Below is the link and a copy of the article from the Wall Street Journal.
ELMHURST, Ill.—Victoria Vasconcellos, the petite founder of an Internet retailer in this Chicago suburb, is in the thick of a regulatory battle that could affect millions of American cigarette smokers.
Ms. Vasconcellos imports electronic cigarettes from a Chinese manufacturer and sells them on her website, Cignot.com, to 14,000 customers. The 48-year-old is part of a growing legion of e-cigarette purveyors who are defying the Food and Drug Administration, which contends the nascent nicotine products are drug devices that require pre-market approval and may pose their own health risks. The FDA began intercepting shipments of the products from China two years ago.
E-cigarettes are battery-powered tubes that turn nicotine-laced liquid into a vapor mist. Sellers say they are potentially less harmful than cigarettes because they don't have the toxins of burning tobacco. A growing number of people who use them say they are an effective way to quit smoking.
The future of the fledgling industry—estimated at $100 million in annual sales and rising—may hinge on the outcome of a case scheduled for oral arguments before a federal appellate court in Washington, D.C., next month. The FDA is fighting to regulate the products as drug-delivery devices, similar to nicotine gums, patches or other nicotine-replacement products. Such a classification would subject e-cigarettes to lengthy and expensive trials to prove they are safe and effective.
But many e-cigarette companies argue that their products are designed to be recreational alternatives to cigarettes, not devices to wean people off nicotine. They say they couldn't afford the high cost of clinical trials, and that any such mandate would drive many of them out of business or force the industry to go underground.
The standoff underscores a growing rift in the public health community about how to solve one of the country's most vexing health problems. About 400,000 Americans die each year of smoking-related disease. Many public-health advocates, including the FDA, say e-cigarettes are unproven as a quit-smoking tool and could prompt nonsmokers to take up the nicotine habit.
But a number of public-health advocates, including the American Association of Public Health Physicians, argue that conventional policies for getting people off cigarettes have fallen short. These groups argue that encouraging smokers to switch to e-cigarettes and other smokeless tobacco products could sharply reduce tobacco-related disease in the U.S.
Dr. Joel Nitzkin, chairman of a tobacco control task force of the public physicians group, says e-cigarettes may prove to be the most promising smoking cessation product currently on the market. He thinks they should be regulated to ensure manufacturing standards are met. But he thinks the FDA's tobacco regulations, rather than the more demanding drug device rules, provide the best framework.
Indeed, the FDA could regulate e-cigarettes under the landmark 2009 law that gave the agency broad power to regulate tobacco products. Under these rules, e-cigarette makers wouldn't be required to go through lengthy and costly pre-market approvals, in most cases. But the FDA maintains that e-cigarettes are actually drug-delivery devices that aren't subject to the tobacco regulations.
While the federal case is pending, sellers of e-cigarettes and "juice"—the nicotine-laced liquid that goes into the devices—continue to pop up online and in malls. 7-Eleven Inc. stores in California, New York, Texas and a handful of other states recently began selling an e-cigarette brand.
Steve McVey and other e-cigarette makers say their smoking devices are a safe alternative to tobacco. The FDA says they should be regulated -- no buts about it. WSJ's Danny Yadron reports.
While the case was pending, Congress, in an unrelated move, passed landmark legislation that gave the FDA authority to regulate tobacco products, which lawmakers broadly defined as "any product made or derived from tobacco that is intended for human consumption." But the agency continued to maintain that e-cigarettes were drug devices, not a tobacco product like a pack of cigarettes or can of snuff.
Richard J. Leon, a judge in the U.S. District Court for the District of Columbia, issued a preliminary injunction against the FDA in January, ruling that Smoking Everywhere and Sottera generally marketed their e-cigarettes as recreational alternatives to cigarettes, rather than as quit-smoking aids. The judge called the FDA's approach a "tenacious drive to maximize its regulatory power." He noted that e-cigarettes contained nicotine derived from tobacco and said they appeared to fall under the provisions of the new tobacco law.
The FDA won a stay of Judge Leon's ruling, pending an appeal to the U.S. Court of Appeals for the District of Columbia Circuit. The agency is still detaining and refusing entry of e-cigarettes, a spokeswoman says.
Several former cigarette smokers say they were able to kick their habit in a matter of days by switching to e-cigarettes. "My breathing is better, my sleeping is better," says Greg Hester, 42, an information-systems worker in Atlanta who had smoked cigarettes for more than 20 years.
Ms. Vasconcellos, the Illinois entrepreneur, says she began smoking at 14 and eventually smoked two packs per day. She tried unsuccessfully to quit using nicotine patches and other products. In early 2009, she tried an e-cigarette and has been using them since.
Ms. Vasconcellos, who previously worked as a computer consultant, found e-cigarettes "so life-changing that I had to let other people know about it." She began Cignot Inc. last year and says it has generated about $1.5 million in sales. Her company's website makes no specific health claims, but calls e-cigarettes a "marvelous alternative to tobacco cigarettes."
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