FDA Loses Second Court Battle over E-Cigarettes

The Food and Drug Administration (FDA) has lost another round in its battle to regulate electronic cigarettes as drug-delivery devices rather than as tobacco products, The Wall Street Journal reported Jan. 24.

E-cigarettes are battery-powered devices that heat cartridges of liquid containing nicotine to create a mist that users inhale. The FDA classifies them as drug-delivery devices like nicotine patches and gums – products that it must approve before they can be marketed.

In December, a three-judge appeals panel in the District of Columbia (D.C.) disagreed with the FDA’s position. The panel ruled that the FDA could only regulate e-cigarettes as drug delivery devices if purveyors made claims that their products would help people quit smoking or had other benefits. 

The FDA appealed the decision, but the U.S. Court of Appeals for the D.C. Circuit sided with the e-cigarette industry. The agency is now considering whether to take the case to the U.S. Supreme Court.

E-cigarette distributors and manufacturers argue that their products are alternatives to cigarettes and should not be subject to pre-approval, as smoking cessation products now are. If e-cigarettes were regulated as tobacco, it would be easier to put new devices on the market.

“We are very pleased with the court’s decision not to rehear the case,” said Gregory Garre, a lawyer for an e-cigarette distributor. “The fact that the full court unanimously declined the government’s rehearing request underscores the force of the panel’s original decision.”