FDA Statement on the Regulatory Status of “Electronic” Cigarettes, Cigars and Pipes

The U.S. Food and Drug Administration has reviewed several electronic cigarettes, cigars, and pipes, and refused their admission for import into the United States. The agency has acted because the products offered for import are unapproved new drugs requiring FDA approval to be legally marketed in the U.S. Additionally, because they are drug-device combinations under U.S. law, they are also adulterated devices (see 21 U.S.C. 351(f)(1)(B)).

These products are devices in which nicotine and other chemicals are turned into a vapor to be inhaled by the user. They are typically designed to look like conventional cigarettes, cigars, and pipes, and be used the same way.

The FDA is concerned about the potential for addiction to and abuse of these products. They may also be perceived as safer alternatives to conventional tobacco use and possibly initiate nicotine use among those who have never smoked, or among former smokers. This could then lead to an increase in the use of conventional tobacco products by young people, with well-known adverse health consequences.

As of March 1, 2009, the FDA has refused 17 shipments of various brands of these "electronic" cigarettes, cigars, and pipes, and their components. The agency will continue to evaluate these products on a case-by-case basis.