WASHINGTON — The dietary supplement industry’s leading trade associations and the U.S. Anti-Doping Agency on Wednesday joined in support of the U.S. Food and Drug Administration’s recent actions to protect consumers from body-building products containing Selective Androgen Receptor Modulators (SARMs) illegally marketed as dietary supplements.
"We are extremely concerned about unscrupulous companies marketing body-building products with potentially dangerous ingredients," advised Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, FDA. "Body-building 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,” he said. “We will continue to take action against companies marketing these products to protect the public health."
"Body-building products that contain SARMs have not been approved by the FDA and are associated with serious safety concerns.”The FDA recently issued warning letters to Infantry Labs, IronMagLabs and Panther Sports Nutrition for distributing products that contain SARMs.
"SARMs are dangerous and illegal, and they pose an immediate risk to consumers, jeopardize the careers of athletes, and have no place in any sports nutrition regimen," the trade associations noted in a joint release.
Together, the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association, the United Natural Products Alliance and USADA shared concerns about these products and are supporting FDA’s efforts to crack down on companies unlawfully manufacturing products containing SARMs.
Prohibited under the S1 Anabolic Agent category of the World Anti-Doping Agency Prohibited List, SARMs have raised serious concerns for FDA, USADA and the legitimate dietary supplement industry, as they have the potential to be misused for athletic performance enhancement due to their anabolic properties and their ability to stimulate androgen receptors in muscle and bone. SARMs are not approved for human use or consumption in the United States, but, despite being prohibited, SARMs have been found in a number of adulterated products falsely labeled as dietary supplements. Some products list the ingredient as
“Ostarine” — one ingredient in the class of SARMs — but the ingredients may also go by an alternative name, or be entirely undisclosed on the label.
In addition to alerting consumers, the five supplement industry trade associations have taken action to remind member companies of the responsibility to ensure that SARMs are not used in their products. FDA regulates the dietary supplement industry and this advisory puts companies on notice that those failing to comply with the law are subject to strict enforcement actions.
Additionally, the advisory serves as a reminder to consumers — particularly amateur and elite athletes — to educate themselves on the dangers SARMs-tainted products pose. There are legitimate sports nutrition dietary supplements that are safe, beneficial and not prohibited by WADA, and it is important for all consumers, including athletes, to engage in due diligence when deciding which products to use and which companies to purchase products from.