A controversial maker of sports supplements, undeterred by a long-pending federal criminal charge, is poised this month to sell a new version of a popular workout powder pulled from the market in 2013 after tests found it contained a methamphetamine-like compound.

Driven Sports, a New York-based firm run by convicted felon and supplement designer Matt Cahill, plans to begin selling Craze v2 in April in the United States and Europe, according to postings by the company on its Facebook page and Internet promotions by Predator Nutrition, a marketing partner in the United Kingdom.

Craze v2 will be “a product unlike any supplement ever made,” according to a blog posting by Predator Nutrition. It’s unclear what ingredients will be in the new version of Craze, which marketing materials say will provide users “Coruscating energy and laser-like focus.” Driven Sports, through an attorney, would only say Craze v2 “conforms to all U.S. federal regulatory requirements.”

The impending return of Craze – especially as prosecutors have taken no action in a 2012 case against Cahill for another allegedly drug-spiked supplement – is drawing outrage and concern from some supplement watchdogs and industry officials. They say it highlights the lack of enforcement of consumer protection laws in the $30 billion supplement industry by the U.S. Food and Drug Administration and prosecutors at the Justice Department – even in one of the highest-profile cases in recent years.

Cahill, the FDA and federal prosecutors declined to be interviewed.

“What we’re seeing here is that this is how the FDA operates: They do nothing,” said Pieter Cohen, an assistant professor at Harvard Medical School whose team published research in October 2013 showing the meth-like compound in Craze – which on its label said its key ingredient came from dendrobium orchid extract. Last October, Cohen and his team published a journal article that showed a different chemical stimulant called DMBA in another Driven Sports product called Frenzy, which the company has marketed overseas for the past year.

On its label, Frenzy indicates the stimulant comes from “Pouchung Tea.” Cohen and his team said DMBA is a close chemical cousin to DMAA, a stimulant the FDA has said is illegal in supplements because there is no evidence it’s natural and because of risks of heart attacks, seizures and neurological conditions. Driven Sports has disputed the chemicals are similar. In February, the Ministry of Health in New Zealand said it was taking action to halt sales of Frenzy because DMBA is prohibited under that country’s Psychoactive Substances Act, according to news reports in that country.

“How could that be, given this history, that the FDA is permitting Driven Sports to introduce a new version of Craze? It’s just mindboggling,” Cohen said.

Steve Mister, president of the Council for Responsible Nutrition, a trade group representing major companies that make supplements, said he’s concerned about what ingredients may be in Craze v2.

“I worry that we continue to see a stream of stimulants coming out of this same company,” said Mister, noting that stimulants can carry health risks depending on the type and dosage. “There are numerous ways under the statute that FDA could go after this company and this is a lack of willpower to enforce the law to protect consumers, this is not a fault with the law.”

Last week the attorneys general from 14 states sent a letter to key members of Congress calling for an investigation of the herbal supplement industry and asking that lawmakers consider giving the FDA a “more robust” oversight role.

“The multibillion-dollar herbal supplements industry is built on the promise that its products will improve the health and well-being of those who use them,” the letter says. But it notes that the news media and scientific community have issued “a series of troubling reports” indicating wide-ranging problems in the industry, including products “secretly laced with dangerous prescription medications.”

The letter cites a USA TODAY investigation of tainted supplements sold by firms headed by executives with criminal backgrounds.. Cahill was included in that report. Liz DeBold, a spokesperson for New York Attorney General Eric Schneiderman, who helped organize the letter, said the office had no comment on Cahill’s history in the industry.

An investigation by USA TODAY in July 2013 reported on Cahill’s 12-year history of introducing new and risky products to the market as federal regulators have struggled to keep up with his changing series of companies. Long before Craze, Cahill sold a designer steroid called Superdrol that caused liver damage in some users. In 2005 Cahill pleaded guilty to felony charges of introducing a misbranded drug into interstate commerce and conspiracy to commit mail fraud for selling a weight-loss product made from an industrial chemical used in explosives and as a pesticide that was briefly a popular diet drug in the 1930s until consumers started going blind or dying.

Supplement regulators at the FDA declined to be interviewed about their oversight of Driven Sports and its products. While the FDA issued a warning letter to Driven Sports about the original version of Craze, the agency didn’t send it until April 2014 – nine months after the firm had already stopped making and selling the product in the wake of USA TODAY’s investigation that prompted Wal-Mart, eBay and other retailers to stop selling it. The FDA’s letter was also six months after additional publicity surrounding the meth-like compound findings by Cohen’s team were published in a scientific journal.

