Which phrase must accompany a structure-function claim on a supplement label?

Which phrase must accompany a structure-function claim on a supplement label?

• A. This claim is backed by FDA approval
• B. This statement has not been evaluated by the FDA
• C. This claim is supported by substantial evidence
• D. This statement has been reviewed by the FDA

Answer: (B)

Structure-function claims on supplement labels are not FDA-approved before marketing, so they must carry a disclaimer indicating that the claim has not been evaluated by the FDA. The exact phrase used is This statement has not been evaluated by the FDA. This matters because these claims describe how the product affects the body rather than diagnosing or treating a disease, and they are not the same as FDA-reviewed or approved statements; using language that implies FDA endorsement would be misleading. Often this disclaimer is paired with a note that the product is not intended to diagnose, treat, cure, or prevent any disease.

Structure-function claims on supplement labels are not FDA-approved before marketing, so they must carry a disclaimer indicating that the claim has not been evaluated by the FDA. The exact phrase used is This statement has not been evaluated by the FDA. This matters because these claims describe how the product affects the body rather than diagnosing or treating a disease, and they are not the same as FDA-reviewed or approved statements; using language that implies FDA endorsement would be misleading. Often this disclaimer is paired with a note that the product is not intended to diagnose, treat, cure, or prevent any disease.