Action regarding FDA: No banter here, please

[StratOvation]

Mickey,

Please feel free to pass this info along to any of the "Movers and Shakers" you have contact with. I believe this could be a huge argument in the defense of the primary e-cig liquid ingredient.

Air Germicide - TIME Clinical study from 1942... But I think it is still valid

Another link re. PG inhalation generously supplied by Kate... http://www.liebertonline.com/doi/abs.../jam.2007.0626

Mike

[Charlie_Russo]

Greetings….

Writing to ask if anyone in the San Francisco Bay Area would be interested in being interviewed for a short news video I am putting together on the topic of e-cigarettes and the pending legislation that they are facing.

I will be conducting interviews over the next week and I am open to hearing any and all testimony from e-cigarette users. I've already gotten some very articulate perspectives from some worthwhile sources and I would like to add to that with more first hand accounts regarding use of the products. Although this is a freelance project, I am speaking with some editors now for this to run as a 3-5 minute video piece on a relevant news website.

Please get in touch if you have any interest. I'm happy to set up a time and location that works well for all involved.

Thanks,

Charles Russo
charlierusso23 at gmail dot com
www charlierusso dot com

[Bill Godshall]

Not sure if it was already posted, but here's an excellent LA Times article on e-cigarettes that ran Saturday.


A high-tech approach to getting a nicotine fix

By Barbara Demick
Los Angeles Times
April 25, 2009
Electronic cigarettes: From China, electronic cigarettes head for the U.S. market - Los Angeles Times

Reporting from Beijing -- Hon Lik used to light up first thing in the morning. He smoked between lectures at the university where he studied Oriental medicine, between bites at lunch, in the lab where he researched ginseng health products. He'd usually burn through two packs by dusk and smoke a third over dinner and drinks with colleagues.

It wasn't until his father, also a heavy smoker, died of lung cancer that Hon finally kicked the habit.

Hon's story could be that of any other nicotine-addicted, middle-aged man in China, where 60% of the men smoke. What distinguishes the 52-year-old pharmacist and inventor is that he found inspiration in the addiction.

One of the strangest gizmos to come out of China in recent years, Hon's invention, the electronic cigarette, turns the adage "where there's smoke there's fire" on its head.

It doesn't burn at all. Instead, it uses a small lithium battery that atomizes a liquid solution of nicotine. What you inhale looks like smoke, but it's a vapor similar to stage fog. (Take that, smoke-free bars!) It even has a red light at the tip that lights up with each drag.

"It's a much cleaner, safer way to inhale nicotine," said Hon, blowing curlicues of e-smoke as he showed off the cigarette in his Beijing office. (He says he doesn't smoke anymore, except for such demonstrations.)

Hon got his first patent on the e-cigarette in 2003 and introduced it to the Chinese market the next year. The company he worked for, Golden Dragon Holdings, was so inspired that it changed its name to Ruyan (meaning "like smoke") and started selling abroad.

This year, it's planning a big push in the United States. A disposable e-cigarette called the Jazz ($24.95 for the equivalent of five packs) is due to hit 7-Elevens in the Dallas-Fort Worth area shortly. Many rival versions, all made in China, are making their way to the U.S., sold mostly over the Internet by small marketing firms.

Unlike nicotine patches and gum, electronic cigarettes are designed to be fun. There are regulars and menthols, as well as chocolate and strawberry. A company in Japan is selling one that is charged by the USB port of a computer.

The e-cigarettes aren't marketed as a way to quit smoking, but as a smoking alternative.

"It's safe smoking -- like smoking with a condom on," said William Taskas, a Canadian distributor who is marketing a product called Smoke- Stik.

What makes the electronic cigarette more than just the latest curiosity from China is the enthusiasm it has inspired among respected anti-tobacco activists.

"This is exactly what the tobacco companies have been afraid of all these years, an alternative method of delivering nicotine that is actually enjoyable," said David Sweanor, an adjunct law professor at the University of Ottawa who specializes in tobacco issues. "It took the Chinese, who are very entrepreneurial, and not burdened with all kinds of regulation, to take the risk."

