In 1994, Congress enacted the Dietary Supplement Health and Education Act (DSHEA),1 a law that dramatically changed the way in which supplements are regulated. In addition to broadening the definition of a dietary supplement to include vitamins, minerals, herbs or botanicals, amino acids, and any combination of these substances, the DSHEA allowed manufacturers to market their products without submitting proof of efficacy or safety to the Food and Drug Administration (FDA). Dietary supplements were assumed to be safe unless proven otherwise by the FDA through postmarket surveillance.2 In addition, under the DSHEA, manufacturers and distributors of dietary supplements were not required by law to record, investigate, or forward to the FDA any reports of illnesses that may have resulted from the use of their products. In response to a number of serious adverse events linked to the supplement ephedra and the limited disclosure of such events by manufacturers, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act in 2006, which mandated reporting of serious adverse events.3 Then, given a significant number of reports of product contamination and false or incomplete labeling,4 the FDA released its final rule for Current Good Manufacturing Practices (cGMPs) for the supplement industry in 2007, stating that manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements.5 By June 2010, all domestic and foreign companies that manufacture, package, label, or hold dietary supplements must be in compliance with the 2007 rule.
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