MedFit Rx sold ‘dietary supplements’ that contained as many as SIX different SARMs in a single product.
Brian Parks, the owner of MedFit Rx Inc., was sentenced to one year and one day in federal prison on February 16, 2021. Parks previously pleaded guilty to one count of distributing unapproved new drugs with the intent to mislead and defraud the Food and Drug Administration (FDA) and consumers.
Parks was convicted as a result of his company’s sale of selective androgen receptor modulators (SARMs). MedFit Rx sold multiple SARM products as “dietary supplements” and “sports supplements”.
Parks also forfeited $1.2 million as part of his plea agreement. The forfeiture represented the amount of money MedFit Rx generated from the sale of its SARM-based products across the United States between June 2017 and September 2019.
MedFit Rx’s SARM products included “BEAST” and “KONG”.
KONG was advertised as containing 5 different SARMs as ingredients – 25mg Ostarine (MK-2866), 10mg Ligandrol (LGD-4033), 6mg Testolone (RAD-140), Ibutamoren (MK-677), and 20mg Cardarine (GW-501516). However, the latter two compounds are not SARMs.
BEAST was advertised as containing 6 different SARMs. It contained lower dosages of the aforementioned ingredients. And it also contained 11.5mg of the SARM known as YK-11.
Parks admitted falsely claiming that MedFit Rx was licensed and registered to sell unapproved new drugs such as SARMs. He took measures to avoid regulatory scrutiny when importing the raw SARM ingredients from China. He also falsely misrepresented that SARM products as dietary supplements.
The FDA noted that selling unapproved new drugs masquerading as “dietary supplements” creates the false impression that the products are safe and legal to use.
The FDA made it publicly known that it considered SARMs an unapproved new drug with potentially dangerous side effects when it sent a warning letter to Panther Sports Nutrition in October 2017. The agency made it clear that SARMs were not dietary supplement and were illegal to sell as such.
The FDA has shown little sympathy for companies that continued to sell SARMs after October 2017.
MedFit Rx started selling SARMs as early as June 2017 and continued to sell the products for several months following the very public FDA warning letter. In fact, MedFit Rx did not stop selling the products until federal prosecutors accused the company of felony charges.
“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.”