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December 08, 2010

Federal Court: E-Cigarettes are Tobacco Products, Not Drug-Delivery Devices

Smoke 'em if you've got 'em: A federal court yesterday upheld a lower court's decision that the nicotine-replacement devices known as "e-cigarettes" should be regulated by the U.S. Food and Drug Administration as tobacco products, NOT drug-delivery devices. The ruling came as welcome news to the thousands of e-cigarette users who've dumped their cancer sticks in favor of what are, arguably, a safer, noncombustible nicotine alternative.  F-butts2

In its December 7 ruling in Sottera v. Food and Drug Administration,  the U.S. Court of Appeals in the District of Columbia upheld a lower court's temporary injunction against the FDA, which tried to stop the company, NJOY, from importing the battery-powered devices from overseas. The appeals court ruled that e-cigs fall under the aegis of the Family Smoking Prevention and Tobacco Control Act of 2009, not the Food, Drug, and Cosmetic Act. As the name implies, the FDCA governs therapeutic and medicinal products.

Never seen or heard of an e-cigarette? Check out this Seven Days article from June about a Rutland company (and Castleton retailer) called Vermont Vapor, which manufactures and sells e-cigarettes and accessories. As the article explains, e-cigarettes have encountered considerable opposition from local and national antismoking groups, despite evidence that e-cigarette vapors do not contain the many thousands of cancer-causing chemicals that are present in regular cigarette smoke.

E-cigarettes have caught fire among former and current tobacco users, who claim that they're the closest thing yet to the real deal. It's one reason why e-cigarette manufacturers now have a seemingly unlikely ally in their camp: Dr. Michael Siegel, a professor in the Department of Community Health Sciences at Boston University's School of Public Health.

A physician who spent two years with the Centers for Disease Control and Prevention’s Office on Smoking and Health, Siegel has done considerable research on tobacco control, secondhand smoke and the effects of tobacco marketing on children and teens. Notably, he served as an expert witness for the plaintiffs in seven major lawsuits against the tobacco industry, including the landmark Engle case, which led to the $145 billion verdict against Big Tobacco. Siegel wrote an amicus brief in the Sottera case, in which he argued that the FDA's interpretation of what constitutes "tobacco products" is unreasonably narrow. 

In recent months, Siegel has been a thorn in the side of the national antismoking establishment, taking them to task for their opposition to e-cigarettes simply because they haven't been as thoroughly scrutinized and tested as cigarettes. (Siegel argues otherwise.) As Siegel put it yesterday on his blog, "This is like telling people in a sinking ship not to use the lifeboat because it has not been thoroughly inspected and tested and certified for safety."

For a more thorough interpretation of yesterday's ruling, check out Siegel's blog, "The Rest of the Story: Tobacco News Analysis and Commentary."

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