Craze manufacturer disputes NSF's discovery of drug tainting
“We are adamantly disputing the results,” said Marc Ullman, the attorney representing Driven Sports.
Researchers from NSF International, Harvard Medical School (HMS) and the National Institute for Public Health and the Environment in the Netherlands (NIPHE) published an article in Drug Testing and Analysis describing their tests of the substance, which is sold in stores and online..
Sturcture similar to methamphetamine
The substance, called N,alpha-diethylphenylethylamine (N,a-DEPEA), has a structure similar to methamphetamine. According to the researchers, the substances is not disclosed as such on the label.
“The health risk of using supplements adulterated with a drug should not be underestimated,” said Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School who has conducted extensive research on supplements.
The crux of the company’s argument is that the product is rigorously tested, and that the product contains an analogous compound—the N,N form—to the one that the researchers found. Further, Ullman said that NSF did not use a validated method to distinguish one version of DEPEA from other. The company’s contention is that the beta version is a natural constituent of dendrobium, an orchid species.
“We think that the fact that there is a very closely related analogue is something that NSF didn’t take into account,” Ullman said. “We use a Swedish lab that has developed a validated method that distinguish between these substances.”
The researchers purchased three samples of the product, one at a GNC store and the other two online, one from a US outlet and the other in the Netherlands. The products were tested with what NSF called its “standard approach of ultra high performance liquid chromatography (UHPLC) coupled to an LTQ Orbitrap XL mass spectrometer.” In the first sample those results “strongly indicated the presence of N,α-DEPEA as opposed to N,N-DEPEA,” the report said. “A review of this substance shows that N,a-DEPEA is likely less potent than methamphetamine but greater than ephedrine,” NSF said. The first sample and its test results have been forwarded to FDA, NSF said.
Several phenylethylamines listed
N,N DEPEA is on of several phenylethylamines listed on the Craze label, which the company says are components of dendrobium. The label says its dendrobium extract is "concentrated for alkaloid content including Dendrobine, Dendroxine, Dendramine, B-Phenylethylamine, N,N-Dimethyl-B-Phenylethylamine, and N,N-Diethyl-B-Phenylethylamine."
“The supplement label listed N,N-DEPEA, a structural isomer of the actual ingredient. The listing of a structural isomer might mislead regulators trying to determine the actual ingredients in the supplement,” the report said.
“We are actively trying to find out now and have been for the past several months since this issue was first raised exactly what the constituents are in dedrobium stem. If they are in there they are naturally occurring as far as we are concerned. Accusations that there are designer drugs in the product are grossly irresponsible,” Ullman said.
Certification questions
“We urge consumers to remain vigilant about the dietary supplement products they choose, especially since products including Craze and Detonate are available in stores and online, and encourage them to look for certification as a sign that the product has been tested and certified to be free of undeclared ingredients or harmful levels of contaminants,” said Ed Wyszumiala, general manager of NSF International’s Dietary Supplement Certification Program.
Ullman retiteratied that Craze is adequately tested, and that the manufacturing and testing facilities are appropriately certified.
“Every single lot of this product as been tested at a DEA registered lab,” Ullman said. “And it was manufactured in a contract manufacturing facility that was GMP certified by NSF itself.”
