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November 11, 1998

Quality Control of Dehydroepiandrosterone Dietary Supplement Products

Author Affiliations

Margaret A.WinkerMD, Senior EditorIndividualAuthorPhil B.FontanarosaMD, Senior EditorIndividualAuthor

JAMA. 1998;280(18):1565. doi:10-1001/pubs.JAMA-ISSN-0098-7484-280-18-jbk1111

To the Editor.— Several steroidal hormone dehydroepiandrosterone (DHEA) commercial products have become available in the United States as so-called dietary supplements. However, DHEA is not a food; it does not occur naturally in the human food chain, and no foodstuff can mimic the physiologic or pharmacological consequences evoked by DHEA, whether endogenously secreted or exogenously administered.1 As dietary supplements, these products do not require evaluation for safety and efficacy by the US Food and Drug Administration (FDA). These products do not have to be manufactured in compliance with the FDA's current Good Manufacturing Practices, nor do they have to meet quality control standards expected of approved drugs.2,3

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