On July 8, 2010, WLF filed a brief in the U.S. Court of Appeals for the District of Columbia Circuit, urging it to prevent FDA from broadening its own jurisdiction by expansively interpreting what is meant by a “medical device.” WLF argued that FDA’s authority to regulate medical devices is limited to products promoted for their therapeutic benefits. WLF asserted that the products at issue in this case, e- cigarettes, are not “medical devices” because they are not promoted for a therapeutic use. If FDA wishes to regulate the sale of e-cigarettes, it may only do so under its authority to regulate tobacco products, WLF said. E-cigarettes are plastic cartridges that allow users to inhale a nicotine vapor in a way that simulates smoking a cigarette. WLF warned that if the courts uphold FDA’s assertion of authority in this case, the way will be cleared for FDA to assert authority over “off-label” uses of FDA-approved drugs and devices, even when the manufacturer has not promoted such uses.

Awaiting oral argument