The European Union is poised to follow the U.S. Food & Drug Administration’s lead in regulating the sale of DMAA-containing dietary supplements. Pressure has been building in the United States and Europe to ban the controversial ingredient, as numerous adverse events have been reported and questions over the stimulant’s source remain unanswered. In recent months, dietary supplements containing DMAA have been linked to a number of serious side effects including hyperthermia, irregular heartbeats, seizures, heart attacks, and strokes.
If you or a loved one has been injured by DMAA, you should contact our DMAA lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
April 30, 2012 – Last week, the FDA sent warning letters to 10 manufacturers and distributors of DMAA products, prompting European health regulators to follow suit.
Under U.S. law, companies who use certain ingredients not marketed in a dietary supplement before Oct. 15, 1994, must submit evidence to the FDA that their products are safe. These companies must provide such notification no fewer than 75 days before marketing their supplements. The establishments contacted by the FDA have been warned that this requirement has not been met.
“From a European standpoint, the US FDA’s position on DMAA is extremely important, and probably decisive,” said Luca Bucchini, PhD from the Italian firm, Hylobates Consulting. “It seems hard for EU sellers of DMAA supplements to prove to national authorities that the FDA is wrong, or for EU authorities to disagree with the Americans, unless the US agency changes its mind.”
To date, the FDA has received at least 42 adverse event reports associated with DMAA-containing dietary supplements including:
- cardiac disorders
- nervous system disorders
- psychiatric disorders
“DMAA is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack,” the FDA press release stated.
For Bucchini and other European health regulators, the FDA’s move to seriously restrict the sale and distribution of DMAA products is definitive and far-reaching.
“Is this the end of the road for DMAA in Europe?” he wondered. “It’s very probable. It would be odd that European authorities take a less precautionary approach than the FDA.”
The FDA sent warning letters to these companies regarding the following DMAA-containing dietary supplements:
Company Product(s) Exclusive Supplements Biorhythm SSIN Juice Fahrenheit Nutrition Lean Efx Gaspari Nutrition Spirodex iSatori Global Technologies, LLC PWR Muscle Warfare, Inc. Napalm MuscleMeds Performance Technologies Code Red Nutrex Research Hemo Rage Black Lipo-6 Black Ultra Concentrate Lipo-6 Black Lipo-6 Black Hers Ultra Concentrate Lipo-6 Black Hers SEI Pharmaceuticals MethylHex 4,2 SNI LLC Nitric Blast USP Labs, LLC OxyElite Pro Jack3d
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