E-cigarettes under fire – why?

Although they may look similar to conventional cigarettes, e-cigarettes are not lit, neither do they contain tobacco. They are battery-powered electronic devices, originating initially from China that, when the user sucks on the mouthpiece, produce a microprocessor-controlled puff of vapour containing nicotine and propylene glycol.  As such, they reproduce the ‘hand-to-mouth’ action of smoking cigarettes but do not, of course, expose the user to the harmful effects of inhaling tobacco smoke. The apparently growing world-wide popularity of e-cigarettes has drawn attention from numerous health agencies and advocacy groups. Intuitively, one might have thought in a positive sense –after all these devices are almost certainly a lot less risky than regular cigarettes and probably less risky even than smokeless tobacco products. But the prevailing attitude has so far been quite the reverse – some regulatory authorities, such as those in Australia have already banned, others such as those in Canada are in the process of restricting their sale, and in the US the FDA are reportedly planning a crackdown against them (http://www.mercurynews.com/ci_11873938?IADID=Search-www.mercurynews.com-www.)

 So what exactly is all the fuss about? Surely offering smokers another, much less risky, alternative to cigarettes to choose from isn’t a bad thing, even if only a small minority switch? But no, all kinds of objections have been raised to try and either get the products taken off the market or dissuade smokers from using them. These include: have not been proven safe; have not been proven to be an effective smoking cessation aid; might attract kids; children might be poisoned by eating the nicotine-containing cartridges that the devices use; they allow smokers to get round smoking bans.  Taking these objections in order: few, if any, things are completely safe and tests so far, albeit on  only one e-cigarette brand, have found no cause of serious concern; they are mostly marketed as cigarette alternatives rather than quitting aids (but if they help people to quit, surely that is an added benefit); the upfront cost of the device plus charger is relatively high (typically US$100 and up) so they would seem unlikely to attract kids – having said that, they certainly should not be marketed to them; whilst the cartridges should be kept out of the reach and sight of children, the same could be said of many products found in the house; the same criticism could be levelled at pharmaceutical NRT products in terms of them being marketed to reduce cravings during temporary abstinence from smoking. And I’m not the only one to question the evidence that e-cigarettes are a hazard (see for example http://www.24-7pressrelease.com/press-release/ecigarettes-under-attack-by-fda-and-who-are-they-really-unsafe-91658.php) Is it simply the case that some hard-liners in tobacco control don’t like e-cigarettes because in the hands of the user they look like conventional cigarettes?  But what do others think about these products and how they should be regulated? Has anyone tried them?

59 comments ↓

#1 smoker gal on 03.16.09 at 11:05 PM

Amazing product as I was giving one for Christmas. I do not feel any negative affect from the use of my E-cig. As a matter of fact I am less winded when I work out. My cloths also no longer have that old smokey odor! I’m all for the use of the product.

#2 e-cig smoker on 03.17.09 at 6:01 AM

I switched to electronic cigarettes (from New Smoke) approximately 2 months ago – it feels alot healthier and my wife and kids don’t complain about smelly clothes or curtains anymore. I would definitely recommend them, they’re healthier than normal cigs for sure

#3 Bill Godshall on 03.17.09 at 2:18 PM

Most opposition to e-cigarettes is coming from tobacco/nicotine prohibitionists who hate all things tobacco, and who have no qualms about sacraficing the lives of 45 million smokers.

I also suspect that drug companies (that sell nicotine gums, lozenges, skin patches, and yes, inhalers that are somewhat similar to the e-cigarette) want the e-cigarette products banned (because they are market competition).

Typical code words for prohibition are “these products have not been proven safe or effective”.

Of course, to the prohibitionist, “safe” means zero risk, which is impossible to achieve (as even water is toxic if you drink enough).

And to the prohibitionist, “effective” means effective as a smoking cessation product, not effective as an alternative to cigarettes.

Most opponents of the e-cigarette simply don’t want any tobacco or nicotine product to be marketed as a less hazardous alternative to cigarettes, or even as an alternative to cigarettes.

The banning of e-cigarettes (and even the calling for a ban on e-cigarettes) provides a potential boost for our efforts to amend Waxman’s FDA legislation with tobacco harm reduction provisions (including redifining e-cigarettes and other smokefree nicotine products as tobacco products).

#4 dc on 03.18.09 at 1:07 AM

Yes e-cigs enemies are many and it’s friends are few. In the red corner we have Big Pharma, Big Tobacco and the governement all who stand to lose a fortune if these either remain unregulated or are not banned outright. In the blue corner we have countless nicotine addicts who have found the answer to their prayers – a device that lets them contine to intake nicotine which replicates the act of smoking and doesn’t hurt their pocket. Nicotine addicts have no lobby while governments can and have stopped the sale of these in a heartbeat. One question I have is why if nicotine is not a regulated substace and the FDA are fubling over what to do it has not one entrepeneur ever marketed a nicotine chewing gum which contains no tobacco and carries no cessation claims and sold it for a quarter of the price of Big Pharma’s ‘egineered’ and certified products? what’s actually preventing them?

#5 FDAGuru on 03.18.09 at 6:00 AM

Guys, why don’t you TRY to understand a little instead of your rants about why e-cigarettes are great.

Let’s say I go and buy aspirin from a credible source. I then use a clean facility to make little packets of if (like good’s powder), come up with a clever name and sell it…..

Now, the toxicity of aspirin is well understood.. I am selling a safe product. A good product, too. FDA will still take me right off the market because I am selling a drug… So, if I don’t comply with applicable monograph, process validation etc, they’ll take my product right off, despite all my huffing and puffing that aspirin is, in fact, safe.

From FDA’s perspective, your believe that the product is safe is really not relevant. FDA has a PROCESS that is intended to protect public safety. FDA perceives its job as managing/enforcing that process.

Nobody from FDA is banning e-cigs — what they are going to say is nicotine is a drug, and if you want to sell a nicotine product, you’re going to have to approve it as a drug. Ruyan’s got plenty of cash — they should have been at FDA two years ago starting the process instead of pursuing this juvenile strategy of selling their product on the web along with hyproponic pot growers and e-tailing of controlled drugs.

#6 Bill Godshall on 03.18.09 at 11:36 AM

FDAGuru’s presents Big Pharma’s spin to protect its niche segment of the tobacco industry (called smoking cessation treatment) from market competion by other tobacco/nicotine manufacturers, whose smokefree products are preferred by more smokers and are less expensive (but otherwise are nearly identical).

To accomplish its selfish financial interests, Big Pharma has given hundreds of millions of dollars to certain anti tobacco, health and medical organizations, university researchers, lobbyists (e.g. Pinney Associates, who tout themselves as public health advocates) to mislead smokers and the public to believe that all of Big Pharma’s expensive nicotine products are safe and effective (and should be used by all tobacco users), while all other smokefree tobacco/nicotine products are addictive, deadly, unsafe and evil (and should never be used by anyone).

In order to protect Big Pharma’s control of the smokefree nicotine market, Big Pharma and its funding recipients have petitioned the FDA ban many competitive smokefree nicotine products (by having the products reclassified as usafe drugs). In response, the FDA protected GSK’s sales and profits by banning competitive nicotine lozenge, skin cream and water products (the latter of which has recently been approved by the FDA as a homeopathic remedy).

