1. Regulation/Legislation
  2. Self-Regulation
  3. SARMs

CRN Recommended Guidelines for SARMs‐Containing Dietary Supplements

Self-regulation

Download printable PDF of guidelines, June 2018

PURPOSE  

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.  

VOLUNTARY GUIDELINES  

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.  

C. Implementation

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, 
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm581630.htm.