What must dietary supplements with structure-function claims include on the label?

• A. This statement has not been evaluated by the FDA.
• B. FDA Approved.
• C. Prescription only.
• D. May cause adverse interactions.

Answer: (A)

Structure-function claims on dietary supplement labels must include a disclaimer that the FDA has not evaluated the claim. This is required because these products aren’t pre‑approved by the FDA, and the disclaimer makes clear that the claim hasn’t been reviewed for safety or effectiveness. It also clarifies that the product is not intended to diagnose, treat, cure, or prevent any disease. The other statements aren’t required: the product isn’t FDA‑approved, isn’t restricted to prescription, and while warnings about adverse interactions are useful, they’re not the mandated disclaimer for structure-function claims.