Reply From The FDA

[fumarole]

And the plans for the e-cig industry to deal with what you say is the situation are...?

The industry as a whole has no plans because it is uncoordinated. Lobbying and PR would help, but is expensive. Clinical trials will not deliver full value for money because evidence of safety and efficacy is by and large irrelevant - all those in a position to take such evidence on board are working for the opposition.

In general, the preferred option is to wait and see what the competition comes up with next, and counter it when it arrives. Basic law says that e-cigarettes can't be killed off directly, but there are enough wrinkles that it might be possible to do it the slow way.

Before we start worrying about clinical evidence or anything of that type, we need to appreciate what the problem is: it's nothing to do with whether e-cigs work, or how well they work, or how safe they are. It's entirely about the money and absolutely nothing else has the slightest relevance.

These are the relevant issues:

• NRTs and associated quit-smoking drugs are a billion dollar a year global market.
• Drugs and therapies such as chemotherapy drugs for the treatment of sick and dying smokers are an even bigger money-earner - ten billion a year, fifty billion a year - who knows?
• This income is under direct threat from e-cigarettes. Every smoker who switches to an e-cigarette takes several thousand dollars out of pharma's pocket. Multiply that by a few million and you see the scale of the problem.
• The same goes for Snus of course - but in the US, the tobacco giants punch the same weight as the pharma giants, and no one in their right mind starts a fight they can't win. In any case, some of the tobacco and pharma firms are co-owned: the perfect solution.
• Some States are nearly bankrupt due to inept financial management, and now depend for their solvency on tobacco tax revenue. E-cigarettes are a direct threat to this, and therefore to the power base of the people in charge.
• The tobacco control industry is funded by pharma. In addition to the financial pressure on them to oppose e-cigs, the practical result of a Sweden scenario would mean many losing their jobs; two very good reasons to oppose harm reduction. So the TC crowd make all the noise, and get the legislation needed by pharma.

In Sweden, the number of smokers was reduced by about 40%, due to the widespread uptake of Snus. Now, 20% of the population are Snusers, and about 12% are smokers. This resulted in the smoking deathrate falling through the floor - a reduction of about 40%. Sweden has the lowest smoking-related deathrate in the developed world.

This was a disaster for pharma in Sweden, since all their smoking-related income collapsed. They are desperate to ensure this does not happen elsewhere - and especially in the USA, their biggest market. They have allocated as much money as it takes to fix the problem, and they do have enough: pharma's declared lobbying spend in 2010 was $267m, and they had more lobbyists in Washington than Congressmen.

The FDA works to pharma's agenda since they pay the bills. In addition, there is a revolving-door staff policy between the two, so that the same people work for both. Enough people in the know have stated that the idea that the FDA is an independent body working for public health is simply laughable - even the scientists who work for it will tell you that.

There are only three things that fix a problem like this:

• The application of funds in the right places
• A sudden, strange desire by the party in power to do the right thing, for unexplained reasons
• The crushing weight of overwhelming public & media opinion, and it becomes a voting issue

It is a waste of time even considering the science or evidence in this situation - utterly and completely pointless. First you have to fix the corruption, or out-manouver the suborned. Any other approach is worthless.

The system is completely corrupt and any discussion of normality - evidence-based decisions and the like - is about as relevant as discussing farming on the planet Jupiter. And about as sane. We can continue to accumulate evidence, as available, but ultimately it is not going to fix the crux of the matter: the people with the power are being paid by the opposition.

It needs to be recognized that hundreds of thousands of lives don't count for a nickel here. Well, strictly speaking, that is wrong - they count for millions taken out of pharma's pocket.

 

[Cool_Breeze]

... In general, the preferred option is to wait and see what the competition comes up with next, and counter it when it arrives.

A point I've made in various ways in the forum is that our industry is 'reactive' rather than 'pro-active.' The statement above supports that notion.

I believe a pro-active stance is much stronger than the lay back and wait mode. Lay back and wait is playing on their turf with 'the opposition' defining the terms. Point-Counterpoint is 'the system,' perhaps the real time waster, and from what is being said in this thread, not much is happening.

The industry needs to redefine the matter on its own terms. Again, I have offered thought on how funds can be raised.

Time to think outside of the box...

 

[Ande]

True enough, though it's often enough difficult to determine what we need to "pro-act."

