Brian Michael Parks, 47, of Apex, North Carolina, and MedFitRX Inc, now known as MedFit Sarmacuticals Inc., a sport supplement company based in Cary, North Carolina, previously pleaded guilty in U.S. District Court for the Western District of Virginia to one count of distributing unapproved new drugs with the intent to mislead and defraud the Food and Drug Administration (FDA) and consumers.
In pleading guilty, Parks admitted that from approximately June 2017 to September 2019, he and his company unlawfully distributed Selective Androgen Receptor Modulators (SARMs) and other substances that the FDA has not approved, including Ostarine (MK-2866), Ligandrol (LGD-4033), and Testolone (RAD-140). SARMs are synthetic chemicals designed to mimic the effects of 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. In connection with his sentence, Parks also forfeited $350,000.
“Bypassing the FDA drug approval process puts consumers at risk,” said Acting Assistant Attorney General Brian Boynton of the Justice Department’s Civil Division. “The department will continue to work with the FDA to investigate and prosecute the illegal distribution of supplements that contain dangerous ingredients.”
“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.”
“‘Sports supplements’ that are manufactured and distributed outside the FDA’s oversight and that contain unapproved and possibly toxic ingredients endanger the health of unsuspecting consumers,” said Assistant Commissioner for Criminal Investigations Catherine A. Hermsen, FDA Office of Criminal Investigations. “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.”
In pleading guilty, Parks also admitted that he intended to mislead and defraud the FDA and consumers by omitting ingredients on MedFitRX product labels, falsely claiming MedFitRX was licensed and registered to sell these new drugs, importing raw drug ingredients with the intent to avoid regulatory scrutiny, and misrepresenting MedFitRX products as “dietary supplements” or “sports supplements” to create the impression that they were safe and legal to use.
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 Civil Division’s Consumer Protection Branch prosecuted the case. This matter was investigated by the FDA’s Office of Criminal Investigations.
