The Dietary Supplements Act 1994 does not require that dietary supplements (broadly defined to include many substances, such as herbs and amino acids, that have no nutritional value) be demonstrated to be safe or effective before they are marketed. The FDA does not review a dietary supplement before it enters the market. The agency is authorized to restrict a substance if it represents a “significant and unreasonable risk” under the conditions of use listed on the label or under which it is commonly consumed. For the purposes of labeling dietary supplements, section 5 of the DSHEA provides for an exemption from labeling requirements for articles in scientific journals, books and other publications used in the sale of dietary supplements, provided that these materials are reprinted in their entirety, are not false or misleading, do not promote a specific brand or manufacturer, other materials are presented to create a balanced view of scientific information, and are physically separated from the supplements being sold.
To be a dietary supplement, a product must also be labeled as a dietary supplement; that is, the product label must include the term dietary supplement or equivalent (p. (e.g., in these studies it was established that no benefit was obtained when nutrients were taken as a supplement) and some studies even showed an increased risk of suffering from the same disease that nutrients were predicted to prevent. Finally, dietary supplement labels must include a national address or a national telephone number to report serious adverse events to the manufacturer, packer, or distributor whose name and place of business appear on the label. The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients that are missing from the diet.
The so-called “Proxmire Amendment” prohibits the FDA from limiting the potency of ingredients in vitamin and mineral products that are not “inherently dangerous” and prevents the agency from removing “useless” ingredients from dietary supplements and irrational combinations of ingredients from the market. To determine if a claim is justified, it is important to consider whether the studies or tests relate to the specific claim being made or to the dietary supplement product itself. However, manufacturers and distributors of dietary supplements should record, research, and send to the FDA any reports they receive about serious adverse events related to the use of their products. These three types of claims are not approved by the FDA and do not require FDA evaluation before being used on dietary supplement labels.
To evade the intent of the law, the supplement industry is organized to ensure that the public is aware of “medicinal uses” that are not on product labels. Office of Nutrition, Labeling and Dietary Supplements, HFS-800 Center for Food Safety and Applied Nutrition Food and Drug Administration 5001 Campus Drive College Park, MD 20740. Al 1085-86 (rejecting the defendants' argument that the FDCA's distinctions between foods, drugs, or dietary supplements are binding on the FTC's application of sections 5 and 12 of the FTC Act). In general, the FDA is limited to enforcing the law after marketing because, unlike drugs that must be shown to be safe and effective for their intended use before they are marketed, the law does not require the FDA to approve the safety of dietary supplements before they reach the consumer.
In addition, the FDA considers advertising when evaluating the intended use of a product labeled as a dietary supplement. This guidance document, which includes examples of statements that could be made in favor of a dietary supplement, outlines the criteria that should be considered in evaluating the nature of the claim and the quantity, type and quality of the evidence that supports it.