The FDA’s Incomprehensible Answer To A Crucial Question About Its E-Cigarette Regulations

The Food and Drug Administration’s legal rationale for regulating e-cigarettes as “tobacco products,” even though they do not contain tobacco, is that they deliver nicotine derived from tobacco. But e-cigarettes do not always do that. There are many varieties of nicotine-free e-liquids, sold in disposable e-cigarettes,replaceable cartridges and bottles for refilling vaporizer tanks. Do those liquids and the systems in which they are used also qualify as tobacco products?

The answer to that question is vitally important for manufacturers, including vape stores that mix their own liquids, since it will determine which products are subject to the onerous, expensive FDA requirements that are expected to put all but the biggest e-cigarette companies out of business. But judging from correspondence that Boston University public health professor Michael Siegel posted today, the FDA is incapable of giving a succinct—or even comprehensible—answer to this basic question.

Siegel, who supports the use of e-cigarettes as a harm-reducing alternative to the conventional kind, says “someone” (presumably a business owner) shared with him the FDA’s response to this question: “Are e-cigs that do not contain nicotine (or any other tobacco extracts) also covered by the FDA deeming regulations? If so, will they also require pre-market approval like products that do contain nicotine?” The agency’s reply, which you can read in its entirety (if you dare) on Siegel’s tobacco policy blog, is more than 1,300 words long and consists mostly of irrelevant boilerplate. When the FDA finally attempts to answer the question, in the 10th paragraph of its missive, the answer makes no sense:

As it relates to e-liquids that contain zero nicotine, generally, if your zero-nicotine productis not made or derived from tobacco, it may still be a tobacco product subject to FDA regulation if it is intended or reasonably expected to be used with or for the human consumption of a tobacco product; or intended or reasonably expected to alter the performance, composition, constituents, or characteristics of a tobacco product (with certain exceptions relating to controlling moisture or temperature for storage and initiating external heat source), your product issubject to FDA regulation. These products will be evaluated on a case-by-case basis. This applies to closed and open system devices that contain zero-nicotine.

“Despite having 11 years of post-secondary school education and a great deal of experience reading and interpreting legislation and regulations,” Siegel writes, “I have no clue what the heck the FDA is talking about.”

As he notes, it is hard to imagine how a nicotine-free e-liquid could be “used with or for the human consumption of a tobacco product.” Possibly the FDA is referring not to liquids but to vaping equipment that can be used with liquids that contains nicotine as well as liquids that do not. If so, it seems to be saying that such equipment counts as a tobacco product even if it is never used to deliver nicotine, provided that it could be used to deliver nicotine. By that logic, a disposable nicotine-free e-cigarette or a closed vaping system that accepts only nicotine-free cartridges would not qualify as a tobacco product—except that the last sentence (“This applies to closed and open system devices that contain zero-nicotine”) seems to say otherwise.

Comprehension of this crucial paragraph is not aided by the syntactically faulty first sentence, which seems to consist of two differently constructed sentences mashed together without regard to grammar or sense. Even if a business owner could figure out what the FDA meant to say, the warning that “these products will be evaluated on a case-by-case basis” makes it impossible for him to predict whether the agency will view him as a lawbreaker.

This exchange gives you a little taste of what’s in store for companies trying to comply with the FDA’s regulations. For most of them, compliance will be prohibitively expensive, costing anywhere from several hundred thousand dollars (according to the FDA) to $1 million or more (according to the FDA’s critics) for every product variation. But as you can see, even figuring out whether a product is covered by the regulations is no small task.

 

From the original link: http://www.forbes.com/sites/jacobsullum/2016/07/25/the-fdas-incomprehensible-answer-to-a-crucial-question-about-its-e-cigarette-regulations/#596413f15b1b

Altria Urges Changes in FDA E-Cigarette Regulations that Would Decrease Its Share of Vaping Market and Help Save Many Smaller Manufacturers

Altria Urges Changes in FDA E-Cigarette Regulations that Would Decrease Its Share of Vaping Market and Help Save Many Smaller Manufacturers

In a move that casts serious doubt on anti-tobacco groups’ maligning of the motives of the tobacco companies in marketing vaping products, Altria Client Services, on behalf of Nu Mark (the maker of Mark Ten e-cigarettes), has submitted comments to the FDA that blast its pre-market tobacco application (PMTA) requirements for e-cigarettes, arguing that these requirements are unduly burdensome, unnecessary, and beyond the scope of the agency’s jurisdiction under the Tobacco Control Act.