Honestly, we need to be both- proactive and reactive.

Reactive, in doing all we can to raise prevent regulations that are arriving, worldwide, every day.

My version of proactive: Spend a little time every day, and a lot of time some days, making sure that people around you know about tobacco harm reduction. Tell people online, at home, at work, at your pub. Inform yourself, argue your case well.

The FDA will never back down simply because we are right and they are wrong. Right and wrong mean nothing to organisations that big. THey will back down because/if we convince enough people to support us that THEY HAVE NO CHOICE. Only then.

We need to counter the FDA's misinformation and smear campaigns. We need to get trustworthy studies done to help us convince others.

But we need to be honest- we aren't gonna convince the FDA with information. Just with strength of numbers.


Best,
Ande

 

[Our House]

True enough, though it's often enough difficult to determine what we need to "pro-act."

Honestly, we need to be both- proactive and reactive.

I'd also like to point out that it's difficult (impossible really) to be proactive against an evil, greedy, power-hungry organization that has already made up its mind on the subject. The potential to lose money is so threatening to Big Pharma (who is really holding the strings that control the FDA) that it has forced the agency to show its hand this early on in the game. If you look at how the FDA is going after ecigs: the methods it is using, the actions it is taking, the press releases given by spokespeople...there is no other conclusion than it being about the power & money. Public health comes 2nd, and that is the hand the FDA has been forced to show on numerous occasions. Considering this is the nation's largest health organization, the one with the most power and control over what we get to put into our bodies, we should all take a brief moment to simultaneously puke in disgust.

So again, how is anyone to be proactive against an agency that is using ex post facto reasoning; assuming a conclusion (ecigs are bad and must be taken away), and then finding evidence to support that conclusion...overstepping bounds and resorting to outright lies whenever necessary? The FDA has asked for evidence (scientific, anecdotal, whatever) about ecig safety on numerous occasions, and then gone on to ignore any evidence that contradicts its conclusion (which is pretty much all of it). The FDA has required vendors to apply for a new drug application (NDA) and then tossed aside any applications received; announcing 7-8 months later that nobody has applied. The FDA has opened a channel for public comments from ecig users and then discarded any positive ones, stating retroactively that it was only interested in gathering negative data about side effects. The FDA has made grandiose claims in court about the alleged harm of ecigs and their alleged appeal to youths, and then folded once pressed for evidence of those claims by the district and appeals court judges; only to continue making those same unsubstantiated claims to the general public (in the form of scary sounding junk pieces, such as this email, with the sole agenda of driving smokers away from ecigs / harm reduction) months after our legal system has debunked them. This is anti-science at its finest. Again, coming from an agency that is hypocritically demanding stringent evidence from us -- evidence that the FDA has given us every indication it will not accept under any circumstances (can't be from other countries, can't be paid for by ecig manufacturers, can't be anecdotal*, etc).

I don't want to sound like I'm wearing my tin foil hat, but both state and federal governments require people to smoke...then quit...then relapse into smoking again. This is the current system, and ecigs are messing with the program. And, as you can plainly see, people are reacting very emotionally. In fact, so emotionally that they have taken a vested "interest" in our health. These officials are all supposed to keep that agenda hidden, while parading around as if they want smokers to quit. In situations like that, there are always instances where the science and/or public awareness is so strong that the hidden agenda is forcibly revealed when they're not willing to concede. Electronic cigarette (and all smoking harm reduction) politics are such an instance. Our job is to keep it that way -- by raising public awareness or by contributing to the scientific data.

*This is one of my favorites. I can see why anecdotal evidence should be ignored, but not as a blanket rule. One person's anecdote is largely unscientific. But what about millions of anecdotes over a long period of time? Shouldn't that count for something?

 

[Nicko]

Some members are expressing fear and hopelessness about this issue, which I agree is serious. But there is something you can do. You can join the revolution that is Ron Paul.

Here is a link to his health care policy on his official website. It's completely unlike anything that any other candidate is suggesting.

Health Care | Ron Paul 2012 Presidential Campaign Committee

I honestly believe that if Americans vote in Ron Paul, the FDA will be crushed.

 

[cigarbabe]

Some members are expressing fear and hopelessness about this issue, which I agree is serious. But there is something you can do. You can join the revolution that is Ron Paul.

