Definition: Dietary Supplements

A dietary supplement (also known as food supplement) is a preparation intended to supply nutrients, (such as vitamins, minerals, fatty acids or amino acids) that are missing or not consumed in sufficient quantity in a person's diet. Some countries define dietary supplements as foods, while in others they are defined as drugs. In the United States, the definition of dietary supplements includes non-medicinal herbal supplements and hormones, such as DHEA, pregnenolone (both steroids) and melatonin. Supplements containing vitamins or dietary minerals are recognised by the Codex Alimentarius Commission (the United Nations' highest authority on food standards) as a category of food. Research suggests that "to maximize human health and lifespan, scientists must abandon outdated models of micronutrients" and that "a metabolic tune-up through an improved supply of micronutrients is likely to have great health benefits."

Regulation in the United States:

In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994 (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 dietary substance for use by people to supplement the diet by increasing the total dietary intake, or

* a concentrate, metabolite, constituent, extract, or combination of any of the above

Furthermore, it must be:

* intended for ingestion in pill, capsule, tablet, powder or liquid form

* not represented for use as a conventional food or as the sole item of a meal or diet

* labeled as a "dietary supplement"

Pursuant to the DSHEA, the Food and Drug Administration regulates dietary supplements as foods, and not as drugs. Unlike pharmaceutical companies, supplement manufacturers are not required to prove the safety or effectiveness of their products; the FDA can take action only after a dietary supplement has been proven harmful.

The DSHEA, passed in 1994, was the subject of extensive lobbying efforts by the manufacturers of dietary supplements. As such, the true level of popular support for the deregulation of the supplement industry is unclear. 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.

Similar confusion about the implications of DSHEA was noted in an October 2002 nationwide Harris poll. Here, 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 are incorrect as a result of provisions of the DSHEA.

Nevertheless, 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."

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