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Wednesday, April 24, 2024 | Back issues
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FDA Can’t Regulate ‘Electronic Cigarettes’

(CN) - The Food and Drug Administration can't block tobacco distributors from importing "electronic cigarettes" into the United States, a federal judge in Washington, D.C., ruled in a decision that could save at least one domestic distributor from going under.

U.S. District Judge Richard Leon rejected the FDA's ban on importation, saying electronic cigarettes are regulated by the Tobacco Act, just like regular cigarettes.

The FDA detained more than 35 shipments headed for the distribution companies Smoking Everywhere and NJOY, saying the products qualified as drug-device combinations under the Food, Drug and Cosmetic Act. In the FDA's view, the electronic cigarettes weren't simply therapeutic; they also affected the structure or function of the body.

Judge Leon disagreed.

"[A]ll they purport to do is offer consumers the same recreational effects as a regular cigarette," he wrote, calling the FDA's argument "bootstrapping run amuk."

Leon said the FDA's rationale would force him to exclude traditional cigarettes from the list of acceptable tobacco products.

"Congress did not intend tobacco products to be drugs merely because they deliver nicotine," Leon wrote.

Smoking Everywhere touts the product as an "alternative to traditional cigarettes that delivers the same sensation as smoking," but "without combustion or the use of cancerous byproducts." Electronic cigarettes vaporize liquid nicotine, allowing the user to inhale nicotine without the tar, carbon monoxide, ash and smell of traditional cigarettes, according to the ruling.

But they are not meant to affect the body in any way different from regular cigarettes, Leon wrote. And the companies never touted them as having therapeutic effects, such as treating nicotine addiction, the ruling states. Instead, the companies were promoting nicotine use by encouraging consumers to use the product as often as they would traditional cigarettes.

The court granted the distributors' motion for a preliminary injunction blocking the enforcement of the FDA's ban on the importation of electronic cigarettes.

Electronic cigarettes are the sole product line for Florida-based Smoking Everywhere, according to the ruling. The distributor's inventory is "already near depletion," and no domestic electronic cigarette makers exist. Smoking Everywhere has sold more than 600,000 electronic smoking kits since it began operating more than a year ago. Competitor NJOY has sold more than 135,000 since its opening in 2007.

Leon said the case demonstrates the FDA's "drive to maximize its regulatory power" - another example of its "aggressive efforts to regulate recreational tobacco products as drugs or devices."

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