The Food and Drug Administration (FDA) has expressed concerns that selective androgen receptor modulators (SARMs), found in products marketed as dietary supplements, have been associated with serious safety risks, including potential to increase the risk of heart attack or stroke, and life threatening reactions like liver damage.1 FDA currently takes the position that products containing SARMs do not meet the definition of a dietary supplement.2
With regard to SARMs, CRN recommends that its members follow the voluntary guidelines described below for their dietary supplement products, and encourages all dietary supplement producers and marketers to follow these recommendations. These guidelines address the distribution and marketing of dietary supplement products containing SARMs.
A. Definition of SARMs for Purposes of this Voluntary Guideline
SARMs are a class of compounds that have similar properties to anabolic steroids, but that are not classified as anabolic steroids. For purposes of this voluntary guideline, the term SARM means a selective androgen receptor modulator, including, but not limited to, ostarine (MK‐2866), ligandrol (LGD‐4033), and other compounds that are considered part of this class.
B. Restraints Against the Distribution and Marketing of SARMs
CRN members should not distribute or market dietary supplement products containing SARMs to consumers.
Effective immediately, CRN recommends that dietary supplement companies comply with these guidelines.
Effective: June 14, 2018
1 FDA In Brief: FDA Warns against using SARMs in body‐building products, Oct. 13, 2017, available at, https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm583021.htm.
2FDA Warning Letter to Infantry Labs LLC (October 23, 2017), available at, https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm582685.htm; FDA Warning Letter to Ironmag Labs (October 23, 2017), available at,
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm582464.htm; FDA Warning Letter to Panther Sports Nutrition (October 23, 2017), available at,