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E-cigarettes are plastic or metal tubes, usually the size of a cigarette, that heat a liquid nicotine solution instead of burning tobacco. That creates vapor that users inhale.
Smokers like e-cigarettes because the nicotine-infused vapor looks like smoke but doesn’t contain the thousands of chemicals, tar or odor of regular cigarettes. Some smokers use e-cigarettes as a way to quit smoking tobacco, or to cut down. However, there’s not much scientific evidence showing e-cigarettes help smokers quit or smoke less, and it’s unclear how safe they are.
The industry started on the Internet and at shopping-mall kiosks and has rocketed from thousands of users in 2006 to several million worldwide who can choose from more than 200 brands. Sales are estimated to have reached nearly $2 billion in 2013. Tobacco company executives have noted that they are eating into traditional cigarette sales, and their companies have jumped into the business.
Some believe lightly regulating electronic cigarettes might actually be better for public health overall, if smokers switch and e-cigarettes really are safer. Others are raising alarms about the hazards of the products and a litany of questions about whether e-cigarettes will keep smokers addicted or encourage others to start using e-cigarettes, and even eventually tobacco products.
"Right now for something like e-cigarettes, there are far more questions than answers," Zeller said, adding that the agency is conducting research to better understand the safety of the devices and who is using them.
At first glance, the FDA’s proposal is "broadly as expected and not as restrictive as some had feared," Wells Fargo Securities analyst Bonnie Herzog wrote in a note to investors.
"It seems to be a responsible approach ... and shows the FDA’s commitment to look at particular e-cigarettes in a science-based way rather than just conjecture," said Jason Healy, president of Blu e-cigs, which is owned by Lorillard Inc. and holds more than 45 percent of the market. "Obviously we’ve got a long way to go. This may be just some calm before the storm."
Healy noted that the e-cigarette landscape and the products themselves will continue to evolve and grow before the regulations take effect, and they will likely spur a consolidation of companies in the market.
In addition to prohibiting sales to minors and requiring health labels that warn users that nicotine is an addictive chemical, e-cigarette makers also would be required to register their products with the agency and disclose ingredients. They also would not be allowed to claim their products are safer than other tobacco products.
They also couldn’t use words such as "light" or "mild" to describe their products, give out free samples or sell their products in vending machines unless they are in a place open only to adults, such as a bar.
Companies also will be required to submit applications for premarket review within two years. As long as an e-cigarette maker has submitted the application, the FDA said it will allow the products to stay on the market while they are being reviewed. That would mean companies would have to submit an application for all e-cigarettes now being sold.
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