Review the FDA disclaimer with the complete claim context

The statutory disclaimer text

“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.”

21 CFR 101.93 contains presentation rules for this disclaimer. When a label or labeling contains more than one covered statement, the regulation also addresses how the disclaimer may be linked to the statements. Review the current text before final artwork approval.

Four separate questions

1. What does the statement communicate? Review express wording, implied meaning, product name, images, testimonials, audience, and nearby text.
2. Is it a permissible type of claim? A disease claim does not become permissible merely because the disclaimer appears nearby.
3. Is the statement substantiated? The manufacturer must have evidence supporting that the statement is truthful and not misleading.
4. Were presentation and notification handled? Review the disclaimer under 21 CFR 101.93 and the notification requirement under section 403(r)(6) of the FD&C Act.

Preserve the relationship

Keep every claim body with its asterisk, symbol, footnote, qualifier, and panel location. This is especially important for OCR: extracting the sentence while losing the linked qualifier can change the apparent meaning. Review website, marketplace, advertising, and social copy separately because the label disclaimer does not automatically qualify every external statement.

Official starting points

• FDA — Structure/Function Claims
• 21 CFR 101.93 — Statements of nutritional support
• 21 U.S.C. 343(r)(6)

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