Big Pharma also protects is nicotine sales/profits by trying to eliminate market competition by tobacco companies. In 2001/2002 GSK, CTFK, ACS, etc. petitioned the FDA to reclassify Star’s Ariva and Stonewall tobacco lozenges (which are nearly identical to GSK’s Commit nicotine lozenge, but taste better and are less expensive). Thankfully, the FDA ruled that Star’s products are tobacco products, which is why they remain on the market today.

Big Pharma and funding recipients also are lobbying US Congress to enact FDA tobacco legislation that would ban all new and recently introduced (since Feb, 2007) smokefree tobacco products from the market (unless/until first approved by the FDA), prohibit tobacco companies from truthfully claiming that smokefree tobacco products are less hazardous than cigarettes, and mislead the public to believe that smokefree tobacco products are just as hazardous as cigarettes.

Unfortunately for the health of smokers, 93% of smokers who tried using Big Pharma’s nicotine gum switched back to cigarettes. So basically Big Pharma is basically saying “Public policy should protect our sales and profits, even it that means sacrificing the health and lives of the vast majority of smokers.”

#7 Troubadour on 03.18.09 at 1:38 PM

Mr. Bill your on target and this Fdaguru guy must be foolish to think the FDA is out to protect people. You ever hear of Chantix Mr GurUUUUUUUUUUUU?

#8 Adrian on 03.18.09 at 3:23 PM

I agree with FDAGuy to the extent that certain quality controls should be in place for any substance intended for, or connected with, human consumption and that includes e-cigarettes. But that aside, I believe the more salient argument here revolves around the word ‘safe’. Few things in life are completely ‘safe’ – and aspirin is not one of them. Indeed, if aspirin were discovered tomorrow it might not even be approved as a medicine. This is because of its various well-known side effects such as gastrointestinal ulcers, stomach bleeding and tinnitus. Yet according to Wikipedia (http://en.wikipedia.org/wiki/Aspirin), over 40,000 metric tonnes of it is consumed world-wide every year. So why is aspirin still allowed to be sold over the counter with no prescription? It’s simply because the benefit/risk ratio is considered acceptable both from a regulatory and a societal standpoint. Because they don’t involve the inhalation of tobacco smoke, if one compares e-cigarettes with conventional cigarettes, one does not need a PhD in toxicology, or a Regulatory Agency to appreciate that the benefit/risk ratio of switching to the former is potentially huge. Indeed the studies performed so far on one particular brand of e-cigarette don’t seem to indicate any cause for undue concern (see http://www.healthnz.co.nz/2ndSafetyReport_9Apr08.pdf and http://healthnz.co.nz/RuyanCartridgeReport21-Oct-08.pdf. Hence I can quite understand where others who have commented on the original post are coming from, especially Bill. Having said that, maybe the debate about e-cigarettes could be a much needed catalyst for new thinking about an approach to the regulation of all nicotine-containing products whereby (irrespective of their origin) they would all come under a separate government agency focused on tobacco harm reduction – and I’m not just thinking about the US here. Whoops –seems like we might have landed up in the regulatory box again! But at the end of the day that’s I guess that’s what it’s all about. For another recent article about the pros and cons of e-cigarettes see the New Scientist (http://www.newscientist.com/article/mg20126951.700-electronic-cigarettes-a-safe-substitute.html).

#9 Bill Godshall on 03.19.09 at 1:27 PM

If the FDA actually considered the known and potential risks and benefits of e-cigarettes, the agency would never seriously consider banning product (as long as cigarettes remain legal).

But the FDA still hasn’t approved, rejected or otherwise responded (other than a required form letter) to the NY State Health Commissioner’s petition (filed more than a year ago) to allow nicotine gums, lozenges and skin patches to be sold in less expensive daily dose packages (instead of expensive weekly dose packages), to be sold in all stores that sell cigarettes, and to make warning labels consumer friendly (so they no longer discourage smokers from using them).

Unless/until the FDA demonstrates that it can reasonably or responsibly regulate the least hazardous nicotine delivery devices (for the benefit of public health), the agency cannot be considered competent to regulate tobacco products.

#10 FDAGuru on 03.19.09 at 3:43 PM

I don’t disagree with you from a normative policy perspective Bill, I am merely predicting what I think the FDA will do….. Hey, if it were up to me, Adrian would be running the whole programme…. My point is merely that people should not get excited about a product that does not past muster with the current regulatory regime unless they credibly believe that the FDA is going to make a substantial policy departure….

#11 CIG GUY on 03.20.09 at 11:05 AM

Bill you really hit it the target. Seems to me the FDA has it’s hands full with tomatoes, peanuts and other pretty innocent products. I too vote for Adrian being called on by the government to formulate policy!

#12 Adrian on 03.20.09 at 5:49 PM

Whilst I’m not sure that I have the availability to respond to the calls for me to formulate policy in this area I am nonetheless grateful for the comments to that effect! But when it comes down to it, I think that FDA Guru makes an important point – it’s about normative thinking. The normative safety-first thinking of regulatory agencies like the FDA is absolutely appropriate when it come to medicines. The public expect this and have come to rely on it. But when it comes to tobacco products I believe a different normative mindset is required. This is one that takes into account that smokers are already consuming an inherently hazardous product and, if they don’t quit, they may well continue to do so unless they are offered an informed choice of less hazardous alternatives for which the regulatory barriers should be lower, rather than higher, than cigarettes. These alternatives include smokeless tobacco products, e-cigarettes and NRT (if only as an adjunct to cutting down their daily consumption). But because of personal preference there is no guarantee that inveterate smokers would switch to such products, no matter what hindrances are placed on either the purchase or use of cigarettes, and that’s their right if they choose not to do so. This makes it all the more important that the search for ‘safer cigarettes’ should continue, even though this is fraught with difficulties and may never be realised, at least in the short-term. When it comes to regulatory authorities, unless a holistic mindset that takes on board these market dynamics can be successfully created within a ‘ring-fenced’ area of an existing medicines control agency I, for one, would argue that it would perhaps be more beneficial to establish a separate agency for tobacco control. But either way I would hope that those agency staff concerned are empowered with new ideas and new thinking. Thinking that, whilst protecting children, also takes on board harm reduction initiatives that are common place in many other areas of public health concern. In the current debate about FDA regulation of tobacco, the US has a chance to show real leadership from a harm reduction standpoint. It really would be a lost opportunity if it didn’t.

#13 smoker gal on 03.22.09 at 1:22 PM

This blog is just a wealth of knowledge. Great reading with excellent input! Love reading it!

#14 Adrian on 03.22.09 at 2:56 PM

Hi smoker gal – glad you have enjoyed it -please keep tuned in for future postings on this and other topics!