In the comments, Altria Client Services expresses particular concern that the burdensome PMTA requirements will force many manufacturers out of business, undermining the Tobacco Control Act’s public health goals.

Altria writes: “The Draft Guidance is not aligned to the FSPTCA’s goal of promoting public health because the complexity of information recommended for the application process and the short compliance period for FDA to complete PMTA reviews may result in some existing ENDS products being forced off the market.”

Altria also notes that FDA itself acknowledged that a large number of e-cigarette companies would go out of business, yet failed to account for this in its regulatory impact analysis.

To remedy the situation, Altria suggests an approach similar to what I have been advocating: the agency should “establish baseline performance standards for ENDS products that, when met, would serve as the basis for an abbreviated or alternative marketing authorization pathway to satisfy the statutory PMTA requirements.”

Two of Altria’s main goals, as stated in the comments, are to:

1) “support manufacturers’ efforts to develop and bring to market innovative products that may advance the public health.”

2) “allow industry participants to engage and compete in a dynamic market.”

The Rest of the Story

For tobacco control advocates and groups which continue to argue that the tobacco companies have failed to change their behavior, they need to check their calendars and realize that we’re now in 2016, not in the pre-Engle time period. Things have changed substantially, and nowhere is this seen more noticeably than with the tobacco industry’s embrace of true harm reduction products, especially e-cigarettes and vaping products.

Many of my colleagues continue to argue that Altria and Reynolds American are insincere in wanting to promote vaping, that they are merely trying to promote smoking by encouraging vaping as a mechanism to avoid smoking cessation, and that their main purpose is to try to recruit new smoking customers by getting youth addicted to e-cigarettes and then encouraging them to proceed on to tobacco cigarette smoking. Many of the anti-tobacco groups continue to accuse Altria and Reynolds American of marketing their products to youth and using slick advertising and youth-oriented flavorings like gummy bear and cotton candy to appeal to kids.

The truth is that these are not your father’s cigarettes. What Altria and Reynolds American are doing with vaping products is nothing like what they used to do with the marketing of tobacco cigarettes.

In fact, Altria and Reynolds American are not offering youth-friendly flavors like bubble gum, cotton candy, and gummy bear. Their marketing is not targeted at youth, either in its advertising placement or content. Their sales practices for Vuse and Mark Ten are notdirected at facilitating the youth purchase of these products.

VUSE
Candy and fruit flavors: None prior to 2015. Only tobacco and menthol. Last year, introduced four new flavors: Mint, Chai, Berry, and Crema.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

MARK TEN
Candy and fruit flavors: None before last year. Only tobacco and menthol. Last year, introduced two new flavors: Fusion and Mint.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

If these companies were truly going after kids, why would they be actively avoiding youth-friendly flavorings? Why would they refrain from selling disposable products, which are much less expensive and are most likely the type that youth purchase?

To be sure, there are a small number of “bad actors” in the e-cigarette industry. But Altria and Reynolds American are not among them.

Please note that I am not arguing here that companies which are selling e-cigarettes via the internet, marketing disposable products, or selling multiple flavors are targeting kids or that they have any desire for youth to use their products. Quite the opposite: these aspects of the market are essential to reach adult smokers and curtailing any of them would decimate the market, leading tens of thousands of ex-smokers to return to smoking and discouraging smokers from switching to vaping products in the future. I am simply pointing out that Altria and Reynolds American are clearly not targeting youth and using these points to demonstrate how inaccurate the anti-tobacco groups are in characterizing the behavior of these companies.

If there were any remaining doubt about the sincerity of the two major domestic cigarette companies in marketing vaping products, it should disappear after reviewing Altria’s comments to the FDA. (First of all, recognize that these comments are not a publicity ploy because the company is not publicizing them — I was unable to even find them online.) In these comments, Altria supports policy changes that are not in its best financial interests in the sense that the current burdensome regulations are in Altria’s favor and without changes to make them less burdensome, these regulations would essentially hand the entire vaping market to Altria and Reynolds American. Virtually no other companies have the financial resources to develop the required PMTAs. So Altria could easily just sit by quietly and then enjoy an oligopoly in the vaping market.

