Two US senators, Orrin Hatch and Sheldon Whitehouse, are pushing a bill to extend the US Drug Enforcement Administration’s (DEA) authority to regulate selective androgen receptor modulators (SARMs), in an attempt to remove illegal products containing these synthetic drugs from the market. Hatch and Whitehouse’s SARMs Control Act of 2018 has received letters of support from the US Anti-Doping Agency and Federal Law Enforcement Officers Association, as well as a number of associations in the dietary supplement industry.

SARMs, designed to mimic the effects of testosterone, have come under increased scrutiny over the past months due to serious safety concerns, including the potential to increase the risk of heart attack or stroke as well as other life-threatening reactions such as liver damage. SARM are not approved by the Food and Drug Administration (FDA) for human use, but are illegally marketed and sold as dietary supplements, and they are banned in all professional and college sports.

“SARMs are synthetic drugs that have negative effects similar to those of anabolic steroids,” Hatch says. “Even though SARMS are not approved by the FDA for human use and pose the same safety risks as anabolic steroids, they have proliferated under a regime in which they are not subject to the same controls. The SARMs Control Act closes this loophole to ensure that the DEA has the authority it needs to prevent abuse and diversion of these dangerous substances.”

“American consumers deserve to know if they’re buying seriously dangerous drugs slipped into everyday dietary supplements,” notes Whitehouse. “This bipartisan legislation will build on successful anti-designer steroids legislation we’ve already passed to help protect American consumers.”

The FDA recently issued warning letters to three companies for distributing products that contain SARMs, noting that the products are unapproved drugs that have not been reviewed by the FDA for safety and effectiveness.

The US Anti-Doping Agency and the Department of Defense Operation Supplement Safety program warn about the risks of SARMs. Despite these enforcement actions and education efforts, SARMs are increasingly being purchased through the Internet by athletes, recreational bodybuilders and members of the armed forces.

The SARMs Control Act of 2018 builds on the success of the Designer Anabolic Steroids Control Act of 2014 (Pub. L. No. 113-260) by extending the Drug Enforcement Administration’s authority to regulate anabolic steroids to include SARMs. Specifically, the SARMs Control Act of 2018 would:

• Amend the Controlled Substances Act (CSA) to add SARMs to the list of Schedule III controlled substances, ensuring that SARMs are regulated in the same manner as anabolic steroids;
• Add a definition of the term “SARM,” including a list of specified substances and a process for the Attorney General to add substances to the definition of SARM;
• Prohibit importing, exporting, manufacturing, distributing, dispensing, or possessing with intent to manufacture, distribute, or dispense any SARM, or any product containing a SARM, unless it is properly labeled;
• Add certain offenses related to SARMs to the definition of “felony drug offense” and the civil penalty provisions of the CSA; and
• Require that the FDA provide to the DEA information related to dietary supplements that the FDA determines may contain a SARM, as it already does for supplements that may contain anabolic steroids.

In response, the Council for Responsible Nutrition (CRN) notes that it has lobbied for the bill “because consumers are put at risk and the dietary supplement industry’s reputation is damaged by companies illegally marketing these unapproved drugs as dietary supplements.”

“We are grateful for the bipartisan support of Senators Hatch and Whitehouse, and we will work diligently with the bill sponsors and other lawmakers to advance and help pass this important legislation,” says Steve Mister, President & CEO, CRN.