#15 Adrian on 03.25.09 at 12:55 PM

American Cancer Society Action Network, ALA, CFTFK and AHF want to snuff out e-cigarettes – they support the call by Senator Lautenberg to do so

http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=104&STORY=/www/story/03-24-2009/0004993931&EDATE=

Statement of the American Cancer Society Cancer Action Network,
American Heart Association, American Lung Association and the Campaign for
Tobacco-Free Kids

WASHINGTON, March 24 /PRNewswire-USNewswire/ — The American
Cancer Society Cancer Action Network, the American Heart Association, the
American Lung Association and the Campaign for Tobacco-Free Kids applaud
Senator Frank Lautenberg of New Jersey’s call for the Food and Drug
Administration to exert its authority and immediately remove e-cigarettes
from the market.

FDA officials have been quoted numerous times in many
publications during the past few weeks saying that e-cigarettes are “new
drugs,” which require prior approval from the FDA before they are allowed to
be sold. Without this approval, e-cigarettes are illegal to market or sell.
Despite these statements, no action has been taken to remove e-cigarettes
from the market.

Currently, e-cigarettes are being sold in 62 kiosks at malls
across the United States, with plans to expand to another 55. E-cigarettes
are also being marketed towards young people, who can purchase them in fruit
flavors and online, without having to verify their ages.

Makers and retailers of these products have been making unproven
health claims about their products, claiming that they are safer than normal
cigarettes and asserting that they can help people to quit smoking. Absent
scientific evidence, these claims are in blatant violation of FDA rules.

In fact, no studies have been done on e-cigarettes to date
regarding their health effects or their effectiveness as cessation aids.
Like the “light” and “low tar” cigarettes that tobacco companies claimed
were healthier for consumers, there is no evidence to back up the claims
made by e-cigarette makers. In September of 2008, the World Health
Organization stated that they have “no evidence to confirm the product’s
safety or efficacy.”

Our organizations thank Senator Lautenberg for his leadership in
urging the FDA to remove these products from the market and echo his call
that the FDA move quickly to remove these products from the marketplace.

While the FDA currently does not have jurisdiction over tobacco
products, it does have jurisdiction over other products that contain
nicotine including e-cigarettes, which have been marketed as delivering
nicotine without tobacco.

SOURCE American Lung Association

#16 CIG GUY on 03.25.09 at 3:42 PM

If you want the truth about Mr. Frank Lautenberger one needs to read Michael Siegels blog on the blogroll. Very interesting!!!!

#17 dc on 03.25.09 at 4:25 PM

A person who accepts money from an industry that sells medicines should never be in a position of authority that lends him the to influence decisions on the publics health an well being. Recently an NPR health shoe host was fired from his job because it was revealed that he had accepted ‘contributions’ from Big Pharm..why is it different for the senators?? Obama was all about limiting industry influence in washington. when is he going to start? This sort of thing is a national disgrace.

#18 Adrian on 03.27.09 at 2:52 PM

In the latest twist to the e-cigarette debate, Health Canada has advised Canadians not to use electronic cigarettes (see: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_53-eng.php). According to their press release, ‘Persons importing, advertising or selling electronic cigarette products in Canada must stop doing so immediately. Health Canada is providing information to interested stakeholders on how to apply for the appropriate market authorizations and establishment licences’

One wonders what those smokers who might have switched to e-cigarettes are supposed to do in the meantime – go back to smoking cigarettes???

#19 RENEGADE on 03.29.09 at 7:56 PM

Yes!
Adrian I’d say that’s their option. I mean looks like the cartel of bad Government, big Tobacco and big Pharma are only interested in the almighty dollar. It’s very disappointing that folks will die because of this alliance. It’s just so disappointing! Just looking to protect the tobacco industry!

#20 John Lauterbach on 03.29.09 at 10:43 PM

If the e-cigs are selling as well as claimed, how come the manufacturers and importers are not willing to make an investment in some basic quality assurance processes (make sure that product composition is constant and free from adulteration), get some delivery data on the “smoke” aerosol from a competent laboratory and publish it, and doublecheck the packaging to make sure an infant or small child cannot easily get into the replacement cartridges.

#21 Bill Godshall on 03.30.09 at 2:32 PM

Per John Lauterbach’s comment, Adriane posted a weblink (above) for Ruyan research on their e-cigarettes.
http://www.healthnz.co.nz/2ndSafetyReport_9Apr08.pdf
and
http://healthnz.co.nz/RuyanCartridgeReport21-Oct-08.pdf

#22 FDAGuru on 03.30.09 at 3:16 PM

I think John L’s comments make sense although part of the problem is that for FDA, there is no middle ground. Quality assurance, child proofing is just part of the story — you need to file an sNDA for approval AS A DRUG.

Please keep in mind that nicotine inhalation is approved already for cessation in Europe — Boots sells these nice little nicotine catridges — they even give you a cigarette like holder for your mouth… No fancy lights or flavors though — it’s a “drug” product.

I think the e-cigarette really would need a new regulatory category to be approved. It’s really not intended to be a “drug” product. That does not mean it cannot make public health contributions, but again, until tobacco and nicotine morph together as a new regulatory category, no dice for e-cigarettes.

#23 TAZ on 03.31.09 at 3:02 AM

Following Comments are accessible on the Blog roll from Michael Siegel. Must agree it’s pretty absurd!

Absurdity Gone Wild: Health Canada Asks Smokers Not to Use E-Cigarettes Because of Safety Concerns, But Not to Refrain from the Known Toxic Ones
In a health advisory issued last week, Health Canada has warned smokers not to buy or use electronic cigarettes because they “may pose health risks” and “have not been fully evaluated for safety” by the government, but in the same advisory, Health Canada expresses no concern whatsoever about smokers buying or using regular cigarettes which are known to pose health risks and which have been fully evaluated for safety and found to be toxic and potentially deadly.

According to the advisory: “Health Canada is advising Canadians not to purchase or use electronic smoking products, as these products may pose health risks and have not been fully evaluated for safety, quality and efficacy by Health Canada. … Although these electronic smoking products may be marketed as a safer alternative to conventional tobacco products and, in some cases, as an aid to quitting smoking, electronic smoking products may pose risks such as nicotine poisoning and addiction. … Canadians who have used e-cigarette products and are concerned about their health should consult with a health care practitioner.”

The Rest of the Story
I have to hand it to Health Canada: this is about as absurd and hypocritical an action that I have seen taken by a government health agency in a long time.

Apparently, Health Canada has deemed that electronic cigarettes — which have little if any known risks — pose such a risk to the health of smokers that they need to issue an advisory not to use the products, but the same concern does not hold for actual cigarettes, which are known to cause serious diseases and even death among many Canadian smokers.

Electronic cigarettes contain nicotine and may pose a risk of nicotine addiction and therefore smokers must be warned not to use these products. However, actual cigarettes – which also contain nicotine but also contain numerous other toxic chemicals and carcinogens – do not pose a risk serious enough that Health Canada opts to ask smokers not to buy or use those products.

Smokers who are using e-cigarettes should call their doctors immediately to inquire about their health effects. But smokers who are using traditional cigarettes need not discuss the health effects with their doctors. They should just continue to smoke without worrying about the health risks. After all, at least the health risks of their products have been very well-studied and well-documented.

