The Food and Drug Administration is considering a rule change that would cut back on how often dietary supplement warnings must appear on packaging, a move experts say could make them easier to miss.<\/p>\n\n\n\n
Unlike prescription drugs, the FDA doesn\u2019t review dietary supplements for safety and effectiveness before they hit the market.<\/p>\n\n\n\n
A 1994 federal law requires supplement companies to include a disclaimer when they make health claims like \u201csupports immune health\u201d or \u201cpromotes heart health\u201d or better memory. According to the law, next to promises about benefits, the packaging must display in boldface type: \u201cThis statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.\u201d<\/p>\n\n\n\n
In a letter to supplement makers dated Thursday, Kyle Diamantas, the head of the FDA\u2019s 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.<\/p>\n\n\n\n
Diamantas said that the agency has rarely enforced the existing rule and that the change would cut down on label clutter and costs.<\/p>\n\n\n\n
He didn\u2019t say when the rule change could take effect, but said the FDA wouldn\u2019t enforce the existing requirement while it reviews the policy.<\/p>\n\n\n\n
\u201cIf 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,\u201d Diamantas wrote in the letter.<\/p>\n\n\n\n
More than three-quarters of Americans take at least one supplement, botanical, mineral or vitamin, according to the FDA. As many as 100,000 supplement products are sold in stores or online in the U.S.<\/p>\n\n\n\n
Dr. Pieter Cohen, an associate professor of medicine at Harvard Medical School, said the FDA\u2019s move could be the first step toward making already weak supplement warnings even weaker.<\/p>\n\n\n\n
\u201cThen you start saying things like, \u2018We only need it on the actual bottle,\u2019\u201d Cohen said. \u201cThen you say, \u2018It only needs to be on the back.\u2019 Then you let the print get smaller.\u201d<\/p>\n\n\n\n
In a statement, Andrew Nixon, a spokesperson for the Department of Health and Human Services, which oversees the FDA, said the change wouldn\u2019t make it harder for consumers to notice the warning, adding that \u201ca growing number of Americans are paying closer to attention to product labels.\u201d<\/p>\n\n\n\n
Dietary supplements are popular among 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 \u201cmagic weight loss cure\u201d or a \u201cmiracle in a bottle.\u201d<\/p>\n\n\n\n
Health Secretary Robert F. Kennedy Jr., who has stated he takes a wide range of supplements himself, said the Trump administration would move to free Americans from what he called the FDA\u2019s \u201caggressive suppression\u201d of vitamins and dietary supplements.<\/p>\n\n\n\n
Scott Gottlieb, a former FDA commissioner, said he wasn\u2019t sure what it meant for consumers but a rule change means supplement makers wouldn\u2019t have to make the disclaimers as prominent, possibly making them easier to miss.<\/p>\n\n\n\n
Cohen countered that because dietary supplements aren\u2019t reviewed before they\u2019re sold, the products can contain different amounts of ingredients than what\u2019s listed on the label \u2014 or ingredients not listed at all.<\/p>\n\n\n\n
A 2023 paper by Cohen published in the Journal of the American Medical Association found that nearly 9 out of 10 melatonin gummy brands were inaccurately labeled.<\/p>\n\n\n\n
\u201cThis further undermines the ability of consumers to understand the true health effects,\u201d Cohen said.<\/p>\n\n\n\n
Steve Mister, the president and CEO of the Council for Responsible Nutrition, a trade group for the supplement industry, said in a statement the group \u201cwelcomed\u201d the FDA\u2019s clarification on warning labels.<\/p>\n\n\n\n
The group previously told the FDA that a single disclaimer on a supplement\u2019s label \u2014 linked to health claims with an asterisk or similar symbol \u2014 is enough to inform people and meet the federal law\u2019s intent.<\/p>\n\n\n\n