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The DSHEA is a US law that limits the government’s ability to regulate the market for dietary supplements and vitamins. It allows supplement manufacturers to sell products with few restrictions, but they must make an affidavit with the FDA that the supplement has been tested for human consumption and has no negative risks. The FDA retains responsibility for investigating consumer complaints and can force manufacturers to recall products if they prove harmful after the fact. The law prohibits manufacturers from claiming that their product can treat, cure or diagnose any condition, and the FDA retains the power to investigate any deceptive or potentially deceptive supplement claims.
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 market for dietary supplements and vitamins. In the United States, all pharmaceutical compounds classified as drugs are subject to strict regulation by the country’s Food and Drug Administration (FDA). The FDA controls how drugs and medications are marketed, dispensed, and advertised. DSHEA’s main thrust has been to displace the class of compounds known as dietary supplements – usually defined as herbal and vitamin compounds – from the definition of a regulated drug. Under the act, the FDA cannot control how dietary supplements are sold except under certain limited circumstances.
Since DSHEA became law, dietary supplement manufacturers have had 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 nutrition products are available over the counter in the United States. The supplements are sold in a wide variety of retailers, from pharmacies to grocery stores and health food stores. However, the DSHEA hasn’t stripped all regulatory rights away from the FDA, and the agency still exercises some oversight of the supplement industry.
While DSHEA does not allow the FDA to determine on its own whether supplements are safe, supplement manufacturers still need to make an affidavit with the FDA that the supplement they plan to sell has been tested for human consumption and has no side effects or negative risks. In this way, the DSHEA shifts the burden of testing and security to the manufacturer. The FDA retains responsibility for investigating consumer complaints and can force manufacturers to recall products if they prove harmful after the fact.
DSHEA critics often point to this post-harm response in their attack on the law. Allowing FDA testing only after a certain threshold of complaints has been registered is an unjustifiable danger, they argue. Advocates, on the other hand, point to the relative benefits of an open market for supplements, from the wide availability of vitamins to the lowest 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.
Labeling is another major section of the DSHEA. The law prohibits manufacturers of dietary supplements from claiming that their product can treat, cure or diagnose any condition. This prohibition applies to both printed labels and advertising claims. Any claims about a supplement’s effectiveness must also be denied with language that indicates the claims have not been evaluated by the FDA. The FDA retains the power under the DSHEA to investigate any deceptive or potentially deceptive supplement claims.
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