Compounds distributed by Osta-Gain” and later “Spectrum Peptides,” The Defendants Falsely Claimed on Company Websites the Drugs Were Sold for “Research Purposes” Only

Two Charlotte Men Plead Guilty To Selling Misbranded Drugs

FOR IMMEDIATE RELEASE

November 13, 2014

United States Attorney Anne M. Tompkins Western District of North Carolina The Defendants Falsely Claimed on Company Websites the Drugs Were Sold for “Research Purposes” Only CHARLOTTE, N.C. – Joseph Marsala, 35, and Brent Bumgarner, 33, both of Charlotte, appeared before U.S. Magistrate Judge David S. Cayer today and pleaded guilty to selling misbranded drugs, announced Anne M. Tompkins, U.S. Attorney for the Western District of North Carolina. A criminal bill of information charging the two men with one count of introducing and distributing misbranded drugs into interstate commerce and aiding and abetting was filed on October 28, 2014. David W. Bourne, Special Agent in Charge of the Food and Drug Administration, Office of Criminal Investigations (FDA-OCI), Miami Field Office and Thomas L. Noyes, Inspector in Charge of the Charlotte Division of the U.S. Postal Inspection Service, join U.S. Attorney Tompkins in making today’s announcement. According to filed court documents and today’s plea hearing, from 2010 to January 2014, the defendants owned and operated two companies, first “Osta-Gain” and later “Spectrum Peptides,” through which they illegally distributed drugs, including “peptides,” and compounds containing the active ingredients of FDA-approved prescription drugs to customers, primarily bodybuilders, for human consumption. Court records indicate that there is an illegal market for peptides, prescription drugs, and compounds containing the active ingredients of FDA-approved prescription drugs among bodybuilders and weight lifters, since it is believed that these substances enhance muscle development. The FDA regulates these products as drugs when they are marketed for human use. According to court records, to avoid detection by the FDA, the defendants made numerous false representations on their companies’ websites, www.osta-gain.com and www.spectrumpeptide.com, claiming that, “ALL products and services offered are for RESEARCH purposes ONLY.” In reality, court records indicate, the products the defendants sold were intended for human consumption, by individuals seeking to build body mass and to counter the side effects of such muscle building drugs. In addition to the illegal drugs, Marsala and Bumgarner also sold the necessary “laboratory supplies” (e.g., pipettes) for bodybuilders to administer the products and distributed dosing information to consumers, court records show. In connection with today’s guilty plea, the court was also advised that even though the defendants claimed the products sold on their websites were for research purposes only, Marsala and Bumgarner held promotional events such as Black Friday sales, Christmas sales, and free T-shirt promotions. The defendants also specifically targeted the bodybuilding community by advertising on websites catering to bodybuilders. According to filed court documents, in April 2013 Osta-Gain was named in a national newspaper article about the illegal marketing of research chemicals to bodybuilders. As a result of that article, the defendants shut down the Osta-Gain website, created Spectrum Peptides and began selling identical products through the new company’s website. During the relevant time period, Marsala and Bumgarner advertised and sold through the two websites approximately $800,000 of misbranded drugs to customers across the United States. During the course of the investigation, law enforcement agents seized approximately $34,012.43 in funds. Marsala and Bumgarner have agreed to forfeit these assets as part of their plea agreement and to pay full restitution, the amount of which will be determined by the Court at sentencing. The defendants have been released on bond. The penalty for introducing misbranded drugs into interstate commerce and aiding and abetting carries a maximum prison term of three years and a $10,000. A sentencing date has not been set yet. The investigation was conducted by FDA-OCI and USPIS. The prosecution is handled by Assistant U.S. Attorney Kelli Ferry of the U.S. Attorney’s Office in Charlotte. The FDA has made available a consumer-friendly form for reporting to the agency adverse events and other serious safety problems with FDA-regulated products, including products catering to bodybuilders for the increase of muscle mass. That form is available athttp://www.fda.gov/ForConsumers/ConsumerUpdates/ucm354560.htm.