Selective androgen receptor modulators (SARMs) are drugs under development for osteoporosis, cancer and Alzheimer’s disease, but Brian M. Parks admitted to selling these and other drug compounds as undeclared ingredients in products marketed as sports supplements and research chemicals.
By pleading guilty to federal charges, he and his Cary, North Carolina-based company MedFitRX, Inc. (now known as MedFit Sarmacuticals Inc.) face an agreed upon forfeiture of almost $1.2 million earned from products sold between June 2017 and September 2019. However, a plea agreement entered by Parks noted the full forfeiture would be due only if he missed an agreed payment of $.35 million by Feb. 15, 2021.
Parks appeared in U.S. District Court for the Western District of Virginia on Nov. 24 and was released the same day after posting an unsecured bond of $25,000. He waived his right to be charged by indictment and face a grand jury on one or more charges, and instead pleaded guilty to one count of introduction of unapproved new drugs into interstate commerce.
The felony charge carries a maximum sentence of 33 months in prison, although the plea agreement allows for a possible total three level reduction for accepting responsibility and cooperating with law enforcement, which would mean a maximum sentence of 24 months imprisonment. Sentencing is scheduled for Feb. 16, 2021.
Brazen SARMs and drug sales, shady business practices
According to court documents, Parks and MedFitRX imported SARMs and other drug ingredients from China from March 2016 to September 2019. The company dissolved in June 2019 and reincorporated as MedFit Sarmacuticals Inc. in September 2019. The defendants were accused of importing these compounds in a manner designed to avoid federal scrutiny, including labeling shipments as “biscuit mix powder,” “corn powder,” “grain mix powder,” “bread mix powder,” and “milk tea powder.”
According to the charges filed by the U.S. Attorney’s Office for the Western District of Virginia, the defendants developed, manufactured and labeled drug products in both North Carolina and Ohio, and they further marketed and distributed these products to the bodybuilding and fitness communities across the United States. The charges claim Parks and his company intended to mislead and defraud customers by misrepresenting these drug products as dietary supplements and failing to disclose the drug ingredients on the labels. They also falsely claimed the company was licensed and registered to sell SARMs.
Among the SARMs named in the charging documents were: Ostarine (Enobosarm, MK-2866), a GTx Inc. investigational new drug (IND); Ligandrol (LGD-4033), a developmental drug from Viking Pharmaceuticals; and Cardarine (Endorobol, GW501516), a collaboration from Glaxo SmithKline and Ligand Pharmaceuticals that was abandoned in 2007 after research linked the drug to increased organ cancer in animal subjects.
Other drug compounds listed as sold by the defendants in products named Black Magic, Kong, Winswole and others included hexadrone, methylstenbolone, trestolone, methylandrostanol, dimethazine, epiandrosterone and tamoxifen, according to prosecutors.
In May 2018, Parks sold two adulterated products to undercover federal agents: Lucky SARMS Magical AF, which contained the SARMs stenabolic (SR9009) and S-23; and Estrovert, which contained methyldienolone, an anabolic steroid prohibited under the Designer Anabolic Steroid Control Act of 2014 (DASCA).
According to court documents, Parks knew in October 2016 these drugs could cause severe health issues, including liver toxicity that could lead to the need for a liver transplant. Further, he tried to avoid federal scrutiny by not registering his company with FDA in 2016 and by telling his employees to hide the MedFitRX drug manufacturing and products from FDA inspectors auditing his other company located in the same facility, the now defunct Musclegen Research. (The Musclegen website forwards to Supps2Go, a new business run by Parks that sells the popular Musclegen product GenePro, and Musclegen’s Facebook page is transitioning to Supps2Go.)
As seen in many other sports-related SARMs businesses, Parks tried to bill his online sales of MedFitRX as “for research purposes only,” but DOJ charged he intended the products to be ingested by humans and even told a prospective customer he could not advise on dosages, instead directing them to his website SaRmsAndPros101.com (no longer active) for more dosage info.
“Parks and his company put his customers’ health at risk when he unlawfully distributed drugs without their being FDA approved,” Daniel Bubar, Acting U.S. Attorney for the Western District of Virginia, said in a DOJ press release. “FDA regulations are integral to safeguarding consumers, and I am proud of our federal team that took on this investigation to ensure the process and the public are protected.”
‘Enforcement works, laws unnecessary’
However, this advanced enforcement action is more the exception than the rule, despite several years of sports-focused brands selling SARMs and illegal steroids/prohormones as supplements or for research purposes. High-profile SARMs sellers such as Dr. Tony Huge and his company Enhanced Athlete, and Seth Williams and his companies Newroids and Newsarms have seemingly escaped advanced federal enforcement action.
Attorney Rick Collins, an expert on steroids and partner with Collins Gann McCloskey & Barry PLLC, acknowledged hundreds of SARMs and peptide companies have sold misbranded products for a long time, but only a small percentage have been prosecuted.
“Why don’t we see more prosecutions?” he asked, in an emailed statement. “My experience having defended a number of these cases across the country is that they are often initiated by one of a small number of FDA-OCI [Office of Criminal Investigations] agents familiar with the subject matter, and then adopted by one of a small number of federal prosecutors interested in investing resources into this area.”
Collins explained a few assistant U.S. attorneys located in certain districts have become knowledgeable about these types of imports and sales, and they are often involved in these prosecutions. “That’s typically how a defendant who lives in one state gets prosecuted in another—sometimes one in which he’s never set foot,” he said.
Collins believes the solution to the illegal SARMs and drug sales to sports and fitness users is enforcement, not more laws. “FDA has made it crystal clear: SARMs are not dietary ingredients and can’t be sold as dietary supplements,” he noted. “Prosecutions like this one demonstrate that we don’t need to pass a SARMs Control Act [which has been introduced several times] to investigate and successfully prosecute individuals and their companies who sell these substances as either ‘supplements’ or ‘research chemicals.’ Whether there will be more SARMs investigations, indictments and prosecutions in 2021 remains to be seen.”
In the DOJ press release, Acting Assistant Attorney General Jeffrey Bossert Clark, Civil Division, promised, “The Department of Justice will continue to work hand-in-hand with FDA to investigate and prosecute anyone who puts personal profit before public health.”