Dietary Supplement

A dietary supplement (also known as food supplement) is intended to supply nutrients, (vitamins, minerals, fatty acids or amino acids) that are missing or not consumed in sufficient quantity in a person's diet. This category may also include herbal supplements which may have added health benefits.

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 bears or contains one or more 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. In addition, the purity and quality of individual brands of dietary supplements are unregulated. However, certain foods (such as infant formula and medical foods) are deemed special nutritionals because they are consumed by highly vulnerable populations and are thus regulated more strictly than the majority of dietary supplements.

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.

A 2001 study, published in Archives of Internal Medicine, found broad public support for greater governmental regulation of dietary supplements than is 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.