The Food and Drug Administration is considering rule change it will reduce the frequency with which food additive warnings appear on packaging, a move experts say could make them easier to miss.
Unlike prescription drugs, the F.D.A. does not consider nutritional supplements safety and effectiveness before they even hit the market.
A 1994 federal law requires supplement companies to include a disclaimer when they make health claims such as “supports immune health,” “promotes heart health,” or improves memory. By law, packages must read in bold letters next to benefit promises: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, treat, or prevent any disease.”
In a letter to dietary supplement makers dated Thursday, Kyle Diamantas, head of the FDA's food division, said the possible proposal would still require companies to include a disclaimer on their products at least once, but would no longer require it to be repeated every time a health claim appears.
Diamantas said the agency rarely follows existing rules and that the change would cut down on label clutter and cut costs.
He did not say when the rule change might take effect, but said the FDA will not enforce existing requirements while it reviews the policy.
“If FDA does not identify significant problems as we continue to review available data and information regarding this request, we will likely propose a rule to modify this requirement,” Diamantas wrote in the letter.
According to the FDA, more than three-quarters of Americans take at least one herbal, mineral or vitamin supplement. As much as 100,000 nutritional supplements sold in stores or online in the US
Dr. Peter Cohen, an assistant professor of medicine at Harvard Medical School, said the FDA's decision could be the first step toward making already weak supplement warnings even weaker.
“Then you start saying things like, ‘We only want it on the bottle itself,’” Cohen said. “Then you say, 'It should only be in 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 more difficult for consumers to notice the warning, adding that “a growing number of Americans are paying more attention to food labels.”
Dietary supplements are popular among figures associated with the Make America Healthy Again movement. Dr. Mehmet Oz, administrator of the Centers for Medicare and Medicaid Services, comes under fire during his confirmation hearing in March for his previous promotions of supplements, he called them a “magic weight loss cure” or a “miracle in a bottle.”
Health Secretary Robert F. Kennedy Jr., who has said he himself takes a wide range of supplements, said the Trump administration will seek to free Americans from what he called an “aggressive crackdown” by the FDA vitamins and nutritional supplements.
Scott Gottlieb, a former FDA commissioner, said he's not sure what this means for consumers, but the rule change means dietary supplement makers won't have to make disclaimers as prominent, possibly making them easier to miss.
Cohen countered that because dietary supplements are not tested before sale, products may contain different amounts of ingredients than stated on the label, or the ingredients are not listed at all.
Cohen's 2023 article published in the Journal of the American Medical Association found that nearly 9 out of 10 brands of melatonin gummies were inaccurately labeled.
“This further undermines consumers' ability to understand the true health implications,” Cohen said.
Steve Meester, president and CEO of the Council for Responsible Nutrition, a trade group for the dietary supplement industry, said in a statement that the group “welcomes” the FDA's clarification on warning labels.
The group previously told the FDA that a single disclaimer on a supplement label, associated with health claims with an asterisk or similar symbol, is sufficient to inform people and meet the purposes of federal law.
