Inspections, Compliance, Enforcement, and Criminal Investigations
November 3, 2011: Two More Manufacturers Plead Guilty to Misbranding Products as Dietary Supplements
BOISE – Two companies charged with causing purported dietary supplements to be unlawfully manufactured and distributed in interstate commerce pled guilty today in federal court in Boise, U.S. Attorney Wendy J. Olson announced.
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.
The charge of introduction and delivery for introduction into interstate commerce of drugs that were misbranded, with the intent to defraud and mislead, carries a maximum fine of $500,000, and is a felony because the defendants acted with the intent to defraud or mislead. According to the plea agreements, the parties have agreed to recommend that DCD, LLC pay a $125,000 fine, and R & D Holdings will pay a $21,000 fine. DCD, LLC and its subsidiary, Advanced Muscle Science, agreed to 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 it agreed not to do so for two years from the date of sentencing.
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.
Sentencing is set for January 17, 2012, in Boise before Chief U.S. District Judge B. Lynn Winmill.
The case was investigated by the Food and Drug Administration, Office of Criminal Investigations.
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