000 supplement products are currently available for sale nationwide, both in stores and online.
The debate comes amid broader political scrutiny of the FDA’s role in regulating supplements. Several prominent figures aligned with the “Make America Healthy Again” movement have criticized what they view as excessive oversight, while consumer advocates argue that reduced warning visibility could leave shoppers less informed about the limits of supplement claims.
As the FDA reviews the policy, the outcome could reshape how supplement health claims — and their disclaimers — appear on shelves across the country.
