Inspections, Compliance, Enforcement, and Criminal Investigations
May 22, 2012: Bodybuilding.com, LLC and Jeremy DeLuca Plead Guilty in Federal Court to Violating FDCA
BOISE – U.S. Attorney Wendy J. Olson announced today that Bodybuilding.com, LLC, and Jeremy DeLuca, former president and vice president of Bodybuilding.com, LLC, pled guilty this morning in federal court in Boise to misdemeanor counts of introduction and delivery for introduction of misbranded drugs into interstate commerce. The charges are all violations of the Food, Drug and Cosmetic Act. As part of the plea, Bodybuilding.com, LLC agreed to pay a $7 million fine and DeLuca agreed to pay a $600,000 fine. The United States agreed to recommend that DeLuca receive probation and not be sentenced to any prison term.
The plea agreements state that between March 2006 and September 2009, Bodybuilding.com, LLC, sold five products misbranded as dietary supplements, when they were actually drugs. The five products were: I Force Methadrol, Nutra Costal D-Stianozol, I Force Dymethazine, Rage RV5, and Genetic Edge Technologies (GET) SUS500. According to the plea agreements, the products were drugs because they contained synthetic anabolic steroids or synthetic chemical “clones” of anabolic steroids that were not dietary supplements and because they were labeled and promoted as products intended to affect the structure and function of the human body (building muscle mass). Jeremy DeLuca's plea agreement states that during the time period charged, he was president or vice president of Bodybuilding.com, LLC, and had authority over products offered for sale on the company's webstore.
“Dietary supplements” must contain one or more “dietary ingredients.” A “dietary ingredient” is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of one or more of these dietary ingredients.
Bodybuilding.com, LLC, is the largest internet retailer of supplements in the world. It does not manufacture dietary supplements, but only retails products made by others. The plea agreement further states that from 2007 to 2009, the FDA compliance officer at Bodybuilding.com, LLC informed company management, including Jeremy DeLuca, that some prohormone products carried on its website contained ingredients that did not qualify as dietary supplements.
Olson stated that Bodybuilding.com, LLC and DeLuca were the fifth and sixth defendants to plead guilty in the District of Idaho's investigation into distribution of misbranded drugs through Bodybuilding.com's website. Product manufacturers Tribravus Enterprises, the makers of I Force Methadrol and I Force Dymethazine; R&D Holdings; and DDC, LLC, doing business as Advanced Muscle Science, pled guilty to corporate felonies for introduction and delivery for introduction of misbranded drugs into interstate commerce, with the intent to mislead and defraud. Bodybuilding.com, LLC, founder and CEO Ryan DeLuca pled guilty on April 9, 2012, to misdemeanor charges.
“Today's guilty pleas signal that retailers, as well as manufacturers, of products sold as dietary supplements have a clear responsibility under the law to ensure that the products they are selling are indeed dietary supplements, and not synthetic steroids or steroid clones masquerading as dietary supplements,” said Olson. “Bodybuilding.com, LLC, Ryan DeLuca and Jeremy DeLuca have now all accepted responsibility for these violations of the Food, Drug and Cosmetic Act.”
Olson said that today's pleas are the culmination of a detailed and thorough investigation that included the execution of search warrants in September 2009 at Bodybuilding.com, LLC's Boise warehouse and Meridian headquarters. “Since the execution of the search warrants, Bodybuilding.com, LLC has worked cooperatively with the FDA and the U.S. Attorney's Office to ensure that it no longer sells products that do not qualify as dietary supplements,” said Olson. “We were able to resolve this case through misdemeanor charges in part because of the actions Bodybuilding.com, LLC, its current management and its general counsel's office have taken over the last two and a half years to prioritize regulatory compliance. We are confident that Bodybuilding.com has put into place procedures to eliminate products with these ingredients from its product line.”
Under federal sentencing law, corporations convicted of violating the Food, Drug and Cosmetic Act can be fined up to twice the gross gain from sales of the misbranded product. According to its plea agreement, Bodybuilding.com, LLC had gross gain of $3.5 million from misbranded prohormone products, including those specifically identified in the plea agreement. Thus, Bodybuilding.com, LLC, agreed to pay a $7 million fine. Jeremy DeLuca has agreed to pay a $100,000 fine for each of the six counts with which he is charged.
“The FDA’s Office of Criminal Investigations is fully committed to investigating and supporting the prosecution of those who sell synthetic steroids or steroid clones but call them dietary supplements. We commend the U.S. Attorney’s Office for their diligence in prosecuting this case,” said Thomas Emerick, Special Agent in Charge, FDA’s Office of Criminal Investigations, Los Angeles Field Office.
Sentencing is set for August 1, 2012, in Boise before Chief U.S. District Judge B. Lynn Winmill.
The Food and Drug Administration, Office of Criminal Investigations investigated the case. Assistant United States Attorney Kevin Maloney and Special Assistant United States Attorney Jim Smith, Associate Chief Counsel of the Food and Drug Administration, prosecuted the case.
# # # # #