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FDA: Electronic cigarettes are a no-no

July 22, 2009 |  2:35 pm

Cigarette 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

Photo: The inventor of an electronic cigarette, Hon Lik, smokes his invention in Beiijng earlier this year.

Credit: AFP/Getty Images

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Comments (114)

What the FDA failed to tell you is the Nicotrol Inhaler and every tobacco derived device sold has the same carcigens -- Electronic Cigarettes are a SAFER alternative to real cigarettes -- the FDA is trying to cover their asses and are grabbin at straws

If you dont believe me research what Nicorette, The Patch and every other cessation device has as far as carcigens goes...

When every pack of cigarettes amounts to being the Surgeon General's business card, I'm not going to fully trust these guys to not be talking out of both sides of their mouths. And wallets.

e cigarettes?

the future aint what it used to be . . . anthatizz for sure

I have been smoking electronic ciggaretts for about 3 months now. I was a pack to a pack 1/2 a day smoker for about 10 years; I could feel the difference physically within weeks. I no longer wake up with a smokers weez in the morning, my sense of smell has improved noticeably, along with my sense of taste. My lungs are noticeably healthier because I take less shallow breaths, and dont get winded nearly as easy, and oh yea, I dont stink like a death stick. Lets compare e-cigs to regular cigarettes and see which one is the real killer. If one wants to pull the "lets think of the kids" strategy, fine, lets. How many kids are being subjected to the thousands of chemicals found in regular cigarettes because their parents smoke? How many of those chemicals are not found in e-cigs...thousands.

Simply put...

Statistics show the average IQ of someone who smokes is lower that the average IQ of someone that does not smoke.

Period.

Wow, looks like the e-Cig industry just took over this message board.

JohnR: You say that it helps you stop smoking - but you haven't stopped. Until you do, I hardly think you can say that it has worked. Smoking less is still smoking.

FDA is not paid by any industry. While often it lags in enforcement and correction, the FDA hardly is a biased industry. Sure it succumbs to political pressure by letting things go to market prematurely or when they should not. But, its data is not fictitious.

I love all of the comments that say the data results are incorrect, yet you cannot cite one legitimate, independent, scientific study to refute it. Stop with your superlatives.

Well, I think its time to relate this information to the nitrosamines found in processed meats, and raise the taxes on slimjims,ham, and hotdogs. We add the nirtates and nitrites to these items and feed them to our children. Pretty smart, huh?
Why not put processed meats on the list of items regulated along with cigarettes?

I'm not a fan of smoking in any form and I don't smoke myself, but... something cigarette smokers can use that won't expose me to second hand smoke? No more getting screamed at when I politely ask smokers to move away from the door? LESS additives and ingredients and carcinogens than regular cigarettes? I'm all for that. I want the FDA to ban regular cigarettes, but they never will. Now they want to ban something that would make things better for smokers and NON-SMOKERS alike? Ridiculous.

This product will not aid you to quit smoking.....You don't need an electronic device to quit smoking, trust me , I know from experience.
Nicotine addiction, oral fixation, peer pressure and lifestyle are still major factors on why people continue to smoke. Everyone can quit smoking if they really choose to, but everyone is in denial because its not as difficult as one thinks.
DON'T BE A FOOL.....
JUST SMOKE REAL CIGARETTES OR DON'T SMOKE AT ALL.....your better off

This product is a joke butt if I could hustle millions out of ignorant consumer...I would too.

"the fact that some liquid nicotine (e-liquid) contaions carcenogenics doesn't concern us that much, because cigarettes(analogues) do too."

"All I can say for certain is that before I got my Intellicig in the mail I was smoking 2 packs of cigarettes per day, at a cost of about 12 dollars. On top of that, I was using an asthma rescue inhaler multiple times through the day.

Now, I smoke 3-5 cigarettes a day, spend about 12 dollars per week on cigarettes and use the inhaler almost never.

Before, I wouldn't leave the house without either, going to lengths to make certain both were with me. Now, it's not even a thought; though I do make certain to pack a spare battery and an extra cartridge if I'm going to be gone for awhile."


