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Glossary

What does the FDA disclaimer on supplements mean?

Written by the Full Measure editorial team, which sells supplements. Approved for publication by the Full Measure owners. Updated .

Drafted with AI assistance from the sources listed below. How we write these

Quick answer

The FDA disclaimer is the two-sentence notice required with any structure/function claim on a supplement label. It says the FDA has not evaluated the claim and that the product is not meant to diagnose an illness or do what only a drug may claim. It must be bold and at least 1/16 inch tall.1,2

Key facts

  • It is required whenever a supplement's labeling makes a structure/function claim, a general well-being claim or a classic nutrient deficiency claim.2
  • There is a singular version for one claim, and a plural version, starting These statements, for more than one.1
  • The wording is fixed by regulation and may not be modified.1,3
  • It must sit right next to the claim, or be linked to it by a symbol such as an asterisk; when it is not adjacent, it goes in a box.1
  • It appears on every panel or page that carries such a claim, including pamphlets and catalogs.1

The exact wording

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.1

With more than one claim, the plural form reads: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.1

The second sentence is there because claiming to diagnose, treat, cure or prevent a disease is something only a drug can legally do.2

Why it exists

The Dietary Supplement Health and Education Act of 1994 put the disclaimer into federal law. Supplements may carry structure/function statements without FDA approval, on condition that the label tells readers the FDA has not evaluated them.2,4

It is not an FDA judgment about the product, good or bad. It means the claim belongs to a category that does not need FDA evaluation before it is used.2

Placement and type rules

  • Next to the claim with nothing in between, or linked to it by a symbol at the end of each claim, with the same symbol by the disclaimer.1
  • Set off in a box whenever it is not adjacent to the claim.1
  • In boldface type no smaller than 1/16 inch.1
  • On each panel or page with a claim, on labels and in labeling such as pamphlets and catalogs.1

The law itself asks for the statement to be prominently displayed and in boldface type.4

When it is not needed

Conventional foods can make structure/function claims without the disclaimer or a notice to FDA. A supplement label whose only claims are nutrient content claims, such as high in a nutrient, follows different rules.5,6

Questions people ask

Does the FDA disclaimer mean a supplement is unsafe?

No. It says nothing about safety. It reflects that structure/function claims are not evaluated by FDA before use; the company is responsible for having evidence that its claims are truthful and not misleading.2

Why do some labels say This statement and others These statements?

The singular form is for one claim. With several claims, each can carry its own disclaimer, or one plural disclaimer can cover them all.1

Can a company reword the disclaimer?

No. FDA's labeling guide says the wording may not be modified.3

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Sources

  1. Code of Federal Regulations, Title 21, Section 101.93: Certain types of statements for dietary supplements. Legal Information Institute, Cornell Law School (eCFR text). Opened 2026-10-07.
  2. U.S. Food and Drug Administration. Questions and Answers on Dietary Supplements. Content current as of August 27, 2026. Opened 2026-10-07.
  3. U.S. Food and Drug Administration. Dietary Supplement Labeling Guide: Chapter VI. Claims. April 2005. Opened 2026-10-07.
  4. United States Code, Title 21, Section 343: Misbranded food (paragraphs r(6), s and w). Legal Information Institute, Cornell Law School. Opened 2026-10-07.
  5. U.S. Food and Drug Administration. Structure/Function Claims. Content current as of March 28, 2024. Opened 2026-10-07.
  6. U.S. Food and Drug Administration. Label Claims for Conventional Foods and Dietary Supplements. Content current as of March 28, 2024. Opened 2026-10-07.

This page is information, not medical advice. Talk to your doctor or pharmacist about your own situation.