The U.S. Department of Justice (DOJ) announced Tuesday that the owner of a sports supplement company has been sentenced to one year plus one day in federal prison after pleading guilty to distributing unapproved drugs.
In November 2020, Brian Michael Parks of Apex, North Carolina, and his company, MedFitRX (now MedFit Sarmacuticals Inc.) pleaded guilty in the Western District of Virginia to one count of unapproved drug distribution with intent to mislead and defraud the Food and Drug Administration (FDA) and consumers; the conduct took place from June 2017 to September 2019. Part of the guilty plea was his admittance to unlawfully distributing through his company selective androgen receptor modulators (SARMs), such as Ostarine, Ligandrol, and Testolone, which intend to mimic testosterone and other anabolic steroids.
“The FDA has long warned against the use of SARMs like those found in MedFit products, including stating in a publicly available 2017 warning letter to another firm that SARMs have been linked to life-threatening reactions including liver toxicity, and have the potential to increase the risk of heart attack and stroke,” the DOJ release said.
Further, Parks admitted in his guilty plea that he intentionally omitted ingredients on his company’s product labels, falsely claimed that his company was properly licensed and registered to sell the products, imported “raw drug ingredients” to “avoid regulatory scrutiny,” and marketed his company’s products as “dietary” or “sports” supplements, feigning their safety and legality, according to the release.
“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,” acting U.S. Attorney Daniel P. Bubar of the Western District of Virginia said. “Our office will continue to closely partner with the FDA to ensure safety and effectiveness in our drug supply.”
The FDA’s Office of Criminal Investigations investigated the case. Prosecutors of the case were Assistant U.S. Attorney Randy Ramseyer of the U.S. Attorney’s Office for the Western District of Virginia and Trial Attorney Speare Hodges of the DOJ Civil Division’s Consumer Protection Branch.
