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Posted April 18, 2014

FDA Questions Ingredient in Workout Supplement

On April 4, 2014, the FDA issued a warning letter to Driven Sports Inc., following a label review which found the company's workout supplement, CRAZE, to be adulterated because it contains the new dietary ingredient Dendrobex.

Dendrobex is described on the CRAZE label as "Dendrobium Extract (stem), (concentrated for alkaloid content including Dendrobine, Dendroxine, Dendramine, B-Phenylethylamine, N,N-Dimethyl-B-Phenylethylamine, and N,N-Diethyl-B-Phenylethylamine)."

However, the FDA noted that the alkaloids B-Phenylethylamine, N,N-Dimethyl-B-Phenylethylamine, and N,N-Diethyl-B-Phenylethylamine do not appear to be present in the Dendrobium species and requested an explanation for their presence in the supplement. The agency also requested a meeting with the company in order to discuss the products it intends to market.

CRAZE was previously found to contain the banned methamphetamine -- like compound, N,alpha-diethylphenylethylamine. While Driven Sports disagreed with this finding, it agreed to stop distribution of CRAZE and destroy its remaining inventory (Note: This statement is no longer available on the company's website).

Supplement manufacturers are required to submit a new dietary ingredient (NDI) notification for ingredients not marketed prior to October 15, 1994, and/or ingredients which have not been present in the food supply as an "article used for food in a form in which the food has not been chemically altered."

See Related Warnings:

Methamphetamine-Like Compound Found In Popular Workout Supplement

Safety of Certain Weight Loss and Bodybuilding Supplements Called Into Question

Another Meth-Like Compound Discovered In Weight Loss Supplements

To read the FDA's warning letter, use the link below.