In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994 as a product taken by the mouth that contains a dietary ingredient that is intended as a supplement to the diet. By virtue of the act, this dietary ingredient could be one or any combination of the following:
- a vitamin,
- a mineral,
- an herb or other botanical,
- an amino acid,
- a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands),
- a concentrate, such as a meal replacement or energy bar or
- a metabolite, constituent or extract.
FDA regulates dietary supplements as foods, and not as drugs. FDA does not preapprove dietary supplments on their safety and efficacy, unlike drugs. Thus, FDA can only go after manufacturers after they have put unsafe products on the market.
The claims that a dietary supplement makes are essential to its classification. If a dietary supplement claims in any way to cure, minitgate, or treat a disease, it would be considered to be a unauthorized new drug and in violation of the applicable regulations and statutes. As the FDA states it:
- No, a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved--and thus illegal--drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.
The only claims that a dietary supplement is allowed to make are structure/function claims. These are broad claims that the product can support the structure or function of the body (e.g., "glucosamine helps support healthy joints"). These claims must be registered with the FDA ahead of time, and there is a requirement that these claims be substantiated. Nevertheless, many critics claim that dietary supplements overstate their importance and their impact on overall health.
- Dietary Supplement Further information
- Dietary Supplement Health and Education Act of 1994
- Dietary Supplements information