Executive Summary
The Dietary Supplement Health and Education Act (DSHEA or the Act) of 1994 was enacted by Congress following public debate concerning the importance of dietary supplements in leading a healthy life, the need for consumers to have current and accurate information about supplements, and controversy over the Food and Drug Administration's (FDA) regulatory approach to dietary supplements. President Clinton, in signing the legislation into law on October 25, 1994, said:
After several years of intense efforts, manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law.
This legislation defines dietary supplements, places the responsibility for ensuring their safety on manufacturers, identifies how literature may be used in connection with sales, specifies types of statements of nutritional support that may be made on labels, specifies certain labeling requirements, and provides for the establishment of regulations for good manufacturing practices. The legislation creates an Office of Dietary Supplements (ODS) in the National Institutes of Health (NIH), with a mandate to coordinate scientific research relating to dietary supplements within NIH and to advise Federal agencies on issues relating to dietary supplements.