E-Cigarettes Not Subject to FDA Regulation, Federal Judge Rules

The U.S. Food and Drug Administration (FDA) cannot block the importation of electronic cigarettes into the U.S. because they are not tobacco products — and thus not under the FDA’s jurisdiction — a federal judge has ruled.

The Washington Post reported Jan. 15 that U.S. District Judge Richard J. Leon sided with two e-cigarette makers, Smoking Everywhere and Sottera, in the case. Leon was harsh in his assessment of FDA’s confiscation of e-cigarettes imported by the companies, calling the action “yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices” and part of a “tenacious drive to maximize its regulatory power.”

Agency officials said they are reviewing the ruling, saying in a statement, “The public health issues surrounding electronic cigarettes are of serious concern to the FDA.”

The FDA does have regulatory authority over some non-tobacco products, such as nicotine gum, based on the fact that they are considered devices used to help smokers quit. However, Leon agreed with lawyers for the e-cigarette companies who contended that the product is another type of cigarette, not a drug device regulated by FDA.