Dietary Supplement Access and Awareness Act

Summary

Dietary Supplement Access and Awareness Act - Amends the Federal Food, Drug, and Cosmetic Act to require manufacturers and processors of dietary supplements to report certain information to the Secretary of Health and Human Services annually, including a list of supplements manufactured and the labeling and major ingredients for such supplements. Requires manufacturers and distributors to report to the Secretary any serious adverse experiences regarding a supplement. Authorizes the Secretary to require a manufacturer to: (1) conduct postmarket surveillance if there is a reasonable possibility of a supplement causing adverse health consequences; and (2) demonstrate that a supplement is not adulterated. Requires the Secretary to establish criteria for making a determination that a dietary supplement may pose a significant risk to minors. Deems the act of selling a dietary supplement to a minor after the Secretary has made such a determination to be an act which results in a supplement being misbranded while held for sale. Deems a dietary supplement to be adulterated if the manufacturer fails to comply with the Secretary's order to demonstrate the drug's safety. Requires the Secretary to consider a dietary supplement or ingredient as presenting an unreasonable risk of injury or illness if the Secretary determines that the risks of such product outweighs its benefits. Allows the Secretary to consider even a relatively small risk of a serious adverse health effect to be unreasonable. Directs the Secretary, acting through the Commissioner of Food and Drugs, to carry out dietary supplement education programs for health care professionals and consumers.

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Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 30 June 2005

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• Introduced in House (PDF)

  Introduced in House · EN · 30 June 2005

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• Introduced in House

  summary · EN · 30 June 2005

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