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. 2017 Nov 28;318(20):2004-2010.
doi: 10.1001/jama.2017.17069.

Chemical Composition and Labeling of Substances Marketed as Selective Androgen Receptor Modulators and Sold via the Internet

Ryan M Van Wagoner  1 , Amy Eichner  2 , Shalender Bhasin  3 , Patricia A Deuster  4 , Daniel Eichner  1
Affiliations

Chemical Composition and Labeling of Substances Marketed as Selective Androgen Receptor Modulators and Sold via the Internet

Ryan M Van Wagoner et al. JAMA. .

Erratum in

Abstract

Importance: Recent reports have described the increasing use of nonsteroidal selective androgen receptor modulators, which have not been approved by the US Food and Drug Administration (FDA), to enhance appearance and performance. The composition and purity of such products is not known.

Objective: To determine the chemical identity and the amounts of ingredients in dietary supplements and products marketed and sold through the internet as selective androgen receptor modulators and compare the analyzed contents with product labels.

Design and setting: Web-based searches were performed from February 18, 2016, to March 25, 2016, using the Google search engine on the Chrome and Internet Explorer web browsers to identify suppliers selling selective androgen receptor modulators. The products were purchased and the identities of the compounds and their amounts were determined from April to August 2016 using chain-of-custody and World Anti-Doping Association-approved analytical procedures. Analytical findings were compared against the label information.

Exposures: Products marketed and sold as selective androgen receptor modulators.

Main outcomes and measures: Chemical identities and the amount of ingredients in each product marketed and sold as selective androgen receptor modulators.

Results: Among 44 products marketed and sold as selective androgen receptor modulators, only 23 (52%) contained 1 or more selective androgen receptor modulators (Ostarine, LGD-4033, or Andarine). An additional 17 products (39%) contained another unapproved drug, including the growth hormone secretagogue ibutamoren, the peroxisome proliferator-activated receptor-δ agonist GW501516, and the Rev-ErbA agonist SR9009. Of the 44 tested products, no active compound was detected in 4 (9%) and substances not listed on the label were contained in 11 (25%). In only 18 of the 44 products (41%), the amount of active compound in the product matched that listed on the label. The amount of the compounds listed on the label differed substantially from that found by analysis in 26 of 44 products (59%).

Conclusions and relevance: In this limited investigation involving chemical analyses of 44 products marketed as selective androgen receptor modulators and sold via the internet, most products contained unapproved drugs and substances. Only 52% contained selective androgen receptor modulators and many were inaccurately labeled.

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Conflict of interest statement

Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Bhasin reported receiving investigator-initiated research grants from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Child Health and Human Development, the National Institute on Aging, the National Institute of Nursing Research, Abbott, Ligand, Transition Therapeutics, Regeneron, Novartis, Althea, Biosensics, Merck, AbbVie, Transition Therapeutics, Metro International Biotechnology, and Takeda Pharmaceuticals (these grants were managed by the Brigham and Women’s Hospital); receiving consulting fees from AbbVie, Novartis, Sanofi, and Regeneron; owning an equity interest in FPT LLC; serving as the chair of the Endocrine Society’s expert panel that developed guideline for testosterone therapy of androgen deficiency in men; and serving on the American Board of Internal Medicine Endocrinology Board’s examination writing committee from 2006 to 2015 and as this committee’s chair from 2011 to 2015. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow of Tested Products Through the Systematic Search and Analytical Process
Figure 2.
Figure 2.. Pharmacological Classes of Appearance and Performance Enhancing Substances Found in the Search
SARM indicates selective androgen receptor modulator; and PPAR-δ, peroxisome proliferator-activated receptor-δ. aIndicates trade name.
See this image and copyright information in PMC

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