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October 19, 2011

Dietary Supplements and Regulation

Author Affiliations

Letters Section Editor: Jody W. Zylke, MD, Senior Editor.

Author Affiliation: US Pharmacopeial Convention, Rockville, Maryland (rlw@usp.org).

JAMA. 2011;306(15):1657-1658. doi:10.1001/jama.2011.1494

To the Editor: The Commentary by Dr Denham1 noted the public health challenges associated with implementing the Dietary Supplement Health and Education Act of 1994 (DSHEA). Through DSHEA, quality standards of the US Pharmacopeial Convention (USP)—a not-for-profit standards-setting organization for drugs, dietary supplements, and food ingredients—are legally enforceable under the food misbranding provisions of the Federal Food, Drug, and Cosmetic Act for manufacturers who label dietary supplements as complying with the United States Pharmacopeia–National Formulary (USP-NF).2 Manufacturers who do not claim compliance with USP-NF, however, are not required to meet these standards,3 with possible implications for quality.4 For example, USP standards include tests for performance as a means of ensuring adequate release of dietary supplement ingredients from the dietary supplement. Further, USP standards ensure consistency in quality over time between and across dietary supplement products that are marketed under the same name.4