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FDA and health experts warn against use of e-cigarettes

Posted by CNN.com on Jul 22nd, 2009 and filed under World News. You can follow any responses to this entry through the RSS 2.0. You can leave a response or trackback to this entry

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WASHINGTON — The U.S. Food and Drug Administration announced Wednesday that laboratory tests on popular smoking devices known as electronic cigarettes have found they contain carcinogens and other toxic chemicals dangerous to humans.

E-cigarettes are battery-operated and contain cartridges filled with nicotine and other chemicals.

E-cigarettes are battery-operated and contain cartridges filled with nicotine and other chemicals.

E-cigarettes are battery-operated and contain cartridges filled with nicotine and other chemicals.

Known as “e-cigarettes,” the devices are battery-operated and contain cartridges filled with nicotine and other chemicals, spiced with flavors such as chocolate, cola or bubble gum.

While manufacturers tout e-cigarettes as a “healthy way” to smoke, federal health officials say the devices turn nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.

“The FDA is concerned about the safety of these products and how they are marketed to the public,” said Dr. Margaret A. Hamburg, commissioner of the FDA.

CNN contacted Florida-based Smoking Everywhere, one of the largest manufacturers of e-cigarettes, after the FDA announcement, and a spokeswoman said the company had no comment.

Because e-cigarettes have not been submitted to the FDA for evaluation or approval, the agency had no way of knowing the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user. That is why the FDA began to test them.

The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of e-cigarettes. In releasing its information, the FDA did not identify the two companies, but said in one sample, diethylene glycol — a chemical used in antifreeze that is toxic to humans — was detected. Other samples detected carcinogens that are dangerous to those who smoke them, the FDA said.

Health Library

The FDA has been examining and seizing shipments of non-U.S.-made e-cigarettes at the U.S. border since summer 2008. To date, 50 shipments have been stopped. The products examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act.

“We know very little about these devices, said Dr. Jonathan Samet, director of the Institute for Global Health at the University of Southern California, “but to say they are healthy — that’s highly doubtful.”

Samet and other health experts attended the FDA announcement on its findings.

Dr. Jonathan Winickoff, chairman of the American Academy of Pediatrics Tobacco Consortium, said parents need to be aware of e-cigarettes. “It is very important that parents let their children know these are not safe and to make recommendations, or even enforce rules that they not be used,” he said.

“Children who use these products may also be using other tobacco products,” said Dr. Matthew McKenna, director of the Office of Smoking and Health, Centers for Disease Control and Prevention. “It’s a good idea to make sure the child is aware of the dangers of tobacco in products in general.”

The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case pending in federal court. The FDA suggested health care professionals and consumers report serious side effects or product quality problems with the use of e-cigarettes to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, fax or phone

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8 Responses for “FDA and health experts warn against use of e-cigarettes”

  1. Steve L says:

    Be sure to look at the levels of the carcinogens they reported finding (can view the report at http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf ) These levels are on par with nicorette gum, the nicotrol inhaler, and other FDA approved nicotine replacement therapies.

    Regarding the Diethylene Glycol – Admittedly, it should not have been found at all. It’s worth noting, though, that it was only found in one sample from one manufacturer (other samples had no traces of Diethylene Glycol). And, the level found in that sample was only 1%. According to the MSDS, the lethal dose is 11.89 g/kg for rabbits. Assuming this can be extended to humans, an average adult male would have to ingest a whopping 855.925 g to receive a lethal dose.

    The entire purpose of thise press release was to use scare tactics to try to get the public to stop buying the electronic cigarette and to instead purchase the products from big pharma or the products from big tobacco (which awards the govt with tax revenue). Otherwise, they would have included the fact that the carcinogen levels found were comparable to approved nicotine replacement therapies and far below those of traditional cigarettes.

    It’s time the media started providing real investigative news, rather than regurgitating press releases that are missing critical information.

  2. Ben says:

    Steve L, good comments and without reading the report (yet), I’m very inclined to agree with everything you’ve just stated.

    I found the article to be misleading at best (since the article causes the reader to think that diethylene glycol is the main ingredient in antifreeze….which it is not…..and doesn’t specify whether the diethylene glycol was at an amount to be dangerous for inhalation)

    I also don’t like the statement about finding carcinogens without specifying what those carcinogens were. Everything in life has carcinogens! So what? I would like to see a side by side comparison of the carcinogens and dangers of the e-cigarette versus the tobacco cigarette. After all, if the FDA is going to validate and legalize tobacco cigarettes and attempt to stop electronic cigarettes, then it stands to reason that they should be able to show that electronic cigarettes are found to be more harmful!

  3. Seth says:

    Total FDA Scare tactics, they need to look deeper. Still no mention of how these Electronic Cigarettes are 100% safer than the “FDA Approved” traditional cigarettes. And have stopped tons of people from killing themselves with traditional cigarettes.