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 way they were being sold, there was no control. A kid could buy it and take too many puffs. You could overdose on nicotine," said Ronald Lam, tobacco control chief of the health department in Hong Kong, where 800 shops were raided last month and the entire e-stash confiscated.

The Food and Drug Administration last month confiscated shipments from three Chinese companies on the grounds they were making false health claims. The agency said in a recent letter to prospective importers of electronic cigarettes that it had not decided on their legality, but was "evaluating them on a case-by-case basis."

Although they're not kicking Marlboro off the shelves in China, the electronic cigarettes have a small but loyal following.

"They're quite popular with both men and women," said Sun Shujuan, a clerk at the tobacco counter of the Beijing City Department Store. Each day, she sells one or two of the reusable cigarettes (a $145 appliance), and a much larger number of the replacement cartridges, which run $9 for the equivalent of five packs of cigarettes. "We have many repeat customers."

Chinese smokers complain that the electronic cigarettes are expensive (most brands here are still less than $1 a pack) and can't be easily shared. In China, cigarettes are the essential lubricant for opening a conversation -- the smoke offered to the cop who has pulled you over, the pack held open by a salesman approaching a prospect.

"What is the point of having cigarettes if you can't give one to a friend?" said Liu Hai, who works as a driver and lives in Chengdu, in Sichuan province.

The United States is considered a far more promising market because of the higher price of cigarettes and the prohibition on smoking in many indoor spaces.

"When you're in Minneapolis in the winter, it's a lot more attractive to spend $24.95 on an electronic cigarette than it is to go out to smoke where it is 20 degrees below," said Alex Chong, chief executive of Ruyan America, the Minneapolis-based U.S. affiliate of Hon's company.

E-cigarettes are already sold legally in some British pubs, where smoking is banned.

Even though the devices are not yet widely available in the United States, the battle lines are being drawn.

The electronic cigarette marketers refrain from calling e-cigarettes a smoking-cessation aid -- in part because under U.S. law, if they made any health claims, they would be subject to FDA approval.

Bill Godshall, head of Smokefree Pennsylvania, estimates that at least 100,000 electronic cigarettes have been sold in the United States. (The gizmo got a boost last month when Leonardo DiCaprio was photographed smoking one on a bicycle.)

"You have these abstinence-only extremists who want to eradicate all nicotine product. But as you've seen, whether we're talking about sex or alcohol or nicotine, abstinence doesn't really work," said Godshall, who has collected 4,000 signatures on a petition to allow e-cigarettes to be legally sold in the United States.

Chong, of Ruyan America, said his company was willing to put its product up for safety testing to win U.S. regulatory approval but not immediately, explaining that it is a $20-million, three-year process. He said that seven laboratories the company commissioned to test the product found no dangerous level of chemicals.

Inventor Hon says the idea of the electronic cigarettes came to him in a dream in 2000: Coughing and wheezing, he imagined he was drowning, until suddenly the waters around him lifted into a fog.

He gave one of the first prototypes to his dying father.

"It was too late for my father, but not for me. I switched over myself to electronic cigarettes."

barbara.demick@latimes.com
Nicole Liu of The Times' Beijing Bureau contributed to this report.

[Bill Godshall]

Electronic Cigarette Interview with Dr Joel Nitzkin.

E Cigarette Direct
E Cigarette Interview With Dr Nitzkin

Dr Joel Nitzkin, Chair of the Tobacco Control Task Force for the American Association of Public Health Physicians Current Federal Tobacco Legislation S.625/H.R. 1180 , gives us his expert opinion on the electronic cigarette.

ECD - You have stated that based on available research e-cigarettes are far safer than cigarettes. How much safer are they, and how sure can we be of their relative safety?

