Federal Judge Denies FDA Authority To Regulate E Cigarettes

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Federal Judge Denies FDA Authority To Regulate E Cigarettes

Post by thrice » Thu Jan 14, 2010 5:12 pm

WASHINGTON—A federal judge said the Food and Drug Administration doesn't have the authority to seize electronic cigarettes because the products don't qualify as devices subject to the agency's regulation.

In a 32-page opinion, U.S. District Judge Richard J. Leon sided with electronic-cigarette makers Smoking Everywhere Inc. and Njoy. He criticized what he called the FDA's "tenacious drive to maximize its regulatory power," saying he found its interpretation of the law "unreasonable and unacceptable."

Representatives of the FDA weren't immediately available for comment. The FDA cited its longstanding authority to regulate drugs and medical devices in claiming the right to bar electronic cigarettes, not a new law passed last year that gave the agency added powers to regulate tobacco marketing.

The FDA has seized shipments of electronic cigarettes, which look and taste like cigarettes, amid concerns the products were being marketed as safer alternatives to traditional tobacco.

Electronic cigarettes are battery-powered tubes that contain an atomizer, a battery and a cartridge filled with liquid nicotine. Florida-based Smoking Everywhere, one of the largest makers of electronic cigarettes, has sold about one million of the cigarettes in the U.S., said company Vice President Ray Story. He declined to give a dollar amount for the sales.

Mr. Story said the opinion is a "big victory for us." He said electronic cigarettes are "less harmful" than traditional cigarettes. The products don't contain tar or produce smoke.

When a user sucks on an e-cigarette, a light-emitting diode causes the tip to glow and the atomizer turns the liquid nicotine into a vapor. The vapor can be inhaled and then exhaled, creating a cloud that resembles cigarette smoke but dissipates more quickly.

Health groups including the American Lung Association have called for e-cigarettes to be removed from the market, saying their safety is unproven and children may be attracted to them.

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