  4. Raven says:

    How Cigarettes are made
    http://www.youtube.com/watch?v=QkTMx-1G0RQ

    Contents of an e- cigarette cartridge
    Several Tobacco Absolute/Essences: Roughly Around 20%
    Liquid extracted from Tobacco Leaves. Natural to tobacco; used as flavorants at minimal levels

    Nicotine (w/ or w/o): 0 – 4%
    Self Explanatory

    2,3,5 Trimethylpyrazine: <1%
    FEMA GRAS; found in barley, almond, asparagus, beef, wheat bread, chicken, cocoa, coffee; used in baked goods, candy, dairy products, cereals.

    2,3 Dimethylpyrazine: <1%
    FEMA GRAS; found in asparagus, peanut, coffee, potato; used in gravies, beverages, candy, baked goods.

    2,5 Dimethylpyrazine: <1%
    FEMA GRAS; found in asparagus, peanut, coffee, potato; used in gravies, beverages, candy, baked goods.

    2 Ethylpyrazine: <1%
    FEMA GRAS; found in beef, coffee, bread; used in baked goods, cereals, candy, dairy products.

    2 Acetylpyrazine: <1%
    FEMA GRAS; found in beef, coffee, popcorn, sesame seed, almond, wheat bread, cocoa, peanut, pork, potato chips; used in frozen dairy products.

    2, 6 Trymethylcyclohex-2-Butene-4-One: <5%
    FEMA GRAS; found in rose, rum, brandy, tea; used in baked goods, candy, chewing gum.

    2, 6 Beta-Ionone: <2%
    FDA-approved food additive; FEMA GRAS; found in carrot, almond, apricot, beer, blackberry, brandy, broccoli, capers, cherry, endive; used in candy, baked goods, ice cream.

    Linalool: <2%
    FDA GRAS; FEMA GRAS; found in banana, beer, blackberry, beans, blueberry, apple, apricot, arctice bramble, artichoke, grape brandy, plum brandy; used in meat products.

    Menthol: <2%
    FDA-approved food additive; FEMA GRAS; found in peppermint plant, honey, mint, rum, cocoa, eggs, guava, raspberry, rice, spearmint; used in candy, mouthwash.

    Methyl Butyric Acid: <2%
    FDA approved food additive; FEMA GRAS; found in apple, apricot, avocado, beef, beer, blackberry, brandy, butter, cantaloupes, carrots; used in cheese, ice cream, candy.

    Rose Oil: <2%
    FDA GRAS; FEMA GRAS; found in roses; used in chewing gum, ice cream, baked goods.

    Ethyl Vanillin (Vanilla Extract): <5%
    FDA GRAS; FEMA GRAS; found in vanilla beans; used in alcoholic beverages, imitation vanilla extract, breakfast cereals.

    Octalactone: <1%
    FEMA GRAS; found in apricot, beef, blackberry, butter, cheese (blue, cheddar, parmesan), cranberry, cream, coconut; used in candy, margarine, baked goods.

    Undecalactone: <1%
    FEMA GRAS; found in beef, butter, coconut, milk; used in baked goods, candy, dairy products, cereals.

    Pure Water: 50%
    AKA – PG: FDA GRAS; FEMA GRAS; found in sesame seed, mushroom; used in confection frostings, cheese, candy.

    Glycerol: <10%
    FDA GRAS; FEMA GRAS; found in beer, cherry, wine; used in milk products, baked goods, meat products.

    Which is worse?
    You decide.

  5. Steve L says:

    Here is some more information regarding the nicotine patch and nicotine gum (which are both FDA approved) having the same carcinogenic nitrosamines, as published in Nicotine & Tobacco Research Volume 8, Number 2 (April 2006) p. 309–313, which is viewable online at http://www.starscientific.com/404/stepanov%20tsna%20in.pdf – see pg 4 of pdf for results.

    Now compare that to analysis that was done in New Zealand on Janty brand ecig cartridges
    (results available at http://www.healthnz.co.nz/RuyanCartridgeReport21-Oct-08.pdf ). When you compare the two, you can easily see that the ecigs have low levels of carcingoens that are comparable to the patch and gum.

    Results from the two documents (note: one has results in nanograms, the other in micrograms, converted to same unit of measure here for your convenience)
    NicoDerm CQ 4mg nicotine patch – has 8 nanograms per patch
    Nicorette 4mg nicotine gum – has 2 nanograms per piece of gum
    Janty ecig cartridge – has 0.26 – 8.183 nanograms per cartridge, depending on nicotine strength, and cartridge is, at minimum, 5 uses.

  6. Sikov Misinfo says:

    I would like to see the FDA make a direct comparison between e-cigarettes and tobacco cigarettes. Then, and only then, can anyone take what they have to say seriously. This is because everyone knows 100% that e-cigarettes are LESS toxic than tobacco products, BUT tobacco products attract tax revenue. Draw your own conclusion on the alarmist warning against e-cigs! Signed, ‘Sikov Misinfo’

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