Here is a link to his health care policy on his official website. It's completely unlike anything that any other candidate is suggesting.
Health Care | Ron Paul 2012 Presidential Campaign Committee

I honestly believe that if Americans vote in Ron Paul, the FDA will be crushed.

I don't care what Ron Paul or any other politician says they're going to do because I have yet to see a single one of them follow up on those campaign promises they make that get them voted into office.
We vote for the person whom we feel is going to do the best for whatever class/affiliation/agenda we belong to and follow them, only to get ...... off when they let us down time and time again. Many of us thought Obama was going to "do the right thing" for people. I certainly believed he would and that goes for Clinton, Bush 1 & 2, Carter and all the rest too....
Back to Obama.... so did he do what was promised and I'll leave you to pick out a promise that was truly fulfilled?
Did he?
Not by my accounting! I was shocked to find out a man who quit smoking with the help of a product that I actually use and love would not be sympathetic to the cause of making pv's and other alternatives available to all who'd want them.
I never thought he would try and regulate pv's and other reduced harm alternatives out of existence! What the hell could he be thinking?
I truly expected better from him I really did.
He is just as bad as all the rest of the "career politicians", he's no different. Which is why I'm asking "Why would Paul be any different"?
He is a lifelong politician doing what they all do to get into office.
Lie to the American people......
Other countries wonder why we are so apathetic when it comes to voting.
C.B.

 

[Vocalek]

A point I've made in various ways in the forum is that our industry is 'reactive' rather than 'pro-active.' The statement above supports that notion.

I believe a pro-active stance is much stronger than the lay back and wait mode. Lay back and wait is playing on their turf with 'the opposition' defining the terms. Point-Counterpoint is 'the system,' perhaps the real time waster, and from what is being said in this thread, not much is happening.

The industry needs to redefine the matter on its own terms. Again, I have offered thought on how funds can be raised.

Time to think outside of the box...

We must think outside the box. "The industry needs to redefine the matter on its own terms," is logical and sensible.

However the industry is fragmented. There are about 100 companies in China that manufacture most of the hardware and liquid. In the US, there are probably thousands of mom-and-pop businesses selling e-cigarettes in (very) small stores and via the Internet. There are several US companies that are selling their products via retail outlets. I know that the FDA has invited the heads of a couple of e-cigarette companies in to talk privately, and my guess would be that they fall among the last group I just mentioned. These would be the companies that make the bulk of their money from selling pre-filled cartridges or disposable units. These companies would have no problem agreeing to eliminating all flavors except tobacco, selling only sealed, non-refillable cartridges, and putting strict upper limits on nicotine content.

Unfortunately, I believe that these actions would greatly reduce the effectiveness of e-cigarettes as an acceptable substitute for smoking. As evidence I give you one clinical trial and four surveys.

Survey 1, (sample size 303) conducted by the folks at Tobacco Harm Reduction [dot] Org, found that 79% of e-cigarette users were no longer smoking. The audience for this survey was drawn mainly from this forum and a few others. http://tobaccoharmreduction.org/wpapers/011v1.pdf

Survey 2, (sample size 2,217) conducted by CASAA, found that 80.4% no longer smoke cigarettes. Those using a nicotine strength of 2.4% or higher comprised 34.2%. The survey also found that 70.1% used non-tobacco flavors (e.g., fruit, candy, beverage) at least occasionally, with 51.9% using these flavors "often" or "always." Participants were drawn mainly from this forum, plus a few others. https://www.surveymonkey.com/sr.aspx?sm=HrpzL8PN5cP366RWhWvCTjggiZM_2b8yQJHfwE9UXRNhE_3d

Survey 3, (sample size 3,587) conducted by Prof. Bullen, University of Aukland (NZ), and JF Etter of Geneva Switzerland) found that 77% of daily users of e-cigarettes no longer smoke.

The main finding of this survey, which enrolled predominantly self-selected visitors of websites dedicated to e-cigarettes, is that e-cigarettes were used largely by former smokers as an aid to quit smoking, to avoid relapse and to deal with withdrawal symptoms, much as people use nicotine replacement therapy (NRT).

