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.
Additional information
Notes on contributors
Jennifer W. Tam
F. U. Alakbarov is Head Scientific Officer, expert in the Oriental and Folk Medicine, Institute of Manuscripts of the Azerbaijan Academy of Sciences, 8 Istiglaliyat str., Baku, 370001, Azerbaijan.
At the time of writing Liya Davydov was PharmD candidate, College of Pharmacy and Allied Health Professions, St. John’s University. Currently, she is Pharmacy Practice Resident, Mount Sinai Medical Center, New York, NY.
Ila Mehra Harris is Assistant Professor, Department of Pharmaceutical Care & Health Systems, College of Pharmacy, and Clinical Assistant Professor, Department of Family Practice & Community Health, Medical School, University of Minnesota, Minneapolis, MN.
Colin J. Briggs is Professor of Pharmacy, Faculty of Pharmacy, University of Manitoba. Recently he completed a secondment to Health Canada, as Senior Science Advisor in the Therapeutics Products Programme with special responsibility for complementary medicines.
Gemma Briggs is Research Assistant, IMPACT, The Injury Prevention Centre of Children’s Hospital, 501G-715 John Buhler Research Centre, Winnipeg, MB, Canada.
Mary Chavezis Professor of Pharmacy Practice, Director of Complementary Medicine Education and Research, The Center for the Advancement of Pharmacy Practice, Midwestern University, College of Pharmacy Glendale, Glendale, AZ 85308.
June Riedlinger was Director of the Center for Integrative Therapies in Pharmaceutical Care, Massachusetts College of Pharmacy and Health Sciences, Boston, MA. Currently he is Adjunct Associate Professor of Neuropathic Medicine, Southwest College of Naturopathic Medicine & Health Sciences, 2140 East Broadway Road, Tempe, AZ 85282.
Gauri Madhav Chauhan and Suresh R. Naik belong to Principal K.M. Kundanani College of Pharmacy affiliated with Mumbai University, Mumbai, India.