Dr Nitzkin - There is no research per se on e cigarettes. The safety information we have is on the delivery of nicotine as a straight product and also on the safest of the tobacco products which basically deliver the same nicotine.

Now the safest of the tobacco products are what they call snus. And the literature on snus, which is evaluated on our website, basically shows that in the best of the epidemiological studies available today snus doesn't increase any cause of death. So that means if there is a health hazard there it is smaller than can be measured with these studies, and with that in mind we would figure that a tobacco product that is delivered with just the nicotine and without any of the other toxic chemicals should be at least as safe.

So if we can figure that the nicotine in the e-cigarettes is basically a generic version of the same nicotine that is in prescription products, we have every reason to believe that the hazard posed by e-cigarettes would be much lower than one percent, probably much lower than one tenth of one percent of the hazard posed by regular cigarettes.

ECD - I spoke to Ash UK and they said there hasn't been enough research on e-cigarettes and that they haven't been chemically tested.

Dr Nitzkin - Well, at least one manufacturer has been chemically tested. There are many different manufacturers of e-cigarettes...

One of the positive things we would hope would come out of FDA legislation would be requirements for quality assurances of manufacturing to make sure that the doses were accurate and to make that there aren't contaminants that would increase the health risk. For example, many of these products have flavourings and I don't know whether or not those flavourings might impose something of a risk. If they do I would think it would be small.

ECD - What research needs to be carried out into the use of the electronic cigarette?

Dr Nitzkin - Well, the first thing which I don't really see as research is quality controlled assessment by an independent lab on an ongoing basis batch by batch to make sure that the chemical content is not contaminated by heavy metals or cancer causing substances. They would also need to make sure that the doses are accurate as stated.

Now there is a big difference of opinion in terms of what other research needs to be done. Those who oppose e cigarettes and the entire family of alternative nicotine delivery devices express the view that to be sure they are safe there have to be tested and controlled clinical trials.

Now the problems with controlled and clinical trials is that it would be a physical impossibility to do that research. Why would it be physically impossible? Because it would involve recruiting a large number, probably several thousand, non smokers, and then getting them to agree to be randomised into one or two or more groups. One of these groups would smoke cigarettes which clearly poses a severe health hazard, and others would test various smokeless products, including e-cigarettes.

Not only that, since these products are not being marketed for short term use of smoking cessation the study would probably have to run a decade or more to show if there are long term effects. Now such a study would cost tens of millions of dollars per product and basically costs aside it would be physically impossible to do. One of the reasons it would be physically impossible to do is that I don't think you could ever recruit non-smokers to expose themselves to that sort of a risk and if you started with smokers you would have a residual risk from the smoking they had already done.

Number two, to be respectable you would probably have to hire an academic center, preferably an American academic center, to do this, and all American academic centers have what they call institutional review bodies that have to approve any research before it is done. And when you have research that has to be done that might pose a health risk to the research subjects but would be of no therapeutic value to the research subjects, their guidelines would prohibit them from approving such a study. That's why I have made the statement, and I have tried to repeat the statement, that the testing guidelines that are built into the current draft of the FDA Tobacco bill would represent a defacto ban on the e-cigarettes.

They'll say well, you can't sell the cigarettes until you can show you have completed these studies to the satisfaction of the food and drug administration and if the studies are impossible to conduct you simply have the products banned. Period.

ECD - That wouldn't just be the e-cigarettes, would it, it would be other alternative products...

Dr Nitzkin - E cigarettes, the sticks, the strips, the orbs, the snus, the camel, the Marlboro products and it would also relate to any other tobacco product that might be marketed as a lower risk or modified risk product.

ECD - Regulation aside, would it be possible to measure the effects of the electronic cigarette on smokers who have already switched to the electronic cigarette?

Dr Nitzkin - That would be very difficult, because the question is compared to what? If most of the people who are smoking electronic cigarettes have been smoking regular cigarettes before, who knows how much of the effects of the regular cigarettes would already be there. Now, our idea, us being the American Association of Public Health Physicians, would be that products such as e-cigarettes and the sticks and the strips and the orbs should be allowed on the marketplace based on the research that has already been done. Once on the market place there would have to be strict quality control of the manufacturing process which would allow the FDA to inspect the plants and require the testing that we talked about done by an outside laboratory.