Electronic cigarette: users profile, utilization, satisfaction and perceived efficacy - Etter - 2011 - Addiction - Wiley Online Library

Survey 4, (sample size 222) conducted by Dr. Michael Siegel et al. of Boston University's School of Public Health surveyed first time buyers of e-cigarettes during a two-week period. Six month point prevalence smoking abstinence among e-cigarette users was 31%. http://www.stop-tabac.ch/fra/images...op_tabac/seigel e cigs am j prev med 2011.pdf

Clinical Trial - Dr. Riccardo Palosa of Italy recruited 40 regular smokers unwilling to quit, providing them with an e-cigarette to study the effect on the number of cigarettes smoked. Cartridges used in this study contains nicotine (7.25 mg/cartridge) dissolved in propylene glycol (233.7 mg/cartridge) and vegetable glycerin (64.0 mg/cartridge). Given the small cartridge size, this works out to ~ 2.3% nicotine.

Sustained 50% reduction in the number of cig/day at week-24 was shown in 13/40(32.5%) participants; their median of 25 cigs/day decreasing to 6 cigs/day (p < 0.001). Sustained 80% reduction was shown in 5/40(12.5%) participants; their median of 30 cigs/day decreasing to 3 cigs/day (p = 0.043). Sustained smoking abstinence at week-24 was observed in 9/40(22.5%) participants, with 6/9 still using the e-Cigarette by the end of the study.

BMC Public Health | Full text | Effect of an Electronic Nicotine Delivery Device (e-Cigarette) on Smoking Reduction and Cessation: A Prospective 6-Month Pilot Study

The latter two studies involved a single brand of e-cigarette with pre-filled cartridges. It appears to me that when e-cigarette users have control over the equipment, nicotine strength, and flavors, the success rates for smoking abstinence can be more than double. Yes, I concede that the sample sizes are very small, but the question begs for a closer look to determine the factors that work toward smoking cessation success.

The consumer groups have tried to get the US vendors to organize, to no avail. Meeting dissolve in a flurry of disagreements.

So now, let's get back to thinking outside the box. What ideas do we have for consumers (since we seem to be the only ones who care enough to take action) to be proactive rather than reactive? Petitions seem to be pretty ineffective. I'm thinking that an ad campaign might be ideal, but those cost buckets and buckets of money.

Cool_Breeze, could you review for us what your money-raising ideas were?

 

[fumarole]

In order to avoid future restrictive legislation on e-cigarettes, you have to outmanouver the FDA. This is probably the most corrupt large government agency in the world, as they completely disregard human life and work as the legislative arm of the pharmaceutical industry in order to protect the industry's income at all costs.

Since they have all the power, that is a tough challenge. An FBI investigation of corruption at the FDA might be a good starting point, with a detailed examination of the private and offshore bank accounts of the directors, plus those of their immediate family members. Or, sacking everyone at the top and replacing them with people who don't take pharma's bribes. Or just examining the way their decisions have killed and will kill thousands of people, and then locking up the decision makers at the FDA and throwing away the key.

As none of these are likely to happen, because this is a giant money machine that nobody can halt, we'll have to come up with some other way to get around them. Millions of dollars of pharma money goes into ensuring that no one rocks the boat. The only achievable goal is a huge amount of publicity that exposes how corrupt the FDA decision-makers are, and how their decisions are made purely for the purpose of protecting the pharmaceutical industry, with total disregard for the resulting loss of life.

What other option is there?

 

[John Phoenix]

I don't care what Ron Paul or any other politician says they're going to do because I have yet to see a single one of them follow up on those campaign promises they make that get them voted into office.
We vote for the person whom we feel is going to do the best for whatever class/affiliation/agenda we belong to and follow them, only to get ...... off when they let us down time and time again. Many of us thought Obama was going to "do the right thing" for people. I certainly believed he would and that goes for Clinton, Bush 1 & 2, Carter and all the rest too....
Back to Obama.... so did he do what was promised and I'll leave you to pick out a promise that was truly fulfilled?
Did he?
Not by my accounting! I was shocked to find out a man who quit smoking with the help of a product that I actually use and love would not be sympathetic to the cause of making pv's and other alternatives available to all who'd want them.
I never thought he would try and regulate pv's and other reduced harm alternatives out of existence! What the hell could he be thinking?
I truly expected better from him I really did.
He is just as bad as all the rest of the "career politicians", he's no different. Which is why I'm asking "Why would Paul be any different"?
He is a lifelong politician doing what they all do to get into office.
Lie to the American people......
Other countries wonder why we are so apathetic when it comes to voting.
C.B.

