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Regulation Uneven as E-Cigarettes Gain Popularity
June 13, 2009

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News Summary

New smokeless, electronic cigarettes have become increasingly popular in the U.S., with smokers buying the devices online even as the U.S. Food and Drug Administration (FDA) has intercepted some shipments of the products, saying that they are unapproved drug-delivery devices.

The New York Times reported June 2 that the battery-powered devices, which deliver a dose of nicotine and flavorings without burning tobacco, have become popular with smokers looking for an alternative to breathing in hot smoke or avoiding bans on indoor smoking. Most are purchased online, but also are for sale in mall kiosks and other retail outlets for about $100-$150.

However, the e-cigarettes have neither been evaluated or approved by U.S. regulators, and the FDA has blocked several shipments from China. "These appear to be unapproved drug-device products, and as unapproved products they can't enter the United States," an FDA spokesperson said.

"We basically don't know anything about e-cigarettes," said Richard D. Hurt, director of the Nicotine Dependence Center at the Mayo Clinic. "They've never been tested for safety or efficacy to help people stop smoking."

"It looks like a cigarette and is marketed as a cigarette," added Jonathan P. Winickoff, of Massachusetts General Hospital for Children and chair of the American Academy of Pediatrics Tobacco Consortium. "There's nothing that prevents youth from getting addicted to nicotine."

The e-cigarettes contain propylene glycol, which is an ingredient of antifreeze and is generally seen as safe in food, although experts don't know if inhaling the chemical is safe.

Australia and Hong Kong have banned e-cigarettes, while other countries regulate them as medical devices. The current FDA tobacco-regulation bill in Congress could give the agency broader power to regulate the devices.

"The FDA has the power to regulate Nicorette gum and the like because it is marketed as a smoking-cessation product," said Kip Schwartz, a lawyer for manufacturer Smoking Everywhere, who asserts that the agency has no such power over e-cigarettes because manufacturers make no such claims.  

COMMENTS ON THIS ARTICLE:

Posted by Propylene Glycol on 15 Jun 09 10:02 AM EDT
Snipped From The CDC Website: FDA considers an average daily dietary intake of 23 mg/kg of body weight to be safe for persons 2-65 years of age (Agency for Toxic Substances and Disease Registry 1997). Propylene glycol is a Generally Recognized as Safe (GRAS) food additive that is widely used in * food and tobacco products, * pharmaceuticals, and * cosmetics.

Posted by Bill Godshall on 15 Jun 09 01:06 PM EDT
Abstinence-only anti-nicotine extremist Richard Hurt is lying when stating that "We basically don't know anything about e-cigarettes," as I've sent him vast amounts of evidence on the products, including research tests on emissions of e-cigarettes at http://www.healthnz.co.nz/coynews.htm Meanwhile, Jonathan Winickoff's comment "There's nothing that prevents youth from getting addicted to nicotine." is also wrong, as an e-cigarette costs $100 for the starter kit and there is no evidence that even one youth (or adult) has ever become addicted to nicotine by using an e-cigarette. Its outrageous when ideologues (especially medical doctors) try to mislead and scare the public in order to keep smokers smoking cigarettes instead of switching to a nicotine alternative that is at least 99% less hazardous than cigarettes.

Posted by maxwood on 15 Jun 09 08:16 PM EDT
1. Richard Hurt needs to be converted into an anti-carbon-monoxide-overdose extremist and let nicotine alone. There's no case of nicotine itself killing anyone except through helping get them hooked on hot-burning-overdose carbon monoxide cigarettes. 2. This reaction is similar to that which occurred with Salvia divinorum, already banned in some states because of one (1) reported suicide of a user, while 400,000 a year (US alone) die of hot burning tobacco cigarettes. 3. Godshall is right, they want the public to keep smoking cigarettes. Why? They want the TAX MONEY.

Posted by Musician on 22 Jun 09 09:26 PM EDT
Bill, I agree with what you wrote. The ecig is a good thing. I know I sure would like for some of my smoking clientele to feel welcome again in a nightclub. I think some know why many anti-tobacco lobbyists who want to appear "altruistic" hate it. The altruism is merely a facade. One that I hope will be exposed beyond any shadow of a doubt very soon.

Posted by marleneb on 22 Jun 09 09:43 PM EDT
The FDA is amiss with the regulation of Nicorette gum. It has a failure rate of 98% for smoking cessation for 1 year. Why would anything be approved with a failure rate like that? If you ask me, all of these experts, the FDA, and the greedy Congress for that matter, should get a different job and let the e-cig prove or disprove it's worth and safety the old fashioned way, with the public!

Posted by Michael J. McFadden on 23 Jun 09 01:06 AM EDT
Winickoff's comment should be taken with more than a grain of salt. I believe he's the researcher behind the news stories about "Third Hand Smoke." That's where an opinion survey was strongly misrepresented in the media as research on literally imaginary "dangers." See http://globalhealthlaw.wordpress.com/2009/01/11/third-hand-smoke/ for the facts on it. . - . Michael J. McFadden, Author of "Dissecting Antismokers' Brains"

Posted by Sandra on 24 Aug 09 12:52 PM EDT
Nicotine is one of the most addictive substances known, both in animals and humans. No other plant material that is smoked is done so compulsively and in preference to other activities as tobacco. You can smoke cannabis before you go to the pub and not have to keep going outside to inhale hot smoke--it's the nicotine addiction that disturbs your evening--or your workday. Some of these comments seem to be from people with a business interest in a certain "scientific spin".

Posted by Gina King on 09 Oct 09 05:40 PM EDT
Again, this is an example of hype and extremity in journalism. I agree with above comments...we do know about electronic cigarettes, we know what's in them, the ingredients have been extensively studied. Big tobacco and big pharma are influencing the FDA, is that a surprise? No. It's unfortunate that big tobacco now sits at the same table as the scientific advisors of the FDA. I dislike the fact that these convicts (big tobacco) are now controlling what is and is not allowed in the marketplace. Electronic Cigarettes are a potentially life saving device. The harm in smoking actually comes from the ignition of the ingredients. E-cigarettes have no ignition...what is in the ingredients is what you inhale. Not so with regular cigarettes. Ignition changed the chemical makeup of what is inhaled.

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