What is the terrible concern that Health Canada has? Are they afraid that smokers might actually switch to these tar-free, smoke-free products and drastically reduce their risk of debilitating disease and death? Are they afraid that these electronic cigarettes might just be a much more effective method of nicotine replacement and successful quitting than pharmaceutical products? Are there afraid that these e-cigarettes might displace sales of pharmaceutical company-produced nicotine replacement products?

It is difficult to understand the source of the hypocrisy and absurdity here, but let me offer two possibilities:

First, it strikes me that there is such a strong relationship between tobacco control and Big Pharma that tobacco control agencies within a national health department might actually feel threatened by the possibility that pharmaceutical smoking cessation products might be displaced by non-pharmaceutical products.

Second, it strikes me that there is a tremendous abstinence-only mindset in tobacco control that isn’t capable of even entertaining the possibility that harm could be reduced by a product that is called a cigarette. The very fact that the product is in the form of a cigarette is simply intolerable to many tobacco control advocates. It is not truly the health of smokers that is of concern; it is the act of smoking that is bothersome and unacceptable. So even if that smoking were to save thousands of lives, it is not a viable option. Better that people should use the traditional products and die then switch to a product which has not been fully studied but which is probably much safer.

This is really an ugly situation because if Health Canada does follow through with its threat to remove e-cigarettes from the market, it is going to result in a tremendous disservice to the public’s health. Many smokers who would otherwise have been exposed only to nicotine are going to switch back to cigarettes and thus be exposed to not only nicotine, but all the other toxins and carcinogens in tobacco smoke.

The vision of tobacco control practitioners appears to be so clouded by concerns other than health that it is resulting in jaw-dropping absurdity and hypocrisy in public health.

#24 Adrian on 03.31.09 at 2:29 PM

Looking at some of the more recent posts here, I am inclined to agree (as FDA Guru suggests) that the only way to sort this out (now and in the future) is to regulate all products that deliver nicotine (even with the connotations that this definition carries) under one regulatory umbrella. And I still think that for this purpose a different mindset is required for that normally applied to approving medicines. But I can’t help but also think that many of the objections levelled against e-cigarettes stem from an institutional paranoia of losing control of the situation. Quality control issues apart (agree with John on that – but see the Ruyan research for their brand, as pointed out by Bill) I would have thought that in any other scenario public health groups would be calling for e-cigarettes to be fast-tracked for (some kind) of regulatory approval. That they are not doing so (quite the reverse!) is to me indicative of a fear of letting consumers make their own decisions in self-regulating the risks they take. The same is true for those instances where consumers are not given accurate and truthful information about the risks of smokeless tobacco versus cigarettes. From a basic human rights perspective this simply can’t be justified. And if e-cigarettes are the catalyst for a fundamental re-think on how nicotine and tobacco products are regulated so that consumers are credited with the intelligence to be able to make healthier choices if they don’t want to, or can’t quit, smoking, then I’m all for the regulatory turbulence that e-cigarettes are obviously causing. I just hope something good will come of it.

#25 smoker gal on 03.31.09 at 2:37 PM

I agree with Adrian and just hope something good comes out of this.

#26 Adrian on 03.31.09 at 2:54 PM

Hi Smoker Gal – thanks; two’s company, just need the crowd now!

#27 Adrian on 04.02.09 at 12:54 PM

For those of you still following the e-cigarette controversy, you might be interested in the views of David Sweanor, as expressed in a recent interview for e-Cigarette Direct (see link below). For those of you who might not know him, and as the preamble to the interview explains, David has worked with numerous companies and organisations, including the International Union Against Cancer, World Health Organization, World Bank and the Pan American Health Organization, on the issue of tobacco harm reduction. He has received both international recognition and prestigious prizes for his work. Well worth a read!

http://www.ecigarettedirect.co.uk/interviews/david-sweanor.html

#28 TAZ on 04.30.09 at 1:26 PM

Here is another great article from Michael Siegel.

American Lung Association Wants to Give Government Seal of Approval to Conventional Cigarettes, But Disallow the Demonstrably Safer Electronic Ones
In a position that can only be described as absurd, the American Lung Association is seeking legislation that would give a government seal of approval to conventional cigarettes — which are known to be extremely hazardous — but wants demonstrably safer electronic cigarettes taken off the market because we don’t know whether nicotine plus 4,000 chemicals and 43 carcinogens is worse than just nicotine.

On the one hand, the American Lung Association is a strong supporter of the FDA tobacco legislation, which even the bill’s supporters admit will give a government seal of approval to conventional cigarettes and create a false impression that cigarettes have been made safer.

On the other hand, the American Lung Association is quoted in a recent WebMD article as arguing in favor of the removal of electronic cigarettes from the market because they haven’t been studied enough to determine whether the delivery of nicotine plus thousands of chemicals and many carcinogens is more hazardous than the delivery of just nicotine. The American Lung Association’s chief medical officer is quoted in that article as stating: “They are nicotine delivery devices intended to be used like a cigarette. What happens to someone who stops inhaling the tars of cigarettes and inhales only nicotine? We don’t know. There is at least the potential for harm.”

The Rest of the Story

What an absurd position. Electronic cigarettes deliver nicotine rather than nicotine plus thousands of chemicals but because they haven’t been studied in clinical trials, they should be removed from the market. Conventional cigarettes deliver nicotine plus thousands of chemicals and many carcinogens and have been extensively studied and found to kill hundreds of thousands of Americans each year, but they must not only remain on the market but must be given an official government seal of approval.

In fact, electronic cigarettes have been studied and this laboratory testing has revealed that these products deliver just what they say they deliver: nicotine. They do not deliver other tobacco constituents in any appreciable amounts. Thus, they are demonstrably safer than conventional cigarettes. It doesn’t take a clinical trial to figure this one out.

Moreover, what Dr. Edelman says about electronic cigarettes – “What happens to someone who stops inhaling the tars of cigarettes and inhales only nicotine? We don’t know” – could also be said about the nicotine inhaler.

While it’s true that there is the potential for harm from electronic cigarettes (nicotine may play a role in the development of cardiovascular disease), there is certainly much less of a potential for harm than there is with conventional cigarettes (which also cause lung disease and cancer).

Electronic cigarettes are being marketed to, and used by smokers, most of whom are trying to quit smoking and stay off of conventional cigarettes. Why would you want to take away this device which is helping many smokers to stay off cigarettes? Especially when conventional nicotine replacement therapy is so dismal in its efficacy.

Once again, you have to question whether the public’s health is the primary concern, or whether there is a more basic ideological consideration underlying the absurdity of the American Lung Association’s position on cigarettes.

#29 Adrian on 05.01.09 at 7:43 AM

I couldn’t agree more with the sentiments expressed by Michael Siegel in the posting that Taz highlights above. I would be the first to agree that quality control checks should be put in place to ensure that the e-cartridges and/or the fluids contained within are not adulterated. But bearing in mind the likely vastly reduced risks compared with smoking cigarettes, banning e-cigarettes outright is the equivalent of banning toy guns while letting real guns remain legally on sale. I think a key issue here is that certain regulators and public health organizations don’t like the fact that ‘smokers are doing it for themselves’. I didn’t think that ‘tobacco control’ meant ‘consumer control’, but in the mind of some, evidently it does.

