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 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 pre-approve dietary supplements 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, mitigate, 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.
Although there is no requirement that a dietarysupplement claim be supported by any specific number of studies, the replication of research results in an independently-conducted study adds to the weight of the evidence.
Dietarysupplement advertisers should be aware that the use of newspaper articles, abstracts of scientific studies, or other "third party literature" to promote a particular brand or product can have an impact on how consumers interpret an advertisement and on what claims the advertiser will be responsible for substantiating.
Marketers of dietarysupplements should be familiar with the requirements under both DSHEA and the FTC Act that labeling and advertising claims be truthful, not misleading and substantiated.
Dietarysupplements refer to products made up of one or more of the essential nutrients such as vitamins, minerals, and protein.
What this means is that when choosing whether to use dietarysupplements, the consumers and, manufacturers have the responsibility of checking the safety of the dietarysupplements and determining the truthfulness of the label claims.
Consumers cannot assume that dietarysupplements are safe, pure, or that the quantities of active ingredients are listed on their labels--the nutritionalsupplement industry is largely unregulated.
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