I agree - BUT

If you study Ron Paul's voting record and what he has always said he believes the man is the Only politician that has Never wavered on his record. You can go way back over 30 years and this man has never changed his mind on a policy. that's quite impressive. Ron Paul has never been swayed bu money and corruption in politics. I believe what happens is some politicians do have good intentions but when they get in office they find it's impossible to fight the big money and big power systems that are against them. They believed a LIE, that you can change the system from within. The system is supposed to be designed with oversight, checks and balances and it once operated that way but cannot anymore due to too much corruption. This country is on a down hill spiral spinning out of control fast and if Ron Paul cannot get in and help get a handle on it, we are doomed to failure as a country. Ron Paul is the only one fighting to restore this country to the place in power " for the people" that it once was. I say he deserves a chance, he cannot do any more harm than all the others who are just going to follow the status quo.

 

[John Phoenix]

So now, let's get back to thinking outside the box. What ideas do we have for consumers (since we seem to be the only ones who care enough to take action) to be proactive rather than reactive? Petitions seem to be pretty ineffective. I'm thinking that an ad campaign might be ideal, but those cost buckets and buckets of money.

Everyone laughed at me a while back when I posted that I would like to see big roadside billboards advertising e-cigs saying all the things we can "get away " with saying about them, that we can prove. You know.. the things vendors are not allowed to say.

What about organizing something that has known to work in the past like cells that grow. Churches do it, businesses like Multi Level Marketing companies (Tupperware, Avon, Amway, Herbalife etc) does it

These can be done cheaply, starting small and they can grow like a virus. Could be something like house parties for e-cigs. CASAA could help and be involved. Thing is we would need a written structure and origination that is planned out and proven. It could be done in such a way as to not advertise certain brands but the e-cig concept itself. The idea is getting people exposed to e-cigs and letting them in turn run with it and so on.

Even though these would have a written organized structure, it would not have one parent organization at the top controlling things. That would turn people off and create power struggle problems we don't need. This could have a website with guidelines and information and all the members could help contribute to this agreed on structure. All the members themselves would share in the project equally thus eliminating the need for a controlling entity.

The purpose of the "cell" meetings would be to introduce smokers to e-cigs and information about e-cigs as well as have them try some e-cigs and flavorings. This could be helped by putting together a cheap package of small e-cigs to pass around with disposable tips - not for sale, just to try. This would not have to be for profit. The hosts can simply reclaim their tester e-cigs at the end and suggest places to purchase e-cigs if anyone is interested in a purchase. We would not want sales for ourselves.. we would want peoples lives to be changed by a safer alternative that may work for them where other things failed. We would be messengers.

( Of course if a host accepted a companies offer for discounts on products sold during the meetings or discounted "tester packages" for the host to use that would help keep cost down for the host and make money for vendors at the same time - without the host actually being a retailer or vendor. These could be "sponsors" and each host could use as many sponsors as they wished as long as they do not unfairly promote a certain product - This is an incentive to get vendors working together with users to further the cause as a whole. Hint Hint)

Evey host of course would have a computer with internet. This could be used to network with other cells and learn the meeting structure off the website - as well as show people how to order e-cig products online as some people are still uncomfortable with that.

You asked for out the box ideas for advertising e-cigs for the purpose of helping the public become more aware of them, and that's the best I can offer. If something like this could work and people can learn to cooperate together then perhaps a trade association will grow out of it.

The thing is, you forget about fighting the Government. You get this e-cig thing so large and everywhere and accepted that the government will cave to the masses. It has happened in the past with other products.

Just an idea. I think I'm done now.. sorry for the book.

 

[Vocalek]

I think that's a very good idea. Bystander1 is already doing something similar to this in West Virginia.

I have posted a new thread called "Outside the Box - E-cig House Parties" in CASAA Forum
in CASAA Public Events and Campaigns. Looking for volunteers to work to fill out this idea.

Here is a link to the CPE&C forum within CASAAforum.org

http://casaaforum.freeforums.org/casaa-public-events-and-campaigns-f15.html

 

[Poeia]

We must think outside the box. "The industry needs to redefine the matter on its own terms," is logical and sensible.

