May 9, 2016: Owner of Bodybuilding Drug Companies Sentenced for Selling Misbranded Drugs
Greenbelt, Maryland – U.S. District Judge George J. Hazel sentenced Gavin Burns Smith, age 45, of New Port Richey, Florida, today to six months of home confinement followed by three years of probation for selling peptides to bodybuilders which were not approved by the FDA for human use. Judge Hazel also entered an order requiring Smith to forfeit $2,102,684.06, the value of the misbranded drugs subject to seizure.
The sentence was announced by United States Attorney for the District of Maryland Rod J. Rosenstein and Special Agent in Charge Mark McCormack of the U.S. Food & Drug Administration, Office of Criminal Investigations’ Metro Washington Field Office.
“Non-FDA approved drugs may be dangerous and contain unknown and harmful ingredients.” said Mark S. McCormack, Special Agent in Charge, FDA Office of Criminal Investigations’ Metro Washington Office. “As we did in this case, we will continue to protect the public by bringing these peddlers of dangerous unapproved drugs to justice.”
According to his plea agreement, from 2010 to April 2012, Smith owned and operated Precision Peptides, located in Lutz, Florida; and from April 2012 to May 2015, he owned and operated DNA Peptides, located in New Port Richey, Florida. Smith placed advertisements on the companies’ websites and sold body-enhancing injectable drugs to individuals seeking to enhance their physiques. These drugs were not approved by the FDA for human use.
On August 22, 2012, law enforcement executed federal search warrants at Precision Peptides and DNA Peptides. At some time thereafter, Smith began operating DNA Peptides out of his residence and continuing to sell drugs using a different website to avoid detection by law enforcement.
Smith caused DNA Peptides and Precision websites to display 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.” Smith used these disclaimers as a ruse to avoid FDA scrutiny.
He advertised his products and website extensively in bodybuilding magazines and conventions. Smith hired professional bodybuilders to promote his products and to claim that they personally experienced results from taking certain products he sold. He also provided information to customers, via the company websites and Facebook pages, on how to self-administer drugs, including recommended dosages and placement of the injections, in order to best produce the desired bodily enhancements.
The drugs Smith sold included Growth Hormone Releasing Peptide-2, Growth Hormone Releasing Peptide-6, Melanotan II, Growth Hormone Releasing Hormone, Ipamorelin, Human Growth Hormone Fragment, Mechano Growth Factor, and Dehydroepiandrosterone, none of which the FDA has approved for use in humans.
On seven occasions from November 21, 2011 to March 12, 2015, Smith sold misbranded drugs to an undercover officer and shipped those drugs from Florida to locations in Laurel, Columbia and Beltsville, Maryland. None of the drug shipments included any directions for use of the products. Additionally, although the labels stated that the products were for research only, Smith intended that the products be consumed by humans.
United States Attorney Rod J. Rosenstein commended the FDA Office of Criminal Investigations for its work in the investigation and thanked Assistant U.S. Attorneys James A. Crowell IV and Kelly O'Connell Hayes, who prosecuted the case.