"We are extremely concerned about unscrupulous companies marketing body-building products with potentially dangerous ingredients. 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,” said Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We will continue to take action against companies marketing these products to protect the public health."
Although the products identified in the warning letters are marketed and labeled as dietary supplements, they are not dietary supplements. The products are unapproved drugs that have not been reviewed by the FDA for safety and effectiveness, the agency stated.
Life threatening reactions, including liver toxicity, have occurred in people taking products containing SARMs. SARMs also have the potential to increase the risk of heart attack and stroke, and the long-term effects on the body are unknown. FDA said consumers should 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.
Healthcare professionals and consumers should also report any adverse events related to the use of these body-building products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.
The dietary supplement industry’s leading trade associations and the U.S. Anti-Doping Agency (USADA) have joined in support of FDA’s actions.
Together, 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 USADA share concerns about these products and are supporting FDA’s efforts to crack down on companies unlawfully manufacturing products containing 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,” they said in a joint statement.
As recognized in a recent FDA advisory, products containing these ingredients are not dietary supplements; they are unapproved drugs that have not been reviewed by the FDA for safety and effectiveness.
Prohibited under the S1 Anabolic Agent category of the World Anti-Doping Agency (WADA) 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 U.S., 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. USADA issues educational resources on an ongoing basis to warn athletes and sports organizations of the negative consequences resulting from using products that contain SARMs, including sanctions and suspension. The industry groups and USADA are committed to amplifying consumer alerts/warnings issued by FDA, and to disseminating tips consumers can use to make smart decisions when choosing sports nutrition 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,” the associations stated. “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. Further, consumers should maintain an open dialogue with healthcare practitioners, and, as appropriate, trusted coaches and trainers, when incorporating products into their training programs or performance goals. Finally, consumers would be wise to manage expectations for their sports nutrition supplement products and should not purchase dietary supplements claiming to have drug-like effects.”