FDA May Reduce How Often Supplement Warnings Appear on Labels

FRIDAY, Dec. 19, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) is weighing a change that could make warning labels on dietary supplements appear less often on packaging.

Unlike prescription drugs, dietary supplements are not reviewed by the FDA for safety or effectiveness before they are sold.

Instead, a 1994 federal law requires companies to include a disclaimer whenever they make health claims, such as “supports immune health” or “promotes heart health.”

That disclaimer must say, in bold 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.”

Under a possible rule change outlined in a letter sent  to supplement makers Thursday, the FDA would still require that warning on the package, but only once, rather than next to every health claim.

Kyle Diamantas, head of the FDA’s human food division, said the agency has rarely enforced the current rule and that updating it could reduce label clutter and costs for companies.

“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 in a letter to supplement makers.

He did not give a timeline for when a final decision might be made, but said the FDA would pause enforcement of the current rule while the policy is under review.

Dietary supplements are widely used in the U.S. The FDA estimates that more than three-quarters of Americans take at least one supplement, and as many as 100,000 different products are sold online or in stores.

Some experts say reducing how often warnings appear could weaken protections for consumers.

“Then you start saying things like, ‘We only need it on the actual bottle,’ ” Dr. Pieter Cohen, an associate professor at Harvard Medical School, told NBC News. “Then you say, ‘It only needs to be on the back.’ Then you let the print get smaller.”

Cohen also warned that supplements can contain different amounts of ingredients than listed on the label, or ingredients that are not listed at all.

In a 2023 study published in the Journal of the American Medical Association, Cohen found that nearly 9 out of 10 melatonin gummy brands were inaccurately labeled.

“This further undermines the ability of consumers to understand the true health effects,” Cohen told NBC News.

The U.S. Department of Health and Human Services (HHS), which oversees the FDA, said the proposed change would not make warnings harder to find. Spokesperson Andrew Nixon said that “a growing number of Americans are paying closer to attention to product labels.”

The possible shift comes as dietary supplements remain popular among figures tied to the “Make America Healthy Again” movement.