FDA can't block importing of 'electronic cigarettes'

By Del Quentin Wilber and Lyndsey Layton
Washington Post Staff Writer
Friday, January 15, 2010; A03

A federal judge ruled Thursday that the Food and Drug Administration may not block the importation of "electronic cigarettes," battery-powered versions of conventional smokes.

The FDA has confiscated imports of the devices since at least 2008, and two suppliers, Smoking Everywhere and Sottera, sued to halt the agency's action.

In ruling for the companies, U.S. District Judge Richard J. Leon determined that electronic cigarettes are tobacco products and are not subject to such restrictions.

"This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices," Leon wrote in a 31-page opinion that granted the companies' request for a temporary injunction against the FDA.

The judge called the FDA's efforts a "tenacious drive to maximize its regulatory power."

In a statement, the FDA said it was reviewing the ruling. "The public health issues surrounding electronic cigarettes are of serious concern to the FDA," the statement said.

In court papers, the FDA said it considers the devices, also known as e-cigarettes, to be unapproved drug-delivery gadgets. E-cigarettes are the size of regular cigarettes and deliver a vaporized nicotine mixture to users.

It contends that e-cigarettes are not traditional tobacco products and that the products promise, among other things, to "alleviate nicotine withdrawal symptoms." The FDA compares the devices to nicotine gum, which it regulates because suppliers promote the gum's ability to help people kick smoking habits. FDA officials are also concerned that e-cigarettes could increase nicotine addiction and tobacco use by children.

Leon, however, sided firmly with attorneys for the makers of e-cigarettes who argued that the product is just another type of a cigarette and not a drug or device subject to strict regulations. They said the FDA should treat e-cigarettes just like Marlboros or Camels.

"We want people to smoke electronic cigarettes as long as they smoke regular cigarettes," said Kip Swartz, an attorney for Smoking Everywhere. "It's just another nicotine delivery system without combustion and without the tar."

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