Do dietary supplements require FDA approval before marketing?

Do dietary supplements require FDA approval before marketing?

• A. Yes
• B. No
• C. Sometimes
• D. Only for prescription products

Answer: (B)

Dietary supplements do not require FDA premarket approval before they are marketed. In the United States, they’re regulated as a category of foods under DSHEA, so manufacturers are responsible for ensuring safety and truthful labeling before products reach the market. The FDA does not approve supplements beforehand; it monitors safety after marketing and can require recalls, issue warnings, or take other enforcement actions if problems arise. There is a premarket notification process for new dietary ingredients, but that is about safety review, not an approval. Supplements may use certain structure-function claims, but they cannot market disease-treatment claims unless the product is approved as a drug.

Dietary supplements do not require FDA premarket approval before they are marketed. In the United States, they’re regulated as a category of foods under DSHEA, so manufacturers are responsible for ensuring safety and truthful labeling before products reach the market. The FDA does not approve supplements beforehand; it monitors safety after marketing and can require recalls, issue warnings, or take other enforcement actions if problems arise. There is a premarket notification process for new dietary ingredients, but that is about safety review, not an approval. Supplements may use certain structure-function claims, but they cannot market disease-treatment claims unless the product is approved as a drug.