Consequences of ineffective regulation of dietary supplements
July 26, 2012
The Consequences of Ineffective Regulation of Dietary Supplements
Donald M. Marcus, MD; Arthur P. Grollman, MD. Arch Intern Med. 2012;172(13):1035-1036. doi:10.1001/archinternmed.2012.2687
Prior to enactment of the Dietary Supplement Health and Education Act (DSHEA) in 1994, the regulatory category of dietary supplements included substances used to treat nutritional deficiencies, such as vitamins and minerals. The DSHEA expanded that category to include botanicals and other traditional medicinal products, thereby excluding these products from effective regulation by the US Food and Drug Administration (FDA).
Under DSHEA, manufacturers of dietary supplements are not required to provide premarketing evidence of safety or efficacy or, prior to 2007, to report adverse events. After 1994, sales of supplements rose rapidly, and in 2007, consumers spent $14.8 billion out of pocket for nonvitamin, nonmineral products such as herbals. Increased consumption of supplements was accompanied by reports of serious adverse events and adulteration of dietary supplements by prescription drugs and heavy metals.
It is important for internists to understand the growing health problems caused by nonvitamin, nonmineral dietary supplements and the need to take action to protect the public.
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