David Winsauer, of Delray Beach, FL, entered the plea in a case brought in 2019 by the US Food and Drug Administation working in concert with the Department of Justice that alleged that employees of Blackstone Labs conspired to sell products marketed as dietary supplements that contained banned ingredients such as anabolic steroids, SARMs (selective androgen receptor modulators) and other illegal ingredients.
Winsauer, 35, worked from 2014 to 2018 for Blackstone Labs, which was based in Boca Raton. According to court filings, Winsauer admitted that he worked with other defendants named in the orginal filings to portray the company’s products as being compliant with federal law when in fact they knew the formulas contained the banned ingredients.
Winsauer admitted that members of the conspiracy also w0rked to continue to sell the products under the radar, including by removing information about illegal products from online marketing to create the false impression that they were no longer selling those products.
Winsauer faces up to five years in federal prison. Another defendant on the original indictment, Robert DiMaggio, 51, of Henderson, NV, has also pleaded guilty and faced similar potential penalties to Winsauer.
The original indictment listed four other co-conspirators: Phillip Braun, 40, of Boca Raton, Florida, Aaron Singerman, 40, of Delray Beach, Florida, Anthony Ventrella, 43, of Boynton Beach, Florida and James Boccuzzi, 36, of Parkland, Florida. The trial date is set for Oct. 21, 2021.
In addition to Blackstone, the original indictment also charged Blackstone Labs and Ventech Labs, two Florida limited liability companies in Palm Beach County, Florida.
“The FDA regulates dietary supplements to protect the health of American consumers,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The Department of Justice will prosecute individuals and companies who undermine that mission by deceiving the FDA.”
“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 for the FDA Office of Criminal Investigations Miami Field Office. “We will continue to investigate and bring to justice those who jeopardize the public health by selling violative products.”
Pattern of repeat violations
This is not the first enforcement action related to some of the defendants. Singerman and Blackstone Labs received an FDA warning letter in April 2015 for selling a product that contained AMP Citrate, otherwise known as DMBA. This stimulant like ingredient, that at one time was claimed to be sourced from a species of orchid, was ruled by FDA to be an illegal ingredient because no NDI Notification had been filed on the substance. The Singerman warning letter was part of a wider FDA enforcement action on DMBA.
DiMaggio received a warning letter in October 2017 for selling a product called “Super DMX 4.0” that contained a SARM. A similar product (now called “Super DMX RX 2.0”) is cited in the indictment filed this week. Earlier in 2017 Ventrella also was sent a warning letter for selling illegal steroids.
Sales continued through August 2018
The original indictment alleged that the defendants continued to sell “hundreds of thousands” of illegal products inside and outside the US until August 2018. The defendants allegedly routed sales through trusted distributors who also conspired to conceal the presence of banned ingredients in the products.
Two of those distributors have also pleaded guilty in connection with the case. According to DOJ, Justin Smith, 35, of Batesville, AK, pleaded guilty on May 18, 2021, to one count of conspiring to sell controlled substances. Smith admitted to distributing more than 60,000 capsules of illegal steroids to consumers in 2015 and 2016.
In a separate but related case, Leonard Shemtob, 39, of Los Angeles, pleaded guilty on May 19, 2021, to one count of conspiring to sell controlled substances. According to court documents, Shemtob owned and controlled Strong Supplements LLC, an online company that sold bodybuilding supplements containing designer steroids.