In addition to that , there would have to be post market research or post market surveillance which I think would have to be done by the federal regulatory agency using the user feeder avenues. This would entail them doing studies, they would enrol regular smokers and e-cigarette smokers and then, over a period of years, while it is on the market and being sold, assess the presence or absence of any kind of adverse effects. You know, I just saw a news reports that crossed my desk today that said the nicorette gum may pose a cancer hazard that previously wasn't suspected. I haven't read the report yet but those are the kind of things that we need to watch out for.

One way or the other I don't think there is any question, there is no possibility that e-cigarettes could be anywhere near as harmful as cigarettes. Cigarettes kill thirty percent of the people who use them. And with e-cigarettes we are talking small fractions of one percent.

ECD - There's a body in the UK, ASH UK, they're not as extreme as some of the American Public Health Associations, but they've said that at least until there has been more research smokers should stick to products such as nicotine patches and gum. How do you rate the effectiveness of these products?

Dr Nitzkin - Well, there are two problems with the nicotine patches and gum.

Problem number one, the way they are formulated means that they don't give the nicotine hit that a smoker desires. It's a long slow release packaging of the nicotine so it doesn't offer the same satisfaction. Problem number two is that these products have only been licenced for use for short periods of time, basically up to twelve weeks as smoking cessation products. Now if somebody is going to suggest that a smoker is going to use one of these products for longer than twelve weeks, then that is what is called an off-label or illegal use of the drug, because it has not been approved for use for longer than twelve weeks.

ECD - Although that would still be better than smoking.

Dr Nitzkin - Oh, it would definitely be better than smoking.

ECD - They're basically running into the same problems as electronic cigarettes, then.

Dr Nitzkin - Yes, the research has never been done in terms of long term effects..

ECD - Now another concern, especially of non-smokers who have been raising this in comments on blogs and articles, is that the electronic cigarette still contains nicotine. Whereas my understanding is that nicotine is not that bad when compared to the use of tobacco. What is your opinion on this?

Dr Nitzkin - Well, nicotine is not innocuous and nicotine is very strongly addictive. Compared to foods and food additives that are acceptable on the market place nicotine would be considered a risky substance because people with underlying heart disease could suffer damage from the nicotine but compared to ciagrettes ... let me try to put this in a kind of simplified perspective this is something that again - I don't know if you have downloaded our harm reduction resolution white paper, but basically at the end of the white paper it talks in terms of order of magnitude differences between tobacco and other products. Tobacco is more than 100,000 times riskier in terms of risk of death from routine use of the product than is normally considered acceptable from a consumer point of view. So if you have a product which is three orders of magnitude less risky than a cigarette, that is less than one tenth of one percent the hazard of a cigarette, that's still 100 more times more hazardous than is generally accepted for consumer products. So, you know, you have these vast differences.

So the question is compared to what? We don't want to encourage non-smokers to take up e-ciagrettes or these alternate devices but we do want to encourage smokers to switch.

ECD - Yes, I spoke to David Sweanor and he said much the same thing.

There is one criticism I have seen which is that we don't know the effect of heating up and inhaling nicotine and that this could potentially cause harm.

Dr Nitzkin - That's true, we don't know the effects of that and we can only guess at what the impact can be. My guess is that it would probably make it somewhat more toxic to people with heart disease, that's research that ought to be done. The other factor that I don't know with e-cigarettes is how much of the nicotine actually gets down to the lung. Is it absorbed from feural mucosal like cigars are, or is it absorbed from the lung by patterns of inhalation like smokers use. It's probably in the lung like smokers do because people I think because people tend to use them in the same way. But that is research that needs to be done, there is an open question there, but compared to what we already know the likely risk would appear to be much smaller than cigarettes...

