What is the FDA considering for dietary supplement warning labels?

The FDA is considering a rule change to require warning labels on dietary supplements to appear less often on packaging, potentially only once per product.

Why does the FDA require warnings on dietary supplements?

The FDA requires warnings on dietary supplements because they are not reviewed for safety or effectiveness before sale, and these warnings inform consumers about the product's status.

Are there concerns about the FDA's proposed change to supplement warnings?

Yes, some experts are concerned that reducing the visibility of warning labels could weaken consumer protections and their ability to understand product accuracy.

Home / Health / FDA Considers Cutting Supplement Label Warnings

FDA Considers Cutting Supplement Label Warnings

19 Dec, 2025

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Summary

FDA may reduce frequency of warning labels on supplements.
Current law requires warnings next to every supplement health claim.
Critics fear reduced warnings will weaken consumer protections.

The U.S. Food and Drug Administration (FDA) is evaluating a policy shift that could alter how warning labels appear on dietary supplement packaging. Unlike prescription drugs, supplements are not pre-approved for safety or effectiveness. A 1994 law mandates a specific disclaimer for any health-related claims made by these products.

The proposed amendment, detailed in a letter to supplement makers on December 18, 2025, suggests displaying the mandatory "This statement has not been evaluated by the Food and Drug Administration..." warning only once on the product, rather than adjacent to each individual health claim. FDA official Kyle Diamantas indicated that current enforcement of this rule has been minimal and that the change could decrease label complexity and expenses for companies.

While the supplement industry has largely welcomed the potential modification, some health experts express concern. Dr. Pieter Cohen of Harvard Medical School warns that reducing the prominence of these disclaimers could diminish consumer safeguards, especially given documented inaccuracies in supplement labeling. The FDA has stated it will pause enforcement of the current rule during its review of the proposed policy change.