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COMMENTARY The Consequences of Ineffective Regulation of Dietary Supplements RIOR TO ENACTMENT OF ports of serious adverse events and nal nature of botanicals and other the Dietary Supple- 352 voluntary reports of moderate nonvitamin, nonmineral products ment Health and Edu- or mild adverse events. However, the and conceals their potential for caus- cation Act (DSHEA) FDA believes that adverse events are ing serious adverse events. P in 1994, the regula- significantly underreported and es- tory category of dietary supple- timates that the annual number of DECEPTIVE MARKETING ments included substances used to all adverse events is 50 000. treat nutritional deficiencies, such as The report noted the magnitude A second GAO report examined vitamins and minerals. The DSHEA of the regulatory problem: the num- whether deceptive or questionable expanded that category to include ber of dietary supplements on the marketing practices were being used botanicals and other traditional me- market rose from 4000 in 1994 to by vendors of dietary supplements dicinal products, thereby exclud- approximately 75 000 in 2008. Even and whether popular herbals were ing these products from effective contaminated with harmful sub- when the agency identifies an un- regulation by the US Food and Drug stances.
JAMA Internal Medicine – American Medical Association
Published: Jul 9, 2012
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