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February 4, 2004

Regulation of Dietary Supplements—Reply

Author Affiliations

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2004;291(5):560. doi:10.1001/jama.291.5.560-b

In Reply: Despite the claim to the contrary by Ms Joseph and colleagues, the recently announced ban on ephedra1 provides excellent substantiation that the current system of postmarketing regulation of dietary supplements does indeed present a "real danger" to the public. As a result of the challenging legal standard in the DSHEA, definitive actions to prohibit sales and distribution of this dangerous product were delayed more than 9 months after clear evidence of harm was available,2 and while additional evidence of harm continues to accumulate.3 Products such as ephedra—like many other dietary supplements—certainly have biological activity and are marketed as such.4 If this agent had been regulated with at least the same degree of oversight as that used for over-the-counter drugs, some ephedra-related morbidity and mortality most likely could have been prevented.