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Issue Date: Vol. 50, No. 9, September 2010, Posted On: 9/13/2010

FDA Says E-Cigarettes Violate Drug, Device Rules

by Staff Reporter
e-cigarette, electronic cigarette, Federal Food, Drug and Cosmetic Act, vending machine product, E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America, Smokey Bayou Inc., E-Cig Technology Inc., ohnson’s Creek Enterprises LLC, Electronic Cigarette Association


WASHINGTON -- Electronic cigarettes sold in the U.S. are being marketed illegally as smoking-cessation aids, the Food and Drug Administration said on Sept. 9.

E-cigarettes and related products sold by five closely held companies require approval as drugs or medical devices because they're promoted to help smokers stop or reduce use of regular cigarettes, the FDA said in warning letters posted on the agency's website. To sell the products, companies must conduct animal and human studies and apply for FDA clearance, the agency said in a separate letter to the Electronic Cigarette Association.

E-cigarettes are metallic tubes filled with a vaporized liquid nicotine mixture. While the devices mimic the look and feel of traditional cigarettes, they don't contain tobacco or produce smoke. The FDA in February won a temporary delay of a U.S. judge's ruling that the agency lacks authority to regulate the products as drugs or medical devices and must allow them to be imported. The case is scheduled for a Sept. 23 hearing.

Warning letters were sent to Gamucci America, a unit of Smokey Bayou Inc. (Jacksonville, FL); E-Cig Technology Inc. (Las Vegas); Ruyan America Inc. (Minneapolis); Johnson Creek Enterprises LLC (Johnson Creek, WI); and E- CigaretteDirect LLC (Parker, CO). The companies have 15 days to respond.

The FDA will evaluate those responses before deciding whether the products should be taken off the market.

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