Author Affiliations: Department of Medicine, Baylor College of Medicine, Houston, Texas (Dr Marcus); and Departments of Pharmacological Sciences and Medicine, Stony Brook University, Stony Brook, New York (Dr Grollman).
Mackay's assertion that the Dietary Supplement Health and Education Act (DSHEA) provides protection for consumers ignores a large body of opinion and evidence to the contrary, including the recent detailed report by the US General Accountability Office (GAO).1 For example, despite more than 13 000 adverse events and hundreds of deaths, it took years for the US Food and Drug Administration (FDA) to remove ephedra from the market. The authority to recall dietary supplements given to the FDA by the Food Safety Modernization Act (FSMA) is a positive recent development. However, its effect in practice is uncertain because it is unclear whether FSMA lowers the high legal barrier for recall created by DSHEA. Moreover, the GAO report identifies additional factors that limit the FDA's ability to identify safety concerns1(pp21-23) and to recall supplements.1(pp23-25)
Marcus DM, Grollman AP. Correcting the Record on Dietary Supplement Regulation—Reply. JAMA Intern Med. 2013;173(2):166–167. doi:10.1001/jamainternmed.2013.1747