But this is not what Altria is doing. The company is actually trying to save at least some vitality in the e-cigarette and vaping market by urging the FDA to weaken the burdensome requirements so that many more manufacturers have an opportunity to stay on the market. And these two tobacco companies are also strongly behind the Bishop-Cole amendment which would grandfather existing vaping products, thus preventing the decimation of the e-cigarette market and the creation of a Big Tobacco oligopoly.

Anti-tobacco advocates are going to have to come to terms with the apparently threatening reality that our long-term mantra is no longer valid. Their entry into the vaping market is not merely a ploy to get youth hooked on nicotine so that they can get new smoking customers. They are legitimately interested in creating a new and robust market for harm reduction products.

Now I am not arguing that financial incentives do not play a role. Of course they do. The companies see an eventual decline in the use of combustible tobacco products in the United States, and they want to be able to derive some economic benefit even as smokers move away from these combustibles. By entering the vaping product market, the companies have an alternative source of revenues to help sustain them. And they can use price increases with their traditional cigarettes to help lessen the financial blow, by protecting revenue even as sales decline. And while their market share will not be nearly as high in a robust, thriving vaping market, the overall market will likely be much greater if there are a large variety of alternative choices for smokers who want to quit but do not feel able to do so without the aid of a vaping device.

But instead of denying that this could possibly be happening, we need to open our eyes and see that this is one example where there is a confluence of public health goals and economic incentives for the vaping industry. Profits from the sale of vaping products increase as the sale of traditional cigarettes fall.

At some point, we need to figure out what our goal is. Is the goal to save lives and improve the public’s health by decreasing the tremendous burden of smoking-related morbidity and mortality. Or is the goal simply to continue an unrelenting attack on the cigarette companies, which creates nice publicity for our organizations’ membership and helps to attract larger donations?

 

Source: http://tobaccoanalysis.blogspot.com/2016/07/altria-urges-changes-in-fda-e-cigarette.html?m=1

Bosses told to give staff on e-cigs EXTRA BREAKS and create special vaping rooms at work to encourage the end of regular cigarettes

Firms have been told to set aside a room to allow staff to smoke e-cigarettes at work and give them extra break-times for their habit.

New official advice urges employers to make the vaping devices a ‘more convenient option’ to encourage workers to give up traditional cigarettes, which are far more harmful.

Workers should not be forced to vape outdoors – in places set aside for regular smokers – because this will ‘undermine their ability to quit smoking’, the advice says.

Bosses-told-let-staff-vape

Public Health England has abandoned the ‘precautionary principle’ towards e-cigarettes after concluding they are around 95 per cent safer than smoking

And, because e-cigarettes deliver a smaller nicotine hit, users should be allowed extra breaks for the ‘frequent interim top-ups’ they need.

Companies are also told to make clear that vaping is not smoking – the guidance reads: ‘To avoid confusion, do not use smoking terminology when referring to e-cigarettes.’

The new guidelines have been issued by the Government watchdog Public Health England (PHE).

Professor Kevin Fenton, National Director of health and wellbeing at PHE, said: ‘The evidence is clear that vaping is much less harmful than smoking and that e-cigarettes are helping many smokers to quit.

‘This new framework will encourage organisations to consider both the benefits and the risks when developing their own policies on e-cigarettes.

‘Different approaches will be appropriate in different places, but policies should take account of the evidence and clearly distinguish vaping from smoking.’

PHE has abandoned the ‘precautionary principle’ towards e-cigarettes after concluding they are around 95 per cent safer than smoking.

It is targeting ill-informed companies which have imposed the same strict rules – normally requiring vapers to go outside, after smoking was banned in all workplaces.

The guidance says: ‘Vapers should not be required to use the same space as smokers, as this could undermine their ability to quit smoking and stay smokefree, particularly among those most heavily addicted.

‘To maximise the number of smokers switching to e-cigarettes, vaping should be made a more convenient, as well as safer, option.’

An indoor space is suggested, because ‘forcing smokers outdoors has increased public visibility of smoking, including to children and young people’.

However, Public Health England says smokers require only “one cigarette every hour or so, and in a short space of time” to achieve the blood nicotine level they crave.

In contrast, the advice states: ‘Vaping provides a generally lower blood nicotine level and takes longer to reach a desired level, requiring frequent interim top-ups.

‘This difference should be taken into account, particularly when developing policies for workplaces.’

E-cigarette vapour can be irritating to people with asthma and other respiratory conditions, it admits and their needs ‘should be taken into account’.

