What's All The Fuss??

Most 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 can'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. Costco Wholesale Corp. in April stopped selling a version on its website because of concerns about the FDA's stance. Wal-Mart Stores Inc. also briefly offered a product on its website this year but discontinued it because it didn't attract much demand and the company was concerned about the FDA's position, a spokesman said.
E-cigarettes have caught fire in part because they mimic the experience of smoking. When a user sucks on an e-cigarette, an atomizer turns the liquid inside into a vapor—which is why the practice is called "vaping" instead of smoking. Consumers typically pay $40 to $120 for a starter kit, and then pay smaller amounts for liquid refills.
E-cigarettes typically contain a solution of propylene glycol—a chemical used to make artificial smoke in theatrical productions—water, nicotine and flavorings such as "espresso" and "simply strawberry." The amount of nicotine varies to accommodate different consumers' preferences. Some e-cigarettes contain no nicotine.
Some scientists say e-cigarettes are probably less harmful than cigarettes because they don't involve the burning of tobacco, which produces most of the toxins that cause cancer and other tobacco-related diseases.
However, no published, peer-reviewed studies have examined the long-term health risks of e-cigarettes. Some scientists are concerned that prolonged exposure to vaporized forms of propylene glycol—generally recognized by the FDA as safe for use in foods such as salad dressings, cake mixes and sodas—might cause harm.
"There are a lot of reasons to believe logically that e-cigarettes offer a safer profile, but I want data that demonstrates safety," says Thomas Eissenberg, a psychology professor at Virginia Commonwealth University who studies nicotine addiction.
In a report released last year, the FDA said it conducted a preliminary review of a few e-cigarettes and found poor quality control. Some cartridges that claimed not to contain nicotine actually did, and ONE of the 18 samples had trace amounts of diethylene glycol,(also found in nicotine patches) a chemical used in antifreeze that is toxic to humans. The FDA says the amount of nicotine delivered varies and isn't standardized, which also raises safety concerns.
E-cigarettes were introduced in China in the mid-2000s and hit the U.S. in 2007, industry executives say. Some countries, such as Canada and Australia, effectively ban their sale, saying they have yet to be fully evaluated for safety and effectiveness. New Jersey and New York's Suffolk County bar use of the product wherever regular cigarettes are prohibited.
The National Vapers Club, an advocacy group for e-cigarette users in Valley Stream, N.Y., estimates that at least 1 million people in the U.S. use the products. The group's president, Spike Babaian, says the number of U.S. e-cigarette companies has ballooned to about 300 from roughly a dozen two years ago.
The FDA began detaining some shipments from China in June 2008 on the grounds that the products were unapproved drug devices aimed at treating nicotine addiction. Smoking Everywhere Inc., a Florida distributor of e-cigarettes, sued the agency in April 2009, claiming that the FDA had no jurisdiction over the products. Another purveyor, Sottera Inc. of Scottsdale, Ariz., later joined the case as a plaintiff.
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."