The FDA has recently issued a consumer warning about the use of SARMs, or selective androgen receptor modulators, in bodybuilding products. The administration wants against the potentially dangerous ingredients that pose serious health concerns to consumers, including (but not limited to) increased risk of heart attack, stroke, and life-threatening liver toxicity.
The long-term health effects of SARMs are still unknown. In a statement, Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said, “We will continue to take action against companies marketing these products to protect the public health.”
Infantry Labs, LLC, IronMagLabs and Panther Sports Nutrition are among companies that have received warning letters from the FDA regarding the inclusion of SARMs in their sports performance supplements. The FDA states the products distributed by these companies contain unapproved drugs marketed as dietary supplements, when they are explicitly not to be classified such.
In response, five major trade associations serving the natural products industry have banded with the U.S. Anti-Doping Agency (USADA) in solidarity with the FDA. The trade associations in support of the FDA’s consumer warning include the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), the United Natural Products Alliance (UNPA), and the USADA. According to a press release, the organizations “share concerns about these products and are supporting FDA’s efforts to crack down on companies unlawfully manufacturing products containing SARMs.”
SARMs, which some dub the “new steroid,” can be difficult to identify because they are sold under many different names. Ingredients that contain SARMs include: ACP-105, Ostarine, Andarine (S4), BMS-564929, GLPG0492, GLPG0634, GSK2849466, GSK971086, GSK2881078, GSK2849866, LG-121071, LGD-2226, LGD-3303, LGD-4033 (now VK 5211), LY2452473 (now TT701), MK-3984, ostarine/enobosarm, RAD-140, S-101479, S107, S23, S-40503, S6, S9.
The FDA has advised consumers to stop using these body-building products immediately and consult a health care professional if they are experiencing any adverse reactions that may be associated with their use. Any adverse reactions related to these products can be reported via the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.