MedicalResearch.com Interview with:
Pieter Cohen, M.D.
Associate Professor of Medicine
Cambridge Health Alliance
Assistant Professor of Medicine
Harvard Medical School
MedicalResearch.com: What is the background for this study?
Response: Dietary supplements lead to an estimated 23,000 emergency department visits each year in the United States (US), and weight loss and sports supplements contribute to a disproportionately large number of these emergency department visits. It is not known which ingredients in weight loss and sports supplements pose the greatest risk to consumers, but there are stimulants found in botanical remedies that might pose risks.
In the current study, we investigated the presence and quantity of higenamine a stimulant found in botanicals and available in sports and weight loss supplements sold in the US.
MedicalResearch.com: What are the main findings?
Response: The presence of higenamine was confirmed in 24 dietary supplements sold in the United States from trace amounts to 62 ±6.0mg higenamine per serving. While the effects of 2.5 and 5 mg of higenamine administered intravenously can lead to increase heart rate, increased cardiac output and variable effects on blood pressure, no trial provides data to permit calculating intravenous to oral dose conversions. Although it is known that higenamine can be absorbed orally, the effect of the dosages found in supplements remain uncertain.
MedicalResearch.com: What should readers take away from your report?
Response: The lax laws in the US governing supplements permit the introduction of experimental drugs to be introduced over-the-counter without FDA approval.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: When present as a constituent of botanicals, higenamine is permitted in supplements because traditional botanical remedies are “grandfathered in” under the Dietary Supplement Health and Education Act of 1994. However, neither synthetic versions of constituents of botanicals nor dosages of natural stimulants above traditional levels are permitted as “grandfathered” ingredients according to the FDA’s 2016 draft guidance on new dietary ingredients. The guidance, however, remains in draft form and has not been finalized. The FDA should finalize the guidance so that the agency limits consumers’ exposure to large dosages of higenamine and similar stimulants when consuming supplements.
Disclosures: I collaborate with NSF International on research studies including this study.
Pieter A. Cohen, John C. Travis, Peter H. J. Keizers, Frederick E. Boyer, Bastiaan J. Venhuis. The stimulant higenamine in weight loss and sports supplements,. Clinical Toxicology, 2018; DOI: 10.1080/15563650.2018.1497171
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