However the industry is fragmented. There are about 100 companies in China that manufacture most of the hardware and liquid. In the US, there are probably thousands of mom-and-pop businesses selling e-cigarettes in (very) small stores and via the Internet. There are several US companies that are selling their products via retail outlets. I know that the FDA has invited the heads of a couple of e-cigarette companies in to talk privately, and my guess would be that they fall among the last group I just mentioned. These would be the companies that make the bulk of their money from selling pre-filled cartridges or disposable units. These companies would have no problem agreeing to eliminating all flavors except tobacco, selling only sealed, non-refillable cartridges, and putting strict upper limits on nicotine content.

Unfortunately, I believe that these actions would greatly reduce the effectiveness of e-cigarettes as an acceptable substitute for smoking. As evidence I give you one clinical trial and four surveys.

Survey 1, (sample size 303) conducted by the folks at Tobacco Harm Reduction [dot] Org, found that 79% of e-cigarette users were no longer smoking. The audience for this survey was drawn mainly from this forum and a few others. http://tobaccoharmreduction.org/wpapers/011v1.pdf

Survey 2, (sample size 2,217) conducted by CASAA, found that 80.4% no longer smoke cigarettes. Those using a nicotine strength of 2.4% or higher comprised 34.2%. The survey also found that 70.1% used non-tobacco flavors (e.g., fruit, candy, beverage) at least occasionally, with 51.9% using these flavors "often" or "always." Participants were drawn mainly from this forum, plus a few others. https://www.surveymonkey.com/sr.aspx?sm=HrpzL8PN5cP366RWhWvCTjggiZM_2b8yQJHfwE9UXRNhE_3d

Survey 3, (sample size 3,587) conducted by Prof. Bullen, University of Aukland (NZ), and JF Etter of Geneva Switzerland) found that 77% of daily users of e-cigarettes no longer smoke.


Electronic cigarette: users profile, utilization, satisfaction and perceived efficacy - Etter - 2011 - Addiction - Wiley Online Library

Survey 4, (sample size 222) conducted by Dr. Michael Siegel et al. of Boston University's School of Public Health surveyed first time buyers of e-cigarettes during a two-week period. Six month point prevalence smoking abstinence among e-cigarette users was 31%. http://www.stop-tabac.ch/fra/images...op_tabac/seigel e cigs am j prev med 2011.pdf

Clinical Trial - Dr. Riccardo Palosa of Italy recruited 40 regular smokers unwilling to quit, providing them with an e-cigarette to study the effect on the number of cigarettes smoked. Cartridges used in this study contains nicotine (7.25 mg/cartridge) dissolved in propylene glycol (233.7 mg/cartridge) and vegetable glycerin (64.0 mg/cartridge). Given the small cartridge size, this works out to ~ 2.3% nicotine.

BMC Public Health | Full text | Effect of an Electronic Nicotine Delivery Device (e-Cigarette) on Smoking Reduction and Cessation: A Prospective 6-Month Pilot Study

The latter two studies involved a single brand of e-cigarette with pre-filled cartridges. It appears to me that when e-cigarette users have control over the equipment, nicotine strength, and flavors, the success rates for smoking abstinence can be more than double. Yes, I concede that the sample sizes are very small, but the question begs for a closer look to determine the factors that work toward smoking cessation success.

The consumer groups have tried to get the US vendors to organize, to no avail. Meeting dissolve in a flurry of disagreements.

So now, let's get back to thinking outside the box. What ideas do we have for consumers (since we seem to be the only ones who care enough to take action) to be proactive rather than reactive? Petitions seem to be pretty ineffective. I'm thinking that an ad campaign might be ideal, but those cost buckets and buckets of money.

Cool_Breeze, could you review for us what your money-raising ideas were?

Surveys are my area of expertise so I tend to be very good at identifying the holes that people will be able to use to discredit the findings. While reading your synopses of the first three I was thinking that the obvious flaw was that the sample groups were skewed -- everyone who agreed to take the surveys were active members of a forum devoted to e-cigarettes. People who had tried it and quit would not be going to the websites where recruiting was taking place.

Then I got to Survey 4 and the Clinical Trial. By starting with non-vapers, they were both able to address the question of the drop-out rate. That is going to be essential information going forward (e.g. recidivism rates for people using e-cigarettes to replace cigarettes vs those of people trying to quit via other methods such as the patch, gum, pills…)

Medical research is not my field but I know that there's nothing wrong with a small sample. The Clinical Trial says it's a pilot study. You don't commit money to a large study until you know if there is something worth studying. Hopefully they will find the funding for a full-scale study and others will try to replicate their results in the peer review process.