WOW. Nice excuses. Addicts will use whatever reasoning they have to justify the addiction, even if that reasoning is far beyond belief. It also is a wise assumption to figure that a lot of these comments come from the jerks who work at the little ecig kiosks at the mall.

For the few chemicals that electronic cigarettes have, it is a big upgrade from regular cigarettes and not all companies have been tested. Ive ran preliminary analysis on the chemical used by the Smoke Fifty-One electronic I use and I did not find anything but safe elements contained on the FDA safe element list.

Propylene is also used in cake mixes, salad dressings, soft drinks, popcorn, food colorings, fat-free ice cream and sour cream.

And yes, cigarettes are bad, etc. Everybody knows this.

Talking about how horrible it is or the "weak" people who do smoke is off topic and pointless; people could go on about any vice or bad habit. So, if you want to bash people who do, please go elsewhere. This isn't about how great and smart you are as an individual.

What the discussion is about is: Why ban something that has less harmful effects (if any) than something that already exists? What's the downside?

@John "Have asthma AND smoking? Talk about dumb!"

I assume that you're talking about me, and I couldn't agree more... that my asthma is the direct result of smoking, a product of the addiction, is really a different discussion. Still, this is a chicken/egg question with an easy answer.

But, since using the e-cigarette-- which is not smoking, but vaporizing-- the incidence of asthmatic episodes is dramatically decreased. I assume that my intelligence has risen proportionately, but who can say for sure?

People are passionate about these products and worried for their future because for many, like me, they are worried that the single greatest positive change to come into their lives in years is now under attack. With typical smoking cessation methods having an effectiveness hovering somewhere around 1%, that there's a product that might provide an interim (or even permanent, but unquestionably safer) solution to cigarettes is a sliver of hope that we will not easily give up.

I do not understand the non-smokers that are speaking out against e-cigarettes; it seems like they are wading into a fight that doesn't affect or concern them in any way. Perhaps it is a holdover from the smoking fight, which did.

Me, for my part, I own my electric cigarette already. I will continue to be able to buy parts and juice, as mine came from Europe rather than the US and should they be banned, it won't really prevent me from being able to purchase what I need to continue use. A wholesale ban will simply prevent those who would make the same decision that I did from easily opting to switch away from "analog" cigarettes. That's a real shame, because it would appear-- at least anecdotally-- that the e-cig has the potential to save many lives. I know that I am now making plans to see my daughter graduate from college in another 18 years; an outcome I was less certain about just months ago.

I am Diethylene Glycol. I am an organic compound. In case anyone is interested I am described by the structural formula HO-CH2-CH2-O-CH2-CH2-OH. I am a clear, hygroscopic (meaning: I attract water molecules in the surrounding environment) , odorless liquid. I am miscible with water and polar organic solvents such as alcohols and ethers. I, Diethylene Glycol, should not be confused with the related compound, ethylene glycol, which is the most common glycol used in coolants.

Many e-cigarette fluids offer a PG flavor. PG is short for my cousin Polyethylene Glycol. Polyethylene glycol is used as a food additive and in pharmaceuticals.

Inga take whatever side you want in this, but your assumption that those who defend the e-cigs are sellers of e-cigs is silly. This is an important product for its users who can't quit smoking but are desperate for something safer. I've been having health problems because of smoking, and the e-cig really helped me to cut back on my smoking and my health problems got a lot better. While e-cigs are sure to carry risks of their own, at this time I (probably along with many others ) am not ready to give up the e-cig.

This is a case of the perfect becoming the enemy of the improved.

It is unfortunate that the non-addicted (the perfect) cannot at least recognize the popularity of electronic cigarettes for what it is--the result of the genuine desire of the addicted to purify themselves and to improve their health.

Those who have both smoked cigarettes and used e-cigs are the only ones who know--and truly understand--the beneficial and revolutionary effect this new invention offers. Others should simply be grateful they are spared the second hand smoke.


"Here's an item that you shouldn't include in your ever-growing arsenal of ..."

