Live Updates Of The FDA’s Public Hearing

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Come Monday a public hearing will offer some of the electronic cigarette industry’s biggest advocates and adversaries  an opportunity to be heard by the FDA.  For those of you unable or unwilling to listen watch the 9 hour session (which you can find here), we’ll be running live updates on this page to keep you apprised of the goings on.

The list below is a rundown of all those scheduled to speak at the hearing in the order they have been scheduled.  Throughout the event, we will be updating this list with basic rundowns of what each presenter says and how, if at all, the FDA members respond.  Members of the e-cig community will likely recognize a few names on the list.  Each individual is allotted 8 minutes to speak and then the FDA members are allotted 8 minutes to ask for clarifications.  The FDA will be accepting further written and electronic comments through January 16th (See Riccardo Polosa’s comments here).

To the FDA, we wish open ears and open minds.  To our advocates, we wish calm articulation.  To our adversaries, we wish sore throats and small bladders.

— Grail Sipes, Office of Regulatory Policy, Center for Drug Evaluation and Research
Presiding officer for the hearing. Meeting is informal, rules of evidence do not apply, no interruptions allowed. If time allows, presenters may be called back up. Ronald Ward (private citizen) is not in attendance. Individuals not scheduled but in attendance may comment during the open public comment time at the end of the session. We look forward to hearing from all involved.

— Gregory Conley, Private Citizen
Individuals are encouraged not to use NRT products beyond 12 weeks, but long term use of NRTs should be considered. Panel must consider incorporating harm and consumption reduction as goals for regulation. Panel should unapprove Chantix warning particularly of well documented cardiovascular issues and suicide. Tinkering with smokers brains can have disastrous results. Sign show that smokers are interested in reducing smoking but not reducing nicotine use. Stop misinforming the public of the impact of these products.
No questions from panel.

— Lorie McClung, Private Citizen
Owner of Nimble Fingers — a small retail shop. 20 year smoker. Failed to quit repeatedly. Would set a quit date, smoke heavier leading up to it, never stopped wanting to smoking, and failed to quit. Purpose is to share personal stories about the success of NRTs. There are real reasons smokers continue to smoke and current cessation methods fail 95% of the time. Gets involved in quitting efforts. Electronic cigarettes have been extremely successful. It is the smoke that causes death or disease. Smokers should be treated like adults and consider that failure to quit is more in the hands of the method than the smoker. Overall, authorities should stop reminding smokers of how hard it is to quit, should treat them like adults, and should allow NRTs to succeed. The word quit should be removed from the vocabulary.
Do you have ideas what could be added to pharmaceutical products to encourage more success? Will be submitting written comments on this topic.

— Carl V. Phillips, PhD, Private Citizen
Long time advocate. Addiction is not well defined and in itself is not a harm. So if the worst thing about nicotine is that it is addictive, that’s hardly a bad thing if other harm is removed. Nicotine has many positive effects and smokers like these effects. Risk needs to be assessed not in comparison to abstinence but in comparison to a percentage scale of harm impact. Smoke-free alternatives are far healthier–a lifetime of use is less harmful than a couple months of relapse smoking. Focusing on the net effect of smoking is necessary to model appropriate methods of combating smoking. People are not black boxes, and theres much that is a rounding error.
Please elaborate on lifetime smokeless vs smoking for a couple month. It’s a basic modeling comparison. There’s reason to believe this is actually a conservative estimate
What of dual users? That model didn’t make any predictions. Duel users were considered as no having quit. They were essentially qualified as bad cases.
Do you have numbers of users that become duel users? Working on that now. Quite difficult. People act on preferences as well as on information. Motivations to quit are not the same or even opposite of motives to continues. Prediction is highly dependent on social factors.
Many promotions focus on use when you can’t use cigarettes. How can that change? Not sure that is a accurate assessment. Merchants are prohibited from making low-risk claims. Removing this restriction could allow merchants to be more honest about the reason to use their products.
What if the same company is marketing both combustible and low-risk products? Many companies are willing to cannibalize their consumers for low risk. Ability to make claims would only help these companies.
Smokers are not idiots. They understand the harm. Yet they still choose to do it. Abstinence is a poor choice from them. The question is, how do we make harm reduction socially acceptable.