ECD But it would be difficult to carry out the research?

Dr Nitzkin - That research would not be terribly difficult to carry out. That research would require one of the companies to hire a skilled researcher to probably get somewhere between 40 and a hundred non-smokers or actually maybe even smokers could do this. Have them randomized, have half of them using e-cigarettes with no nicotine, the others using e-cigarettes with nicotine, and then you could measure cardiac status, and you could measure other blood tests to see what is going on. That would not be a difficult study to do.

Let me clarify, let me add one thing to that statement. That would be an easy subject to do it you are looking at acute short term health effects. That would not give you any ideas as to whether or not there is a long term effect like an increased risk of cancer. The increased risk of cancer study would require decades to complete. And probably it couldn't be done.

ECD - Health groups such as Cancer America are concerned that the existence of an alternative to smoking will prevent smokers from quitting, and may encourage young people to take up smoking. Is this a concern you share?

Dr Nitzkin - Yeah, this is a major concern. And this is a concern - and keep in mind with the FDA tobacco bill, it was negotiated between Campaign for Tobacco Free Kids and the Phillip Morris company.

The Campaign for Tobacco Free Kids has as their only concern keeping children and teenagers from initiating tobacco use. In their minds all tobacco and tobacco related products are evil and any time you add any new product to the marketplace you increase the risk of teens initiating tobacco use. So they are therefore unalterably opposed to the addition of any new tobacco or tobacco related products to the market place because in their minds until proven otherwise the impact of that product will be to dramatically increase teen use of nicotine. I know of no research that has been done - every one of the e-cigarette companies I have talked to have claimed that they do not market their product to teenagers but neither are our cigarettes ostensibly marketed to teenagers, so there would have to be some other studies done to determine the extent to which teenagers use e-cigarettes or any of these other products

ECD - I'm just thinking that when I was a kid there was a certain kind of child who would take up smoking. And part of the attraction was that it was bad for you and it was forbidden. I'm just wondering if the sort of child who is going to do that is going to take up smoking whether it is cigarettes or e-cigarettes...

Dr Nitzkin - Well, my guess is that if somebody like that is going to take up a product they're going to take up the real thing not fake cigarettes. And what they use and whether or not they use it will be largely dependent on what their peers use, their friends and what they see their parents using in the home.

ECD - So there is a danger of that...

Dr Nitzkin - There is a danger. We don't know how much of a danger there is. Now let me put it yet another way. Cigarettes currently cause 400,000 deaths a year in the United States. If we get all those smokers to switch from regular cigarettes to e cigarettes or one of the other alternate nicotine delivery products we would reduce that death toll from 400,000 a year to less than 4000 a year, maybe as low as 400 a year. Now, if we addicted every man, woman and child in the United States to e-cigarettes - we currently have 20% of the American population using tobacco products - and we'd multiply that by 5, so even at our worst estimates of 4000 deaths a year you'd have 20,000 deaths a year that's still a huge reduction from 400,000 a year.

ECD - And if you then if you take that world wide...

Dr Nitzkin - Yeah... so there are unanswered questions, and a lot would have to do with how the products are marketed, how they are regulated and so on but every time you introduce a new product to the marketplace you do add a risk that there will be some teenagers that will be attracted to that product that otherwise would not be attracted to cigarettes or any of the others.

Let me point out one factor in particular. Women tend to be very concerned about their weight. People smoke or take up smoking and one of the major reasons for women to smoke is that it resets their body weight limit and generally they can expect to lose anywhere from 5 to 7 or 8 pounds and maintain that weight loss. That for many women is a lot of weight and the reason they keep smoking. If women think that there is a product out there that doesn't carry the risks of smoking or the yellow stained fingers of smoking, that will enable them to lose their weight, such a product could be very attractive to a large number of young women.

