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Dietary supplement

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Definition of Dietary Supplements

Dietary supplements were defined in a law passed by Congress in 1994. A dietary supplement must meet all of the following conditions:

  • It is a product (other than tobacco) intended to supplement the diet, which contains one or more of the following: vitamins; minerals; herbs or other botanicals; amino acids; or any combination of the above ingredients.
  • It is intended to be taken in tablet, capsule, powder, softgel, gelcap, or liquid form.
  • It is not represented for use as a conventional food or as a sole item of a meal or the diet.
  • It is labeled as being a dietary supplement.

In the United States, dietary supplements are regulated as foods, not drugs. Therefore, premarket evaluation and approval by the Food and Drug Administration (FDA) are not required unless specific disease prevention or treatment claims are made. The FDA can, however, remove from the market dietary supplements that it deems unsafe. Because dietary supplements are not formally reviewed for manufacturing consistency, there may be considerable variation from lot to lot.

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