FDA Warning Letter Issued to Maker of ‘Craze’ Workout Supplement

FDA_warns_makers_of_CRAZE_regarding_ingredientMatt Cahill, who runs Driven Sports, has received a warning letter from the U.S. Food and Drug Administration (FDA) over concerns about the ingredients in Craze, a controversial workout supplement that is reported to have a methamphetamine-like compound. According to the letter, the agency questions whether several ingredients that are claimed to be from dendrobium orchids actually come from the plant. The FDA says that the proprietary blend of ingredients listed as “Dendrobex” made the product adulterated under federal law, since the agency was not aware of evidence that the ingredient was present in food supply. Additionally, the company never submitted any paperwork to have it permitted as a new dietary ingredient.

USA Today reports that Cahill is a felon with a history of putting unsafe products onto the market. USA Today conducted an investigation last year on Cahill and his track record as a supplemental designer, and noted that Driven Sports stopped selling Craze in the wake of this report. Following USA Today’s investigation, major retailers such as Wal-Mart have stopped selling Craze.

Steve Mister, a top supplement industry official and president of The Council for Responsible Nutrition, said the trade group  “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,”

The FDA said it was aware of Driven Sports’ intentions to market and sell new products, and warned that any product containing “Dendrobex” could lead to the seizure of products and injunctions against manufacturers and distributors. USA Today also reports that Driven Sports began selling a new product called Frenzy this month. The pre-workout powder is being promoted as the replacement for Craze, with the same kind of “rage” and “aggression” produced during workouts.  However, Frenzy is not going to be sold in the United States; the product is unlikely to receive regulatory scrutiny from UK regulators at the Medicines and Healthcare Products Regulatory Agency.

The letter also cited an independent study showing that Craze contains a meth-like compound, N,alpha-diethylphenylethylamine. Since this compound is not known to be found in the food supply and there is no paperwork to show that it is a new dietary ingredient, products with this compound would be considered adulterated.

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