ECD - One question I didn't send you before our interview but is something that worries me is that if the electronic cigarette is as safe as experts like you think isn't it ethically wrong to remove the choice from people of having a safer smoking alternative? I mean the information is out there, the debate is out there, the product assessment is out there - shouldn't smokers be allowed to make their own choice?

Dr Nitzkin - Well, we think so but that is not the prevailing opinion here in the United States. The problem is, dating back to the 1960's and the original surgeon general's reports on tobacco and tobacco related illness they did not differentiate between deaths due to cigarettes and deaths due to other tobacco products. And they set as the national goal a tobacco free society. Once you subscribe to the concept of a tobacco free society you then consider all tobacco and tobacco related products as equally harmful no matter what the science says. I mean you feel that it would be in the best interest of American society to stop any new tobacco products from entering the marketplace. The goal quite frankly is prohibition.

ECD - So similar to the prohibition on alcohol...

Dr Nitzkin - yes.

ECD - And do you think it would be as unsuccessful?

Dr Nitzkin - Well, I think if they moved in that direction what you would see is a lot of illegal sales and a lot of smuggling. But not only that, even with that smuggling you would not get anywhere near the health benefits that you could if the products were legal and their was honest communication about the relative health risk.

ECD - The Tobacco bill has raised a lot off opposition from those involved in Tobacco Harm Reduction. Could you explain the concerns over the tobacco bill?

Dr Nitzkin - There was a document we posted on our website just a couple of days ago. That listed our proposed amendments to the tobacco bill and the amendments to deal with the issues we think should be changed, number one is a friendly and positive attitude towards harm reduction, to invite the products into the market place but then through manufacturing and quality control and post market sureveillance assure the safety and do the research needed to adjust our estimates.

Number two remove other limitations from the regulatory agency having to do largely with marketing concerns and issues.

The third one, I am speaking off the top of my head without looking at the document, has to do with the cigarette warnings as a specific issue because the warnings for any smokeless product says: "Warning - this product is not a safe alternative to cigarettes". And that wording has convinced 87% of american smokers that all tobacco products are equally hazardous.

Then the fourth change is we question the choice of the food and drug administration as the regulatory agency because by doing it it creates a situation whereby the food and drug administration is certifying the safety of current cigarettes as they are currently formulated.

Finally we feel that the bill has to give the federal agency independent authorisation to do health education post market surveillance and research not by the individual tobacco companies but by the federal agency that paid for through the tobacco company user fees. But you know another way of looking at our concern is the fact that this piece of legislation has been sold to health organisations to endorse and to congressmen here in the United States to sponsor using a summary in the description of the bill which is extremely inaccurate and which does not reflect the actual impact the bill will have if passed.

ECD - Given the concerns raised by doctors and tobacco harm reduction activists like yourself, what, in your opinion, is the main motivation for pushing the bill through?

Dr Nitzkin - I think ever since the early 1990's when Richard Kessler who was then the secretary of the food and drug administration agency tried to regulate cigarettes and the supreme court said he couldn't do so without congressional authorisation, key legislators in both houses of congress have been trying to develop and pass a bill that would give the federal government authority to regulate tobacco products. And I think that what has happened at this point is that they have been working on it for so long they don't care what the bill says they just want to pass a bill to get their foot in the door. And they are track sore and they have this one which you know is a severely flawed bill but it has got the votes to pass so they want to pass it. So now they claim that now there is regulation even it is totally dysfunctional and totally inadequate. and so this is the current junction, this is one of the reasons why they are trying to push as it is, with no amendments. They succeeded in doing that in the house of representatives and it looks like they are going to try and do the same thing in the senate.

Many thanks to Dr Nitzkin for making the time available for this interview.

[Smokin'Sandy]

Newbie here...

I received my ecig last Saturday and once I figure out how to make it give me a full feeling on inhalation as a tobacco cigarette, I will switch.

