The US Department of Justice, working in concert with the Food and Drug Administration, filed the case against the defendants who are accused of selling products that contain anabolic steroids and other illegal ingredients.
SARMs, anabolic steroids listed
The list of illegal ingredients contained in the products includes SARMs (selective androgen receptor modulators), the pro hormones dimethazine, methylstenbolone and methyl-l-etiocholenol, and picamilon, which has been ruled by FDA to not be a legal dietary ingredient.
The 14-count indictment, which was handed down by a grand jury in US District Court for the Southern District of Florida, lists these defendants: Phillip Braun, 38, of Boca Raton, Florida, Aaron Singerman, 39, of Delray Beach, Florida, Robert DiMaggio, 49, of Henderson, Nevada, Anthony Ventrella, 41, of Boynton Beach, Florida, David Winsauer, 32, of Boca Raton, Florida, and James Boccuzzi, 34, of Parkland, Florida.
The indictment also charged Blackstone Labs and Ventech Labs, two Florida limited liability companies based in Palm Beach County, Florida.
“Fraud by supplement manufacturers and distributors is extremely dangerous for consumers, who rightly assume that a dietary supplement product sold in stores or online will not contain unapproved drugs,” said Assistant Attorney General Jody Hunt for the Department of Justice’s Civil Division. “These products are not safe and that is why we will continue to aggressively pursue and prosecute those who import, manufacture, and distribute dangerous and illegal ingredients for fraudulent purposes.”
“Consumers who use dietary supplements expect those products to be safe. When they contain drugs that are not FDA-approved, the health of the public is put at risk,” said Catherine A. Hermsen, Acting Director, FDA Office of Criminal Investigations. “We will continue to pursue and bring to justice those who place consumers’ health in jeopardy.”
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 indictment alleges that the defendants continued to sell “hundreds of thousands” of illegal products inside and outside the US until August 2018. The indictment alleges the defendants fraudulently represented that those products and pills were high-quality, legal dietary supplements. According to the indictment, the defendants created an illicit manufacturing company and routed sales of illegal products through trusted distributors, knowing that the products were unsafe or could not legally be sold to consumers.
The multi-count indictment includes potential penalties of up to 15 years in prison and $500,000 fines for each count.
Enforcement welcomed, but more could be done
Attorney Marc Ullman, of counsel with the firm Rivkin Radler, said he welcomed the news of the indictment. Ullman has long been critical of what he has characterized as languid enforcement by FDA.
“Some of these people seem to think, ‘What’s the worst that can happen to me? A warning letter?’ No, you can get indicted. This should serve as a warning of the risk of ignoring warning letters and the risks of flouting the law by selling anabolic steroids and other likely illegal substances masquerading as dietary supplements,” he said.
But Ullman said yet more could be done. Unless speeders know speeding tickets are being handed out, the individual citations don’t do much, so to speak.
“There should more of this. Where is FDA’s own press release? Why isn’t this indictment the lead story on the news section on FDA’s home page? Secret enforcement is no deterrence,” Ullman added.