In response to the growing concern of adulterated products within the dietary supplement industry, officials at the U.S. Food and Drug Administration (FDA) have acknowledged that they intend “crack down” on the influx of fraudulent practices committed by manufacturers. In what has already been established as a strict regulatory campaign, the FDA has played an integral role in the prosecution of several companies. However, the most decisive FDA victory came on June 5, when Bodybuilding.com pled guilty to selling dietary supplements that had been tainted with undisclosed steroids.
Bodybuilding.com is an American online retailer/manufacturer that specializes in the distribution of sports supplements and nutritional products. In addition to operating a satellite company, Athletes.com, the franchise markets its own line of sports nutrition products under the brand name Higher Power. Founded by Ryan DeLuca in 1999, Bodybuilding.com has grown exponentially in the last decade. By 2008, the once independently owned company was worth an estimated $100 million. It now markets itself as the “largest online sports nutrition company in the world.”
However, there was a three year period in which Bodybuilding.com committed several violations of the Food, Drug and Cosmetic Act. According to representatives, “The FDA has concluded that a small handful of Bodybuilding.com’s products contained labeling that was not compliant with FDA laws.” Those products included I Force Methadrol, Nutra Costal D-Stianozol, I Force Dymethazine, Rage RV5, and Genetic Edge Technologies.
While labeled as dietary supplements, these products were in direct violation of federal law. Accordingly, they were in fact drugs because they contained synthetic anabolic steroids or synthetic chemical variations of steroids. The undisclosed inclusion of such ingredients not only violates federal law, but places consumers at an increased risk of adverse health events.
Having pleaded guilty to the aforementioned transgressions this week, Bodybuilding.com’s chief executive, Ryan DeLuca, has agreed to pay a fine of $600,000. Furthermore, the company has agreed to pay an additional $7 million for knowingly selling dietary supplements with undisclosed steroids. Deluca is to be sentenced on June 20 and is not expected to receive a custodial punishment.
According to representatives, the guilty plea “signals that retailers, as well as manufacturers, of products sold as dietary supplements have a clear responsibility under the law to ensure that the products that they are selling are indeed dietary supplements, and not synthetic steroid clones masquerading as dietary supplements.”
Federal law, in association with the recent FDA crack down, has proven to be a vital component in the fight against tainted dietary supplements. According to Neal-Kababick, a proponent of the recent FDA actions, “there is no safe harbor as science continues to shine a light in every dark corner where clandestine activity resides.” He continues to acknowledge “This landmark case combined with the statements and guidelines for retailers shows that the FDA’s Office of Criminal Investigations and the AG’s Office are not blowing smoke. They expect retailers to take on the responsibility of assuring that they are selling compliant products.”
The recent litigation against Bodybuilding.com should serve as a warning to other retailers in the industry who are committing fraudulent practices of their own. Accordingly, the manufacturers of the supplements involved in this case have already been fined. California-based Tribravus Enterprises, otherwise known as IForce Nutrition, was sentenced in May 2011 for distributing drugs that were labeled as dietary supplements. Subsequently, January of this year witnessed R&D Holdings LLC was fined for committing similar transgressions.
Do I Have a Dietary Supplement Lawsuit?
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