We urge manufacturers, distributors, retailers and regulators to work together to remove this unapproved stimulant from the marketplace to help protect consumers from potentially harmful health effects.
ANN ARBOR, Mich. (PRWEB) October 08, 2014
Researchers from global public health organization NSF International, Harvard Medical School and the National Institute for Public Health and the Environment in the Netherlands (RIVM) have found an unapproved synthetic stimulant - 1,3-Dimethylbutylamine or DMBA – in 12 over-the-counter dietary supplements. The findings were published in the peer-reviewed journal Drug Testing and Analysis.
This is an important finding, as DMBA is chemically similar to other harmful stimulants such as DMAA, which was banned by regulatory agencies in the US, UK, The Netherlands, Brazil and elsewhere because of its links to negative health events such as strokes, heart failure and sudden death. There are no known safety studies on DMBA and its health effects are entirely unknown.
“While regulatory authorities work to remove harmful stimulants such as ephedrine and DMAA from supplements, new synthetic stimulants such as DMBA continue to crop up to take their place,” said NSF International Senior Research Scientist John Travis. “Without proper studies, the health impact of this new stimulant is entirely unknown. We urge manufacturers, distributors, retailers and regulators to work together to remove this unapproved stimulant from the marketplace to help protect consumers from potentially harmful health effects.”
“The literature states that this new drug has been tested on dogs and cats with severed spinal cords. It’s never been tested in humans. It is absurd that consumers are being exposed to adulterated over-the-counter workout and weight loss supplements sold at some of the largest supplement retailers in America. The risks are entirely unknown,” explains Dr. Pieter Cohen, an Assistant Professor of Medicine at Harvard Medical School. “The possibility to cause harm is real. It’s a close cousin of DMAA, which is currently being investigated as the cause of bleeding strokes, heart failure and sudden death,” said Dr. Cohen, who is also an Internist at Cambridge Health Alliance. “It is essential to steer clear of this new drug.”
Consumers are urged to avoid products containing this substance, which may be listed on product labels as “4-amino-2-methylpentane citrate,” “AMP citrate,” “1,3-dimethylbutylamine citrate,” “4-amino-2-pentanamine,” “Pentergy,” “4-AMP” or “extracted from pouchong tea.”
A recent independent survey conducted on behalf of NSF International indicated that 51 percent of consumers are concerned about the safety and quality of dietary supplements. Consumers are encouraged to look for NSF certified dietary supplement and sports nutrition products, which have been tested against the American National Standard for dietary supplements (NSF/ANSI Standard 173). Third party certification to this standard, which consists of regular facility audits and product testing, helps protect consumers by verifying that dietary supplements are manufactured in a GMP (Good Manufacturing Practices)-compliant facility, are free of adulterants and unapproved compounds, have accurate labels and do not contain harmful levels of specific contaminants.
The NSF Certified for Sport® certification program goes a step further by additionally screening dietary supplements for more than 200 athletic banned substances. The Certified for Sport® program is used by the MLB, NFL, NHL, PGA, LPGA Canadian Center for Ethics in Sport (CCES) and the New York City Police Department.
“NSF International’s Dietary Supplement and NSF Certified for Sport® certification programs help retailers protect their customers by allowing consumers and athletes to make more informed decisions, knowing that what is on the label matches what is in the bottle, and they are not consuming any unintended and potentially harmful substances like DMBA,” said Travis.
Background on the research paper: Using ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS), NSF International and RIVM scientists found DMBA in 12 of the 14 dietary supplement products analyzed (85.7%) with DMBA content ranging from 13 to 120 mg per serving. According to the recommended daily intake on product labels, consumers of these products would ingest 26 to 320 mg of DMBA per day. Additionally, DMBA was listed on product labels as “4-amino-2-methylpentane citrate,” “AMP citrate,” “1,3-dimethylbutylamine citrate,” “4-amino-2-pentanamine,” “Pentergy,” “4-AMP” or “extracted from pouchong tea.” The full research is published in the journal, Drug Testing and Analysis, and can be downloaded here: http://onlinelibrary.wiley.com/doi/10.1002/dta.1735/full.
For more information about NSF International’s Dietary Supplement Certification programs, visit NSF's website or contact David Trosin at dtrosin(at)nsf(dot)org or +1 734-827-6856.
Editor’s note: If you would like to set up an interview with an NSF dietary supplement expert, email Greta Houlahan at media(at)nsf(dot)org or call 734-913-5723.
About NSF International (http://www.nsf.org): NSF International is a global independent organization based in Ann Arbor, Mich., that writes standards, and tests and certifies products for the water, food, health sciences and consumer goods industries to minimize adverse health effects and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide. Operating in more than 155 countries, NSF is accredited by the American National Standards Institute (ANSI) and is a Pan American Health Organization/World Health Organization Collaborating Center on Food Safety, Water Quality and Indoor Environment.
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 International 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.