Vapor Lock: Most e-cigarettes, which deliver nicotine via water vapor, are made in China.
Everybody Hates Cigarettes
Even smokeless ones--which both the FDA and the state of California have in their sights.
By Jessica Lussenhop
PHILIP Horne, owner of E-Smokey Treats, pulls what looks like a ballpoint pen out of a jar on his coffee table and takes off the cap, revealing a red LED light where the pen point should be. He puts the other end up to his mouth and takes a drag. The light glows and Horne exhales what looks like a cloud of smoke into the living room of his Seabright home, which also doubles as E-Smokey Treats headquarters. The "smoke" smells as sweet as a Jolly Rancher, with just the slightest edge to it. "There are a bunch of different flavors," Horne says, the most popular being "Marl" (for a Marlboro-like flavor) followed by menthol and watermelon. "Smoke is what has all the carcinogens and tar that clogs up the lungs. Nicotine is a poison, so it's not exactly good for you, but it's better than inhaling a campfire."
Horne is one of a handful of U.S. dealers of "electronic cigarettes," devices that deliver users a dose of liquid nicotine that's atomized into a water vapor and inhaled. The vapor curbs cravings but doesn't create secondhand smoke, meaning users can technically use it anywhere without fear of violating smoking bans in restaurants, bars or--in the case of Santa Cruz--downtown corridors or beaches.
Horne, who's been a smoker for 20 years, says he went into the business after cutting down significantly on his own smoking with help from the e-cigarette. "I enjoy the whole ritual," he says. "It's a very close simulation. I do occasionally smoke--usually when I'm superduper stressed."
Horne has found himself reaching for his real smokes a little more often lately now that the Federal Drug Administration and the state of California are looking to shut him down. "If the FDA hadn't stepped in, I probably would've done close to $3 million in sales this year," he says. "It's kicking my ass, to be honest with you."
E-cigarettes have been on the FDA's radar for some time now, but this summer the agency issued press releases and preliminary research suggesting that the product is not as safe as dealers say it is.
"The FDA took the position that e-cigarettes were a drug delivery device. They deliver nicotine," says FDA spokeswoman Siobhan Delancey. "People could conceivably be using these for the rest of their lives, and we want to make sure those lives are long."
Most, if not all, electronic cigarettes and their accessories are manufactured in China, which means it's hard to know exactly what's in them. Delancey says very limited preliminary testing has shown the presence of diethylene glycol, an ingredient in industrial antifreeze, and tobacco-related carcinogens.
"We don't know what the long-term effects are of inhaling just nicotine," she says. "FDA regulates on the basis of safety and efficacy. We want to know it's safe." Delancey says since none of the e-cigarette companies has completed a drug application package, extensive testing of the products has never been done. There are also currently no age restrictions or warning labels on the products.
The FDA is currently ensconced in a legal battle with e-cigarette company Smoking Everywhere, which has sought an injunction to prevent the FDA from stopping its shipments from entering the country. Though Delancey says there's no telling when a ruling will come, Horne--who had a shipment worth $30,000 impounded by the FDA in July--says that from what he hears, there could be a ruling any day now. If the FDA wins, all shipments of e-cigarettes will be stopped at the border.
Closer to home, state Sen. Ellen Corbett (D-San Leandro) has legislation on Gov. Schwarzenegger's desk that would ban e-cigarettes in the Golden State until the FDA has had a chance to approve them. The issue came to her attention, says spokeswoman Lynda Gledhill, after the Santa Clara County District Attorney issued a warning about an e-cigarette kiosk in the Great Mall in Milipitas.
"This kiosk was right by a store that a lot of teenagers go to. They had clearly been targeting teenagers," Gledhill says.
Although the original legislation was only meant to ban the sale to minors, Gledhill says the overwhelming support the bill received inspired Corbett to expand the language into a total ban. The governor has until Oct. 12 to sign the bill. It would go into effect in January 2010.
Horne has been watching the proceedings nervously. He says if the FDA halts the import of e-cigarettes into the United States, he is poised to move E-Smokey Treats to Ireland. If the FDA loses its court case but California enacts its ban, he says he will simply move to another state. Although he says he would be fine with the product being regulated or taxed, he is deeply suspicious that, rather than simply regulating the e-cigarette, the FDA is going to cave to pressure from more powerful industries and ban the product.
"My company alone is costing the tobacco companies and the pharmaceutical companies millions of dollars a year," he says.
The FDA's Delancey insists that the agency just needs an application from e-cigarette companies.
"Conceivably, they could be on the market legally if they were to bring in a good application that had well-balanced clinical trials," she says.
She estimates that drug applications generally take six to 10 months for approval, but Horne estimates his business will be long gone by then. And though he admits that the FDA has a point, he argues that a total ban takes away the option from smokers like him who've tried everything in the past to quit or at least cut down on their health risks. "If you say it's a smoking cessation device, then it does fall under FDA jurisdiction," he says. "So I can't technically say that, but I have thousands of customers who don't smoke cigarettes anymore."
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