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U.S. Department of Health and Human Services

About FDA

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Are dietary supplements approved by FDA?

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
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