For another article by Michael Siegel on e-cigarettes see below:

http://tobaccoanalysis.blogspot.com/

Electronic Cigarettes the Feature of Los Angeles Times Article
An article published Saturday in the Los Angeles Times discusses electronic cigarettes, and the differing approaches being taken to this novel product in various countries.

While e-cigarettes are widely available in some countries, others have banned their sale. As the article reveals: “Even without smoke or fire, electronic cigarettes are sparking controversy. Australia, Canada and Hong Kong have banned them on the grounds that they have not been sufficiently tested for safety.”

The article includes two important quotes from tobacco control experts. David Sweanor, an adjunct law professor at the University of Ottawa, stated: “This is exactly what the tobacco companies have been afraid of all these years, an alternative method of delivering nicotine that is actually enjoyable. It took the Chinese, who are very entrepreneurial, and not burdened with all kinds of regulation, to take the risk.”

Bill Godshall, the executive director of Smokefree Pennsylvania and a frequent commenting contributor to The Rest of the Story stated: “You have these abstinence-only extremists who want to eradicate all nicotine products. But as you’ve seen, whether we’re talking about sex or alcohol or nicotine, abstinence doesn’t really work.” According to the article, Godshall has “collected 4,000 signatures on a petition to allow e-cigarettes to be legally sold in the United States.”

The Rest of the Story

Congratulations to Bill Godshall and to Dave Sweanor for being willing to publicly put the protection of the health of smokers above the knee-jerk, ideological opposition to a smoking device that we have unfortunately seen far too much within the tobacco control movement. Congratulations to Bill also for his efforts to persuade the FDA to allow e-cigarettes to be legally sold in the United States.

This is an important effort that could result in saving countless lives.

I find it interesting and quite informative that while anti-smoking groups are promoting nicotine replacement therapy via pharmaceutical products – which have dismal efficacy – they are seeking a ban on nicotine replacement therapy via e-cigarettes, which appear to actually be reasonably effective.

What is informative about the inconsistent treatment of these different products by the anti-smoking groups is that there does not seem to be a primary concern for the public’s health. Instead, the primary concern appears to be either for the financial well-being of the pharmaceutical companies or for the ideological notion that the act of using a cigarette-like device is to be scorned.

It is absurd to argue that e-cigarettes must be banned because they have not been sufficiently tested for safety. Regular cigarettes have been sufficiently tested for safety and they have been found to be unsafe. But they are still on the market. So why all the concern about testing e-cigarettes for safety? Since they deliver nicotine but not the tar, we know that they are going to be safer than conventional cigarettes. I maintain that it isn’t truly safety and health concerns that are leading the anti-smoking groups to call on an e-cigarette ban. I think it is a combination of the financial influence of the pharmaceutical companies on tobacco control and the ideological resistance to the idea that any act of smoking could be tolerated.

#30 Desert Dude on 05.01.09 at 12:34 PM

Gotta love Mike Siegel! Says it straight!

#31 Bill Godshall on 05.01.09 at 5:51 PM

Smokefree Pennsylvania sent the following letter to the FDA in response to the agency’s proposed actions (below) against smokefree nicotine inhalers called e-cigarettes.
- – -

Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880

May 1, 2009

Ms. Heather Zawalick
US Food and Drug Administration

Per your recent e-mail (below), Smokefree Pennsylvania strongly urges the FDA to cancel its planned activities next Tuesday, and to consider the
enormous public health disaster the agency would create by banning smokefree nicotine inhalers called e-cigarettes.

Denying 45 million cigarette smokers access to exponentially less hazardous smokefree nicotine alternatives would result in millions of preventable
deaths among smokers, millions of nonsmokers continuing to be exposed to tobacco smoke pollution, and tens of thousands of e-cigarettes users
reverting back to smoking cigarettes. It is absurd for the FDA to even contemplate protecting the deadliest nicotine products (cigarettes) from market competition by the least hazardous nicotine products.

Cigarette smoking is 100 times deadlier than smokeless tobacco use, while smokefree nicotine products pose even fewer risks. Switching from cigarettes to smokefree tobacco/nicotine alternatives reduces smoker’s health risks nearly as much as quitting all tobacco/nicotine use. And millions of smokers have already sharply reduced their health risks by
switching to smokefree tobacco/nicotine alternatives. Please review a report I coauthored: “Tobacco harm reduction: an alternative cessation strategy for inveterate smokers” at http://www.harmreductionjournal.com/content/3/1/37

In contrast to recent claims by e-cigarette prohibitionists, hundreds of thousands of smokers have quit smoking and/or reduced cigarette consumption
by switching to e-cigarette products, and thousands have written testimonials at
http://www.thepetitionsite.com/1/keep-life-saving-electronic-cigarettes-available and
http://www.e-cigarette-forum.com/forum/ describing their experiences with these less hazardous nicotine alternatives. Meanwhile, test results on the Ruyan e-cigarette http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf found no product hazards.

Also in contrast to claims by prohibitionists, there is no evidence that e-cigarette products have been marketed to youth, nor is there evidence of youth use of e-cigarette products (most of which cost more than $100). And most e-cigarette companies do not make claims that their products are smoking cessatoin aids. As such, the FDA should not be classifying these
products as drugs (in an thinly disguised effort to ban them).

The sensible policy solution is for US Congress to enact reasonable and responsible tobacco/nicotine regulatory policies to allow e-cigarettes and
other smokefree nicotine products (that are marketed as alternatives to cigarettes) to remain on the market, and be regulated as a separate category of tobacco products. Smokefree tobacco harm reduction provisions in legislation recently introduced by Rep. Buyer (H.R. 1261) and Senators Burr/Hagan (S. 579) would achieve this policy goal. The US Senate also can
amend pending FDA tobacco legislation by Rep. Waxman (H.R. 1256) or soon-to-be-introduced legislation by Senator Kennedy with these or similar
harm reduction provisions.

Most e-cigarette companies support reasonable and responsible regulations for their products. If the FDA is truly interested in reducing the leading cause of preventable disease, death and disability, it would join us in urging the US Senate to enact these sound public health policies.

Since 1990, Smokefree Pennsylvania has advocated policies to reduce tobacco smoke pollution indoors, increase cigarette taxes, reduce tobacco marketing
to youth, preserve civil justice remedies for victims, expand smoking cessation services, and inform smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.

For disclosure, neither Smokefree Pennsylvania nor I have received any funding from tobacco, drug or e-cigarette companies.

Thank you for your consideration, and feel free to contact me anytime.

Sincerely,

William T. Godshall, MPH
Executive Director

- – -

From: Zawalick, Heather (CBER) [mailto:Heather.Zawalick@fda.hhs.gov]
Sent: Wednesday, April 29, 2009 4:08 PM
To: Zawalick, Heather (CBER)
Subject: [LIKELY_SPAM]FDA Outreach: FDA Takes Enforcement Action on
Electronic Smoking Products, Entering Clearance

Subject/Headline: FDA Takes Enforcement Action on Electronic Smoking Products

Planned Release Date: May 5

Driving Event: Compliance action

Rollout Plan: Extensive rollout planned including press conference at HHS, press release, fact sheet, video for upload to YouTube, podcast, consumer article, consumer Q &A, key message points, internal media Q & A, Op-Ed, photos of products for posting on Internet.

