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Owner Of Bodybuilding Drug Company Pleads Guilty To Selling Misbranded Drugs
Drugs Sold for Bodybuilding Enhancements Were Not Approved for Human Consumption
January 14, 2015
Greenbelt, Maryland
Gregory Tamborello, age 65, of Lutz, Florida, pleaded guilty today to selling misbranded drugs, in connection with the sale of bodybuilding drugs to consumers which were not approved by the FDA for human use.
The guilty plea was announced by United States Attorney for the District of Maryland Rod J. Rosenstein and Special Agent in Charge Antoinette V. Henry of the U.S. Food & Drug Administration, Office of Criminal Investigations.
“We will aggressively pursue those who endanger the public health by distributing unapproved and potentially unsafe drugs,” said Antoinette V. Henry, Special Agent in Charge, FDA’s Office of Criminal Investigations. “We will remain vigilant in protecting the public from the purveyors of these illegal and dangerous products.”
According to his plea agreement, from March to August 2012, Tamborello owned and operated Precision Peptides, located in Lutz, Florida, through which he sold body-enhancing injectable drugs to individuals seeking to enhance their physiques. These drugs were not approved by the FDA for use in humans.
Tamborello sought buyers for his drugs by placing ads in bodybuilding magazines and websites, promoting his business at bodybuilding conferences and by offering drugs for sale on his website. His website displayed numerous disclaimers stating that all products sold were for “research/laboratory use only.”
Additionally, prior to purchasing the products from the website, each customer was asked to certify that he or she read the disclaimer that the “chemicals/materials for sale here are . . . not intended for human ingestion.” Yet Tamborello intended that the products be used by consumers for bodybuilding purposes, and knew that consumers were in fact using them for that purpose.
The drugs Tamborello sold included Mechano Growth Factor, Myostatin Propeptide, and T3 (Liothyronine), none of which the FDA has approved for use in humans.
On May 8, 2012, an undercover federal agent ordered drugs from Tamborello’s website. Tamborello shipped two vials of “mechano growth factor,” a vial each of “Myostatin Propeptide,” “Delta Sleep Inducing Peptide,” “T3 (Liothyronine),” “DHEA,” and three vials of “Sildenafil Citrate” to Columbia, Maryland. Tamborello provided no directions for use of the drugs or adequate warnings on the packages.
From March to August 2012, Precision Peptides generated at least $210,000 in revenue.
Tamborello faces a maximum sentence of one year in prison and a $100,000 fine. U.S. District Judge George J. Hazel has scheduled sentencing for April 17, 2015 at 9:30 a.m.
United States Attorney Rod J. Rosenstein commended the FDA Office of Criminal Investigations for its work in the investigation and thanked Assistant U.S. Attorney Kelly O. Hayes, who is prosecuting the case.
http://www.justice.gov/usao/md/news...panyPleadsGuiltyToSellingMisbrandedDrugs.html
Drugs Sold for Bodybuilding Enhancements Were Not Approved for Human Consumption
January 14, 2015
Greenbelt, Maryland
Gregory Tamborello, age 65, of Lutz, Florida, pleaded guilty today to selling misbranded drugs, in connection with the sale of bodybuilding drugs to consumers which were not approved by the FDA for human use.
The guilty plea was announced by United States Attorney for the District of Maryland Rod J. Rosenstein and Special Agent in Charge Antoinette V. Henry of the U.S. Food & Drug Administration, Office of Criminal Investigations.
“We will aggressively pursue those who endanger the public health by distributing unapproved and potentially unsafe drugs,” said Antoinette V. Henry, Special Agent in Charge, FDA’s Office of Criminal Investigations. “We will remain vigilant in protecting the public from the purveyors of these illegal and dangerous products.”
According to his plea agreement, from March to August 2012, Tamborello owned and operated Precision Peptides, located in Lutz, Florida, through which he sold body-enhancing injectable drugs to individuals seeking to enhance their physiques. These drugs were not approved by the FDA for use in humans.
Tamborello sought buyers for his drugs by placing ads in bodybuilding magazines and websites, promoting his business at bodybuilding conferences and by offering drugs for sale on his website. His website displayed numerous disclaimers stating that all products sold were for “research/laboratory use only.”
Additionally, prior to purchasing the products from the website, each customer was asked to certify that he or she read the disclaimer that the “chemicals/materials for sale here are . . . not intended for human ingestion.” Yet Tamborello intended that the products be used by consumers for bodybuilding purposes, and knew that consumers were in fact using them for that purpose.
The drugs Tamborello sold included Mechano Growth Factor, Myostatin Propeptide, and T3 (Liothyronine), none of which the FDA has approved for use in humans.
On May 8, 2012, an undercover federal agent ordered drugs from Tamborello’s website. Tamborello shipped two vials of “mechano growth factor,” a vial each of “Myostatin Propeptide,” “Delta Sleep Inducing Peptide,” “T3 (Liothyronine),” “DHEA,” and three vials of “Sildenafil Citrate” to Columbia, Maryland. Tamborello provided no directions for use of the drugs or adequate warnings on the packages.
From March to August 2012, Precision Peptides generated at least $210,000 in revenue.
Tamborello faces a maximum sentence of one year in prison and a $100,000 fine. U.S. District Judge George J. Hazel has scheduled sentencing for April 17, 2015 at 9:30 a.m.
United States Attorney Rod J. Rosenstein commended the FDA Office of Criminal Investigations for its work in the investigation and thanked Assistant U.S. Attorney Kelly O. Hayes, who is prosecuting the case.
http://www.justice.gov/usao/md/news...panyPleadsGuiltyToSellingMisbrandedDrugs.html