The FDA has finally prevailed in a two year long battle against manufacturers of DMAA (dimethylamylamine), an illegal stimulant being used in dietary supplements. On July 2, 2013, one of the last remaining manufacturers of DMAA, Texas-based USPlabs, agreed to voluntarily destroy the remaining DMAA products sitting in its warehouse. USPlabs manufactures two DMAA products: Jack3d and OxyELITE Pro.
The success of the FDA was hard fought. In December 2011, after the death of two Army soldiers during routine PT due to DMAA, the Department of Defense ordered all such products off the shelves of GNC stores on Army bases.
In April 2012, the FDA sent warning letters to a dozen manufacturers warning that DMAA was an unlawful ingredient and could not be marketed in the U.S. Additionally, the FDA noted 42 adverse events were reported by consumers of DMAA products. In response to the FDA warning, all of the manufacturers except USPlabs agreed to stop selling DMAA products.
As the adverse events continued to pile up over 80, USPlabs staunchly defended its Jack3d and OxyELITE products and refused to stop marketing the products. In April 2013, the FDA made a public safety alert warning consumers not to use these products as they could result in serious cardiovascular injuries and death.
The FDA continued to weigh its legal options in shutting down the production and marketing of DMAA in this country. In conjunction with the Justice Department two actions were filed against GNC and warrants were received to seize all DMAA products from GNC warehouses. After continued negotiations and under threat of enforcement action by FDA, USPlabs finally capitulated and agreed to no longer manufacture DMAA.
The Department of Defense recently completed an epidemiological study of DMAA in soldiers. While it had several methodological problems, the results nonetheless demonstrated that soldiers using DMAA for more than 80 days were 3.5 times more likely to have multiple serious adverse events. And those who had two or more serious adverse events were twice as likely to have taken DMAA.
FDA has said of DMAA:
Is it safe to consume DMAA?
No, FDA does not have any information to demonstrate that consuming DMAA is safe. FDA is very concerned about DMAA and we advise consumers not to purchase or use any dietary supplement containing DMAA. This substance narrows blood vessels and arteries, which can elevate blood pressure, and may lead to cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack, as well as seizures and other neurological and psychological conditions. FDA has received 86 reports of adverse events involving products containing DMAA. These events include psychiatric disorders, heart problems, nervous system disorders, and death.
Shockingly, however, Jack3d and OxyELITE can still be purchased at GNC. GNC and USPlabs continue to attempt to sell the remaining inventory of these products to avoid financial loss and while exposing consumers to continued, unreasonable risks.
DMAA had already been banned by Canada, New Zealand and several European countries over safety risks.
If you or a loved one have taken Jack3d, OxyELITE Pro or any other product containing DMAA please contact us today.