FDA: Electronic cigarettes are a no-no


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Here’s an item that you shouldn’t include in your ever-growing arsenal of electronic devices, including cellphones, iPods, PDAs, GPS trackers and laptops: the e-cigarette. The Food and Drug Administration today released an analysis of 19 varieties of electronic cigarettes that says that half contained nitrosamines (the same carcinogen found in real cigarettes) and that many contained diethylene glycol, the poisonous ingredient in antifreeze. Some that claimed to have no nicotine were found to have low levels of the drug.

E-cigarettes are promoted by their manufacturers as safer than traditional cigarettes because they do not burn tobacco. Instead, a lithium battery in the cigarette-shaped device heats a solution of nicotine in propylene glycol, producing a fine mist that can be inhaled to deliver nicotine directly to the lungs. An LED glows red at the tip and they even emit puffs of white smoke similar to that seen in stage shows. The devices are available in more than 4,000 retail outlets nationwide, as well as on many websites, with a starting cost of $40 to $70. Over the last year, sales have grown from about $10 million to $100 million, according to the Electronic Cigarette Assn., the industry’s trade group. They also come in a variety of flavors, including chocolate, mint and apple, which make them appealing to children and adolescents.


Most of the e-cigarettes are produced in China, where they have become very popular. The varieties tested by FDA, however, were produced by Smoking Everywhere, a Florida company, and Njoy Cigarettes of Scottsdale, Ariz. In a telephone news conference, agency officials said ‘quality control processes used to manufacture these products are inconsistent or nonexistent.’

They have become very controversial. Some countries, like Australia, have banned them because their health risks are unknown. Action on Smoking and Health, an anti-tobacco group headed by activist John Banzhaf, has petitioned the FDA to regulate the products and Sen. Frank R. Lautenberg (D-N.J.) has called on the agency to remove them from the market immediately, a call that has been echoed by the American Heart Assn., the American Lung Assn. and other groups.

Even though the e-cigarettes are marketed as healthy, critics charge that the delivery of nicotine directly to the lungs speeds its passage to the brain, enhancing the drug’s addictive properties. Critics also said the devices are appealing to the young and could serve as a learning aid to promote smoking of actual cigarettes. Stop-smoking experts say the devices are not useful for ending cigarette addiction because they do nothing to interrupt the hand-to-mouth behavior that is an integral part of the habit.

For its part, the FDA has classified e-cigarettes as a drug delivery device, which subjects them to regulation and requires proof of safety. The agency has been examining and detaining the product at the border, halting more than 50 shipments, but has not taken any steps to remove it from the U.S. market. The FDA has been sued by manufacturers that say the agency has no jurisdiction over the device because it is not marketed as a stop-smoking aid.

The discovery of carcinogens and toxins in at least two products may encourage the FDA to step up its actions against manufacturers. The agency, however, has not said whether it will move against the makers of the tested products.

‘Electronic cigarettes should be absolutely avoided because they clearly have toxic elements,’ said Dr. Jonathan Whiteson, a pulmonologist at New York University Langone Medical Center. ‘It is proven now that electronic cigarettes contain toxic elements. Electronic cigarettes play no role in smoking cessation and don’t add to a healthier lifestyle.’


-- Thomas H. Maugh II