Electronic Cigarettes' Nicotine Vapor Stokes U.S. Regulators

Electronic cigarettes are pitting regulators against anti-smoking forces on whether to allow sales now to speed efforts to help smokers quit or ban them until they are proven safe and effective.

Proponents of the battery-powered devices that produce a nicotine vapor instead of tobacco smoke urge the Food and Drug Administration to consider them a tool for smokers seeking a tobacco-free alternative. The American Lung Association wants sales suspended unless proven in clinical drug trials.

“The tobacco-control community is kind of split” on e- cigarettes, Kenneth Warner, dean of the University of Michigan School of Public Health, said in an interview. “Some people are convinced that anything that has any kind of nicotine or tobacco in it must be subject to the FDA’s review and approval. Others think it’s almost certainly less harmful than cigarettes.”

The FDA is appealing a U.S. District Court ruling that the agency lacks authority to regulate the devices as drugs because they are recreational, not therapeutic. Potential users spend $1.2 billion on smoking-cessation products and $80 billion on cigarettes a year, according to the U.S. Centers for Disease Control and Prevention. The FDA said e-cigarettes may work with smokers the way methadone clinics wean heroin addicts by giving them a less harmful form of an addictive substance.

Photographer: Utrecht/AFP/Getty Images

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Photographer: Utrecht/AFP/Getty Images

Most e-cigarettes deliver a flavored, nicotine-filled vapor -- and are sold with starter kits containing atomizers, batteries and cartridges. They are available online starting at about $40. The agency said it has blocked imports of more than 800 e-cigarette shipments since 2008, most from China.

Promoter Heigl

“While nicotine seems to be the primary ingredient in the cartridges, it is simply unknown how many other chemicals are present and in what amounts,” Siobhan DeLancey, an agency spokeswoman, said by e-mail. A 2009 FDA analysis found some nicotine levels exceeded amounts specified in labels, she said.

E-cigarette demand is getting a boost from celebrity users like actress Katherine Heigl as well as Internet availability. Heigl puffed on one during an appearance in September on CBS’s “Late Show,” telling host David Letterman the cigarette wasn’t harmful.

SmokeStik International Inc., the producer of Heigl’s e- cigarette, posted a statement after the appearance saying the company doesn’t make health or safety claims, adding to similar disclaimers already on its website and packages. The FDA can regulate as drugs cigarette alternatives that carry therapeutic claims, according to the court ruling.

FDA Warnings

The U.S. e-cigarette market consists of several dozen closely held companies including Toronto-based SmokeStik, which hasn’t received FDA warnings and doesn’t market products as smoking-cessation devices.

FDA officials warned five companies in September they were making improper health claims. Las Vegas-based E-Cig Technology Inc. violated agency rules by saying on its website that e- cigarettes can “help you reduce or quit smoking habits,” the agency said in a letter in September.

Warning letters were sent to Gamucci America, a unit of Smokey Bayou Inc. in Jacksonville, Florida; Ruyan America Inc. in Minneapolis; Johnson Creek Enterprises LLC in Johnson Creek, Wisconsin; and E-CigaretteDirect LLC in Parker, Colorado.

Ruyan America hasn’t sold products containing nicotine in the U.S. since May 2009, the company’s president, Bill Bartkowski, said Sept. 9 in an interview. E-Cig Technology, Johnson Creek and E-CigaretteDirect didn’t respond to e-mails sent through websites, while Smokey Bayou didn’t reply to a voicemail left at a listed phone number.

Competing With Patches

E-cigarettes need the same FDA drug review as nicotine gum, patches and other approved cessation aids, said Howard Marsh, chief medical officer of GlaxoSmithKline Plc’s consumer health- care division.

Glaxo’s Nicorette was the top-selling brand-name drug for nicotine replacement in the year through June, with $144.6 million in sales, or 12 percent of the smoking-cessation market, based on data from IMS Health Inc., a research firm in Norwalk, Connecticut.

“You’ve got to be fair to consumers,” Marsh said in an interview. “They need the reassurance that these products have undergone the same degree of rigor in terms of demonstrating safety and efficacy.”

Smokers seeking to quit need alternatives to FDA-approved nicotine replacement therapies such as gum and patches, which have a “95 percent failure rate,” Bill Godshall, founder and executive director of Smokefree Pennsylvania, said Oct. 27 at an FDA workshop.

Almost 500,000 smokers have switched to e-cigarettes in the three years they have been available in the U.S., he said.

Approval Costs

Godshall agrees with a ruling in January by U.S. District Court Judge Richard Leon that the FDA should regulate the devices under a 2009 tobacco law which doesn’t require safety and efficacy trials for cigarettes. The FDA won a delay of Leon’s decision in February while awaiting a ruling from the U.S. Court of Appeals in Washington.

E-cigarettes may save 5.3 million people who would otherwise die from smoking-related illnesses in the next 20 years, said Joel Nitzkin, former chairman of the Green Cove Springs, Florida-based American Association of Public Health Physicians tobacco control task force.

Unless e-cigarette companies can prove the gadgets are safe, “people should not use them because we don’t know what they are,” said Paul Billings, vice president of national policy and advocacy at the American Lung Association in Washington.

For Elaine Keller, an e-cigarette user and vice president of the nonprofit Consumer Advocates for Smoke-Free Alternatives Association, the potential for risk is worth the benefit.

“Maybe it’s not 100 percent safe, but it certainly is safer,” she said.

To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net

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