DSHEA had enormous consumer support as evidenced by the approximately 2 million letters sent to members of the U.S. Congress in support the act (Soller, 2000). The legislation sought to be responsive to the public and was passed in the spirit of improving the health of Americans and empowering consumers to make their own choices about preventive health care practices. In doing so, however, DSHEA designated that supplements be regulated similarly to foods. This crucial distinction exempted manufacturers from conducting premarket safety and efficacy research and eliminated FDA’s premarket regulatory authority. Before DSHEA, FDA attempted to regulate dietary supplements as foods evaluating the safety of all new ingredients, including those used in dietary supplements. DSHEA eliminated this requirement, and as a result, the dietary ingredients used in dietary supplements are no longer subject to the premarket safety evaluations required of other new food ingredients or for new uses of old food ingredients. They must, however, meet the requirements of other safety provisions (FDA, 1995). Table 9-3 shows how dietary supplements are regulated in comparison to foods and drugs.

The establishment of dietary supplements as foods limited FDA’s premarketing regulatory authority and placed FDA in a reactive, postmarketing role. If FDA can prove that a supplement presents a significant or unreasonable risk of injury or illness when it is used as recommended on the label, it may remove a product from the market. This occurred in 2004, when FDA prohibited the sale of dietary supplements containing ephedrine alkaloids. To substantiate its ruling, FDA conducted a risk-benefit analysis of ephedra and examined evidence from the known pharmacology of ephedrine alkaloids, the peer-reviewed literature on effects of ephedrine alkaloids, and reported adverse events after consumption of the product. Review “showed little evidence of ephedra’s effectiveness except for short-term weight loss, while confirming that the substance raises blood pressure and stresses the heart” (http://nccam.nih.gov/health/alerts/ephedra/consumeradvisory.htm). FDA determined that data did not indicate a health benefit sufficient to outweigh the short- and long-term risks of use (e.g., increased blood pressure, and heart rate) (FDA, 2004). Adverse event analysis is complicated by the fact that supplement manufacturers are not required to report adverse events.

DSHEA authorized FDA to establish good manufacturing practice regulations specific to dietary supplements, and these are in development (FDA, 2003a). However, until these practices are implemented, manufacturers are