In a statement, the FDA said that regulators “reached out to Driven Sports” about discontinuing the marketing of Craze before they sent the warning letter. The FDA said the formal letter was issued “to reinforce with Driven Sports and the industry as a whole the gravity of the safety concerns” about the use of a proprietary ingredient in the original Craze called Dendrobex, which the company said came from dendrobium orchids.

Driven Sports has said that the original Craze did not contain any undisclosed amphetamine-like or meth-like ingredients and that teams of independent scientists at labs in the U.S., the Netherlands, Sweden and South Korea have been mistaken in their findings. Driven Sports has disputed the scientists’ findings with tests by its own consultants, and recently has hired other scientists to develop “a reliable test method” for what the company says are natural compounds.

Cahill has had a federal felony charge hanging over him for nearly three years for selling a workout supplement called Rebound XT back in 2008 that allegedly contained an anti-estrogen drug. The case is unusual, legal experts say, in that despite legal rights to a speedy trial it has remained open without any public action since the initial charging documents were filed by federal prosecutors in August 2012.

James O’Reilly, a University of Cincinnati law professor and author of a legal text on food and drug law, said such a lengthy prosecution delay likely means the defendant has entered into a deal to cooperate in an investigation.

“It probably means they are holding this hammer to assure he will participate actively in uncovering who else was involved and what the details are,” said O’Reilly, who notes he has no direct knowledge of Cahill’s case. Once the investigation is finished, “they would either dismiss the case or allow him to plead to a much lesser charge,” he said.

Marc Ullman, an attorney for Driven Sports, said in an email: “We categorically reject any suggestion that Mr. Cahill is cooperating with the authorities in connection with this or any other matter. The only party that seems to be interested in this so-called investigation is USA Today.”

But Ullman offered no explanation for why the case remains open without any public action – including any filing by attorneys for Cahill seeking dismissal of the charge. “As to why it remains open, who knows? But again, only USA Today seems to care,” Ullman replied in another email.

The U.S. Attorney’s Office in San Jose, which brought the charge against Cahill, also wouldn’t explain why the public docket shows no action in the open case and whether federal officials have delayed prosecution because Cahill is a cooperating witness.

“As I am sure you know, we simply cannot comment on the existence or non-existence of an investigation,” Assistant U.S. Attorney Abraham Simmons said in an email.

Officials at the FDA’s Office of Criminal Investigations, which helped bring the charge against Cahill in 2012, had no comment.

That this charge was pending against Cahill while he was marketing the first version of Craze troubles Cohen, who said it sends the wrong message to the industry.

“Was there any penalty whatsoever for introducing Craze? No, and that was apparently going on simultaneously at the time of this criminal complaint,” Cohen said. “If you can do that and there is no consequence in a setting where you’re being scrutinized … why would you stop there? You get a sense of complete impunity to do whatever you want.”

Mister, of the Council for Responsible Nutrition, said fringe players in the supplement industry every day calculate their risks of being caught and punished. “We need to see law enforcement agencies committed to enforcing the law,” Mister said. “There need to be consequences … if you violate the law you need to be prosecuted. If that happened, it would change behavior.”

Dan Fabricant, who ran FDA’s supplement division until last spring and now heads the industry’s Natural Products Association, said he’s “cautiously optimistic” that there’s nothing in the new version of Craze that would cross any regulatory lines.

“We really have to see what’s in it,” Fabricant said. “I’m hoping anybody that had that much spotlight on him would want to make some changes in the way he conducts business.”

Ullman, Driven Sports’ attorney, said the company works with labs “to ensure that the only ingredients in its products are those listed on the label. Driven Sports has never sold any product with any undisclosed ingredients.”

If Craze v2 contains any new dietary ingredients that weren’t already on the market before 1994, or if it contains synthetic ingredients, it is required by supplement regulations to notify the FDA 75 days in advance of its intent to use those ingredients and provide evidence for why the ingredient is reasonably expected to be safe.

If such a notice isn’t filed and a supplement contains a new ingredient, the FDA can declare it adulterated and take actions that include recalls, seizures and prosecutions, Mister said.

While Driven Sports won’t yet reveal what ingredients are in Craze v2, Ullman, the company’s lawyer, said the product “contains no new dietary ingredients.” While the company anticipates Craze v2 will be sold starting this month, he said, “The product will not be released until it has satisfied all of Driven Sport’s (sic) requirements for regulatory compliance.”

If the new Craze really doesn’t contain any new ingredients, Cohen said, there likely still are many who will buy it because of the reputation of its predecessor. “It could be that Craze v2 is an opportunity to make some quick cash with a new product that’s not really new at all,” he said.


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