— Linc Williams, Private Citizen/Documentary Director
Documentary film maker. Smoked for 23 years. The only person I blamed for my smoking was me. 17 years of that I was trying to quit. The last 10 years used around 4 packs a day. Tried just about everything to quit. Had uncontrollable rage and suicidal thoughts using Chantix. Most successful was 9 months of using tons of patches and lozenges. Average quit time was about 1 month. Spent close to $17,000 attempting to quit. Was overweight and taking 8 oral medications and resigned to continue smoking. Today I’m 28 months smoke-free, healthier, and even ran a 5k. I was a duel user for 3 months — but while duel using I only smoking 1 pack a day. Eventually found that I preferred the nicotine alternatives. My choice of nicotine today is electronic cigarettes and snus. I will never give up nicotine. 8-12 weeks is not enough to break a serious cycle. Chantix should be removed from the market completely. The government should invest in harm reduction strategies. Revise the view of all tobacco products as the same thing.
Thank you for sharing. We have data that support that NRTs and Chantix can help some people quit. Are you approaching this as either/or? Are you saying remove all that and just look towards long-term use? I believe the 5% that quit using these programs can likely quit using NRTs. If you only pursue the ideal, you lose a lot.
So you don’t think they should be unapproved? I do think Chantix should be completely removed from the market.
What was different about electronic cigarettes that made them work? They bring the pleasure back. Patches and lozenges are not enjoyable. Cigarettes catch you at your weakest. Primarily, it is the breathing in and out that makes the difference.
Would you recommend e-cig manufacturers go for cessation Most manufacturers are too small to play at the level of the FDA. Large companies are not the norm. It’s just not realistic. Research requirements basically say don’t try.
If 12 weeks is not long-term, what is? There is not set limit. I knew one guy that was on the patch for 4 years. Placing a limit creates a stigma and demoralizes the smokers and often sends them back to smoking.
So tobacco cessation should be smoking cessation? Should tobacco maintenance be a public health goal? I think the goal should be quitting smoking and making these options attainable and affordable.
What if doctor had suggested continuing the use of both patch and lozenges? I probably still be doing both.

— Elaine Keller, The Consumer Advocates for Smoke-free Alternatives Association
The rate of smoking may have changed, but the number of smokers is back where it started 21 years ago. We need to try the carrot rather than the stick to encourage quitting. A fast track should be implemented for modified risk tobacco products. Any non-smoked form of nicotine is safer than smoked. Nicotine abstinence triggers relapse. Smokers that quit experience more depression, but are ill-equipped to deal with it. Smokers can’t be expected to take a pill for each of the individual issues brought on by attempting to quit. Worst of all, the government needs to stop saying that all tobacco products are the same
Source for statistic 62% of smokers earn less than $36,000 a year? Not sure I documented where I got that from.
FDA does not control costs of products. Would costs help quitting smoking? Couldn’t hurt.
I’ve read data that Pancreatic cancer occurs more in users of snus. How should these products be labeled? The person who noticed that increase did two studies with conflicting results. What we need is more research and give the most accurate information to the public.

— Phil Daman, Esq, Daman and Associates LLC
Not in attendance.

