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.

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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:

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