Craze manufacturer disputes NSF's discovery of drug tainting

By Hank Schultz

- Last updated on GMT

Craze manufacturer disputes NSF's discovery of drug tainting

Related tags: Nsf international, Dietary supplement, Nsf

The news that NSF and two collaborators have found a methamphetamine-like compound in the popular pre-workout sports supplement Craze is being disputed by the product’s manufacturer, Driven Sports.

“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.”

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4 comments

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N,N- vs. N,a-DEPEA

Posted by Mark Roman, Ph.D.,

The analytical data is clear from the paper. The compound in question is N,a-DEPEA, a new methamphetamine analog. Despite Ullman's assertion that the two compounds are "very closely related analogs..." and that this "is something that NSF didn't take into account," these compounds are not difficult to distinguish analytically, and his comments are inaccurate and misleading. The product ion in the CID mass spectrum at M/Z 133.101 is definitive - this indicates a loss of 45.058, which occurs with the loss of C2H7N, or ethylamine. It would be virtually impossible to lose this moeity if it were the N,N- analogue; one would expect a loss of diethylamine, (MW 73.09), yet there is no product ion in the mass spectrum corresponding to this loss. Furthermore, the NMR data obtained by the Korean Forensic Service on the isolated compound would easily distinguish between these two isomers, and I find it highly doubtful that the researchers (and the NMR software) would give an inaccurate chemical shift assignment to the compound. There are thus 2 orthogonal techniques that yield the same results.

I also question the statement about the Swedish lab using a "validated method." This is structure elucidation, not quantitative analytical chemistry. I am wondering what performance characteristics the Swedish lab determined during their validation work?

Comments about method validation, GMPs, etc. are simply obfuscation of the obvious analytical data that points to this being a synthetic analogue to methamphetamine with unknown safety risks in humans.

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GMP Registered Facilities

Posted by Marc Ullman,

The last item in NSF's "response" suggests a lack of understanding of the requirements of the dietary supplement GMP regulation that is particularly troubling given NSF's claims allegations of intentional adulteration and misbranding.

The Dietary Supplement GMP regulations require that all manufacturers take appropriate steps to identify every dietary ingredient used in a product and to make sure that the product meets specifications for strength and purity. (This includes meeting label claims and not having added adulterants).

The suggestion that a customer can only be sure "that what is on the dietary supplement label is in the product AND that the product does not contain undeclared ingredients or unsafe levels of contaminants, if the product itself has been tested and certified via NSF’s Dietary Supplement Certification program" demonstrates a fundamental lack of understanding of the purposes and nature of the Good Manufacturing Practices regulation. That this statement could be made by the NSF Director of Dietary Supplement Certification is particularly concerning.

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USPLABS DEFENSE

Posted by Mark D. Rustad,

USPLabs raised the same type of defense relative to DMAA. Then it was Geranium extract. Now it is Orchid extract.

It would seem to me that this issue can be resolved by asking U.S. Customs to trace back all imported Dendrobrium to its manufacturing source. I rather doubt that one will find an obscure Chinese farmer with his two billion orchids extracting "Den" for XYZ Sports. What one is more likely to find at the source is a pharmaceutical plant outside Shanghai. Please ask XYZ Sports to disclose it warranties and representations to U.S. Customs. Who is the importer of record for this material? How many grams of "Den" are used in each unit of sale. How many have been produced to date? Where are the import records that tie these weights from the kilogram down to the gram? Much of this material offered to those of us that produce sports nutrition dietary supplements are handled by Chinese exporters who use China's version of Fed Ex. Follow the import trail carefully and you will discover the rest of the story. U.S. Customs and FDA both as stand alone entities and ,especially when working in tandem, are a formidable force. Then we will see if the tone, tenor and facts of the story change. Be sure to find samples of products containing 'Den" that are back dated 12 months.

Mark Rustad, President, Panthera Pharmaceuticals, LLC

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