The Food and Drug Administration is considering a rule change that would reduce the frequency with which warnings about dietary supplements must appear on packaging, a move that experts say could make them easier to ignore.
Unlike prescription drugs, the FDA does not review the safety and effectiveness of dietary supplements before they hit the market.
A 1994 federal law requires supplement manufacturers to include a disclaimer when making health claims such as “supports immune health,” “promotes heart health” or improved memory. By law, alongside promises of benefits, packaging must display in bold letters: “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.”
In a letter to supplement makers Thursday, Kyle Diamantas, head of the FDA’s food division, said the possible proposal would still require companies to include the disclaimer on their products at least once, but it would no longer require it to be repeated every time a health claim appears.
Diamantas said the agency rarely enforced the existing rule and the change would reduce label clutter and costs.
He did not say when the rule change might take effect, but said the FDA would not enforce existing requirements while it revises the policy.
“If FDA does not identify significant concerns as we continue our review of the available data and information regarding this application, we will likely propose a rule to modify this requirement,” Diamantas wrote in the letter.
More than three-quarters of Americans take at least one supplement, botanical, mineral or vitamin, according to the FDA. Up to 100,000 supplements are sold in stores or online in the United States.
Dr. Pieter Cohen, an associate professor of medicine at Harvard Medical School, said the FDA’s decision could be the first step toward further weakening already weak warnings about supplements.
“Then you start saying things like, ‘We only need it on the bottle itself,'” Cohen said. “Then you say, ‘It just needs to be on the back.’ Then you let the print get smaller.
In a statement, Andrew Nixon, a spokesman 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, adding that “an increasing number of Americans are paying more attention to product labels.”
Dietary supplements are popular among figures linked to the Make America Healthy Again movement. Dr. Mehmet Oz, administrator of the Centers for Medicare and Medicaid Services, was criticized during his confirmation hearing in March for previously promoting supplements that he described as a “magic bullet for weight loss” or a “miracle in a bottle.”
Health Secretary Robert F. Kennedy Jr., who said he takes a wide range of supplements himself, said the Trump administration will act to free Americans from what he called the FDA’s “aggressive suppression” of vitamins and dietary supplements.
Scott Gottlieb, a former FDA commissioner, said he wasn’t sure what that meant for consumers, but a rule change would mean supplement makers wouldn’t have to put disclaimer warnings as prominently, which could make them easier to miss.
Cohen countered that because dietary supplements are not reviewed before being sold, products may contain different amounts of ingredients than listed on the label — or ingredients that are not listed at all.
A 2023 article by Cohen in the Journal of the American Medical Association found that nearly 9 out of 10 melatonin gum brands were inaccurately labeled.
“This further undermines consumers’ ability to understand the true health effects,” Cohen said.
Steve Mister, president and CEO of the Council for Responsible Nutrition, a trade group for the supplement industry, said in a statement that the group “welcomes” the FDA’s clarification of warning labels.
The group previously told the FDA that a single disclaimer on a supplement’s label — linked to health claims with an asterisk or similar symbol — was enough to inform people and meet the intent of the federal law.
