Will the FDA stop requiring warnings on dietary supplements?

The FDA is considering reducing the frequency of warnings, not eliminating them entirely. They would still be required at least once on the packaging.

Why is the FDA changing warning label rules for supplements?

The FDA cited reducing label clutter and costs for manufacturers as reasons, noting infrequent enforcement of the current rule.

Are dietary supplements safe if warnings are less prominent?

Experts worry that less prominent warnings could make it harder for consumers to notice potential issues, especially since supplements aren't FDA-reviewed before market.

Home / Health / FDA May Loosen Supplement Warning Labels

FDA May Loosen Supplement Warning Labels

16 Dec, 2025

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Summary

FDA considers reducing frequency of supplement warning labels.
Experts fear weakened warnings could mislead consumers.
Nearly 9 out of 10 melatonin brands had inaccurate labels.

FDA May Loosen Supplement Warning Labels

The Food and Drug Administration is contemplating a revision to its regulations that would decrease the mandatory display frequency of warning labels on dietary supplement packaging. This proposed alteration could potentially make these important disclaimers less visible to consumers, raising concerns among health experts.

Currently, federal law mandates that supplement packaging include a disclaimer, such as "This statement has not been evaluated by the Food and Drug Administration," whenever health claims are made. The FDA acknowledges that enforcement of this rule has been infrequent and suggests the change would reduce label clutter and costs for manufacturers.

Critics argue that weakening these warnings could further obscure the fact that supplements are not subject to pre-market review for safety and efficacy, unlike prescription drugs. Past studies have shown significant labeling inaccuracies, undermining consumer trust and understanding of product contents.