FDA to regulate e-cigarettes as tobacco products

The Food and Drug Administration said Monday it plans smokeless electronic cigarettes as tobacco products regulation and will not attempt to regulate them under stricter rules for drug delivery devices. By Ed Andrieski, AP

Users and distributors say e-cigarettes address both nicotine addiction and behavioral aspects of smoking.

By Ed Andrieski, AP

Users and distributors say e-cigarettes address both nicotine addiction and behavioral aspects of smoking.

The Federal agency said Monday that it intends to propose amendments to the rules of procedure for the treatment of e-cigarettes the same traditional cigarettes and other tobacco products in a letter to stakeholders.The news is considered a victory for the makers and distributors of the devices, which continue to gain popularity worldwide.E-cigarettes are plastic and metal devices that heat a liquid nicotine solution in a disposable cartridge, vapor that the "smoker" inhales. A small light on the tip even glows like a real cigarette.Users and distributors say e-cigarettes address both nicotine addiction and behavioral aspects of smoking — keeping the cigarette, the puffing, the smoke come out to see and the hand movement — without the more than 4,000 chemicals found in cigarettes.First sold overseas in 2002, e-cigarettes are not readily available in the us until the end of 2006. Now, the industry has grown from the thousands of users in 2006 to several million worldwide, with tens of thousands of new e-smokers every week.No timeline has been set on the proposed rules to change.The FDA said e-cigarettes can still be regulated as drugs or drug-delivery devices if they are "sold for therapeutic purposes," — for example, if a stop-smoking aid.Jason Healy, President of the e-cigarette maker Blu Cigs, called the news a good first step, but said that the pending rule changes will be more economical for "weeding out the shady companies."Right now, "you can potentially sell snake oil," said Healy. Nearly 46 million Americans smoke cigarettes. About 40% try to shut down each year, according to the Centers for Disease Control and Prevention. But unlike nicotine patches or gum, e-smokes have worked in a legal grey area.The FDA lost a lawsuit last year after trying for the treatment of e-cigarettes as drug-delivery devices, instead of tobacco products, because e-cigarette nicotine in tobacco is removed from heat. It had until Monday to December to appeal to the u.s. Supreme Court, a Federal Appeals Court electronic cigarettes as tobacco products should be regulated by the FDA instead of as a drug-delivery devices, which have stricter requirements such as expensive clinical trials to prove the products are safe and effective as a stop-smoking aid.Some sellers of e-cigarettes sued the FDA in 2009 after the Agency told Customs officials access of shipments in the us to refuse a federal judge ruled that the FDA does not stop shipments, which say that the Bureau had exceeded his authority.Last September, FDA warning letters to different makers of electronic cigarettes or its components, say that the companies are breaking the law with unsubstantiated health claims and poor manufacturing practices.The FDA also had said the tests found the liquid in some electronic cigarettes contain toxic substances — in addition to nicotine, which is toxic in large quantities — as carcinogenic substances occurring naturally in tobacco. Most e-cigarettes are imported from abroad.However, some public health experts say the level of the carcinogenic substances are similar to those found in nicotine replacement therapy, because the nicotine in all products is extracted from tobacco.

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