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European Health Regulators Look to FDA for Guidance on DMAA

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
  • death

“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

Do I Have a DMAA Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in DMAA lawsuits. We are currently accepting new cases in all 50 states.

Again, if you or a loved one has been injured by DMAA, you should contact our lawyers immediately by clicking the link below or calling toll free 1-800-773-0849. You may be entitled to compensation for your injuries and we can help.

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