What warning must a dietary supplement carry?

What warning must a dietary supplement carry?

• A. Must carry a warning that the FDA has not reviewed the product
• B. Must be labeled as FDA-approved
• C. Must include the drug's indication
• D. Must include a prescription-only status

Answer: (A)

Dietary supplements aren’t approved by the FDA before they reach the market, so their labels must include a warning stating that the FDA has not evaluated the product. This communicates that safety and efficacy claims haven’t been reviewed by the agency. A typical accompanying line is that the product is not intended to diagnose, treat, cure, or prevent any disease. The other options don’t fit because supplements aren’t FDA-approved products, don’t require a drug indication, and aren’t labeled as prescription-only.

Dietary supplements aren’t approved by the FDA before they reach the market, so their labels must include a warning stating that the FDA has not evaluated the product. This communicates that safety and efficacy claims haven’t been reviewed by the agency. A typical accompanying line is that the product is not intended to diagnose, treat, cure, or prevent any disease. The other options don’t fit because supplements aren’t FDA-approved products, don’t require a drug indication, and aren’t labeled as prescription-only.