Is dietary supplements approved by the FDA before marketing?

• A. True
• B. They are approved by FDA before marketing
• C. False
• D. They require FDA efficacy testing before marketing

Answer: (C)

Dietary supplements are not approved by the FDA before they reach the market. Under the Dietary Supplement Health and Education Act, the manufacturer is responsible for ensuring safety and truthful labeling, and there is no pre-market FDA review or approval for most dietary supplements. The FDA’s role is post-market: it monitors safety, inspects facilities, enforces labeling rules, and can take action if problems arise, including recalls or removing products from the market. There is a limited pre-market requirement for a new dietary ingredient (a notification to FDA at least 75 days before marketing), but this is not approval and does not guarantee safety or efficacy. Efficacy testing before marketing is not required for dietary supplements, and disease treatment claims must be avoided or require drug approval. So the statement that they are approved by the FDA before marketing is not accurate.