The Government Plans to Restrict E-Cigarettes

The Food and Drug Administration announced it will act to ensure its right to impose marketing, manufacturing and safety restrictions on "electronic cigarettes."

In a letter posted to the FDA's website Monday, Dr. Lawrence R. Deyton, director of the FDA's Center for Tobacco Products, said the agency will act to regulate e-cigarettes as tobacco products. The agency will propose new regulatory language that would specifically define e-cigarettes as a tobacco product.

Electronic cigarettes do not burn tobacco directly, but allow a user to inhale heated nicotine derived from tobacco and suspended in a fluid canister. Instead of emitting tobacco smoke with a consumer's use, electronic cigarettes and their users release only water vapor. While those who make and sell electronic cigarettes maintain the devices are far safer than smoking cigarettes, the FDA contradicts that, noting that half of the 19 brands of e-cigarettes it sampled contained nitrosamines, a carcinogen found in real cigarettes, and many contained diethylene glycol, a poisonous ingredient in antifreeze.

Between 2008 and 2010, the FDA determined that certain electronic cigarettes (e-cigarettes) were unapproved drug/device combination products and detained and/or refused admission to those offered for import by Sottera, Inc. and other manufacturers. Sottera, Inc. challenged that determination in court.

The U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), recently issued a decision with regard to e-cigarettes and other products “made or derived from tobacco” and the jurisdictional line that should be drawn between “tobacco products” and “drugs,” “devices,” and combination products, as those terms are defined in the FD&C Act. The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes.