The associations, along with the U.S Anti-Doping Agency, said that they support FDA’s recent efforts to crack down on the unlawful manufacturing of body-building products containing selective androgen receptor modulators.
The American Herbal Products Association (Silver Spring, MD), the Consumer Healthcare Products Association (Washington, DC), the Council for Responsible Nutrition (Washington, DC), the Natural Products Association (Washington, DC), and the United Natural Products Alliance (Salt Lake City), announced that they have joined forces with the U.S. Anti-Doping Agency (USADA) to combat the unlawful manufacturing of body-building products containing illegal and dangerous ingredients known as selective androgen receptor modulators (SARMs). The associations, along with USADA, said that they support FDA’s recent efforts to crack down on the unlawful manufacturing of body-building products containing these ingredients.
As Nutritional Outlook previously reported, the issue of sports-supplement adulteration has seen significant improvement since the passage of the Designer Anabolic Steroid Control Act of 2014 (DASCA). DASCA named many anabolic agents that are considered “controlled”; however, since that amendment, many other metabolic agents not specifically named in the regulation, including SARMs, have found their way into the market. Products containing SARMs are, in some instances, being marketed as dietary supplements, but are in fact unapproved drugs that the trade associations state “have not been reviewed by the FDA for safety and effectiveness.”
According to the associations, SARMs are highly dangerous, and “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.” Further, SARMS are not approved for human use or consumption in the U.S. under the S1 Anabolic Agent category of the World Anti-Doping Agency (WADA) Prohibited List. Thus, FDA, USADA, and the dietary supplement industry are focusing efforts on rooting out adulterated products containing SARMs, sometimes listed as “Ostarine” on product labels. Ostarine, the organizations note, is one ingredient that falls within the SARMS ingredient category, though the ingredients may also appear on labels under alternative names, or be entirely undisclosed.
The supplement industry organizations have taken steps to ensure that products containing SARMs are located and removed from the market. Specifically, the associations have alerted consumers to the dangers of using products containing SARMs. They have also “taken action to remind member companies of the responsibility to ensure that SARMs are not used in their products.” USADA, for its part, issues ongoing educational resources to inform athletes and sports organizations of the negative consequences of using products that contain SARMs, which include sanctions and suspension.
In a press release, the industry groups state that they, alongside 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’s advisory regarding products containing SARMS states that companies that fail to comply with the law are subject to strict enforcement actions. Ultimately, FDA advises, it is highly important that consumers educate themselves about SARMs-tainted products. While there are many legitimate sports nutrition supplements that are safe and beneficial, it says, consumers should be wary of products claiming to have drug-like effects.