FDA regulation of e-cigarettes rebuffed again

The agency has one more legal option -- the U.S. Supreme Court -- to prove why the popular products should face the same tests as medical devices.

By — Posted Feb. 14, 2011

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The Food and Drug Administration has lost another battle in its fight to regulate what goes into so-called electronic cigarettes.

The U.S. Court of Appeals for the District of Columbia Circuit on Jan. 24 said it would not review a decision blocking the products from FDA regulation as medical devices. An FDA spokesman said the agency is considering its legal and regulatory options. The FDA still could try to take the case to the U.S. Supreme Court.

An appellate panel of three judges in December 2010 said e-cigarettes did not meet the definition of medical devices under the Federal Food, Drug and Cosmetic Act. The classification would have required clinical trials for e-cigarettes.

Devices fall under that law only when marketed for therapeutic use, the judges said. E-cigarette manufacturers proved that their products are marketed for smoking pleasure and not cessation, according to the court.

The judges allowed the FDA jurisdiction over the products as "tobacco products," but that regulation includes less control and would take more time to implement.

"We were disappointed in the court's decision," said Tom Glynn, PhD, director of cancer science and trends at the American Cancer Society. "It really leaves e-cigarettes in a kind of netherworld."

E-cigarettes are battery-powered products designed to look like traditional cigarettes that allow users to inhale nicotine vapor without fire, smoke or ash. The product contains liquid nicotine, an ingredient derived from tobacco plants that has prompted safety concerns from public health organizations.

Studies show thousands of people use e-cigarettes daily, and the products generate an estimated $100 million annually in sales, Glynn said. Health advocates are not necessarily against the products as a whole, he said, but they want to make sure the ingredients are safe.

"What's the effect of putting that into your lungs?" he asked.

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