— Jonathan Foulds, PhD, Society for Research on Nicotine and Tobacco (SRNT)
SRNT does not accept money from tobacco industry. I and other members to private consulting however. Smoking leads to about 50% death rate among users. Tobacco use should be seen as a life threatening condition. Comparison should not be to use of drugs and treatments, but rather to the ultimate risks of continued smoking. There have already been published studied of NRT and concludes that continued cessation is more likely to continue with NRTs. NRTs can be used beyond 12 weeks and this should be advised on. Patients should use NRTs until they can go 14 consecutive days without cravings — however long that takes. We don’t need to invent complicated new NRTs. There is fear that if one is using NRT and smokes, that must stop the NRT or something bad will happen. This increases failure rate. We shouldn’t hesitate to throw help to smokers out of concern that the treatment might have negative effects.
Has the concept of craving been accurately defined? My opinion, there is not a lot of difference between craving, urge, desire, etc. My expectation is that these have very little difference in the minds of smokers.
Is there a difference between casual and provoked cravings? There is a miss-characterization of smoking cravings that suggests they only exist as an effect of withdrawal, but smokers experience cravings while smoking. We need more subtle and sophisticated measures for these effects.
Recommendation on regulating pack sizes. Giving smokers an option tends to lead them to the wrong one. Smaller and more affordable NRTs should be available in addition to large, long-term packages. most NRT packs are closer to $50 and that’s a barrier to the therapy.
Should the concept of craving be removed from the equation? It could be far more specific, but mainly, laboratory studies need to be more precise so that subjects aren’t answering long retrospective questions.
Defining lapse or relapse — How can day to day smoking be better tracked without dramatically increasing the cost of weekly or monthly trials? My two-cents — If it’s cost, accuracy is not as much a concern if expansive double blind trials are conducted. Alternatively, biochemical trackers can be used to test and measure residual effects and components.
What of reduce to quit options? Labeling implies quitting gradually with most NRTs is dangerous. Evidence suggests this isn’t the case. Offering more flexible quitting options can help dramatically.
Is it important to have an objective outcome in treatment? The requirement is that products help people quit smoking. So reductions aren’t tracked as much in studies done for the FDA. Reducing the number of cigarettes is important, but reducing harm is the bigger concern. Smokeless nicotine sources do this.

— Michael B. Steinberg, MD, MPH, FACP, Association for the Treatment of Tobacco Use and Dependence (ATTUD)
I help people stop smoking, I have seen the bad things that happen when people fail, I have received funds from organizations. ATTUD uses evidence-based methods to help individuals quit– not anecdotes, tales, and belief. Speaking from the trenches, we have vast amounts of data supports smoking cessation medications. However, labeling is not clear or accurate and for over the counter treatments, this is a problem. Many physicians are forced to contradict labeling because of these situations. The excessive amounts of warning scare potential quitters and often suggest these methods are as bad as continuing to smoke. Yet the same amount of warnings are not found on actual cigarettes. It is unlikely individuals meaning to quit will need more than the 12 weeks, but should be allowed to if necessary. There should be more flexibility in dose and duration for these products. Labeling is a clear barrier. Only products with evidence based support should be encouraged as opposed to “other” products discussed here today. Hospitalized smokers forced to abstain and use medication often have good experiences with those medications.

— Danny McGoldrick, Campaign for Tobacco-Free Kids
Too many people are dying and not enough people are quitting. Even the best quit rates in clinical work are less than optimal. More and better ways to help smokers quit are necessary. On tobacco side, continue research on ways to reduce or eliminate the ability of tobacco products to addict users. We need new interventions to further improve the likelihood of smokers attempting to quit and successfully quitting. Nicotine provided in ways branded as methods to quit should be watched for simply providing bridge products and supplementing smoking when smoking can’t be done. We support a fast-track process for new cessation products. Post-market surveillance should be used in conjunction with clinical trials to confirm success of cessation products. FDA should support private industry’s efforts to help smokers quit.
No questions.

— Angela Jones, American Cancer Society Cancer Action Network, Inc.
We support the use of fast track approval for cessation and NRT options. 52% of smokers attempt to quit each year, but only 7% succeed. A fast track process would help combat the massive totals of disease and death sooner rather than later. There is much need for more alternatives to improve the likelihood of quitting. We support the approval of long-term NRT use. We urge evidence-based standards when investigating clinical effects of new options. FDA should also consider impact on the population level — cessation attempts, continued tobacco use, etc.
Use of fast track — What does smoking cessation mean? Can indefinite use of NRT be a fast track option? We’re talking about total cessation from smoking and nicotine use. We’re not prepared to give a final stance on that without more long-term research.
No questions.

