Apex, NC—A North Carolina resident and his sports nutrition company have pled guilty to a felony charge relating to the introduction of unapproved new drugs into interstate commerce, according to the Department of Justice.
Brian Michael Parks, of Apex, NC, and his company MedFitRX, Inc., also known as MedFit Sarmaceuticals Inc, based in Cary, NC, pled guilty in the U.S. District Court for the Western District of Virginia. Parks admitted that between June 2017 and September 2019, he and his company unlawfully distributed Selective Androgen Receptor Modulators (SARMs) and other unapproved substances including Ostarine, Ligandrol, and Testolone.
FDA has been warning against SARMs for years, according to the DOJ’s statement, noting that SARMs have been linked to liver toxicity and could increase the risk of heart attack and stroke.
Parks also admitted that he intended to mislead and defraud FDA and consumers by omitting ingredients on MedFitRX product labels, falsely claiming that his company was licensed and registered to sell the new drugs, and misrepresenting MedFitRX products as dietary supplements or sports supplements.
“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 in the statement. “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,” added 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 has agreed to forfeit $1.2 million, reflecting the amount of product he sold across the country in retail stores and on the internet.
“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.”