Analysis of Ephedra-Free Labeled Dietary Supplements Sold in the San Francisco Bay Area in 2003

Abstract

Objective: To sample dietary supplements (DS) labeled as ephedra-free to evaluate whether products met their labeling claim.Methods: One control DS product containing ephedra alkaloids and 29 DS labeled as ephedra-free were purchased from various retail locations in San Francisco. All products were sent to the California Department of Health Services (CDHS), Food and Drug Laboratory for content and quantity analysis. All laboratory personnel were blinded to product names and labeled contents. All DS products were screened for the presence of undeclared drugs, ephedra alkaloids, and heavy metals including lead, arsenic, cadmium and mercury. All products were also evaluated for compliance with the labeling requirements of the Dietary Supplement Health and Education Act (DSHEA) of 1994.Results: None of the DS labeled as ephedra-free tested positive for the presence of ephedra alkaloids; as expected, the control product did test positive. Heavy metals were detected in three ephedra-free labeled DS products. All 24 products that tested positive for caffeine listed caffeine or a botanical source of caffeine on the DS label. All but two products were in compliance with DS labeling as required by DSHEA.Conclusions: This study demonstrates that manufacturers met their labeling claims for ephedra-free products. Special attention should be given to the presence of heavy metals and other drugs like caffeine, synephrine, and botanical sources of caffeine as these ingredients have replaced ephedra.