Which statement about FDA approval of dietary supplements is correct?

• A. They must be approved by the FDA for safety and efficacy.
• B. FDA pre-market approval is required for safety or efficacy.
• C. They are not required to prove safety and efficacy before marketing.
• D. The FDA does not require pre-market approval for safety or efficacy.

Answer: (D)

Dietary supplements aren’t brought to market through FDA premarket approval. Under DSHEA, manufacturers don’t have to submit safety or efficacy data to the FDA for premarket clearance before selling a supplement. Instead, the responsibility for ensuring safety and truthful labeling sits with the manufacturer, and the FDA can take action after marketing if problems arise. That’s why the statement that the FDA does not require pre-market approval for safety or efficacy is correct. The other options imply a premarket approval process that doesn’t exist for supplements, which is why they’re not accurate.