 

[Bill Godshall]

The underlying problem is that about 20-25 years ago (following enactment of the 1986 law requiring inaccurate fearmongering "not safe", "mouth cancer" and "tooth loss" warnings on smokeless tobacco products), the US DHHS (including CDC, US SG, SAMHSA and the FDA in 2009) and NIH (including NCI and NIDA) have had "abstinence-only" and "all-tobacco-is-addictive-and-harmful" policies, but those federal policies/programs/propaganda (which were dormant during the Bush administration) have been exponentially expanded by Obama administration officials at DHHS, FDA, CDC, NIH.

And for those who haven't been paying attention, the Obama administration adopted and has attempted to implement an e-cigarette prohibition policy (and would have appealed its court loss in SE/NJOY v FDA to the Supreme Court had they thought they could prevail). Although the Obama administration agreed to comply with Judge Leon's ruling, the FDA (and apparently the White House) still has an e-cigarette prohibition policy.

On issues regarding tobacco and e-cigarettes, the Obama administration has continuously and increasingly misrepresented the scientific and empirical evidence in order to promote and defend the administration's abstinence-only all-tobacco-products-are-addictive/harmful/evil policy.

The single most effective solution (to keep e-cigarettes legal to sell and buy) for 2013-2017 is for a Republican to beat Obama in next year's election. All of the Republican candidates oppose unnecessary and excessive government regulation of industry/business, and probably wouldn't let the FDA extend Chapter IX of the FDCA to e-cigarettes or other currently unregulated tobacco products.

If Obama wins reelection, e-cigarette consumers and vendors will face four more years fighting (and perhaps losing to) FDA's e-cigarette prohibition agenda.

Our key one year goal (for 2012) is to prevent Obama/DHHS/FDA from proposing/approving a "deeming" regulation to apply Chapter IX of the FDCA to e-cigarettes and other currently unregulated tobacco products.

The most effective strategy to achieve that goal is to convince/enlist key Republicans in US Congress to help us oppose/delay and prevent the FDA's planned regulatory power grab over unregulated tobacco products.

The reason why US Senate Democrats and e-cigarette prohibitionists are urging the FDA to quickly propose/approve a "deeming" regulation (which would ban e-cigarettes) is because they know that Obama may only be a one term president (and that a Republican successor wouldn't allow FDA to propose the "deeming" reg.), and that even if Obama wins reelection, it will be more difficult for the FDA to propose/approve the "deeming" regulation during his second term if the Republicans win control of the US Senate next year (which has a 50/50 chance of occurring).

In the next few weeks, I hope to report some important developments (that we are currently working on behind the scenes) with some key members of Congress.

Also, even if the FDA proposes/approves a "deeming" regulation in the next 12 months, I've been informed that at least one e-cigarette company is preparing to challenge it in federal court.

 

[Cool_Breeze]

We must think outside the box. "The industry needs to redefine the matter on its own terms," is logical and sensible.

However the industry is fragmented. .......

..........

..........The consumer groups have tried to get the US vendors to organize, to no avail. Meeting dissolve in a flurry of disagreements.

So now, let's get back to thinking outside the box. What ideas do we have for consumers (since we seem to be the only ones who care enough to take action) to be proactive rather than reactive? Petitions seem to be pretty ineffective. I'm thinking that an ad campaign might be ideal, but those cost buckets and buckets of money.

Cool_Breeze, could you review for us what your money-raising ideas were?

Vocalek - Thank you for the reinforcement of my thoughts.

Other followers of this thread and those offering thoughts - Thank you as well.

At some point we need to put aside the 'Howevers' and 'Buts' and do the work of overcoming them. The real work in that is overcoming the independent nature of persons in a voluntary collaboration. It is helpful to have acknowledged, respected leadership.

That 'the industry is fragmented' is understood. Consider that for a large part in the industry, the center of gravity is right here at ECF. Pardon me if there is some other broader collection. For many of us, the main theater for action is with the United States and its various governments. "You've got to start from where you're at."

I suspect there are persons here, both in positions of responsibility and otherwise disposed, that are broadly connected with individuals and entities throughout the industry. Communication across a large part of our domestic industry and consumer base should not be too difficult.

