April 16, 2013 — In a new Consumer Warning, the U.S. Food and Drug Administration (FDA) is updating the public on the steps they are taking to ensure that dietary supplements containing DMAA are no longer distributed or sold. The agency has determined that DMAA supplements are illegal. Furthermore, they are warning that they have received 86 adverse event reports, including 5 deaths. Side effects associated with DMAA include elevated blood pressure, heart attacks, psychiatric disorders, and more.
The FDA announcement has been published about a year after the agency sent 10 warning letters to manufacturers of DMAA supplements. Only one manufacturer, USPLabs, has stopped selling DMAA. Unfortunately, USPLabs also sells the two most popular DMAA supplements, Jack3d and OxyElite Pro. The supplements continue to be sold by GNC, one of the largest retailers of supplements in the United States.
The FDA communication indicated that USPLabs defended the use of DMAA in dietary supplements by submitting published studies. After reviewing the studies, the FDA found that they were “insufficient to defend the use of DMAA as an ingredient in dietary supplements.”
Since the controversy surrounding DMAA began a few years ago, USPLabs and other manufacturers have consistently defended DMAA as a “natural” botanical extract from the geranium plant. However, no independent scientist has been able to verify this claim. Herbal supplement associations do not recognize DMAA, and most experts agree that DMAA is actually a synthetic substance. In fact, the pharmaceutical company Eli Lilly & Co. originally manufactured DMAA as a nasal decongestant spray in 1948. Its approval was withdrawn in 1983.
The FDA warned that they intend to take further steps to remove DMAA from the market. These steps may include an official ban of DMAA, more warning letters or public announcements, and asking USPLabs to issue a voluntary recall. If these efforts are not sufficient, the FDA could work with U.S. marshals to seize and destroy DMAA products and even bring criminal charges against manufacturers.
The FDA also commented on the challenge of regulating dietary supplements:
“With dietary supplements, there is no pre-market approval, and once a product is on the market, the burden is on the FDA to prove that a product is unsafe.”
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