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Friday, December 10, 2021

Federal Jury Convicts Florida Man for Role in Defrauding FDA and Distributing Designer Anabolic Steroids Labeled as Dietary Supplements

On Dec. 9, a federal jury in Fort Lauderdale, Florida, convicted James Boccuzzi, 37, of Boca Raton, Florida, of one count of conspiracy to defraud the U.S. Food and Drug Administration (FDA) and one count of conspiracy to distribute controlled substances.

Boccuzzi is the 11th defendant convicted in connection with Blackstone Labs LLC, a Boca Raton company that sold millions of dollars of products labeled as dietary supplements. According to court documents and evidence presented at trial, Boccuzzi who was Blackstone’s director of sales, and his co-conspirators, including Phillip “PJ” Braun, Aaron Singerman, Blackstone Labs LLC and others, conspired to defraud the FDA and to manufacture and illegally distribute anabolic steroids that were controlled substances. Evidence presented at trial established that the steroid products sold by Blackstone Labs and affiliated companies became illegal controlled substances in December 2014 under a new federal law, the Designer Anabolic Steroid Control Act, which amended the Controlled Substances Act. Evidence at trial established that despite knowing about the law and its impact on the legality of Blackstone’s steroid products, Boccuzzi and his co-conspirators continued selling the products for more than 18 months.

The evidence also showed that Boccuzzi and his co-conspirators quickly sold off other Blackstone products containing certain stimulants after they received an FDA warning letter notifying them that the products were unlawful to sell as dietary supplements. Further, the evidence showed that the conspirators concealed the sales of other products containing research chemicals despite knowing that the products could not legally be sold as dietary supplements.

Braun and Singerman each pleaded guilty on Nov. 17 to conspiracy to distribute controlled substances and to selling unapproved new drugs. Blackstone Labs pleaded guilty on Nov. 19 to the same charges as Braun and Singerman, as well as to conspiracy to defraud the FDA and to commit mail and wire fraud. Five other individual defendants and two corporate entities involved in the sale of Blackstone Labs products previously pleaded guilty to related charges.

“It is illegal to sell drugs and controlled substances as dietary supplements,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The department will work with its law enforcement partners to prosecute individuals and companies that market potentially dangerous products, such as designer steroids, in violation of the Controlled Substances Act and the Federal Food, Drug and Cosmetic Act.”   

“Products mislabeled as dietary supplements can pose a serious risk to the health of U.S. consumers,” said Special Agent in Charge Justin C. Fielder of the FDA Office of Criminal Investigations (FDA-OCI) Miami Field Office. “We will continue to investigate and bring to justice those who jeopardize the public health by selling violative products.”

Boccuzzi was remanded to the custody of the U.S. Marshals following trial, and he is scheduled to be sentenced on Feb. 17, 2022, in Fort Lauderdale before U.S. District Judge William P. Dimitrouleas of the Southern District of Florida. Boccuzzi faces a maximum penalty of 15 years in prison. Braun, Singerman, and Blackstone are scheduled to be sentenced on Jan. 27, 2022. The court will determine any sentences after considering the U.S. Sentencing Guidelines and other statutory factors.

The trial and plea agreements resulted from a multi-year investigation conducted by the FDA-OCI Miami Field Office.

Trial Attorneys Alistair Reader and Stephen Gripkey, Senior Litigation Counsel David Frank, and Assistant Director John W. Burke of the Civil Division’s Consumer Protection Branch are prosecuting the cases with assistance from Assistant U.S. Attorney Daren Grove of the Southern District of Florida.

Topic(s): 
Consumer Protection
Component(s): 
Press Release Number: 
21-1231
Updated December 10, 2021