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E-Cigarettes: FDA Puts Its Foot Down on False Smoking-Cessation Claims

You’ve probably heard of e-cigarettes, the nicotine-less battery-powered devices that only resemble the real thing. Manufacturers have recently started marketing them as stop-smoking aids, since the…

You’ve probably heard of e-cigarettes, the nicotine-less battery-powered devices that only resemble the real thing.  Manufacturers have recently started marketing them as stop-smoking aids, since the devices allow smokers to inhale a liquid nicotine solution instead of tobacco smoke.  However, the FDA recently cracked down on e-cigarette makers, warning them that they must stop making unsubstantiated claims about the supposed effectiveness of e-cigarettes as smoking cessation tools.

According to the Federal Food, Drug, and Cosmetic Act, companies cannot claim that their product can treat a disease unless the product has been proven effective, yet all five e-cigarette manufacturers make the same claim that their product can cure nicotine addiction.  In response, the FDA sent the companies warning letters, including E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (also known as Smokey Bayou Inc.), E-Cig Technology Inc., and Johnson’s Creek Enterprises LLC.  Thus far, the warning action only applies to the five companies that received letters but the FDA pledged to continue to investigate other e-cigarette manufacturers.

Some of the named companies were also targeted for selling liquid medications, such as the erectile dysfunction medication Cialis or the weight-loss drug rimonabant.  Instead of taking the normal pill version of the medication, consumers were able to purchase the liquid versions from e-cigarette manufacturers, place the medicine in the cartridges that come with e-cigarettes, and inhale the vapor.  The five companies have 15 days to respond to the FDA’s warnings.

David Mittleman

David Mittleman

A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.

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