The above 3 paragraphs are seed. Now for the nutriment.

A very large percentage of the suppliers of goods are internet based. A very large percentage of those suppliers offer discount incentives...coupon codes. A checkbox with a statement, "I prefer to donate my discount to efforts to maintain our freedom of vaporing." That's just an example of possible text.

Certainly there are mechanics in setting up a donation system across a variety of suppliers. As well, an organization or organizations responsible to those who donate need/s to be identified. A statement of goals and some plan for achieving these goals by such organization/s will be useful to those who donate.

I suppose it won't take much reflection by any of us to say, "Yeah, but..." in recognition of some obstacle or hindrance to such notions. I ask this: Before you post, 'But...,' hang onto that thought. Hold it until you begin to see a solution to the impediment and post the solution instead. Is that not the hallmark of a collaborative effort?

Thank you for your time and effort to read, understand and reflect on this post.

 

[DragonflyVaper]

Deleted.... found answer.

 

[Amutt]

A very large percentage of the suppliers of goods are internet based. A very large percentage of those suppliers offer discount incentives...coupon codes. A checkbox with a statement, "I prefer to donate my discount to efforts to maintain our freedom of vaporing." That's just an example of possible text.

Certainly there are mechanics in setting up a donation system across a variety of suppliers. As well, an organization or organizations responsible to those who donate need/s to be identified. A statement of goals and some plan for achieving these goals by such organization/s will be useful to those who donate.

I've seen this suggested before and think its a good idea. I imagine lots of people who wouldn't go out of their way to donate somewhere otherwise, wouldn't think twice about throwing a dollar or two toward the cause when it just means they check a box.

 

[Cool_Breeze]

Thank you for the supportive comment.

 

[Nicko]

I don't care what Ron Paul or any other politician says they're going to do because I have yet to see a single one of them follow up on those campaign promises they make that get them voted into office.
We vote for the person whom we feel is going to do the best for whatever class/affiliation/agenda we belong to and follow them, only to get ...... off when they let us down time and time again. Many of us thought Obama was going to "do the right thing" for people. I certainly believed he would and that goes for Clinton, Bush 1 & 2, Carter and all the rest too....
Back to Obama.... so did he do what was promised and I'll leave you to pick out a promise that was truly fulfilled?
Did he?
Not by my accounting! I was shocked to find out a man who quit smoking with the help of a product that I actually use and love would not be sympathetic to the cause of making pv's and other alternatives available to all who'd want them.
I never thought he would try and regulate pv's and other reduced harm alternatives out of existence! What the hell could he be thinking?
I truly expected better from him I really did.
He is just as bad as all the rest of the "career politicians", he's no different. Which is why I'm asking "Why would Paul be any different"?
He is a lifelong politician doing what they all do to get into office.
Lie to the American people......
Other countries wonder why we are so apathetic when it comes to voting.
C.B.

What an awful thing to say about Ron Paul.

He does not lie. And lobbyists gave up visiting him long ago. Why? Because they know they will get nothing from him.

To be totally negative about Ron Paul is about the worst thing for the vaping community.

If you read about Ron Paul's political history, you will see he is NOT like all the others.

 

[throatkick]

Personally, I feel the govt doesn't want people to quit smoking. It's big business. Without people suffering from the negative effects of smoking, pharmaceutical companies would be out a lot of money. Sickness is a big money maker for them and they'll do whatever they can to ensure money making illnesses are always around.
I'm convinced that many of today's illnesses could be cured and even possibly be wiped from existence, but these breakthroughs in science will never see the light of day because pharmaceutical companies rely on sick, dying people to keep them rich.

I will take this a step further and say that they have reached the stage of actively creating illness for the unsuspecting.

 

[mg7454]

We should start a new petition to address shutting down the FDA...

I got this email on my phone and I was super ....... They were thinking we were uneducated hipsters who don't know our arses from our heads, and that's what makes me the most angry.

We should start a petition of Doctors who support the use of e-cigs!
There are plenty of Doctors out there who are well-informed of the pros of e-cigs and the cons of tobacco.

And how does the FDA include e-cigs as a tobacco or smoking device anyway.
It is not either!

Join CASAA now!
We ALL need to pull it together before the FDA wins this war!​