The federal government continued their steroid witch-hunt targeting the dietary supplement industry with a raid of Bodybuilding.com on Thursday, September 24, 2009. The criminal investigation accuses Bodybuilding.com and its corporate officers of illegal marketing and distributing several anabolic steroids, unapproved new and misbranded drugs labeled fraudulently as dietary supplements, specifically “Madol”, “Tren”, “Superdrol”, “Androstenedione”, and “Turinabol”.
Only androstenedione and Turinabol are legally classified as anabolic steroids; these ingredients were not disclosed on the product labels. The FDA has asserted that Madol, Tren and Superdrol are also anabolic steroids. However, only the DEA has the authority to administratively add these substances to the Controlled Substances list. The DEA has NOT yet made this determination. These ingredients have been widely and openly sold as listed ingredients in dietary supplements for years.
The FDA media strategy most likely intentionally staged the raid to coincide with the first day of the 2009 Olympia Weekend. The Olympia Expo, the centerpiece of the Olympia Weekend, includes a large number of sports nutrition companies as exhibitors. The Bodybuilding.com has had a prominent presence at the Expo for several years and is the main sponsor of the 2009 IFBB Mr. Olympia, the top competition in professional bodybuilding. Read more
FDA Commissioner Margaret Hamburg identified “enforcement of the law” as the overriding objective of the FDA under her leadership at a presentation for the Food and Drug Law Institute in Washington, D.C. on August 6, 2009.
Hamburg cited the FDA raid of American Cellular Labs and the FDA public health advisory regarding steroids in supplements as examples of the increased enforcement activity by the agency; Hamburg promised additional efforts targeting the “illegal sale of anabolic steroids” sold “under the guise of dietary supplements”.
Hamburg did not specifically identify the Dietary Supplement and Health Education Act (DSHEA) by name in her speech. Nonetheless, her comments may provide some guidance to sports nutrition companies recently affected by increased FDA enforcement and provide clues to the future of DSHEA.
FDA Special Agent Jeff Novitzky, the agent who has become the face of the federal government witch-hunt against steroid users in professional sports during the BALCO scandal, has move his attention to investigating dietary supplement companies suspected of selling designer anabolic steroids.
Novitzky’s latest steroid investigation targeted two popular products sold and marketed as dietary supplements, “Tren Xtreme” and “Mass Xtreme”. These products were manufactured by American Cellular Labs Inc. (ACL) and sold exclusively through Max Muscle Sports Nutrition (MMSN) stores and via the ACL website (”Two Dietary Supplements Said to Contain Steroids,” July 23).
The exact nature of the business relationship between ACL and MMSN is unclear. Maurice Sandoval, the owner of the Max Muscle San Francisco franchise and the Regional Marketing Director for Max Muscle, was identified as the chief executive of ACL in a government affidavit. Sandoval told the New York Times that he sold ACL in 2008. ACL, Max Muscle San Francisco, and Sandoval’s residence were targets of search warrants executed on July 23, 2009.
The FDA investigation did not involve any steroid contaminants or undisclosed anabolic steroids. Federal investigators specifically targeted the openly listed ingredients in Tren Xtreme and Mass Xtreme commonly referred to as “Tren” and “Madol”, respectively. Read more
