A former employee of Blackstone Labs on Thursday pleaded guilty to conspiring to defraud FDA by hiding information about illegal products labeled as dietary supplements, the U.S. Department of Justice (DOJ) announced.
David Winsauer worked for Blackstone Labs from 2014 to 2018, and according to court documents, he helped to manage the supplement company’s marketing, website and direct-to-consumer sales.
The U.S. government and Winsauer agreed that if the case proceeded to trial, the government would prove beyond a reasonable doubt the crime of conspiracy to defraud the United States. Winsauer knew “Blackstone Labs operated in a manner that was intended to impair, impede, obstruct and defeat the FDA’s ability to regulate food, drugs and dietary supplements,” according to a “factual proffer” filed with the U.S. District Court for the Southern District of Florida.
For instance, Winsauer knew that at the direction of co-defendants Phillip Braun and Aaron Singerman, Blackstone Labs depicted itself on social media, the firm’s website and in communications to and from consumers as a company that manufactured products in compliance with federal law, according to the factual proffer. But the factual proffer stated Braun, Singerman and Winsauer knew Blackstone Labs’ portrayals were untrue.
Winsauer also knew “Braun, Singerman, Blackstone Labs and other co-conspirators arranged to remove information about illegal products from Blackstone Labs’ website and online marketing to create the impression that Blackstone Labs was no longer selling those products,” the factual proffer stated. Yet, Winsauer knew several of the co-defendants “continued to sell unlawful products after they were removed from Blackstone Labs’ website and public advertising,” according to the factual proffer.
Winsauer is scheduled to be sentenced Nov. 12 and faces a maximum penalty of five years in prison, DOJ said.
“The FDA regulates dietary supplements to protect the health of American consumers,” Acting Assistant Attorney General Brian Boynton of DOJ’s Civil Division, said in a news release. “The Department of Justice will prosecute individuals and companies who undermine that mission by deceiving the FDA.”
In 2019, Blackstone Labs and its co-founders were indicted by a federal grand jury for selling illegal substances in products marketed as dietary supplements, including anabolic steroids. Key employees and manufacturing partners also were named in the 14-count indictment.
One of the defendants, Robert DiMaggio, a co-founder of Blackstone Labs, pleaded guilty in 2019 to count one of the charges, and he is awaiting sentencing.
Six co-defendants are scheduled to go to trial on Oct. 12. However, they recently requested a continuance due to the COVID-19 pandemic. After the motion was filed, U.S. District Judge William Dimitrouleas scheduled a hearing for Sept. 24 to review the request to postpone the trial.
Robert Buonauro, an attorney representing Winsauer, did not immediately respond to a request for comment concerning his client’s guilty plea. Attorneys for the other co-defendants scheduled for trial in October also did not immediately respond to requests for comment.