Tennessee seller of ‘e-cigarettes’ fights FDA regulation

A Goodlettsville company that sells high-tech devices that simulate cigarette smoking is doing battle with the federal government, which wants to regulate them to safeguard consumers’ health.

PureSmoker is one of a handful of “e-cigarette” companies that have been subjected to repeated seizures of their electronic cigarette shipments from China by the Food and Drug Administration over the past two years.

The FDA argues that e-cigarettes, which produce a nicotine-infused vapor that users inhale in flavors such as pina colada or cinnamon, should be regulated like any drug or drug delivery device. Those require expensive and time-consuming clinical trials before they can be sold to people.

Late last week, the agency headed to a federal appeals court in Washington, D.C., to argue that it has the jurisdiction to seize and regulate the products. The outcome will determine the FDA’s role in regulating the increasingly popular devices — used by many consumers as a way to stop smoking — and whether companies like PureSmoker can stay in business.

PureSmoker owner Steve McVey and other e-cigarette company owners argue that because their product contains tobacco-derived nicotine, it should be regulated the same way all tobacco products are: with rules governing ingredients and limiting marketing to adults only, but without costly clinical testing.

“It’s ludicrous to regulate this as a drug, when we make no health claims whatsoever,” McVey said. “If you do that, what you’re essentially doing is asking 1 million users who’ve tried every other way to quit — and only done it with e-cigarettes — to go back to smoking regular cigarettes.”

In the meantime, no agency is regulating the estimated $100-million-a-year industry or examining products like PureSmoker’s, which are sold almost exclusively online and at some shopping mall kiosks.

Critics warn of possible health risks with some of the products. A lab test of random e-cigarette samples by the FDA in July found trace amounts of the same ingredients found in antifreeze, the federal agency said. It didn’t name the brands in a news release describing the testing.

Several states — New York, New Jersey and Oregon among them — have moved to ban the products. In Tennessee, the state attorney general is “monitoring” the situation, a spokeswoman said.

Smokers inhale vapor

At the back of a nondescript office park across the street from RiverGate Mall, PureSmoker lab worker Jeff Hildebrand consults handwritten notes in a spiral-bound notebook. He studies proportions of ingredients to pour into a beaker of “Kanna Scotch,” a flavor of liquid, or “e-juice,” the company sells for use in its e-cigarettes.

The “best cigarettes” actually are battery-operated metal cylinders that heat nicotine-laced liquid into a vapor that smokers inhale.

PureSmoker creates and sells online nearly two dozen flavors, such as PB&J, pina colada, Berry Medley and Nutty-ella. Starter kits with metal cigarettes run from $30 to $120. A 30-milliliter vial of e-liquid — estimated to last 10 days — costs $22.

McVey said the company used to import the liquids from China, but after the FDA seized two shipments worth $60,000 at two ports over the past six months, he hired the 28-year-old Hildebrand by placing an ad on Craigslist.

Hildebrand moved to Nashville four years ago to start a band called Manic Bloom, but said he has a background in chemistry.

Hildebrand said the e-liquids consist of three main ingredients: vegetable glycerin (to thicken the liquid), propylene glycol (the same ingredient used to create the mist in fog machines) and nicotine in varying strengths. Hildebrand adds flavorings created from food extracts and oils. Customers can order their flavor and one of three nicotine-infused strengths.

The company claims 16,000 steady customers and $1.3 million in sales last year.

McVey, an ex-smoker, started the business four years ago. He says he kicked his own cigarette habit by using e-cigarettes. Now, he chain “vapes” — slang for inhaling the product vapors. Regular e-cigarette users call themselves “vapers.”

“It’s everything about smoking except the nastiness,” said McVey, a 26-year-old California transplant. “You inhale it. You get a throat hit. But there’s no combustion, no smoke going into your lungs.”

McVey says his e-cigarettes aren’t marketed as a way to quit smoking. Products like nicotine gum and patches are considered drugs or drug-delivery devices and are strictly regulated. That’s something e-cigarette operators want to avoid.

“We are not in the business of trying to help people stop smoking,” McVey said. “We’re just offering this product to the public.”

Shelley Covington, executive director of Smoke Free Tennessee, says her group is concerned about the products, which come in a variety of colors and in flavors ranging from bubble gum and cotton candy to spicy fireballs.

“They try to market these as hip, cool and modern,” Covington said. “The companies are saying they are a safe way to quit, but we don’t even know what’s in them. There are currently no regulations on how much nicotine they deliver. And we know we don’t want our kids getting their hands on nicotine products.”

PureSmoker directs consumers who say they’re under 18 years old away from its website, but McVey says there’s no guarantee of who buys.

“We try our best to make sure it doesn’t get into the hands of minors, but in the end kids are kids,” he said.

Health-care professionals caution that nicotine is highly addictive. Dr. Jamila Williams, a smoking cessation expert with Meharry Medical Center, said she’d feel more comfortable if e-cigarettes were regulated and subjected to clinical trials.

“I don’t really know what it is that my patients are consuming, or what effect it has on their health,” Williams said.

source: tennessean.com

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