UPDATED on Aug. 1, 2017
USADA has issued a warning to athletes that ostarine, a selective androgen receptor modulator (SARM), is not approved for human consumption but has been the cause of numerous positive doping tests involving sports supplements.
“Sometimes it’s on the label, sometimes it’s not," said Travis Tygart, CEO of USADA.
In its July 25 advisory, USADA reported a recent uptick in supplement contamination and supplement-related incidences involving ostarine. The agency said it has logged 13 doping cases involving the use or possession of ostarine dating back to 2014.
“[These compounds] are prohibited in sport," Tygart said, adding SARMs are not legal in dietary supplements. “It’s also a health concern."
USADA warned that even when supplement labels declare ostarine, it can be called many different names, including MK-2866, enobosarm, (2S)-3-(4-cyanophenoxy)-N-[4-cyano-3-(trifluoromethyl)phenyl]-2-hydroxy-2-methylpropanamide, and GTx-024.
Ostarine in dietary supplements
Ostarine has been developed by pharmaceutical company GTx Inc. under an Investigative New Drug (IND) application. According to FDA, “substantial clinical investigations have been instituted and made public with regard to treatment of cancer cachexia, or muscle wasting." The compound is only legally available for investigational (i.e. research) use.
The World Anti-Doping Agency (WADA) banned ostarine back in 2008.
FDA sent a warning letter to supplement company Biogenix USA LLC back in 2014, advising ostarine was not a legal dietary ingredient.
In 2015, the agency issued a consumer advisory about a bodybuilding supplement from Extreme Products Group (EPG) that claimed to contain anabolic steroids, and INSIDER discovered several other EPG products contained prohormones and ostarine.
In 2016, GTx told INSIDER it had become aware of companies selling dietary supplements purported to contain ostarine, which would be in violation of GTx patent and trademark rights, not to mention federal law. GTx employed lawyers and internet investigators to root out and stop this practice, and many such violators agreed to stop selling ostarine.
GTx said it also notified FDA of its concerns and had engaged the agency, including its Office of Criminal Investigation (OCI).
In May 2017, FDA announced a voluntary recall of all lots of Tri-Ton brand supplements from Dynamic Technical Formulations was issued after tests showed the products contained ostarine and fellow SARM andarine.
In the absence of consistent federal action against dietary supplements adulterated with SARMs, a string of competitor lawsuits were filed beginning in 2015 against companies making sports supplements containing ostarine, alleging unfair competition.
Sports nutrition moving on from Ostarine?
In its current advisory, USADA noted 36 sports supplements on its High-Risk List were labeled or found to contain ostarine.
INSIDER researched many of the supplements that were put on the list for containing ostarine—several date back to 2015—and most appeared to have been withdrawn from sale or reformulated to remove ostarine.
USADA doesn’t necessarily follow-up with every product listed on the High-Risk List, but it welcomes positive change.
“While we don’t know whether or not the products have been reformulated, which in our opinion they all should be, we certainly hope the awareness being raised on the matter will lead to the removal of illegal products in dietary supplements," a USADA spokesperson told INSIDER.
Despite the progress in removing SARMs from dietary supplements, some marketers still sell such products.
Some overseas brands and suppliers are selling SARMs as sports supplements. For example, U.K. company Alphaform Labs advertises several SARM supplements on its website and notes distribution in Europe.
Even stateside there are holdouts.
Enhanced Athlete, a Cheyenne, Wyoming-based brand owner, still shows products for sale (backordered) containing ostarine, andarine, ligandrol (LGD-4033, patented by Ligand Pharmaceuticals and developed/investigated by Viking Therapeutics as VK-5211 for hip fracture recovery) and other SARMs.
“We are prepared for a raid, I’ll just say that," said Enhanced Athlete founder Anthony Hughes (aka Dr. Tony Huge), in a YouTube video posted in March 2017. “I am an attorney; I’m a strategist. I assume that we will be raided and for no good reason other than the government wants to suppress our ability to get things to become superhuman."
In the clip, Hughes said any raid of his company would likely be by FDA for selling a drug not approved for human consumption. He stated the government is a nanny state and the regulatory system is set up to benefit the wealthy pharmaceutical industry, which has many high-powered lobbyists.
“[Trump] is the first president who isn’t owned by special interests," Hughes stated, in the video. “Whether people love him or hate, I think there is going to be a kind of revolution in our government as far as changing its priorities."
FDA referred INSIDER’s inquiry on ostarine/SARMs to the agency’s Center for Drug Evaluation and Research (CDER), which divulged little about its policies or enforcement priorities related to ostarine.
“As a public health agency, we are committed to doing everything we can to protect the American public, not only through regulation and enforcement, but also through education, outreach, and collaboration with entities outside FDA," CDER said, in an emailed statement. “As a policy matter, the FDA cannot discuss pending or potential enforcement actions except with the firms or individuals who are subject of those actions."
However, CDER assured INSIDER, "FDA is concerned with products labeled/marketed as dietary supplements that contain SARMs."
USADA eyes legislative solution on SARMs
USADA is concerned about the ongoing issue of SARMs in sports supplements and is hoping to change regulation and even the law.
“We are … looking at legislative options and working with the industry to … get it off the market," Tygart said, advising athletes to be cautious and manage the risk in the meantime.
A spokesperson from USADA told INSIDER legislative efforts could resemble those of the Designer Anabolic Steroid Control Act (DASCA), which was passed into law on a bipartisan basis and had the support of the dietary supplement industry, sports organizations and health groups.
“We hope to engage in a similar process to address the issue of SARMs being illegally placed, sometimes without the knowledge of consumers, in otherwise safe and healthy nutritional supplements," the spokesperson said. “We’ve already reached out to some in the industry and hope to collaborate with them and others to create an achievable solution to rid the market of these illegal and risky products."
For more, check out the Healthy INSIDER Podcast SARMs in Sports Nutrition, featuring Rick Collins, an expert on sports supplements and partner with the New York-based law firm Collins Gann McCloskey & Barry PLLC.
Collins is also speaking about the dark side of sports nutrition in the sports nutrition workshop at this year’s SupplySide West trade show in Las Vegas.