Why?? Because the FDA says so? That corporate money infested hazard to the health of Americans? I have never smoked EVER in my 39 years, but I feel for all the smokers who've commented on how e-cig have helped them. The FDA is idiotic and prey to corporate and special interests.

@Roy - "Simply put...

Statistics show the average IQ of someone who smokes is lower that the average IQ of someone that does not smoke.

Period."

Could you please give us a link to these statistics that determine the relative intelligence of smokers and non-smokers?

To the best of my knowledge there are no scientific studies that have proven your assertion, outside of those produced by anti-smoking advocacy groups.

As many others have pointed out, the main societal problem with cigarettes is the fact that non-smokers are introduced to detrimental effects against their will.

Any non-smoker that chooses to look at their fellow human beings (that happen to choose to smoke) as less than themselves is without compassion, understanding, or a general goal of societal cooperation.

PS - If the cause of smoking is stupidity, there is no cure and all cases of ex-smokers are actually impossible miracles, because how else could a stupid smoker suddenly become smart without a direct intervention from G-d? ;-D

I have been manufacturing Ecigs for over 30 years right here in the USA. At first they were Electric Bongs , then Electric Vaporizers. Now I have produced over 1 million Ecigs since 2006. I test every oz of my products. The filter has some Carcinogens But are approved by FDA. Even McDonalds uses same plastic in their straws. I have tested the Nicotrol Inhaler with the same tests as FDA used and have came up with lots worse results that FDA found in their test of ECigs. Two years ago I tested air in 50 cities and found Carcinogens levels higher that what the found in their tests. So watch out LA, FDA will shut down your air supply next. I have also tested the hose used in oxygen supply systems and found traces of Carcinogens.

My daughters Tampon has higher levels of Carcinogens than ecigs. My grandson pacifier has higher levels. Glycol is used in almost all cosmetics and lipbalm, toothpaste. Poly Glycol is used in dairy cattle every day.

If Ecigs are under so much light why is it that the FDA recomends the use of electric Vaporizors for patients on medicail marijuana.

FDA report list all the products found in Eliquid. But it looks like it was wrote by a child maybe they shuold candy coat the work place so they could more, safer reports done.

Have you noticed that US goverment still has not outlawed cigarette on military bases.

I have just came back from a tour of americain hospitails that are thinking of using Nicotine in their inhalers so that smokers are not all stressed out and can consantrate on healing.

I have trucking companies that have installed passthrough units in the truck for their drivers. I also have a school that installed them in their buses.

I was in Utah last week Vapin away in a restrant/bar. I sold over 50 units right there. The owned came over and gave be a big cash tip, because customers were staying longer and spending more. He ordered 500 units. By time I got back home he had ordered another one thousand.. I also have 3 Casinos that sell the packs to customers and furnish new cartridges while customer is at their location.

This is a multimillion dollar business, that is causing people to spend more money every where. Which makes for more jobs. It looks like FDA would be tring to help solve the problems. No instead the will loan car manufactoy money to stay in business of manufacturing Carcinogens producing bombs.

WOW, I just can't believe this. I am a distributor for a certain Florida based company and I reached out to the FDA and CDC back in April. I received a response from both CDC and the FDA and here are their responses.

Question to CDC on 4/26/09 and to FDA on 5/13/09 I would like to know if the CDC/FDA has been asked to investigate the use of the electronic cigarette. I am curious if this is truly a healthy alternative to smoking. I am a smoker and have tried to quite many times. I've tried the patch, I've tried cold turkey and I've tried Chantix. To no avail, I haven't been able to stop. The electronic cigarette seems to be my next choice is trying to quite. But I see the FDA has not approved it. Does the CDC have any research studies on this?

CDC's responses from 5/12/09: Thank you again for contacting the Centers for Disease Control and Prevention. There is no peer-reviewed study that provides evidence that e-cigarettes are a safe or effective smoking cessation aid.
Additionally, it is unclear what health effects these products could have on users or if they can lead to misuse.

