NSF International Discovers Emerging and Potentially Harmful Adulterant in Dietary Supplements
Potentially Harmful Adulterant Called N,alpha-diethylphenylethylamine (N,a-DEPEA) Found in a Dietary Supplement
ANN ARBOR, Mich., CAMBRIDGE, Mass., & BILTHOVEN, Netherlands – Researchers from global public health organization NSF International, Harvard Medical School and the National Institute for Public Health and the Environment in the Netherlands have published an article in Drug Testing and Analysis describing the public health implications of an emerging and potentially harmful substance found in a dietary supplement sold in stores and online.
The substance, called N,alpha-diethylphenylethylamine (N,a-DEPEA), has a structure similar to methamphetamine and was found in a consumer dietary supplement product called Craze (marketed by Driven Sports, Inc.). Additionally, the substance (N,a-DEPEA) is not disclosed on the label. The substance was found as part of a collaborative testing project conducted by scientists at NSF International, Harvard Medical School (HMS) and the National Institute for Public Health and the Environment (NIPHE) in the Netherlands.
“Alarmingly we have found a drug in a mainstream sports supplement that has never been studied in humans,” says Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School who has conducted extensive research on supplements. “The health risk of using supplements adulterated with a drug should not be underestimated.”
In separate testing, NSF International scientists also detected N,a-DEPEA in a different supplement called Detonate by Gaspari Nutrition. Regulators may want to consider taking action to warn consumers.
“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, which helps protect consumers by verifying what is on the dietary supplement label is in the package and that the product does not contain other undeclared ingredients or unsafe levels of contaminants.
This collaborative testing project was developed in response to several failed urine drug tests by professional athletes after taking an over-the-counter workout product called Craze marketed by Driven Sports, Inc. After extensive testing and a review of the product’s label at NSF International’s laboratory in Ann Arbor, Mich., scientists at NSF International, HMS and NIPHE confirmed that the substance N,N-diethylphenylethylamine was listed on the label but N,a-DEPEA, an emerging and potentially harmful designer stimulant, was found. A review of this substance shows that N,a-DEPEA is likely less potent than methamphetamine but greater than ephedrine.
The compound that is listed on the label of Driven Sport’s Craze product, N,N-diethylphenylethylamine, is alleged to be a constituent of dendrobium orchid extract. This claim made by Driven Sports cannot be confirmed. After an extensive search of the scientific literature, NSF International, HMS and NIPHE scientists did not find any evidence to support the claim that N,N-diethylphenylethylamine or any phenylethylamines (PEAs) are constituents of dendrobium orchid extract.
As mentioned earlier, the article outlining the results of this collaborative testing project is published in Drug Testing and Analysis by NSF International Senior Research Scientist John Travis, Harvard Medical School’s Dr. Pieter Cohen and the National Institute for Public Health and the Environment’s Bastiaan Venhuis. The paper can be downloaded from Drug Testing and Analysis’ library.
NSF International helped develop the only accredited American National Standard for dietary supplements (NSF/ANSI Standard 173). NSF’s accredited dietary supplement certification program is based on this standard. The program includes a label and formulation review, testing to verify the supplement does not contain harmful levels of contaminants, and two facility audits annually to confirm compliance to good manufacturing practices (GMPs). Products certified to the stringent NSF Certified for Sport® program include additional steps to screen supplements for more than 180 athletic banned substances.
“NSF International’s Dietary Supplement and Certified for Sport® Certification Programs help retailers, consumers and athletes to make more educated decisions knowing that what is on the label matches what is in the container and they are not consuming any unintended substances like N,a-DEPEA,” said Wyszumiala. The NSF program is used by the NFL, NHL, MLB, PGA, LPGA, the Canadian Centre for Ethics in Sport (CCES) and the New York City Police Department.
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About the Craze testing project: Samples of Craze were purchased online and in stores in the U.S. and Europe. Each sample had a different lot number. Samples were analyzed by NSF International (Ann Arbor, Mich.) using ultra performance liquid chromatography (UPLC) coupled to an LTQ Orbitrap XL mass spectrometer. Samples were also analyzed by the Netherlands’ National Institute for Public Health and the Environment using a UPLC-quadruple-time-of-flight mass spectrometer. The identity of N,a-DEPEA was confirmed using nuclear magnetic resonance with a reference standard by the Korean Forensic Service. The results of this collaborative testing project were submitted to the United States Food and Drug Administration (FDA).
More background about Detonate testing: Detonate was purchased from a U.S. retail store. The analysis was performed by NSF International (Ann Arbor, Mich.) using ultra performance liquid chromatography (UPLC) coupled to an LTQ Orbitrap XL mass spectrometer. The identity of N,a-DEPEA was confirmed by comparison of the chromatographic retention time, accurate mass measurement and product ion fragmentation to that of a reference standard.
About NSF International: NSF International is an independent global organization that writes standards, and tests and certifies products for the food, water, consumer goods and health sciences industries to minimize adverse health effects and protect the environment (nsf.org). Founded in 1944, NSF is committed to protecting human health and safety worldwide. Operating in more than 150 countries, NSF is accredited by the American National Standards Institute (ANSI) and has been collaborating with the World Health Organization since 1997 in water quality and safety, food safety and indoor environments.
The NSF Health Sciences Division offers training and education, consulting, auditing, GMP and GLP testing, certification, R&D and regulatory guidance for the pharmaceutical, medical device and dietary supplement industries throughout the product life cycle. NSF wrote the only accredited American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard. The NSF Health Sciences Division operates globally throughout North America, Europe, the Middle East, Africa, Asia and Latin America.
NSF International offers ISO 13485 registrations for medical devices and CE marking delivered through NSF International Strategic Registrations, Ltd. (NSF-ISR), as well as drinking water filtration certification through the NSF Global Water Division. Additional services include safety audits for the food and water industries, environmental and sustainability services through NSF Sustainability and training courses through NSF Training and Education.