— David Abrams, PhD, Schroeder Institute for Tobacco Research and Policy Studies at Legacy
Has 35 years experience in tobacco cessation. We ask for more flexible standard for cessation. Level the playing field by allowing cessation products to reach smokers in the same ways smoking does. Risk of NRTs pales in comparison to continued smoking. We recommend greater use of fast track. A product does not need to be risk free, just clearly less harmful than cigarettes. Post market surveillance is acceptable in these cases. NRTs should be offered in more flexible ways — reduce to quit strategy, long-term, relapse deterrent, etc. NRTs show success for relapse prevention. Smaller pack size would also increase accessibility. Increasing access, effectiveness, and reach, smoking rates can be reduced dramatically. Fast tracking should be less burdensome. It is critical the FDA regulate tobacco-derived nicotine products. Immediate action is needed and we should not be complacent.
How can we best reduce premarket burden and how can we best perform post market surveillance? Will submit on this. Characteristics of current NRTs are well known. If we keep combusted tobacco use as the comparison, we can easily identify promising products. We have previous research capable of meeting the basic need for understanding in this area.
Research you can provide would be helpful. New products should have appropriate negotiations handled, but substantial reductions can still be made when compared to combustable nicotine delivery. One could argue that we would far rather see these products tested in post-market situations than continue the death and disease existing now.
Fast track occurred with Chantix and it’s looking bad. Is there a difference? It needs to be handled on a case by case basis. Certainly a drug is in need of more sufficient testing. In the case of Chantix, the excess risk involved at a population level are relatively small in comparison to continued smoking. I believe these concerns are largely overblown and nearly insignificant at a population level.
Where do you see e-cigarettes in this process? They are certainly accumulating evidence– though I’m not sure it’s sufficient. They are not without risk and there is concern about non-standardized use. Overall I don’t think enough research has been done on the quality control. I don’t think e-cigarettes — as good as they may appear — should skip this process. On the other hand, they do show promise, this is an innovative product, but is could certainly move to the fast track option. We do need more research that does not use a sample of convenience. We need more to say that they do work, that they are better than other NRTs and that they are safe for long term use. Fast tracking is an option.
Are there unintended consequences should nicotine containing products be made far more available? There is complexity here depending on whether you use a individual view or population level view. This is a largely untested area even though it is part of the mission of many groups. Ultimately the comparison needs to be made to combustable cigarettes. Many products — e-cigs and snus — are already available and we are already running the experiment. So far, they appear to be working, but we can’t answer that question yet. In general, we need better simulations of the results. Restrictions on sales of all nicotine products to minors should be pushed. Nicotine absent the “dirty” deliver method is a promising drug.
More on the models. We don’t have good population estimates of quitting attempts and success models. Less than 20% of attempted quitters use evidence-based options. Simply raising this rate would help improve our situation.
Post-market — thoughts on the pregnant population? I’d rather not here. Will do written comments. In short, the harm of smoking during pregnancy far out weigh the harm of providing nicotine to expecting moms to prevent smoking. It’s a tricky area. Similar is the use of NRT in adolescents that sincerely want to quit — the concern is that you might be promoting addiction rather than fighting it.
More on research. The studies done are generally in ideal circumstances. But even dual use can be a very positive option. Generally duel use leads to reduced use and any reduction in harm should be encouraged. The concern is that at a population level, alternatives could undermine indoor air laws, marketing limitations, etc. At the same time, many more might reduce their consumption and eventually quit, far out weighing the negatives. But you can’t make a general comparison between a short-term and long-term smoker. The model won’t tell us what happens in the real world, but more than likely the rewards out weighs the risks.

— Bill Godshall, Smokefree Pennsylvania
I’m hear to urge the FDA to stop protecting the tobacco industry from smoke-free alternatives. Do not fast track any more drugs for tobacco dependence, remove Chantix from the market (or require dramatically more accurate warning labels), do not qualify cessation products as such without at least a 20% success rate, require success rates of cessation products be printed on label to inform consumers. The FDA should never again ban or needlessly restrict smoke-free alternatives. The FDA has not yet clarified statements about electronic cigarettes that are misleading or completely wrong. The FDA should remove statements on it’s website stating that no nicotine product has proven that it is safer than cigarettes. Smokers have a right to accurate information and affordable alternatives. Some other speakers are in favor of fast tracking and NRTs, but they are against electronic cigarettes — this is a conflicted stance.
Do you believe other forms of tobacco are safe? Chewing tobacco is 99% less harmful than smoking. So, no, it’s “not a safe alternative to smoking,” but it is a 99% safer alternative to smoking.
Can you include that research? I have multiple times and I will again.
Clarify bans on electronic cigarettes. E-cigs from after 2007 will not be grandfathered in and regulation essentially sets them up to fail. Many of the regulations threaten public health more than they protect it.

