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FDA Warns of DMAA Dangers and Bans Distribution
Ennis & Ennis, P.A. reports that the FDA is warning of the dangers of DMAA and is working to ensure that any dietary supplements containing the stimulant, dimethylamylamine (DMAA) will no longer be distributed or sold in the U.S. marketplace.
The FDA warnings follow over 60 reports of illness or death associated with supplements containing DMAA. The reports include heart problems and nervous systems and/or psychiatric disorders. To remove DMAA from the market, the FDA has warned 11 companies that dietary supplements containing DMAA are illegal. Nearly all of the companies using DMAA agreed to cease distribution of products containing DMAA. The one company who failed to comply, USPLabs, responded to the FDA’s warnings by submitting studies challenging the FDA’s findings. However, after the FDA reviewed the studies submitted by USPLabs, it found the information insufficient to allow the continued use of DMAA. According to Daniel Fabricant, director of FDA’s Division of Dietary Supplement Program, the FDA is finalizing a formal response to USPLabs to reflect its findings. The USPLabs’ products are the popular Oxy Elite Pro and Jack 3D, so consumers should cease use of these products.
The FDA’s authority over dietary supplements differs from its authority over drugs and medical devices. The FDA must take significant scientific and legal steps in order to force the removal of dietary supplements that may be unsafe or illegal as dietary supplements are subject to adifferent oversight process. With dietary supplements, there is no pre-market approval, and once it hits the market, the burden is on the FDA to prove that a product is not safe. As the FDA continues this process, consumers are urged to check labels and avoid any supplements containing DMAA. DMAA is referred to by several other names including:
Consumers are urged to report any health problems associated with supplement use to the company and to the FDA and to consult their physician before using any supplements. Ennis & Ennis, P.A. continues to offer free, nationwide, confidential consultations to anyone who used supplements containing DMAA and suffered a cardiac event or other physical injury by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.