I just wanted everyone here to know that I contacted my Senators regarding the Waxman bill. Here is what I sent to them:

Senator XXXX,

I am writing today in regards to the Waxman bill that will soon be put in front of you for your vote. I feel this bill would be damaging to those of us that do smoke and want to find a safer way to acquire nicotine. I just recently acquired an electronic cigarette that I feel will allow me to continue with my nicotine habit without the extremely harmful effects of smoking tobacco. Please consider the amendments to this that is put forth by Joel L. Nitzkin, MD, MPH; Chair AAPHP Tobacco Control Task Force.

I fear that the passage of this bill in its current form will cause many, if not all, of smokers to once again continue, or resume, this dangerous habit.

The amendments proposed can be found here: ( I can't post the URL yet)

For convience, I have posted the number one amendment below:

1. Need to ease introduction into the marketplace for Modified Risk Tobacco Products and alternative nicotine delivery products and inform current smokers of the value of, while restraining their use by teens. This will require amending the requirements for research by manufacturers and modification of the warning labels. Easy access to these products will make it possible to save the lives of 4 million of the 8 million current adult smokers who will otherwise die of a tobacco-related illness over the next 20 years. This is because even the best of our smoking cessation protocols, with pharmaceutical products, fail in 95% of the smokers willing to use them, per results measured 12 months post-intervention.

I have tried many ways to quit smoking, but have failed. I have smoked for 32 years and find it hard to quit because I enjoy the effects of nicotine. If I can have my nicotine delivered in a safe manner, then I see no reason why I need to stop.

Please consider this when you cast your vote.

Sincerely,
Sandy XXXX

I hope all of us will contact our senators and maybe, just maybe we can continue to "vape" legally.

[arifg]

I think it makes sence to cooperate with Reason magazine on our e-cig issue. That exactly their case. Their sites: reason.com and reason.tv

[OutWest]

Thank , Bill, for posting that interview with Dr. Nitzkin.

[hason74]

i contacted my senatror, here is his reply.

Dear Jason:

Thank you for contacting me in regards to electronic cigarettes. It was good to hear from you. ^^^(this part wouldn't copy and paste, so i typed it)^^^

Jason, you mentioned your concerns regarding the

u.s. Food and Drug Administration (FDA)
regulation of electronic cigarettes. As you may know, the FDA has reviewed several electronic
cigarettes, cigars, and pipes, and refused these products at the United States border. According
to the FDA, it has acted because these products offered for import have not been reviewed by the
agency.
In general, the FDA has the authority and responsibility to ensure that drugs and medical devices
are safe and effective before these products can be marketed to the public in this country. Under
the law, it is the responsibility of the manufacturer to demonstrate that the product is safe; the
FDA does not have to prove that a product is unsafe. I understand your view that these products
provide health benefits by helping consumers break their addiction to tobacco products. You
may wish to contact the FDA at 1-888-INFO-FDA to express your views on this issue.
Sincerely,

_

I ~_ I~(

KENT CONRAD

United States Senate

So, he gave me a phone number, don't know if i will call it, maybe, but thought it was nice that he sent me a letter, i sent to the house also, haven't heard back from him yet. ND won't get anything done in regards to ecig's but every little bit helps.

[OutWest]

In general, the FDA has the authority and responsibility to ensure that drugs and medical devices

are safe and effective before these products can be marketed to the public in this country

.

And that's the rub. They insist on seeing these as drugs and medical devices. Which, if it's being marketed as a cure your nicotine addiction device, then yeah, it is. But if it's a smoking alternative, then it shouldnt be considered a medical device. After all, a smoking alternative is simply another way to feed one's nicotine addiction.

One of the problems is that legislators and the FDA cant seem to seperate "stop smoking" from "stop nicotine addiction". In many ways the ecig is no different than if a person chooses to use Skoal or chewing tobacco over smoking, theyre all different ways to get nicotine fix.

[Bill Godshall]

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
Harm Reduction Journal | Full text | Tobacco harm reduction: an alternative cessation strategy for inveterate smokers

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/kee...cigarettes-ava
ilable 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/RuyanCartr...t30-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