Author Affiliations: Departments of Medicine and Immunology, Baylor College of Medicine, Houston, Texas (Dr Marcus); Departments of Pharmacological Sciences and Medicine, School of Medicine, Stony Brook University, Stony Brook, New York (Dr Grollman).
Prior to enactment of the Dietary Supplement Health and Education Act (DSHEA)1 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).
Marcus DM, Grollman AP. The Consequences of Ineffective Regulation of Dietary Supplements. Arch Intern Med. 2012;172(13):1035-1036. doi:10.1001/archinternmed.2012.2687