Federal regulators have warned the maker of the once popular sports supplement Craze about its proprietary blend of ingredients and tests showing an undisclosed methamphetamine-like compound in the product, records made public Tuesday show.
The warning letter from the U.S. Food and Drug Administration, dated April 4, comes months after New York-based Driven Sports had stopped making Craze in the wake of a USA TODAY investigation — and as the company has introduced a replacement product called Frenzy that it is selling only outside the United States.
Officials with Driven Sports did not respond to requests for comment. The company is run by Matt Cahill, a felon who has a history of putting risky products on the market through a changing series of companies as regulators have struggled for years to keep up, USA TODAY reported last summer. Cahill has declined repeated requests for interviews.
The FDA's warning letter is the first public action or comment the agency has made about Craze and about concerns that have been raised about its safety for more than a year.
The warning letter questions whether compounds listed on Craze's label as coming from dendrobium orchids are really found in the plant. And it says the proprietary blend of ingredients listed on Craze's label as "Dendrobex" made the product adulterated under federal law, given the agency is not aware of any evidence that the ingredient has been present in the food supply and the company never submitted paperwork to have it allowed as a new dietary ingredient.
The FDA notes that an independent study by a research team including a scientist at Harvard last October found that Craze contained a meth-like compound, N,alpha-diethylphenylethylamine. The agency said it's not aware of this compound being found in the food supply and that without paperwork declaring it a new dietary ingredient, products containing it would be considered adulterated.
The letter said the agency is aware of Driven Sports' plans to introduce new products and warns that continued sales of products containing "Dendrobex" could result in the seizure of products and injunctions against manufacturers and distributors. The FDA further told Cahill the agency is requesting he come in "for a meeting to discuss the products that you intend to market." The agency gave him 15 days to reply in writing about what steps have been taken to correct the violations itemized in the letter and ensure that similar violations don't recur.
Driven Sports has said that Craze did not contain any undisclosed amphetamine-like or meth-like ingredients and that teams of scientists at labs in the U.S., the Netherlands, Sweden and South Korea have been mistaken in their findings.
Last week, the International Olympic Committee sanctioned a Polish bobsledder who failed a drug test in Sochi that detected the designer stimulant. The bobsledder blamed Craze, records show, but Olympic officials weren't sympathetic given the amount of information available on the Internet before the Winter Games about the potential for the product to be tainted.
After USA TODAY's investigation last July, Wal-Mart and other retailers stopped selling Craze, which was named the 2012 New Supplement of the Year by Bodybuilding.com. In October, after scientists from Harvard and other labs published test results in scientific journals showing a methamphetamine-like compound in Craze, Driven Sports disclosed on its website that it had suspended production "several months ago while it investigated the reports in the media regarding the safety of Craze."
It's unclear whether the warning letter is the only action the FDA is taking relating to Cahill's business practices. A spokesman for the Drug Enforcement Administration told USA TODAY last fall that the agency could pursue a criminal investigation in cases where a dietary supplement is found to be spiked with illegal drugs or compounds similar to them.
The FDA, in a statement to USA TODAY, said it was important to issue the warning letter even though Driven Sports stopped selling Craze last year.
"Before the warning letter was issued, the agency took immediate action by reaching out to Driven Sports to discuss discontinuing the marketing of the firm's CRAZE product," the FDA said. "Regardless of the fact that the firm discontinued marketing the product, the safety concerns associated with the product are significant enough to merit formal documentation to reinforce with Driven Sports and the industry as a whole the gravity of these safety concerns."
U.S. Rep. Henry Waxman, D-Calif., said Tuesday the FDA needs better tools to get risky supplements off the market quickly and prevent them from being sold in the first place.
"This isn't the first time we've seen problems with dietary supplements marketed for performance enhancement and it won't be the last time," Waxman said. "The law puts FDA in a position of always being several steps behind those who want to market dietary supplements, including supplements that pose real risks."
Records show regulators have been slow over the years to sanction Cahill for putting potentially dangerous products on the market, and by the time they take action he often has already introduced his next product.
Cahill has had a federal felony charge pending against him in California since August 2012. While court records show the case remains open, prosecutors have not taken any public actions or filed any additional public documents since charging Cahill 20 months ago with putting on the market in 2008 another sports supplement — Rebound XT — that contained an undisclosed anti-estrogen drug. In March 2013, a federal grand jury was hearing testimony in the case, according to a former Cahill business partner and a copy of the subpoena he received about Rebound XT. A spokesman for the U.S. attorney's office declined to comment on the status of the case.
In 2005, Cahill pleaded guilty to felony charges of conspiracy to commit mail fraud and introduction of a misbranded drug into interstate commerce for selling weight-loss pills he and a business partner made by mixing a highly toxic pesticide with baking powder and stuffing it into capsules. Cahill received a 24-month sentence. As he was headed to prison in the weight-loss pill case, Cahill put a designer steroid on the market called Superdrol that was later linked to serious cases of liver damage, records show.
This month, Driven Sports began selling Frenzy, a pre-workout powder being touted as the replacement product for Craze and that reviewers praise for the kind of "rage" and "aggression" it produces during workouts.
But Driven Sports isn't selling Frenzy in the United States and has told its distributor in the United Kingdom, Predator Nutrition, that it cannot ship the product here, according to postings by both companies on Twitter, Facebook and their websites. "Frenzy ("Foreign-zy") was never intended to be sold in the USA," wrote Driven Sports on its Facebook page.
Even so, tubs of Frenzy were being sold last week on eBay's U.S. site for about $100 each.
Frenzy is unlikely to receive scrutiny from U.K. regulators at the Medicines and Healthcare Products Regulatory Agency. "Only a relatively small proportion of sports supplements fall under the MHRA's regulatory remit," said press officer Matthew Niizeki. The agency gets involved only "if there is a suspicion they contain a medicinal ingredient, or they make a medicinal claim."
In response to USA TODAY's inquiry about Frenzy, Niizeki said agency staff "do not consider the product medicinal, as such it would not fall under our regulatory remit." It was not immediately clear whether Frenzy could face scrutiny from another U.K. agency. Frenzy doesn't list the "Dendrobex" or "Dendrobium" extract that was on Craze's label. Instead, Frenzy lists other ingredients that the label says include "Pouchung Tea" and "Pentergy."
Steve Mister, a top supplement industry official, said the FDA's warning letter to Driven Sports is an example of the agency enforcing a federal rule "that has long been under-enforced" requiring supplement manufacturers to demonstrate any new dietary ingredient is reasonably expected to be safe.
The Council for Responsible Nutrition "applauds FDA for exercising its enforcement tools under this provision, and we hope that the agency will continue this enforcement, sending a strong message to the industry that compliance with the (rule) is mandatory," said Mister, the trade group's president.
To read the full Supplement Shell Game series, go to supplements.usatoday.com.
Follow USA TODAY investigative reporter Alison Young: @alisonannyoung
The designer of popular bodybuilding supplements has flourished despite a federal criminal conviction and parents and consumers who say his products have done serious harm over the years.