— Kathleen Dachille, Legal Resource Center for Tobacco Regulation, Litigation and Advocacy, University of Maryland School of Law
FDA should have a comprehensive approach to nicotine regulation. Gaps in regulation will be exploited by the tobacco industry. For the last 50 years companies have been subversively finding ways to increase impact of nicotine. That tobacco companies are buying e-cigs should concern us that they will become a source of smoking continuation. E-cigs are available to minors anywhere that has not expressly banned it. None of the provisions in the tobacco control act apply to e-cigs. While there may be viable and safe uses for e-cigs, we don’t want to see them in the hands of children. Regulation of e-cigs is non-existent and no one has responsibility. Involvement of the tobacco industry in the NRT market is concerning. These companies intentionally created cigarettes designed to maintain addiction, destroyed documents, and marketed to minors. It is unlikely they are buying into the electronic cigarette market as a way to reduce addiction.
Do you feel that there can never be addiction without harm? I’m not a doctor, but where we are in the spectrum now is no where near where you are talking about. I would like us to reach a point where that question is worthwhile.

— John R. Hughes, MD, Private Citizen
Not in attendance.

— Gilbert Ross, MD, American Council on Science and Health
Creative approaches to smoking regulation are required to appropriately reduce smoking rates. Judgement based on the –albeit justified — mistrust of the tobacco industry will only continue to allow things to continue. The tobacco industry’s stated goals now are not the same as in the past. There is no “safe” tobacco product — but we allow them to exist for the grater good. Smokeless forms of tobacco use are up to 2 magnitudes of order safer than smoking. Approved cessation method fail far too much. Addiction to nicotine continues to prevent quitting and the quitting process takes so long that damage is already done. It is not the nicotine that kills, but the most dangerous and devastating method of delivery is also the most prevalent and accessible. On electronic cigarettes — what’s in e-cigs is far cleaner than tobacco cigarettes. I’m not one to go on feelings or gut, but we do not have time to wait for extensive research to decide e-cigs are useful. There is also no evidence that e-cigs or any smokeless tobacco products act as gateway for non-smokers or minors. The law does not need to be changed or broken to support e-cigs. We recognize that times have changed, but the smoking rate decline has plateaued. Reduced cigarette sales and increased smokeless sales is exactly what we want. Tobacco will not go away and public health authorities that bend the truth to argue for abstinence will have to change their views.
No questions.

— Scott D. Ballin, JD, Health Policy Consultant
We need a more civil and transparent discussion to lead to a more meaningful tobacco regulation. A more consistent regulatory scheme is needed to keep up with the changes in the tobacco industry — cigarettes, NRT, and others. Much of the regulations came from the 1990s and the early 2000s. Much has changed. These regulations were well intended, but are now outdated. The use of the term tobacco where smoking would be more appropriate has created a number of issues for new technology that can’t be regulated as smoking products. We need more clear definitions of tobacco, smoking, cessation, relapse, and more. Legislation is not clear because these terms are not clear. The average consumer thinks nicotine is what causes cancer. A more educated consumer base will assist in transitioning people to safer products. Allowing competition — rather than preventing it through regulation — will make the market better. We need a new center for tobacco, nicotine, and alternative products so that they can be regulated individually and appropriately. FDA should continue to run workshops like this one to continue the dialogue. Incentives should be provided for companies that reduce risk in smokers.
No questions.

— James E. Dillard III, Altria Client Services Inc. on behalf of Philip Morris USA Inc. and U.S. Smokeless Tobacco Company LLC
Cigarette smoking is the most hazardous form of tobacco use. Prevention and cessation strategies are not enough to succeed in the real world. A Harm reduction approach can compliment these. There is overwhelming evidence that smokeless tobacco is far less harmful than cigarettes. This is undeniable. 30% of adult smokers want an alternative. This year we launched a tobacco derived nicotine product called Verve discs. Regulation can help tobacco consumers make informed decisions. Concern that individuals will make the wrong decision is not a good enough reason not to provide the information as accurately as possible. Harm reduction can advance public health goals.
Where do you see a dual user on the harm reduction spectrum? Can these products be gateways for kids? The issues with combustable tobacco products exist around the exposure of tobacco smoke. Users need a transition period to quit. The goal needs to recognize that dual use can happen, but the end point is total transition away from combustable product. As for kids — tobacco product should be for adults only. Based on studies, even with new products on the market, smoking rates in youth continue to decline.
Data on what percent dual use? We’re beginning to look at that. It’s difficult to make a claim now. Basically we’ll have to feel it out, make assumptions, push forward, and look back retrospectively.
Will offering these products reduce cessation or increase initiation? Can that be altered? Can’t answer that today. We don’t know how to minimize the unintended consumers, but we are studying and discussing.