Other background, hidden factors: Action involves three largest distributors. One of the distributors has just sued FDA seeking a restraining order to prevent us from holding their product at the border. There is keen interest in this subject. E-cigarette kiosks are all over
town, including Montgomery Mall. They’re being advertised as a safer alternative to cigarettes. Our concern is that this might introduce nonusers to nicotine use. This is a drug delivery device. The content of the products have not been analyzed by FDA. To be sold, they would have to be approved by the agency.

Spokespersons: Janet Woodcock and Deborah Autor

Heather Zawalick
FDA/OC/Office of Legislation
301-827-0090
Heather.Zawalick@fda.hhs.gov

#32 Adrian on 05.04.09 at 3:13 PM

Presumably as a result of being faced with the apparent possibility of compliance action by the FDA (see above) there are strong rumours that the US e-cigarette companies are about to go on the offensive with the release of various material in support of the potential of these products being a valuable tool in tobacco harm reduction. So I guess the message is to watch out for a ramping up of interest in not just e-cigarettes in particular but hopefully harm reduction and nicotine regulation in general. Time for consumer interests to win out over vested interests??

#33 tobaccotoxdoc on 05.04.09 at 3:38 PM

Three things here: 1) History — are the various types of e-cigs in question different enough from the FAVOR devices of 1984 to warrant FDA acceptance now, when FAVOR was rejected? 2) I have yet to see relevant data on the chemistry and toxicity of the mainstream and sidestream aerosols emitted by the e-cigs? 3) Also, I have not seen anything about safety packaging for the refills. Are they packed to F1 standards?

#34 Adrian on 05.05.09 at 10:32 AM

John
1) Good point you make about FAVOR. In theory not a lot of difference besides the e-cigarettes producing a visible mist and being a lot more high tech. But in practice the e-cigarette seems to be far more widely used and also has attracted the support of various public health individuals in terms of it being a potential tool for tobacco harm reduction. I guess like is the case for most things, timing is (or could be) everything!

2) The original work by Health New Zealand (HNZ) on the safety-profiling of the Ruyan® product (see: http://www.healthnz.co.nz/2ndSafetyReport_9Apr08.pdf and
http://healthnz.co.nz/RuyanCartridgeReport21-Oct-08.pdf ) was updated at the recent SRNT meeting in Dublin via a poster by Murray Laugesen from HNZ. Here is a brief summary of the poster content: No gamma-emitting nucleotides were found to be present in the assembled Ruyan® V8 e-cigarette. The cartridge (labelled 16mg) liquid (1.06g) was found to contain 1.4% nicotine, 90% propylene glycol, o.1% glycerol and 8.8% water. Of 35 PAHs tested for in the earlier (2008) studies on the cartridges, benzoalphapyrene was not detected. Of the remainder, 4 were detected, but these were not human carcinogens. No carcinogenic heavy metals were detected at the limit of 0.2micrograms per gram. Other compounds found in the liquid included toluene, ethanol, bipyridine, propan-1-ol, tripropylene glycol and beta nicotyrine in trace quantities. In the headspace above the cartridge liquid, acetaldehyde was detected at 5parts per million and acrolein at 0.3parts per million. Other cigarette toxicants found to be absent or not detected at 0.01 ppm or more were acrylonitrile, benzene, 1,3, butadiene, m-o and p- cresols, ethylene oxide, hydrogen cyanide, styrene and xylenes. Testing of the Ruyan® V8 mist for smoke toxicants found that for over 50 such toxicants, none were found in any but trace quantities. Mercury was detected in trace quantity of 0.17ng per e-cigarette, which was just above the reporting limit of 0.13 ng and within the reported 38% coefficient of variation. Puff per puff delivery of nicotine was about 10% that of similar puff on a cigarette. Although absolute safety does not exist, a conclusion from these tests was that e-cigarette emissions relative to cigarette smoke are likely to be 100 to 1000 times safer. At the same time, it was also concluded that further studies are needed – I don’t disagree with that, the more information the better. As smoke is only generated when the user sucks on the mouthpiece I’m not sure that there is such a thing as side-stream smoke to measure in any quantity.

3) Regarding your comment on child tamperproof packaging, I agree with you, this is a potential concern, but may be overcome to some extent by the launch of disposable pre-loaded products like the Ruyan® Jazz. But might be best if you were to contact direct the various manufacturers to check out the current situation on whether their cartridge packaging meets the F1 standard or not.

#35 FDAGuru on 05.07.09 at 9:15 AM

No props for the soothsaying guru — called this one right out….

#36 ecig user on 06.06.09 at 1:51 PM

The FDA, along with many other large groups and lobbies, is subject to funding and bribes from companies in Big Pharm and Big Tobacco. Even if e-cigs are proven through testing to have no adverse health effects and would qualify with FDA standards for sale otherwise, they are most likely to be banned because of the willingness of Big Tobacco and Big Pharm to throw out money to the FDA to stop their customers from using these smoking alternatives.
Think now of the lives of those 45 million smokers. Do they not deserve the chance to better their health by these alternatives? a large amount of smokers decide they want to quit, but are unable to because of the psychological addiction to the act of smoking. Personally, I am addicted to the act, not the nicotine.
One may say that this is false, but after purchasing an e-cig pack i have not smoked a traditional cigarette for several weeks now. i decided to get the e-cigs in non-nicotine to test this, and still have not smoked a traditional cigarette since. Taking this product off of the market would do much more harm than good, considering the risk to benefit ratio. The FDA legalizes and bans many drugs and products simply for the purpose of profit, and one example of this would be the vitamin B-17. look it up on google or your favorite search engine. FDA banned vitamin B-17, a vitamin proven to greatly reduce risk of cancer and fight of carcinogens. Why you may ask? Big pharm gets a large percentage of their profits through cancer patients.
although i do agree these e-cig companies should have gone through rigorous testing to prove that their products are safe.
think about it…

#37 outside1 on 06.06.09 at 10:20 PM

Several companies have offer zero-nicotine, e-cigarettes.

#38 outside1 on 06.06.09 at 10:23 PM

(Correction)several companies offer zero nicotine content, e-cigarettes.

#39 fedup on 06.07.09 at 2:23 AM

I hate to gripe but its a shame we live in a country where our government is controlled by a bunch of crooks. Only interested in the special interests that line their pockets with cash! Our government sure will be the demise of this great country as our freedoms to smoke cigarettes or now even unbelievably e-cigs is controlled by folks in positions that have very little conscious. May the blood of all those who die from smoking cigs that found ecigs haunt the folks ruling against them, Matt Myers you make me sick! You and your deal with the devil – Philip Morris!

