DMAA Removed from UK Market

LONDONThe Medicines and Healthcare products Regulatory Agency (MHRA) ruled DMAA (1,3 -dimethylamylamine) supplements are unlicensed medicinal products and should be removed from the U.K. market. In particular, MHRA called out the sports supplement Jack3D (from USPlabs LLC), saying it and other DMAA-containing products pose potential risks to public safety.

This U.K. ban is one in a line of restrictions and warnings governments have put on the workout/weight-loss supplement. In July 2012, the Food Safety Authority of Ireland (FSAI) the Irish Medicines Board (IMB) advised sport, health stores and Irish-based companies to halt sales of food supplements or products containing DMAA and told consumers not to purchase DMAA supplements.

The Food Standards Australia New Zealand (FSANZ) issued a similar warning in June 2012, encouraging consumers who have purchased products containing DMAA to discard them. In the United States, FDA sent warning letters to 10 DMAA marketers questioning the products legality and safety, and in December 2011, the Department of Defense halted the sales of DMAA products within military facilities.

The MHRA, which regulates medicines and medical devices in the U.K., said the ban is necessary because DMAA can narrow the arteries and raise the heart rate. The agency said it has been linked to suspected adverse drug reactions worldwide, ranging from shortness of breath and heart attacks to  at least one fatality. The MHRA previously issued eight urgent notices instructing retailers to remove Jack3D and any other DMAA containing products from sale.

These products may claim to increase performance, but contain powerful ingredients which can have serious side effects," said David Carter, Manager of MHRAs Medicines Borderline Section. We recommend that people only use approved products and speak to a qualified medical practitioner if they have any concerns about any supplements they may be taking."

DMAA is also banned under the prohibited list of banned substances by the World Anti-Doping Agency. This is a significant step forward for all competitive athletes as methylhexaneamine (DMAA) is a banned substance in-competition that frequently appears in over-the-counter and Internet-bought products, but not clearly on the label," said Graham Arthur, director of legal at U.K. Anti-Doping.  "Athletes who use sports supplements need to choose reputable manufacturers who can justify their claims with scientific evidence, and have their products screened to minimize the risk of testing positive for a substance on the World Anti-Doping Agencys Prohibited List. U.K. Anti-Doping continues to work closely with the MHRA to protect the health of athletes and to prevent doping in sport."

Nutrex Research Inc., a company that received a DMAA warning letter from FDA , said at least seven studies support the view that DMAA is reasonably expected to be safe under its intended conditions of use. In its response to FDA's warning letter Nutrex also pointed to the millions of doses that consumers have used over the years to show when used as directed, dietary supplements containing DMAA have a record of safety.

USPlabs has also offered up safety studies, reporting five clinical safety trials sponsored by the company have been published on products that contain its 1,3 -DMAA: Jack3d® & OxyELITE Pro® ingredients. Refuting FDA's claim that DMAA is a synthetic ingredient, DMAA has also recently reported a analytical study has confirmed the presence of DMAA in geranium sourced from China.