Additional Information from the Washington Post
FDA can't block import of 'electronic cigarettes,' judge rules
By Del Quentin Wilber
Washington Post Staff Writer
Thursday, January 14, 2010; 3:14 PM
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.
Two e-cigarette suppliers, Florida-based Smoking Everywhere and Arizona-based Sottera, sued the FDA over its decision to block and confiscate their products.
Regulators consider e-cigarettes, which deliver nicotine without tobacco or combustion, to be unapproved drug devices and has told makers that they must first get federal approval for them.
The FDA believes that electronic cigarettes are a "drug-device combination," not a tobacco product, and are subject to stricter regulations than cigarettes or cigars. For at least a year, the FDA has confiscated e-cigarettes when they reach U.S. ports.
In granting a temporary injunction blocking the FDA from confiscating or preventing the importation of e-cigarettes, U.S. District Judge Richard J. Leon ruled that the devices are essentially a modern-day tobacco product. He found that the FDA had overstepped its authority in trying to block their importation.
"This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices," Leon wrote. "Unfortunately, its tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable."
