Inspections, Compliance, Enforcement, and Criminal Investigations
January 17, 2012: Two Manufacturers Sentenced for Misbranding Products as Dietary Supplements
BOISE – Emphasizing that punishment was necessary to deter others and to protect consumers, Chief U.S. District Judge B. Lynn Winmill today imposed probation and fines on two companies that earlier had pled guilty to causing purported dietary supplements to be unlawfully manufactured and distributed in interstate commerce, U.S. Attorney Wendy J. Olson announced. DCD, LLC was fined $125,000 and R & D Holdings $21,000, approximately equivalent to the revenue associated with the sales of the violating products. As a condition of probation, DCD, LLC and its subsidiary, Advanced Muscle Science must implement a testing protocol for its products to ensure future products sold as dietary supplements do not contain synthetic steroids. R & D Holdings no longer manufactures or distributes supplements or drugs and the Court ordered it not to do so for two years from the date of sentencing as a condition of its probation.
The companies pled guilty in November 2011. According to the plea agreements, DCD, LLC dba Advanced Muscle Science (DCD), and R & D Holdings, LLC dba Culver Concepts, Bradley Asgard, and Bjorklund (R & D Holdings), misbranded products as dietary supplements, when the products were actually drugs, as defined under the Food, Drug and Cosmetic Act (FDCA) and the Dietary Supplement Health and Education Act (DSHEA). The charges were brought in federal court in Idaho because the companies delivered their products to a retail company located in Idaho for further distribution throughout the United States.
According to the plea agreements, DCD distributed the products “Dienedrone” and “Liquidrone,” and R & D distributed “Orafinadrol 50,” “Microdrol” and “Methyldrostanolone,” as dietary supplements. The FDA found that the active ingredients in the products were synthetic anabolic steroids, or synthetic chemical clones of anabolic steroids, which were not dietary ingredients, but rather unapproved drugs under the Food, Drug and Cosmetic Act. The products did not meet the DSHEA legal definition of a dietary supplement, nor did they meet any other definition of food.
DCD, LLC dba Advanced Muscle Science was organized as a Nevada LLC, with offices in California and Michigan. R & D Holdings was located in Irvine, California. Both companies distributed their products to a large Internet-based retailer that has its headquarters in Meridian, Idaho, and maintains warehouses in Boise and elsewhere.
“These prosecutions and today's sentencings are necessary to protect the public from synthetic steroids masquerading as dietary supplements,” said Olson. “DCD, LLC's testing protocol and R&D's agreement not to manufacture these products are positive steps for the dietary supplement industry as it struggles throughout the country to ensure that consumers are using only safe products.”
In May 2011, Tribravus Enterprises dba IForce Nutrition, headquartered in Vista, California, was sentenced in U.S. District Court in Idaho for distributing the products “17aPheraFLEX,” “Dymethazine” and “Methadrol,” as dietary supplements.
The case was investigated by the Food and Drug Administration, Office of Criminal Investigations.
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