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Court Rules FDA Lacks Authority To Ban E-Cigarettes

December 9, 2010

A U.S. appeals court ruled on Tuesday that the federal government cannot block the sale or import of electronic cigarettes, and can only regulate “e-cigarettes” as tobacco products and not as drugs.

The ruling by the three-judge appellate panel of the U.S. Court of Appeals for the D.C. Circuit angered tobacco activist groups, who view the ruling as a victory for the e-cigarette industry.

The decision allows e-cigarette maker Sottera Inc. to begin importing its NJOY products. 

NJOY has imported and distributed e-cigarettes since 2007, and markets the battery-powered devices for “smoking pleasure” rather than as a therapeutic or smoking cessation product.

“Electronic cigarettes are battery-powered products that allow users to inhale nicotine vapor without fire, smoke, ash, or carbon monoxide,” the appellate court said in its ruling.

“The liquid nicotine in each e-cigarette is derived from natural tobacco plants.”

Congress gave the FDA authority to regulate tobacco products, but not ban them altogether, in 2009.

Tuesday’s ruling upholds a lower court decision from January in a case brought by NJOY.

“The FDA’s refusal to admit NJOY’s products into the United States obviously destroyed the firm’s ability in the United States to cover its costs for purchase or production of e-cigarettes,” the appeals court said Tuesday.

Sottera Inc., which markets NJOY products as an alternative to cigarettes, praised the ruling.

“The ultimate impact of this court decision will be to lift the current import restrictions on NJOY electronic cigarettes and provide a regulatory framework for NJOY to make progress on its mission to be the most responsible electronic cigarette manufacturer on the market,” said the company in a statement.

The FDA had sent warnings in September to five makers of electronic cigarettes, saying the companies were marketing their products illegally as stop-smoking aids, and that the agency intended to regulate the products as drugs.

In October, e-cigarette maker Smoking Everywhere Inc. settled a civil suit brought by the state of California by agreeing not market their products to minors or to claim that its products are safe tobacco alternatives.  Under the terms of the settlement, sales of Smoking Everywhere products are banned to anyone under the age of 18.

The American Legacy Foundation, an educational group created with funds from tobacco industry court settlements, expressed disappointed with the ruling.

“Despite claims that electronic nicotine delivery systems are a safer alternative to smoking, their novel construction has raised challenging concerns for other risks, including their appeal to young people with flavors like strawberry or chocolate as well as their appeal to people who would use them to bridge times when they cannot smoke and might otherwise be trying to quit,” the AFP quoted Cheryl Healton, who leads the group, as saying.

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