A North Carolina resident and his sport supplement company pleaded guilty today to a felony charge relating to the introduction of unapproved new drugs into interstate commerce, the Department of Justice announced.
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, 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. 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 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.
“Drugs must undergo FDA approval to ensure they are safe and effective for the public, and this defendant put consumers at risk by deliberately ignoring that process,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division. “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.”
“FDA enforces laws that are designed to protect the public health by ensuring, among other things, that drugs are safe and effective for their intended uses. Drugs disguised as supplements, of unknown origin and possibly toxic ingredients, that are manufactured and distributed outside the FDA’s oversight, endanger consumers,” said Assistant Commissioner for Criminal Investigations Catherine A. Hermsen. “We remain committed to pursuing and bringing to justice those who mislead the public and attempt to subvert the regulatory functions of the FDA by distributing unapproved and potentially dangerous products.”
“Parks and his company put his customers’ health at risk when he unlawfully distributed drugs without their being FDA approved,” said Acting U.S. Attorney Bubar. “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.”
In connection with his plea, Parks agreed to forfeit $1.2 million, reflecting the amount of MedFitRX products he sold across the United States through retail outlets and over the internet.
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.
U.S. District Judge James P. Jones heard the defendants’ guilty pleas in federal court in Abingdon, Virginia, and set sentencing for Feb. 16, 2021.
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 Department of Justice Civil Division’s Consumer Protection Branch are prosecuting the case. This matter was investigated by the FDAs Office of Criminal Investigations.
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Author: November 25, 2020