Author Affiliation: Council for Responsible Nutrition, Washington, DC.
The commentary by Marcus and Grollman1 on dietary supplement regulation disregards provisions in the law that already provide the protection for consumers and the authority for US Food and Drug Administration (FDA) that the authors call for. Under the Dietary Supplement Health and Education Act (DSHEA) (Pub L No. 103-417; 108 Stat 4325), the FDA can remove unsafe products from the market if that product presents an “imminent hazard”2 or “significant or unreasonable risk.”3 In addition, the supplement industry recently helped pass the Food Safety Modernization Act (Pub L No. 111-353; 124 Stat 3885), a new law that gives the agency mandatory recall authority. The authors cite statistics from the FDA regarding adverse events but then discard these relatively low numbers in favor of relying on what “ . . . the FDA believes . . . ” to be underreported figures. Beliefs should not have the same evidence as facts, and the facts are that between 2007 and 2010, there have been 4194 serious adverse events reported for dietary supplements4 compared with 471 000 reports of serious adverse events related to drugs or biological products.5
MacKay D. Correcting the Record on Dietary Supplement Regulation. JAMA Intern Med. 2013;173(2):166-167. doi:10.1001/2013.jamainternmed.1028