#40 VaporGirl on 06.11.09 at 1:23 AM

I have used the e-cigarette for a month now and have not picked up a tobacco cigarette since. I am very proud of that considering I smoked for 25 years and I am 35 yrs old. I am hoping this really is a healthy alternative, although there is a lot of debate. This is why I signed up on this site. I wanted to know what The Doctors think of this product. If there is a link on this site with their opinions on it could someone please post it? I signed up on Becomeanex.com because I blogged about how great I feel about breaking this habit. I am getting bashed on this site. If there are other folks on here who have succeeded with the e-cig please follow this link and comment.

http://community.becomeanex.org/profiles/blogs/my-ecigarette-review-helped-me

There are like 20 people jumping on me telling I really didn’t quit smoking at all. I need some back up here. But what I really want are some opinions about this from doctors. Thank you for reading!

#41 OTP Kid on 06.11.09 at 10:14 AM

E-cigarettes will either be banned or highly controlled by the FDA. I believe you may be missing the point. While you can argue the benefits of Ecigs all day long, the simple fact is that the product will be portrayed as a smoking placebo to take the place when the smoker cannot smoke; thus, it will encourage continued smoking rather than quitting. Once this argument is publicized, there will be no putting the genie back in the bottle. Because the politicians and beureacrats will ALWAYS err on the side of the safe choice, the products will be doomed. The naivete’ of these boards, this one in particular, is incredible. But it certainly explains why the industry cannot stem the decline, it’s full of idiots.

#42 AJ on 06.12.09 at 9:53 AM

Don’t be so sure that Big Tobacco and Big Pharma stand at odds with regard to tobacco-free nic delivery systems. The tobacco companies have been working on delivery using chemically synthesized nicotine for some time that duplicates the spike-and-decline cycle of nicotine in the bloodstream which is so vital to the experience and addiction.

You can be sure that the Chinese government has banned these products for use at home. One trillion cigarettes per year, a massive growing industry and hundreds of factories are vital contributors to their economy. They are studying tobacco-based reduced harm alternatives for domestic use.

The US will not want an untaxable tobacco-free cigarette, and neither Big Tobacco nor Big Pharma want to see these upstart start-ups stepping on their toes.

#43 Desert Dude on 06.17.09 at 12:58 PM

AJ it would be interesting to see what would take place if PM were to modify an electronic device with tobacco as to how it would be perceived!

#44 Laurie on 06.18.09 at 8:37 AM

It amazes me that the electronic cigarette has been around for so long and never raised an eyebrow. Tobacco prices have been raised so high that people searched and found an alternative, and only now the special interest groups want to put the kaibosh on this product. Ruyan has had many tests done, and the FDA has been aware of this products from the very begining. Only when Kennedy decided he is dying and wants to leave a legacy while the FDA sits on ther collective butts waiting to be told what to do by funding group is the controversy comming to the surface. This is a no brainer. The electronic cigarette is an alternative to tobacco. The FDA can regulate the amount of nicotine one can ingest up to and comparable to regular cigarettes allowing a greater latitude to distributors. Many people will benifit from the sale of these products. Eco friendlier, non second hand smoking devices will make money for everyone, lets face it, pharmacies cannot make money off a dead smoker. But, a live person will need medication for years to come. The FDA knows they overstepped their bounds by holding shipments at the boarders, but they are being protected by political corruption. It is always about money and power. There is no way the FDA has not already begun testing this long ago since it was introduced years ago and was given studies way before the controversey. Just how stupid do they think we are? The political BS makes me sick, while others are dying of approved cancer sticks.

#45 fedup on 06.19.09 at 12:59 AM

I just love what you have to say Laurie! Hey I think that you’ve hit it on the button. I’ve been saying it I’m just plan fedup with the bs. I saw today where Obama is going to have a liberal tv network in the white house. OH thats just absolutely marvelous – the whitehouse will now be a reality show just like the rest of the crap that gets served up on the liberal hollywood message board called primetime.

#46 premiumecigarette on 06.29.09 at 1:48 AM

There are few friends and many enemies of e-cigarette.
Best thing is that the they doesn’t produce the second hand smoke. E-Cigarette growing world-wide now days. we can say that its very helpful smoking device rather than the real cigarette to help the global warming problem for world. As we personally advised that use it with safe hands. Keep away the electronic cigarettes cartridges from the small children. Although its safe to smoke everywhere. so i’m again telling you that enjoy the electronic cigarette with safe hands.

#47 Laurie on 06.29.09 at 7:38 PM

Aloha Fed-Up.

Thank you for your comment. I did see the video where Obama is going to answer the most asked questions written in by the public. Hmm? This gives me an idea. What if everyone across the globe pro-e-cig, were to write in questions about the e-cig and how they help other to achieve personally a better quality of life. Questions like:
Is the e-cig going to be included as a medical device supported by the new healthcare bill because the FDA is attempting to regulate its purchase to line their pockets. Will millions die because the FDA has overstepped their bounds by halting the import while medicines not regulated are killing people… Hmm?
I think he would have to address this device in person.
I think when people act like boobs, wanting to do a reality vid-op, like the President is doing, we need to look at this as an opportunity to utilize the situation to our advantage. From my understanding he owns one already…hmm I see and opportunity. What say you?

#48 Bill on 09.07.09 at 4:09 AM

Umm, I will have to say this I find myself smoking these more than I did with my usual cigarette.

I find myself needing to hold one in my mouth without a thought. When I used to smoke cigarettes I would smoke approximately 1-1 1/2 pack a day but now.

I find myself holding it in my mouth without a thought at least 30 times a day.

Can’t say whether or not it’s bad, but I can say that I can work out more easily, BUT, I find myself smoking much more, and I also seem to have throat problems. When I cough I feel a pain, and sometimes I have pains after smoking these.

#49 Adrian on 09.07.09 at 2:15 PM

I’m not a clinician, so I am not qualified to give you medical advice; but if you are having throat problems and experiencing pain when you cough it would seem sensible that you consult your physician as soon as possible.

#50 Mistman on 09.16.09 at 12:54 PM

Wow! I saw a great new product the other day! Imagine an inhaler that used aroma therapy to soothe the savage smokers urges! Pretty neat!

#51 Pamela on 09.20.09 at 9:19 AM

Why would the FDA approve a nicotine inhaler and not the ecigarette? Cause the nicotine is absorbed in the mouth? You can read about that here. http://www.nytimes.com/1997/05/06/us/fda-approves-inhaler-as-stop-smoking-aid.html?sec=health&spon=
Seems like the study should be done by asking people that use the ecig how they feel. That is the way it usually works thought…right?? So far I haven’t read about anyone dying from the ecig.
I’m the only one that can tell a doctor how I feel and if something is working for me or if I’m experiencing any kind of side effects.. They do that to “approved” medicine’s all the time and they don’t know all the side effects until someone is using the drug. I am constantly seeing lawyers on TV trying to get people to call them if they have suffered severe side effects or even death of a loved one from these “approved” drugs. Since I’ve been using the ecig. I feel better than I have in yrs. and don’t cough all the time like I had been. I also haven’t smoked a tobacco cigarette in 8 days and only started using the ecig 2 weeks ago. I can actually smell again. Im the experiment just like anyone else that has tried the ecig. Want to know the side effects? Ask the people that use the ecig. They are the tested.
Im also seeing a new product called Chantix being advertised that has been approved by the FDA that has some bad side effects “Suicidal Thoughts” WOW!! I also read that about 78 people have killed themselves taking this new FDA “approved” product. If the Tobacco cigarettes don’t kill us ..looks like the FDA will find a way to help us do it ourselves using there “approved ” methods. I remember heard about a Dr. that was helping people commit suicide a few yrs. ago..What was his name …Kevorkian ???..or maybe its spelled FDA ? Just a thought.

