E-Cigarettes Win Court Ruling

Electronic cigarettes moved a step closer to being regulated just like mainstream tobacco products on Tuesday when a federal appellate court unanimously upheld an injunction against the Food and Drug Administration’s attempt to ban them or regulate them more strictly as drugs.

E-cigarettes are battery-powered tubes that look like cigarettes. They deliver nicotine by vaporizing a nicotine-derived liquid without combustion. Their distributors say this makes them more healthy than cigarettes. They can even deliver steam to exhale like a clean, smoke-free smoke.

The F.D.A., concerned with marketing claims of products that deliver a highly addictive substance, has tried to ban e-cigarettes as unapproved drug delivery devices.

But the federal appeals court in Washington, D.C., upheld a lower court injunction against the F.D.A. ban. The appellate court said the F.D.A. should regulate them under the 2009 legislation that set up a Center for Tobacco Products. E-cigarettes are marketed for the pleasure of a product, not for the therapeutic benefit of a drug or medical device, the court said.

Jeffrey Ventura, an F.D.A. spokesman, said in a statement on Tuesday, “We are studying the opinion and considering next steps.”

The e-cigarettes in the case were manufactured by Sottera of Scottsdale, Ariz., doing business as NJOY. It sells the products and refill cartridges on a Web site requiring certification that the buyer is 18 years old. A starter kit costs $79.99.

Quit-smoking products like nicotine patches and gum and the Pfizer pill Chantix are regulated by the federal drug law, which requires them to be proven safe and effective. The tobacco law allows the F.D.A. to regulate ingredients and marketing claims in “any product made or derived from tobacco,” but shifts more of the burden of proof to federal regulators.

The F.D.A. tried to regulate all tobacco products as drugs in 1996. The Supreme Court ruled against that by a 5-4 vote in 2000, leading to work in Congress to develop the tobacco control act that passed last year.

The appellate court ruling was hailed by advocates of e-cigarettes, who say they are much safer than cigarettes.

“This is a huge victory for public health and civil justice,” Bill Godshall, founder of Smokefree Pennsylvania, a nonprofit group supporting e-cigarettes, wrote in an e-mail message. “It’s time for F.D.A. officials to come to their senses by reclassifying (and promulgating reasonable regulations for) e-cigarettes as tobacco products.”

The American Heart Association was among the antitobacco groups to support a drug ban or tighter regulation.

“We’re gravely concerned about the implications of today’s ruling,” the association’s chief executive, Nancy Brown, said in a statement. “The appeals court has cleared the way for the industry to peddle these products to consumers without any scrutiny as to their safety or efficacy. There is no scientific evidence that e-cigarettes are effective smoking cessation devices and, until they undergo rigorous evaluation by the Food and Drug Administration, they should be pulled from the marketplace. With this ruling, e-cigarette manufacturers will continue to make misleading claims that their products can help smokers quit.”

The Campaign for Tobacco-Free Kids, a Washington advocacy group, said the ruling would leave an unregulated period before the F.D.A. could assert jurisdiction.

“This decision will allow any manufacturer to put any level of nicotine in any product and sell it to anybody, including children, with no government regulation or oversight at the present time,” the campaign’s president, Matthew L. Myers, said in a statement. “We urge the government to appeal this ruling to the U.S. Supreme Court. “