FDA says it may relax warning label rule for dietary supplements

Source: NBC News

Dec. 15, 2025, 1:21 PM EST


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. Unlike prescription drugs, the FDA doesn’t review dietary supplements for safety and effectiveness before they hit the market.

A 1994 federal law requires supplement companies to include a disclaimer when they make health claims like “supports immune health” or “promotes heart health” or better memory. According to the law, next to promises about benefits, the packaging must display in boldface 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.”

In a letter to supplement makers dated Thursday, Kyle Diamantas, the 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 that the agency has rarely enforced the existing rule and that the change would cut down on label clutter and costs. He didn’t say when the rule change could take effect, but said the FDA wouldn’t enforce the existing requirement while it reviews the policy.

Read more: https://www.nbcnews.com/health/health-news/fda-supplements-warning-label-rule-change-rfk-jr-rcna249321

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The agency had originally regulated dietary supplements as "food" and generally under the criteria for food labeling. Then Orrin Hatch in the Senate and Henry Waxman in the House, pushed through the Dietary Supplement Health and Education Act of 1994

Basically, it restricted these products from claiming what often rose to benefits similar to actual pharmaceuticals without undergoing any of the levels of testing that are required for drugs.