Seems like it should be illegal to approve anything that causes anyone to experience those kinds of side effects. Oh but wait…Maybe they wont know that unless people try them out. I’ll keep trying out my new ecig. Hope I don’t get suicidal thoughts.

Pardon the sarcasm…couldn’t resist.

Happy Vaping !!!!

#52 Desert Dude on 10.02.09 at 2:38 PM

Pam
Your so on target! The FDA is just a pawn of the Anti-Tobacco movement! We need to band together and stop the nonsense!
DD

#53 TAZ on 10.02.09 at 6:01 PM

Found this of interest!

Commenting on an article in Suburban Journals of Greater St. Louis, which quoted the Food and Drug Administration spokeswoman Siobhan DeLancey saying that the agency does not know if smoking e-cigarettes is “any better” than smoking regular cigarettes, Prof. Michael Siegel of Boston University School of Public Health said this means the FDA also does not know if cigarette smoking is any more dangerous than using e-cigarettes, and “[w]hen the FDA says cigarette smoking may be no more hazardous than the use of a device that essentially delivers just nicotine and propylene glycol, you know we have serious problems with tobacco control in this country.” (tobaccoanalysis.blogspot.com 10/01)

#54 Chris on 10.16.09 at 5:57 PM

I find all of these comments linking the FDA to “big tobacco” and “big pharm” to sound like wacky conspiracy rants. I am a supporter of the idea of e-cigs. I think an alternative to tobacco that provides the feel of a traditional cigarette, through design and vapor, while helping addicted individuals satisfy nicotine cravings is a wonderful idea. But, I also think such products need to be tested to make sure they are reasonably safe alternatives to clearly dangerous traditional cigarettes.

What good would a product be if it replaced one set of dangers with new ones? How do we, as consumers, know, for sure, that inhaling the propylene glycol that produces the vapor intended to simulate the look and feel of cigarette smoke is indeed as safe as the e-cig industry would have us believe? And why on earth did half of the 19 FDA tested e-cigs contain nitrosamine, which is a cancer-causing chemical found in antifreeze?

The FDA is a government agency, and as such is subject to the kind of bureaucratic thinking that all government agencies tend to follow. Thus, I would agree that the FDA is not handling their concerns over e-cigarettes as efficiently as they should be. And I suppose there is some level of lobbying taking place by those who stand to lose money over the sale of e-cigs (as well as those staunch anti-smoking bigots who feel that any activity tied to smoking should be prohibited regardless of actual public health issues.)

But I also think the FDA ultimately acts in the best interests of public safety. We all remember the rash of dangerous toys and other products that flowed into the US from China last year. If most e-cigs come from China, who is to say that they are not just as dangerous? Have we not learned our lesson about the poor Chinese government regulations regarding the manufacture and sale of items containing potentially dangerous chemicals and substances?

E-cigs must be tested and regulated by the FDA. They must pass the same kind of rigorous testing that all drugs, foods, ingested chemicals, etc. must pass in order to be deemed safe for human consumption. However, that being said, the FDA needs to take the same staunch stance against traditional cigarettes. If the FDA feels so strongly that a product with no obvious heath risks needs to be banned until further testing can be completed, certainly they should ban real cigarettes, which have been tested for decades and proven, over and over, to be deadly.

So I guess what I am saying here is that the FDA is right to question the safety of e-cigs, but in pushing for their ban, they are revealing not so much a conspiracy to keep “big tobacco” and “big pharm” rolling in dough from the sale of cigarettes, Chantix, and nicotine replacement products, but rather their deep hypocrisy in failing to protect the public against recognized dangers from already approved products.

Chantix is toxic. Cigarettes cause cancer and heart disease. Nicotine is an addictive drug. All of these items are very, very bad for people, yet they are either approved by the FDA (i.e., Chantix) or allowed to be sold without FDA approval (i.e. cigarettes.) So why does the FDA feel the need to ban e-cigs now? Why not allow them to remain on the market until adequate testing is completed and a full, detailed analysis of the real dangers, or lack thereof, of e-cigs is released?

I hope e-cigs remain available as a smoking alternative. I want to try e-cigs myself. I believe that using e-cigs in public places where traditional smoking is prohibited should be allowed. I believe adults have the right to ingest nicotine if the choose to. I believe that traditional cigarettes should be banned by the FDA as dangerous to the public safety. And if conclusive evidence can be found to prove that e-cigs are, indeed, dangerous, I believe they should be banned as well.

But for now, with no real evidence to condemn e-cigs, I believe they should be sold freely and without regulation.

#55 TobaccoToxDoc on 10.17.09 at 3:34 PM

It is unfortunate that those on the business side of e-cigs have failed to retain comptent toxicological consultants to help them out of the current situation. A reasonable expenditure on their part at this time could help them save their products from being banned entirely.

#56 Bill Godshall on 10.19.09 at 11:48 AM

Unfortunately for public health, the FDA, CTFK, ACS, AHA, ALA and subsequently US Congress rejected my repeated urgings to amend to the recently enacted FDA tobacco legislation to define e-cigarettes as new category of tobacco product, and to regulate them accordingly.

Had that occurred, it would be illegal to market e-cigarettes to minors, and manufacturing standards and product testing for e-cigarettes would be forthcoming.

The FDA can still save its own face and save millions of lives by proposing regulations to define e-cigarettes as tobacco products. This also could be a negotiated outcome of the lawsuit filed by Smoking Everywhere against the FDA.

#57 Angel on 10.29.09 at 3:26 PM

All health issues aside, the reason e-cigs will not be accepted is due to the human desire to ban other people’s “bad” habits. When nicotine in all forms is outlawed, we’ll see the crackdown on obesity elevate. Eventually, we’ll work on making sure that no genetically inferior babies are born. After all, less than superior humans are a cost to all of society.

#58 NotSurprised on 12.22.09 at 8:03 PM

This whole issue is a great example of how we as Americans are losing our freedom. The government wants to control and tax everything we use. They use the media and big pharmacy companies and big tobbaco companies to shove pills and booze and cigarettes in our face. So they can profit and we die. They dont want us to have choice of something they cant properly regulate. Hello. Marijuana ring a bell? Can u even believe it? I havnt yet tried an e-cigarette but i do smoke cigarettes and i hate it. How can the vapor of an e-cigarette possibly be worse than a real cigarette. I want to see an American made e-cigarette. I want to see studies done. I dont want to see u bashing a product that looks like it could bring hope to millions. The government needs to stop helping themselves and start helping the American people that put food on their table.

#59 kathy sayles on 01.11.10 at 12:18 AM

i would like cancel your e- cig . 01/10/10 i have call many times. thanks please email me to comm.

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