— James Walmsley, MD, Johnson and Johnson Consumer Services EAME Ltd.
Interest here is as the marketers of Nicorette. The ultimate aim of any therapeutic intervention should be complete cessation. NRT should not perpetuate it’s own use. Data confirm cessation rate in combination therapy –that is, long-term slow release to fight withdrawal with short-term high impact to fight breakthrough cravings). There is an important opportunity to help smokers with no motivation to quit or smokers that can’t quit quickly. Treatment of smoking addiction should be flexible to meet the wide range of needs different quitters have. Total cessation should be the first focus of any NRT product. Various NRTs should be compared by a comparable strength scale to allow accurate evaluation of various products.
How do you envision combination therapy being offered? The United Kingdom has worked on this for a while and it’s a difficult. All smokers are different. Essentially, labeling that advised against combination use was removed so physicians could advise combination therapy without contradicting the labeling.
Safety of combination therapy. Evidence suggests smokers are good at gauging the amount they need — so overdose is not an issue.
Do any countries with less restriction on combination use have studies to support this? I don’t have anything on that now.
Are you suggesting that behavioral components don’t matter as much as delivering nicotine to smokers attempting to quit. Essentially yes. In general, if you are going to compare NRTs, the amount of nicotine is what matters and not the method of delivery.
Can companies support the efficacy and safety of long-term NRT use? I can’t answer that. Every smoker is different, and many quitters have a lapse. We shouldn’t be afraid to help them through that no matter how long it is from treatment.
Are there challenges to this study process? That’s not what I’m talking about. I’m just presenting a case for longer term use. Many authorities have taken this topic onboard.
We have not approved nicotine — only individual products. Do you think we can do away with individual approval? Is ad-lib dosing acceptable. There is bio-equivalence. There is a strong case that we have enough evidence to bridge this issue. The models I have are based on a single dose comparison.
Can you speak a little on NRT and quitting motivation? Motivation changes constantly. If we can improve the rate and power of motivation, we can make quitters out of people unmotivated to quit. Motivation changes on a second to second basis.

— Howard S. Marsh, MD, GlaxoSmithKline Consumer Healthcare
Today’s greatest public health benefit comes from quitting smoking. It is never too late to quit or attempt to quit. Traditional clinical trials may no longer be the best way to lead NRTs and nicotine medications to market. Acceptable NRT duration should be increase to prevent quitters from returning to smoking. A long-term study found that 5 year use of NRTs seemed to have no negative impact on users’ health. The conclusion is that any amount or NRT for any period of time is better than smoking. Availability of many forms and flavors of NRT only improves the chances a smoker will attempt to and successfully quit. Requiring abrupt cessation has not worked. Many smokers are scared of the idea of abrupt cessation. Most smokers prefer to quit gradually. A variety of approaches available in other countries are not well supported in the US. Over-the-counter labeling do not provide the best understanding to consumers of how their use can assist in smoking cessation. Nicotine should be provided to assist with smoking cessation, but the ultimate goal should still be total cessation.
More on high-dose NRTs. Many people don’t use the current products correctly. Many actually underdose. Better use of these products will negate the need for high-dose alternatives for most smokers.
Does reduce to quit work? A study we ran does suggest that. But smokers are individuals. What we suggest is a more flexible approach to quitting.
Are there data to support the approach with total quitting as the end goal? Basically, yes. Reduce to quit or long-term use may needed to be make that happen however.
Do we know the difference between someone that can and can’t quit and how best to approach a given individual? We do have some knowledge on this. Again, each smoker is an individual. Social and psychological concerns need to be considered. For this reason quitting groups, programs, and online support work well. Providing support is key.
Can people self select the best cessation area for them? I’m not prepared with a definitive response. It is an area that warrants investigation.
Have studies proved that NRTs can offer craving control to users? That’s basically why they exist. I can’t say whether this has been clinically proven, but if one were to use them for craving control, that would be a safe use for them.
Are you suggesting that instead of clinical studies, we allow labels based on the common sense of the health community? Yes. It is essentially unnecessary to have clinical investigations into every possible outcome of a promising NRT.

