Presence and Quantity of Botanical Ingredients With Purported Performance-Enhancing Properties in Sports Supplements

 Well! You're on your own with supplements, better start your own testing lab.

The supplements in the US have zero guarantee of purity or efficacy due to the fucking stupidity of the US Congress passing the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Presence and Quantity of Botanical Ingredients With Purported Performance-Enhancing Properties in Sports Supplements

Pieter A. Cohen, MD^1,2; Bharathi Avula, PhD³; Kumar Katragunta, PhD³; et al John C. Travis, BS⁴; Ikhlas Khan, PhD³

Author Affiliations Article Information

JAMA Netw Open. 2023;6(7):e2323879. doi:10.1001/jamanetworkopen.2023.23879

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Editorial

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• Invited Commentary
  Ensuring the Safety and Value of Supplements
  Peter Lurie, MD, MPH

Introduction

Since the US Food and Drug Administration (FDA) banned ephedra from dietary supplements in 2004, supplement manufacturers have promoted a complex variety of alternative botanical compounds for sports enhancement. Extracts of Rauwolfia vomitoria containing α-yohimbine, the caffeine-like compound methylliberine, the partial β₂-agonist halostachine, the plant steroid turkesterone, and norepinephrine-like octopamine are all found in plants and are promoted in dietary supplements for their stimulant or anabolic effects.^1-3

The FDA does not preapprove these ingredients, or any supplement ingredient, for either efficacy or safety before their introduction, but FDA inspections have found that supplement manufacturers often fail to comply with basic manufacturing standards, such as establishing the identity, purity, or composition of the final product. Given the products’ potentially complex physiologic effects and concerns regarding manufacturing quality, we determined the accuracy of dietary supplement labels declaring R vomitoria, methylliberine, halostachine, octopamine, and turkesterone.

Methods

Dietary supplement products were included in this case series if they were labeled as containing 1 of the following ingredients: R vomitoria, methylliberine, turkesterone, halostachine, or octopamine. All products were purchased online, and products were excluded if the actual label did not list 1 of the 5 ingredients. Powder from the dietary supplement products was reconstituted in methanol and analyzed for the presence and quantity of the 5 ingredients and FDA-prohibited ingredients by liquid chromatography quadrupole time-of-flight mass spectrometry. See the eAppendix in Supplement 1 for additional details.

Results

Of the 63 products purchased, 6 did not list 1 of the 5 ingredients on the label; therefore, 57 products were analyzed (13 listing R vomitoria; 21, methylliberine; 8, turkesterone; 7, halostachine; and 8, octopamine). Twenty-three of 57 products (40%) did not contain a detectable amount of the labeled ingredient. Of the products that contained detectable amounts of the listed ingredient, the actual quantity ranged from 0.02% to 334% of the labeled quantity (Table). Six of 57 products (11%) contained a quantity of the ingredient within 10% of the labeled quantity.

Seven of 57 products (12%) were found to contain at least 1 FDA-prohibited ingredient (Table). Five different FDA-prohibited compounds were found, including 4 synthetic simulants, 1,4-dimethylamylamine, deterenol, octodrine, oxilofrine, and omberacetam. Six products contained 1 of these prohibited ingredients, and 1 product contained 4 different prohibited ingredients.

Discussion

Eighty-nine percent of dietary supplement labels did not accurately declare the ingredients found in the products, and 12% of products contained FDA-prohibited ingredients. A prior study⁴ of dietary supplements, before the FDA ephedra ban, found that 6 of 12 products (50%) contained ephedra within 10% of the labeled amount. In a more recent study⁵ of caffeine content of sports supplements, 9 of 20 products (45%) contained a quantity of caffeine within 10% of the labeled quantity. In the current study, which to our knowledge is the first to quantify these 5 supplement ingredients, only 11% of products were accurately labeled and 5 different FDA-prohibited ingredients were found, including an unapproved drug available in Russia (ie, omberacetam), 3 drugs formerly available in Europe (ie, octodrine, oxilofrine, and deterenol), and 1 drug that has never been approved in any country (ie, 1,4-dimethylamylamine).⁶

The study has limitations, including that the sample size was small, only 1 sample of each brand was analyzed, and only supplements containing 1 of 5 targeted ingredients were analyzed. It is not known whether the results are generalizable to other botanical ingredients in sports supplements or whether quantities might also vary among batches within a given brand. Given these findings, clinicians should advise consumers that supplements listing botanical ingredients with purported stimulant or anabolic effects may not be accurately labeled and may contain FDA-prohibited drugs.

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Article Information

Accepted for Publication: May 21, 2023.

Published: July 17, 2023. doi:10.1001/jamanetworkopen.2023.23879

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2023 Cohen PA et al. JAMA Network Open.

Corresponding Author: Pieter A. Cohen, MD, Department of Medicine, Cambridge Health Alliance, 300 Broadway, Somerville, MA 02143 (pcohen@challiance.org).

Author Contributions: Drs Cohen and Avula had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.