The CDC has not released a statement on e-cigarettes and suggests contacting the Food and Drug Administration (FDA). For more information, please contact Kevin Budich at kevin.budich@fda.hhs.gov.

Regarding your past attempts to quit, the clinical practice guideline, "Treating Tobacco Use and Dependence," shows that the best success rates are realized when people combine cessation counseling with an approved medication. Also, with some people, a combination of medications is more effective. You may want to talk to your physician. You can also contact your state quitline for more information. The state quitlines provide free counseling and information; many have other services to offer. To reach your state quitline, call 1-800-QUIT-NOW
(1-800-784-8669) and you will be automatically transferred to the quitline that serves your area code. You can also call 1-800-4-CANCER for information about services provided through the National Cancer Institute.

Please let us know if we can be of further help.

Response from FDA 5/13/09 (Kevin M Budich Compliance Officer Division of New Drugs & Labeling Compliance): Thank you for your inquiry (attached) regarding electronic cigarettes.

The "electronic" cigarettes, cigars, and pipes that we have reviewed are drug-device combinations under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(g)(1)) with their "drug" uses, as defined by section 201(g) of the Act (21 U.S.C. § 321(g)), as the primary mode of action. These products contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes, cigars, and pipes, and to produce a mist or vapor upon each inhalation by the user that resembles and tastes like the smoke produced by conventional tobacco products. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional tobacco products. And, like the conventional tobacco products, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction. These products are designed with a re-chargeable battery-operated heating element that volatilizes the chemical constituents contained within replaceable cartridges. These cartridges may or may not include nicotine. Thus, these "electronic" cigarettes, cigars, pipes, AND their components are intended to affect the body's structures and functions and/or to treat or prevent withdrawal symptoms of nicotine addiction. (See 21 C.F.R. 201.128 for the meaning of "intended uses.")

Since we are not aware of any data establishing that such products are generally recognized among scientific experts as safe and effective for these "drug" uses, they are "new drugs," as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed with FDA in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. None of these so-called "electronic" cigarettes, cigars, pipes, OR their components, is covered by an approved NDA. Nor are any of these products covered by an approved application for premarket approval (PMA) in accordance with section 515(a) of the Act (21 U.S.C. 360e(a)), or by an approved application for an investigational device exemption (IDE) under section 520(g) of the Act (21 U.S.C. 360j(g)).

There may be a perception among some users that electronic cigarettes, cigars and pipes are safe alternatives to conventional tobacco products or that they are a safe and effective means to quit smoking conventional forms of tobacco. However, FDA is not aware of any scientific data to support that perception. Since these products have not been submitted to the FDA for evaluation or approval, the agency has no way of knowing the amounts of nicotine or the kinds and amounts of other chemicals the vast array of products deliver to the user. FDA is concerned that these products may introduce young people to nicotine use which may lead to an increase in the use of conventional tobacco products with well-known, adverse, health consequences. Additionally, it is unclear what health effects these products could have on users or if misuse or product failure could lead to nicotine poisoning or other serious adverse health consequences.

Therefore, the marketing of the "electronic" cigarettes, cigars, pipes, AND their components, as described above, in the United States violates sections 505 and 501(f)(1)(B) of the Act (21 U.S.C. 355 and 351(f)(1)(B)) and they are subject to enforcement action. For example, FDA has detained and refused several importations of various brands of these "electronic" cigarettes, cigars, and pipes, AND their components.


For your information, there are a number of proven and safe cessation aids that smokers can use to quit for good. The U.S. Public Health Services, Treating Tobacco Use and Dependence: 2008 Update recommends using a combination of proven cessation interventions including FDA approved nicotine replacement therapy and/or non-nicotine medications and counseling to more than double a smoker’s chances of quitting successfully. Free help is available to smokers in all states by calling 1-800-QUIT-NOW or by visiting www.smokefree.gov.

I hope this is helpful.

