A judge in the U.S. District Court for the Western District of Virginia has sentenced Brian M. Parks to one year and one day in federal prison for introducing unapproved new drugs into interstate commerce with the intent to mislead FDA and defraud consumers. Per terms of his agreement, he forfeited US$350,000.
Parks pleaded guilty in December 2020, admitting he sold selective androgen receptor modulators (SARMs) as sports supplements and research chemicals through his Cary, North Carolina-based company MedFitRX, Inc. (also known as MedFit Sarmacuticals Inc.). He acknowledged selling SARMs including Ostarine (MK-2866), Ligandrol (LGD-4033), and Testolone (RAD-140) from June 2017 to September 2019.
In pleading guilty, he also accepted responsibility for importing raw drug materials with intent to avoid regulatory scrutiny, omitting the SARM ingredients from product labels, falsely claiming MedFitRX was licensed and registered to sell such drugs, and misrepresenting MedFitRX products as “dietary supplements” or “sports supplements” to imply they were safe and legal to use.
“When Parks marketed drugs masquerading as dietary supplements that had not been approved by the FDA, he sidestepped important safeguards to protect the public, and committed a serious crime,” said Acting U.S. Attorney Daniel P. Bubar of the Western District of Virginia. “Our office will continue to closely partner with the FDA to ensure safety and effectiveness in our drug supply.”
Catherine A. Hermsen, assistant commissioner for criminal investigations, FDA Office of Criminal Investigations (OCI), added such unapproved and potentially toxic drug products made and sold outside of FDA’s oversight are dangerous to unsuspecting consumers. “Today’s actions represent our continued commitment to pursuing and bringing to justice those who mislead the public and intentionally attempt to subvert the regulatory functions of the FDA through the distribution of unapproved and potentially dangerous products,” she said.