The FDA may allow warning labels to appear just once per package rather than after every health claim<\/p>\n<\/h3>\n
By I. Edwards HealthDay Reporter<\/b>
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FRIDAY, Dec. 19, 2025 (HealthDay News) \u2014 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.<\/p>\n
Unlike prescription drugs, dietary supplements are not reviewed by the FDA for safety or effectiveness before they are sold.<\/p>\n
Instead, a 1994 federal law requires companies to include a disclaimer whenever they make health claims, such as \u201csupports immune health\u201d or \u201cpromotes heart health.\u201d<\/p>\n
That disclaimer must say, in bold type:<\/p>\n
\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
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.<\/p>\n
Kyle Diamantas<\/a>, head of the FDA\u2019s human food division, said the agency has rarely enforced the current rule and that updating it could reduce label clutter and costs for companies.<\/p>\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 a letter to supplement makers.<\/p>\n 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.<\/p>\n 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<\/a> are sold online or in stores.<\/p>\n Some experts say reducing how often warnings appear could weaken protections for consumers.<\/p>\n \u201cThen you start saying things like, \u2018We only need it on the actual bottle,\u2019 \u201d Dr. Pieter Cohen<\/a>, an associate professor at Harvard Medical School, told NBC News<\/em>. \u201cThen you say, \u2018It only needs to be on the back.\u2019 Then you let the print get smaller.\u201d<\/p>\n Cohen also warned that supplements can contain different amounts of ingredients than listed on the label, or ingredients that are not listed at all.<\/p>\n In a 2023 study published in the Journal of the American Medical Association<\/a><\/em>, Cohen found that nearly 9 out of 10 melatonin gummy brands were inaccurately labeled.<\/p>\n \u201cThis further undermines the ability of consumers to understand the true health effects,\u201d Cohen told NBC News<\/em>.<\/p>\n 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<\/a> said that \u201ca growing number of Americans are paying closer to attention to product labels.\u201d<\/p>\n The possible shift comes as dietary supplements remain popular among figures tied to the “Make America Healthy Again” movement.<\/p>\n U.S. Health Secretary Robert F. Kennedy Jr<\/a>. has said he personally takes many supplements and has criticized what he has called the FDA\u2019s \u201caggressive suppression\u201d of vitamins and supplements.<\/p>\n Former FDA Commissioner Dr. Scott Gottlieb<\/a> said the change could allow companies to make disclaimers less noticeable, though it remains unclear how consumers would be affected.<\/p>\n The supplement industry welcomed the move. Steven Mister<\/a>, president and CEO of the Council for Responsible Nutrition, said one clear disclaimer \u2014 linked to health claims with a symbol \u2014 is enough to meet the law\u2019s intent and inform shoppers.<\/p>\n More information<\/strong><\/p>\n The U.S. Food and Drug Administration has more on dietary supplements<\/a>.<\/p>\n