Kevin M. Budich
Compliance Officer
Food and Drug Administration
CDER/Office of Compliance
Division of New Drugs & Labeling Compliance
OTC Drugs Team
10903 New Hampshire Ave.
WO51-5174
Silver Spring, MD 20993

301-796-3304
kevin.budich@fda.hhs.gov

So, after I received all these responses, I asked the ecig company if they submitted their product to the FDA and they informed me that they have submitted their product many time to the FDA to test and they have never received a response.

Lets make this what its really about. Its not the device thats the issue, if it were then "water pipes" wouldve been taken off the market ages ago (come on, we ALL know what those are for) The issue that the FDA is claiming to have with this product is the nitocine-liquid. Im not sure whats up with them bringing up diethylene glycol, im pretty sure thats old news and most people use PG (propylene glycol) or VG (vegitable glycerin). The vegitable glycerin you'd use is food grade, so i highly doubt that its got stuff used in antifreeze, unless bakeries are trying to slowly poison us.

My husband and I recently discovered e-cigarettes when our state doubled our taxes on cigarettes and we'd had enough. You can't tell me that this doesn't have something to do with this FDA investigation. They don't want you to stop smoking-how can they get your money if you do? When a specific group of Americans are targeted for taxation when others are not(ex. drinkers)it just does not seem to be the "Freedom" concept our country was based on. Gee we also use a hand to mouth action when we eat. Will they come up with a new tax for every pound you're overweight? E-Cigarettes in no way claim that they are for quitting smoking but I don't see how they could be classified any different from the gum or the patches. Will this again be crammed down our throats with no proof?

Does anyone find it odd that the FDA only mentions by name the two companies that are currently suing the FDA for their handling of this type of product?

This is the best thing I ever saw. I have been trying to convince my friends and family for the past 10 years that the FDA and Big Tobacco have been in bed together and today the FDA convinced them for me. Thanks FDA!

I love my personal vaporize and If its banned I will be in court with the army of vap users that are forming in the forums as we speak. Were setting up a class action lawsuit and we need everyones support. Look for more information on the e-cig-forum.

Oh and for the idiot who said the "e-cig industry" is in the chat room, please think before you speak. Try to order an ecig.. look at how many different companies are involved and look at how many countries are involved. Its EXTREMELY obvious there is no market since there's no "headquarters" (like you would find with big tobacco). Anyone can tell its a wide open market with tons of people trying to find their place. Hell you can only buy these things in a small variety of locations outside the internet Plus the liquids are made ALL over the place by MANY different sources using MANY different recipes.

Now to the IQ moron. Well you just showed us how low your number is if you honestly believe that. Or maybe your willing to challange a 20 year smoker to a live IQ test (for money of course). Just let me know the date, location and how much cash your willing to lose.

One last thing.

For those telling us the only safe way to stop smoking is to stop smoking well.....you can't smoke something that produces NO SMOKE. The term smoking and e-cig should have never been used. Its called a "Personal Vaporizer" that produces water vapor. Yeah you know in science when they tried to teach you about when cooler air meets warmer air you see vapor? So if they ban these things well they need to ban "breathing outside in the winter"

KEEP ON VAPIN'!

What the FDA has failed to tell the public is that they have had their "findings" available since May 4th. If the electronic cigarette is so dangerous, why withhold that information from the public?

This study was un-peer reviewed and after it's release, many doctors weighed in including Dr. Michael Siegel http://tobaccoanalysis.blogspost.com where he noted many flaws in the study and what also came out is that the control, a nicotine inhaler wasn't studied OR the test results were withheld. Why? Because what they found in the electronic cigarette is also found in all of the NRT's as well. Now why would they want you to think the ecig is bad and not the gum, the patch or the inhaler?

There is no doubt that the electronic cigarette manufacturing process needs higher standards. The Electronic Cigarette Association http://www.ecassoc.org would love to work with the FDA, but the FDA clearly has an agenda of it's own: Keep nicotine in the pharmaceutical companies control.

In our society, do we really have only room for the "quit or die" philosophy or is it time to start allowing the products of tobacco harm reduction to be given a fair shake?

Do not fall for this manipulated study. Educate yourself with facts.
http://www.e-cig.org

 


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