Pre-workout supplement marketer Driven Sports will not be launching any new products containing any Dendrobium-related ingredients in the future, says the company’s legal counsel in response to a warning letter from the FDA.
New York-based Driven Sports issued a statement on its website at the start of January that it had stopped distributing Craze over six months earlier, and it was completing the destruction of any remaining inventory to which it had access.
Despite being about 10 months out from the last distribution of Craze, the FDA issued a warning letter dated April 4, 2014 , stating: “According to the statement dated January 8, 2014, on your website, drivensports.com, due to reports of the presence of N,alpha-diethylphenylethylamine in Craze, which you dispute, you had stopped distributing Craze and were in the process of completing destruction of any remaining inventory to which you have access. You have not conducted a recall of this product.
“In addition, you have announced plans to market new products, but have not specified whether they will contain Dendrobex. As explained below, even if Craze does not contain N,alpha-diethylphenylethylamine, the presence of Dendrobex in Craze renders this product adulterated under the Federal Food, Drug, and Cosmetic Act (the Act).”
Little or no legitimate product left on the market
In a statement to NutraIngredients-USA, Marc Ullman from law firm Ullman, Shapiro & Ullman LLP, which represents Driven Sports, told us that the company would not be issuing a recall. “Craze has not been manufactured or distributed for months,” he said. “There should be little or no legitimate product left on the market.”
Ullman added that the company has ceased use of Dendrobex, “and does not intend to use it or any other Dendrobium related ingredient in the future”.
Craze hit the headlines following the publication of scientific papers in Drug Testing and Analysis and the Journal of Analytical Toxicology that alleged that the product tested positive to a compound called N,alpha-diethylphenylethylamine (NADEPEA), also known as N-ethyl-1-phenyl-2-butylamine or ETH, reported to have possible amphetamine-like stimulant activity.
Despite disputing the findings of both studies, and funding a study of its own that found no NADEPEA, Driven Sports decided to permanently remove Craze from the market.
NutraIngredients-USA contacted the FDA for comment, but none had been received in time for publication. An article in USA TODAY carried the following statement from the Agency explaining its position: “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.
“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.”