USP Quality Review

No. 64, Issued 04/99

Dietary Supplements Are Deemed to Be Foods

The DSHEA considerably altered the way FDA regulates dietary supplements. Botanical products historically used for medicinal purposes are currently subject to the same regulations governing food products in the United States. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) has authority over botanical products used as dietary supplements. The center does not approve these products prior to marketing. In addition, manufacturers of dietary supplements are not bound by the stricter regulations that govern prescription and nonprescription medications overseen by the FDA's Center for Drug Evaluation and Research (CDER). Although the legislation authorizes the FDA to establish “good manufacturing practice” (GMP) regulations, it indicates that the regulations be modeled after the GMP guidelines in effect for the food industry, which principally deal with issues of sanitation.