Mentor Man Indicted For Selling Drugs Not Approved By The FDA
A Mentor man was indicted for marketing and selling at least $220,000 worth of suntan and/or erectile dysfunction drugs that were not approved by the Food and Drug Administration, said Steven M. Dettelbach, United States Attorney for the Northern District.
Timothy J. Parr, 31, was indicted in federal court on one count to distributing misbranded drugs.
“These regulations are mandated to ensure drugs made available to the public are safe and have been properly tested,” Dettelbach said. “This defendant ignored those regulations in an effort to make money.”
“Today’s announcement demonstrates the continued commitment of FDA's Office of Criminal Investigations to aggressively pursue those who distribute unapproved and misbranded drugs,” said Special Agent in Charge Antoinette V. Henry of FDA’s Office of Criminal Investigations. “We will remain vigilant in our efforts to protect consumers from these potentially dangerous products.”
Parr formed U.S. Lab Research, Inc., and later, U.S. Lab Exports, Inc., which he operated from his home. The businesses existed to market and sell drugs over the Internet which had not been approved by the FDA, according to the indictment.
Parr, through U.S. Lab Research, Inc., and later, U.S. Lab Exports, Inc., sold injectable peptide drug products and injection aids to consumers over various web sites. These products included Melanotan I, Melanotan II and Bremalanotide, which were unapproved injectable drugs. Melanotan I and Melanotan II were marketed as producing the equivalent of a sun tan while Bremalanotide was known to cause erections in male subjects, according to the indictment.
From 2008 through December 2010, Parr sold approximately $220,000 in misbranded drugs, according to the indictment.
Parr, through his companies, marketed the drugs as “for research only” and “not for human use,” which he did to avoid FDA scrutiny.” He also labeled containers as “sun screen” to avoid scrutiny, according to the indictment.
This case is being prosecuted by Assistant U.S. Attorney James V. Moroney following an investigation by the FDA’s Office of Criminal Investigations.
If convicted, the defendant’s sentence will be determined by the court after a review of the federal sentencing guidelines and factors unique to the case, including the defendant’s prior criminal record (if any), the defendant’s role in the offense and the characteristics of the violation.
An indictment is only a charge and is not evidence of guilt. A defendant is entitled to a fair trial in which it will be the government’s burden to prove guilt beyond a reasonable doubt.