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Dietary Supplement Act

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Dietary Supplement Health and Education Act of 1994

In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 199410 (DSHEA) as a product that is intended to supplement the diet and contains any of the following dietary ingredients:

a vitamin
a mineral
an herb or other botanical (excluding tobacco)
an amino acid
a concentrate, metabolite, constituent, extract, or combination of any of the above

Pursuant to the DSHEA, the Food and Drug Administration (FDA) regulates dietary supplements as foods, and not as drugs. While pharmaceutical companies are required to obtain FDA approval proving the safety or effectiveness of their products prior to their entry into the market, dietary supplements, like food, do not need to be pre-approved by FDA before they can enter the market.

The DSHEA, passed in 1994, was the subject of lobbying efforts by the manufacturers of dietary supplements. At the time of its passage DSHEA received strong support from consumer grassroots organizations and members of Congress. In recognition of this, President Bill Clinton, on signing DSHEA into law, stated that "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." He also noted that the passage of DSHEA "speaks to the diligence with which an unofficial army of nutritionally conscious people worked democratically to change the laws in an area deeply important to them" and that "In an era of greater consciousness among people about the impact of what they eat on how they live, indeed, how long they live, it is appropriate that we have finally reformed the way government treats consumers and these supplements in a way that encourages good health."

Popular support may have been based on a misunderstanding of the situation after the deregulation of the supplement industry. A large survey by the AARP, for example, found that 77% of respondents (including both users and non-users of supplements) believed that the federal government should review the safety of dietary supplements and approve them before they can be marketed to consumers.22 In an October 2002 nationwide Harris poll, 59% of respondents believed that supplements had to be approved by a government agency before they could be marketed; 68% believed that supplements had to list potential side effects on their labels; and 55% believed that supplement labels could not make claims of safety without scientific evidence. All of these beliefs were incorrect as a result of provisions of the DSHEA.

A 2001 study, published in Archives of Internal Medicine, found broad public support for greater governmental regulation of dietary supplements than was currently permitted by DSHEA. The researchers found that a majority of Americans supported pre-marketing approval by the FDA, increased oversight of harmful supplements, and greater scrutiny of the truthfulness of supplement label claims.


Dietary supplements wikipedia

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