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

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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.

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