FDA warns maker of controversial workout supplement Craze

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 now made public show.

The supplement was pulled from GNC stores on military installations in October.

The warning letter from the U.S. Food and Drug Administration, dated April 4, comes months after New York-based Driven Sports had already 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 U.S.

Officials with Driven Sports and the FDA were not available for comment by press time.

Driven Sports 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 since the agency is not aware of any evidence 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 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.

Driven Sports said 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.

This month, Driven Sports began selling Frenzy, a pre-workout powder being touted as the replacement product for Craze, and one that reviewers praise for the kind of “rage” and “aggression” it produces during workouts.

But Driven Sports isn’t selling Frenzy in the U.S. 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 recently on eBay’s U.S. site for about $100 each.