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FDA cracks down on claims by makers of e-cigarettes

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Companies that sell electronic cigarettes are taking heat for advertising claims that their products can help smokers kick the habit, and they may face stiff federal regulation.

The owner of a fast-growing Tucson-based company that sells its own brand of e-cigarettes, Green Nicotine, says he welcomes regulation to tone down the health claims he carefully avoids.

"Technically, because it doesn't have FDA (U.S. Food and Drug Administration) approval, I can't say it will help you quit smoking," said Sean Schoepflin, founder and CEO of Green Nicotine.

"I think there needs to be some regulation of how it's marketed, about how it's labeled."

But Schoepflin said banning e-cigarettes or subjecting them to costly federal drug approval is an unnecessary step that would limit a healthier alternative to real cigarettes - not to mention potentially kill his fast-growing business.

Since starting sales in June 2009 at the Foothills Mall, Green Nicotine has sold more than $1 million worth of products online and in retail outlets, said Schoepflin, who worked as an automotive sales manager before launching the company in early 2009.

The company has expanded to 21 locations - mainly company-operated mall kiosks - in Tucson, Mesa and Tempe, as well as Salt Lake City; Orange County, Calif.; St. Louis; and Fort Lauderdale and Miami, Fla.

Green Nicotine's success reflects an industry whose annual sales are $100 million and growing, according to industry estimates.

But the FDA is moving to regulate e-cigarettes and their nicotine components as drugs. And some states also have moved to ban e-cigs.

The FDA sent letters last week to five e-cigarette distributors - not including Green Nicotine - warning them of various violations of the Federal Food, Drug, and Cosmetic Act, including unsubstantiated claims and poor manufacturing practices.

The FDA - which has fought in court to halt shipments of some e-cigs from China - warned the companies to halt advertising their products as aids to quit smoking and said the electronic cigarette products addressed in the warning letters "are subject to FDA regulation as drugs."

The agency warned in July 2009 that in its tests of 18 e-cigarettes made by two leading suppliers, it found they contained carcinogens and toxic chemicals, in one case including diethylene glycol, an ingredient used in antifreeze.

The companies that received warning letters were E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson's Creek Enterprises LLC.

The Electronic Cigarette Association, a trade association of e-cigarette distributors, has blasted the FDA's stance.

The trade group - whose president is former Arizona Rep. Matt Salmon - says the FDA's testing was flawed and that e-cigarettes contain far less harmful chemicals than regular smokes.

While nicotine is toxic, it is not considered a carcinogen, or cancer-causing substance.

The trade group notes that the American Association of Public Health Physicians (AAPHP) has advocated a permissive policy toward e-cigarettes, contending their use could save millions of lives if they help smokers break the habit.

The FDA, the e-cigarette group and the AAPHP agree that e-cigarettes should not be sold to minors.

Schoepflin said his company is careful not to market its products as smoking-cessation aids, and he only markets the products to adult smokers.

In its advertising, the company cites the elimination of secondhand smoke and the absence of cancer-causing chemicals in Green Nicotine products.

Shoepflin said his product provides a "cleaner" dose of nicotine than some others, noting that he acquired a half-interest in a manufacturing plant in Beijing partly to assure quality control.

Green Nicotine won't sell to minors or use fruit flavors critics say could attract kids, though the company offers a mint-flavored product, he added.

While Schoepflin is careful about touting his product as an aid to quit smoking, the company offers two strengths of nicotine cartridges, high and low, so users can step down in dosage as they wish.

Stephen Michael, director of the Arizona Smokers Helpline, in the Mel and Enid Zuckerman College of Public Health at the University of Arizona, said people do use e-cigarettes to quit smoking, but he doesn't recommend them.

"Our stand on it is the same as the FDA - it's not tested," he said, noting that every e-cigarette tested by the FDA contained carcinogens.

"No one is quite sure what comes out of them."

Until the safety of e-cigarettes is assured, Michael said, he recommends medical alternatives such as over-the-counter nicotine gum and patches, or nicotine inhalers, which are available only by prescription.


Green Nicotine sells a starter kit with a lithium ion battery-operated vaporizer, battery charger and four nicotine cartridges for a list price of $169, though it's often discounted, said Sean Schoepflin, founder and CEO of the Tucson-based company.

A 10-pack of refill cartridges runs $39.

That may seem steep, but it amounts to about $1.56 per equivalent pack of regular smokes, Schoepflin said. By comparison, regular cigarettes go for about $4.50 to $8 a pack.

David Wichner Arizona Daily Star Arizona Daily Star | Posted: Thursday, September 16, 2010 12:00 am