E-Cigarette Makers Face Regulatory Scrutiny

Laura Enderle, Assistant Editor
Published Online: Friday, September 10, 2010

In marketing electronic cigarettes as a healthy way to kick the habit, e-cigarette manufacturers are acting illegally, the FDA announced Thursday. The agency issued warning letters to 5 companies that produce electronic cigarettes, which regulators now consider drug delivery devices subject to the same oversight as drugs and medical devices.

Smokeless and battery operated, e-cigarettes offer smokers an alternative to traditional smoking cessation products, such as gums or lozenges. A glowing tip and plume of water vapor mimic the look and feel of a cigarette, with some versions delivering nicotine or other inhalants through a refillable cartridge inserted into the device. Sellers and some researchers argue e-cigarettes are less dangerous than cigarettes because they do not produce toxins that result from burning tobacco; however, no comprehensive research has been conducted to prove their safety, according to an earlier report by the Wall Street Journal.

Citing sub-standard manufacturing practices and unsubstantiated drug claims, the FDA’s letter said the 5 companies acted in violation of the Federal Food, Drug, and Cosmetic Act. In some cases, the devices were used to deliver pharmaceutical agents—including rimonabant, an obesity management drug, and tadalafil, an erectile dysfunction drug. Companies accused of the violations include E-CigaretteDirect LLC, Ruyan America Inc, Gamucci America (Smokey Bayou Inc), E-Cig Technology Inc, and Johnson’s Creek Enterprises LLC.

The warning letter also outlined the New Drug Application process, the regulatory pathway each company will be required to follow in order to continue selling electronic cigarettes to consumers. “FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed,” the letter read.




 



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