On Tuesday December 7th, the D.C. Circuit Court of Appeals affirmed a lower court’s ruling in Sottera, Inc. v. FDA, No. 10-5032, (D.C. Cir. Dec. 7, 2010) holding that that the Food and Drug Administration (FDA) could not regulate as a medical device the electronic cigarettes (often referred to as “e-cigarettes”) at issue in that case. Instead, the court affirmed the district court’s finding that FDA’s authority over these e-cigarettes, as labeled, was limited to that over traditional tobacco products.

E-cigarettes are battery-powered reusable products that allow users to inhale nicotine vapor without fire, smoke, ash, or carbon monoxide. Manufacturers of e-cigarettes market their electronic nicotine delivery products as a safer, cheaper, and more environmentally-friendly alternative to traditional cigarettes. Designed to look like traditional cigarettes complete with a small LED light on the tip that glows red when activated, each contains an atomizer and a rechargeable battery. These products are viewed by some as a potentially viable alternative to traditional cigarettes, causing their popularity to increase in recent years.