FDA Eyes Fewer Supplement Warning Labels, Sparking Debate Over Consumer Safety

In a move that could make health warnings on dietary supplements harder to spot, the Food and Drug Administration is considering a rule change that would reduce how often the mandatory disclaimer appears on product packaging.

The Proposed Rule

A letter sent to supplement manufacturers on Thursday from Kyle Diamantas, the head of the FDA’s food division, outlined a potential policy shift. Diamantas wrote that the new proposal would still require companies to include the disclaimer at least once, but it would no longer mandate that the statement be repeated every time a health claim is made. The FDA has rarely enforced the current requirement, and Diamantas said the change would cut down on label clutter and costs. He added that the agency would suspend enforcement of the existing rule while it reviews the policy.

> “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.

Background on the Disclaimer

Under a 1994 federal law, supplement companies must include a disclaimer whenever they make claims such as “supports immune health,” “promotes heart health,” or “better memory.” The law requires that, beside the benefit claim, the packaging display in boldface type: “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 they reach the market.

Market Size and Consumer Use

The FDA reports that more than three‑quarters of Americans take at least one supplement—botanical, mineral, or vitamin. Roughly 100,000 supplement products are sold in U.S. stores or online.

Industry Reactions

Steve Mister, president and CEO of the Council for Responsible Nutrition, a trade group representing supplement makers, said the industry “welcomed” the FDA’s clarification on warning labels. Mister noted that the group had previously told the agency that a single disclaimer linked to health claims with an asterisk or similar symbol is sufficient to inform consumers and meet the law’s intent.

Andrew Nixon, a spokesperson for the Department of Health and Human Services, which oversees the FDA, said the change would not make it harder for consumers to notice the warning. Nixon added that “a growing number of Americans are paying closer to attention to product labels.”

Expert Concerns

Dr. Pieter Cohen, an associate professor of medicine at Harvard Medical School, warned that the FDA’s proposal could be a first step toward weakening already fragile supplement warnings. Cohen said:

> “Then you start saying things like, ‘We only need it on the actual bottle,’” Cohen said. “Then you say, ‘It only needs to be on the back.’ Then you let the print get smaller.”

Cohen also highlighted the lack of pre‑market review, noting that supplements can contain different amounts of ingredients than listed or even ingredients not listed at all. He cited a 2023 paper he published in the Journal of the American Medical Association, which found that nearly nine out of ten melatonin gummy brands were inaccurately labeled. Cohen added:

> “This further undermines the ability of consumers to understand the true health effects,” Cohen said.

Scott Gottlieb, a former FDA commissioner, expressed uncertainty about the impact on consumers but pointed out that the rule change would mean supplement makers could make the disclaimer less prominent, potentially making it easier to miss.

Political Context

The issue has drawn attention from political figures tied to the Make America Healthy Again movement. Dr. Mehmet Oz, the administrator of the Centers for Medicare and Medicaid Services, was criticized during his confirmation hearing in March for previously promoting supplements he described as a “magic weight loss cure” or a “miracle in a bottle.” Health Secretary Robert F. Kennedy Jr., who says he takes a wide range of supplements himself, stated that the Trump administration would work to free Americans from what he called the FDA’s “aggressive suppression” of vitamins and dietary supplements.

Key Takeaways

• The FDA is considering a rule that would allow the disclaimer to appear only once per product, rather than with every health claim.
• The current 1994 law requires a bold disclaimer next to each benefit claim, but enforcement has been rare.
• Experts fear the change could make warnings less noticeable, while industry groups welcome the simplification.

The debate over how best to protect consumers while keeping supplement labels clear continues as the FDA moves forward with its review. The final rule, if adopted, could reshape how dietary supplement warnings are presented on the market.