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FDA 101: Dietary Supplements

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How Are Supplements Regulated?

If you are considering using a dietary supplement, you should know that:

  • The FDA does regulate dietary supplements; rather, it treats them like foods rather than medications. Unlike drug manufacturers, the makers of supplements don’t have to show their products are safe or effective before selling them on the market.
  • Federal law requires that every dietary supplement be labeled as such, either with the term "dietary supplement" or with a term that substitutes a description of the product's dietary ingredient(s) for the word "dietary" (e.g., "herbal supplement" or "calcium supplement").
  • Federal law does not require dietary supplements to be proven safe to FDA's satisfaction before they are marketed.
  • For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA's satisfaction that the claim is accurate or truthful before it appears on the product.
  • In general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.
  • Dietary supplement advertising, including ads broadcast on radio and television, falls under the jurisdiction of the Federal Trade Commission.
  • Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.
  • Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals.
  • It is not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease.

 

 

Are Supplements Safe?

Many dietary supplements have clean safety histories. For example, millions of Americans responsibly consume multi-vitamins and experience no ill effects.