No. Dietary supplement manufacturers and distributors are not required to obtain approval from FDA before marketing dietary supplements. Before a firm markets a dietary supplement, the firm is responsible for ensuring that
- the products it manufactures or distributes are safe
- any claims made about the products are not false or misleading
- the products comply with the Federal Food, Drug, and Cosmetic Act and FDA regulations in all other respects
- What is the difference between a dietary supplement and a conventional food?
- What is a dietary supplement?
- If I take vitamins already, should I be eating foods that are fortified with vitamins as well? Is there such a thing as taking too many vitamins?
- Is a dietary supplement a food or a drug?
- Are foods that contain added nutrients considered "enriched"?
- Are dietary supplements approved by FDA?