Brian Michael Parks, 47, of Apex, North Carolina, was sentenced to one year and one day in federal prison after pleading guilty to introducing unapproved new drugs into interstate commerce.
Parks, the owner of 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 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.
Brian Michael Parks, 47, of Apex, North Carolina, was sentenced to one year and one day in federal prison. The sentence was handed down after he pleaded guilty to distributing unapproved new drugs with the intent to mislead and defraud the FDA and consumers. The crime occurred from approximately June 2017 to September 2019.
Brian Boynton, Acting Assistant Attorney General of the Justice Department’s Civil Division, stated, “Bypassing the FDA drug approval process puts consumers at risk. The department will continue to work with the FDA to investigate and prosecute the illegal distribution of supplements that contain dangerous ingredients.”
Brian Michael Parks admitted to intentionally 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.
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Key Facts
- State: North Carolina
- Category: Drug Trafficking
- Source: DOJ Press Release â†â€â€
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