New legislation introduced yesterday in the U.S. Senate would give the Drug Enforcement Administration (DEA) increased power to enforce against selective androgen receptor modulators, or SARMs. SARMs are synthetic drugs designed to mimic the effects of testosterone and are unapproved for use in dietary supplements but are sometimes found in products such as sports supplements targeting bodybuilders. The SARMs Control Act of 2018 introduced yesterday by Senators Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI) would add SARMs to the DEA’s list of Schedule III drugs and ensure that SARMs are regulated similarly to anabolic steroids.
FDA has not approved SARMs for use by humans and recently ramped up efforts to enforce against products marketed as dietary supplements illegally containing SARMs. Last October, the agency announced it had sent warning letters to three companies marketing dietary supplements containing SARMs. In a press statement, Donald D. Ashley, JD, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, said, “Bodybuilding products that contain selective androgen receptor modulators, or SARMs, have not been approved by the FDA and are associated with serious safety concerns, including potential to increase the risk of heart attack or stroke and life-threatening reactions like liver damage. We will continue to take action against companies marketing these products to protect the public health.”
The bipartisan SARMs Control Act of 2018 extends the power the DEA has under the 2014 Designer Anabolic Steroids Control Act, to include authority over SARMs. In addition to adding SARMs to the list of Schedule III drugs, the bill prohibits the illegal import, export, manufacture, and distribution of SARMs.
“SARMs are synthetic drugs that have negative effects similar to those of anabolic steroids,” said Senator Hatch in a press statement. “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.”
The bill received wide support from leaders of the dietary supplement industry, who have vocally advocated the need to ban SARMs from supplements. Last fall, industry associations joined the U.S. Anti-Doping Agency to warn consumers about SARMs in supplements. Following the introduction of the new SARMs Control Act, supplement industry associations, plus Travis Tygart, president and CEO, U.S. Anti-Doping Agency, released a joint statement showing support. Supplement industry leaders included Michael McGuffin, president, American Herbal Products Association (AHPA; Silver Spring MD); Scott Melville, president and CEO, Consumer Healthcare Products Association (Washington, DC); Steve Mister, president and CEO, Council for Responsible Nutrition (CRN; Washington, DC); and Loren Israelsen, president, United Natural Products Alliance (UNPA; Washington, DC). The statement reads: “Each of our organizations has consistently supported efforts to enact and enforce laws to protect consumers, eliminate bad actors marketing illegal substances masquerading as legal products, and prosecute criminals who manufacture and sell them. Your bill will help move toward this goal. The SARMs Control Act is a bold step, adding teeth to prevention and enforcement efforts in the battle against illegal substances being marketed as legitimate products. The dietary supplement industry and USADA stands ready to work with you and all of Congress to deliver a strong bill to the President.”