— Mark Anton, What A Smoke, LLC
FDA should stop protecting the tobacco industry from smokeless tobacco products. Less than one percent of tobacco related death and disease come from smokeless tobacco. While quitting is great, switching to smokeless is nearly as good. The FDA should encourage approval of long-term cigarette alternatives. Currently it would require tens of millions for an e-cig manufacturer to obtain status as a modified risk tobacco products. The guidance available is complex and confusing to e-cig companies. There’s essentially no way to provide accurate information to consumers or become qualified as what it is and does. In testing, e-cigs have already been shown as far safer than cigarettes and quite successful as a replacement for cigarettes. The FDA should not fight all tobacco products and should instead advise smokers to use smokeless alternatives at all possible times. The FDA should clarify that nicotine can be obtained from safer sources than cigarettes. Deeming regulations would essentially ban electronic cigarettes.
Please clarify how electronic cigarettes would be banned? As covered by Godshall, the grandfathering rule in place only works for e-cigs from before 2007. Almost all electronic cigarettes entered the market after than and those on the market then are extremely obsolete now.

— Robert Jack, Blue Mist Vaping
Began using e-cig in 2009 and immediately started the company. Many customers are lifelong smokers who were only able to quit with e-cigs. Reads a couple personal accounts of electronic cigarette triumphs for long-term smokers — highlighting in particular, a veteran with advanced MS. I recognize both quality and safety are concerns, but I believe our industry is willing and capable of meeting these concerns. Consumers want options for lower risk products. We should make them available.
Shouldn’t e-cig have to do the studies to be marketed as a cessation product? I believe we already have much of the information necessary to demonstrate effectiveness. Banning e-cigs out front because the industry can’t afford these studies is not acceptable.

— Lou Ritter, American E-liquid Manufacturing Standards Association (AEMSA)
E-liquid is an issue of relevance as the basis of e-cigs. By some estimates, over 5 million people are using electronic cigarettes globally. There are links on the AEMSA website pointing to the safety and cleanliness of electronic cigarettes. There are stories all over the community of how electronic cigarettes have profoundly impacted smokers’ lives. Nicotine and tobacco should be separated in definition. Nicotine is toxic in large quantities and should be controlled and handled professionally, but not all things containing nicotine should be regulated the same. E-liquid is a new area that cannot be treated exactly like tobacco cigarettes. Professional research is still being doing on the effect of e-cigs. Already, they’ve proved themselves profoundly less harmful than cigarettes. We have the technology, means and wisdom to offer successful harm reduction. Quit or die has proved enviable and inhumane.
How would you become aware of any reports of e-cig related death or disease? We are involved in all facets of the industry and we and those we know have yet to find any instances of such.
What is the experience of someone that smokes versus someone that uses electronic cigarettes? I smoked for 33 years. And in the last 2 years have not because of electronic cigarettes. I have seen someone die from it. Using an e-cig, I don’t get sick nearly as much anymore.
If cigarettes were only available for 3 years, would we be seeing the same things we see with e-cigs now? That’s not relevant. They have been around and we promoted them and made them appealing. Ritter gives a fairly impassioned speech that would be better listened to than paraphrased.
More on available research. It’s all on our website. We brought in leading experts and looked at all the possible ways we could investigate e-liquid quality. We investigated the quality and accuracy of e-liquid. There’s a lot involved in making sure we match commercial food regulation.
What regulatory role should the government play in this sphere? The government should draw on the experts and organizations already in existence. Regulations could be developed to straddle liqueur distillation and food manufacturing.

— Additional Questions: David Abrams, PhD, Schroeder Institute for Tobacco Research and Policy Studies at Legacy
Expand need for individuals with 20 pack years to quit being higher than individuals with less. Lung cancer risk curve exponentially takes off around 20 pack years of exposure. Any reduction in consumption is a good thing, but it’s more important the longer someone has been smoking. I can share the data with you.

— Adjured!!

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