What is the DSHEA?

C. Mitchell

The Dietary Supplement Health and Education Act of 1994, commonly known by the acronym DSHEA, is a United States law that limits the government’s ability to regulate the dietary supplement and vitamin market. In the U.S., all pharmaceutical compounds that are classified as drugs are subject to strict regulation by the country’s Food and Drug Administration (FDA). The FDA controls how medicine and drugs are marketed, dispensed, and advertised. The main thrust of the DSHEA was to move the class of compounds known as dietary supplements — usually defined as herbal and vitamin compounds — out of the definition of a regulated drug. Under the act, the FDA cannot control how dietary supplements are sold except in certain limited circumstances.

Dietary supplements are sold at pharmacies, grocery stores, and natural food stores.
Dietary supplements are sold at pharmacies, grocery stores, and natural food stores.

Since the DSHEA became law, dietary supplement manufacturers have enjoyed the opportunity to sell supplements on the open market with relatively few restrictions. It is for this reason that vitamins, herbal remedies, and various natural health nutrition products are available over the counter in the United States. Supplements are sold at a wide variety of retailers, from pharmacies to grocery stores and natural food stores. The DSHEA did not take away all of the FDA’s regulatory rights, however, and the agency still exercises some oversight in the supplement sector.

The FDA retains power under the DSHEA to investigate any potentially deceptive supplement claims.
The FDA retains power under the DSHEA to investigate any potentially deceptive supplement claims.

Although the DSHEA does not permit the FDA to itself determine whether supplements are safe, supplement manufacturers must nevertheless make a sworn declaration with the FDA that the supplement they intend to sell has been tested for human consumption, and has no adverse side effects or risks. In this way, the DSHEA shifts the testing and safety burden onto the manufacturer. The FDA maintains responsibility for investigating consumer complaints, and can compel manufacturers to pull products if they are found to be harmful after the fact.

The DSHEA prohibits the manufacturers of dietary supplements from making any unsubstantiated claims about the effectiveness of the product.
The DSHEA prohibits the manufacturers of dietary supplements from making any unsubstantiated claims about the effectiveness of the product.

Critics of the DSHEA often point to this post-harm response in their attack of the law. Allowing FDA testing only after a certain threshold of complaints has been logged is an unjustifiable danger, they argue. Proponents, on the other hand, point to the relative benefits of an open supplement market, from wide vitamin availability to lower price and ready competition. The FDA has only intervened in a small number of cases, and only a handful of those questioned supplements have been forcibly discontinued.

The DSHEA limits the regulation of dietary supplements and vitamins.
The DSHEA limits the regulation of dietary supplements and vitamins.

Labeling is another of the major sections of the DSHEA. The law prohibits dietary supplement manufacturers from claiming that their product is capable of treating, curing, or diagnosing any condition. This prohibition applies both to printed labels and to advertising claims. Any statements about a supplement’s efficacy must also be disclaimed with language indicating that the statements have not been evaluated by the FDA. The FDA retains power under the DSHEA to investigate any deceptive or potentially deceptive supplement claims.

Pharmacists and healthcare providers can help people evaluate the safety and effectiveness of dietary supplements.
Pharmacists and healthcare providers can help people evaluate the safety and effectiveness of dietary supplements.

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