But vaping should be only be banned outright in schools or other workplaces where children are present, the guidance states.

Around 2.8m adults in Great Britain use e-cigarettes, almost all of whom are smokers or ex-smokers – with few young people taking up the habit, Public Health England says.

Vaping has become the most popular method for quitting smoking ‘and a developing body of evidence shows that they can be effective’.

Source: http://www.dailymail.co.uk/news/article-3696634/Bosses-told-let-staff-vape.html

E-cigarettes could cut smoking-related deaths by 21 percent: study

E-cigarettes could lead to a 21 percent drop in deaths from smoking-related diseases in those born after 1997, according to a study published in Nicotine & Tobacco Research.

The study, funded by the National Institute on Drug Abuse, the National Cancer Institute and the Cancer Intervention and Surveillance Modeling Network, found that under most plausible scenarios e-cigarettes and other vapor products have a generally positive public health impact.

Multiple studies have sought to assess the impact of e-cigarettes on public health, with conflicting results. Earlier this year a University of California study of high school students found that those who used e-cigarettes were more than twice as likely to also smoke traditional cigarettes.

The latest study differs from prior ones because it summarizes patterns of use from national data, the authors said. Previous studies have used local data that may have unusual patterns and are not necessarily representative of the whole country.

The study distinguishes between youths who vape who would not otherwise have taken up any nicotine product, and those who vape, who would otherwise have smoked cigarettes. When both those populations are taken into account, the benefit outweighs the harm, according to the study.

Many experts believe there are health benefits for smokers who switch completely to e-cigarettes.

“While the data are still not as clear as we would like, we present the entire picture with national data so we think our estimates are as good as we can get,” said David Abrams, executive director of the Schroeder Institute of Tobacco Research and Policy Studies at the Truth Initiative.

Most previous studies count as e-cigarette users anyone who has vaped within the past 30 days. That can include someone who goes to a party and vapes once or twice.

“Those are not the people we are concerned with,” David Levy, a professor of oncology at Georgetown Lombardi Comprehensive Cancer Center and the study’s lead author said in an interview. “We tried to get an idea of the number of people who progressed to established use.”

QQ截图20160718094459

(See there for more details)

On May 5, the FDA announced a final rule extending its tobacco authority to include e-cigarettes, pipe tobacco, cigars and hookah. The rule, which becomes effective in early August, requires companies to seek marketing authorization for any tobacco product introduced after Feb. 15, 2007.

Levy and other e-cigarette advocates say excessive FDA regulation could stifle the development of safer products that could more effectively displace cigarettes.

 

Source: http://www.foxnews.com/health/2016/07/15/e-cigarettes-could-cut-smoking-related-deaths-by-21-percent-study.html

Johnson Seeks Answers from FDA on Burdensome E-Cigarette Regulations

Johnson Seeks Answers from FDA on Burdensome E-Cigarette Regulations

WASHINGTON — Sen. Ron Johnson (R-Wis.), chairman of the Senate Homeland Security and Governmental Affairs Committee, sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf raising concerns about the agency’s recent e-cigarette regulation, which could create undue burdens on small businesses and possibly lead to negative unintended health consequences.

Johnson asked the FDA whether it will revise its rule if scientific findings indicate that e-cigarettes are safer than traditional cigarettes.

“Unfortunately, the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences,” Johnson wrote in the letter. “The costly impact the rule will have on e-cigarette manufacturers will stifle innovation and make it harder for e-cigarette companies to continue to offer products that serve as an alternative to smoking. It is possible that without a cost-effective alternative, some consumers will resort to traditional cigarettes.”

The letter can be found here and below:

May 17, 2016

The Honorable Robert M. Califf, MD

Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Dr. Califf:

The Committee on Homeland Security and Governmental Affairs is examining the regulatory burdens that federal agencies place on small businesses.  On May 5, 2016, the U.S. Food and Drug Administration (FDA) finalized a new regulation that expanded its authority over electronic cigarettes, commonly known as “e-cigarettes.”  I write to request your assistance in understanding the consequences that this new regulation may have on small businesses and the public’s health.

According to the FDA, the final rule extends “the Agency’s ‘tobacco product’ authorities in the [Federal Food, Drug, and Cosmetic Act],” as amended by the Family Smoking Prevention and Tobacco Control Act, to include other products such as e-cigarettes.  The new rule prohibits the sale of e-cigarettes to people under the age of 18.

The regulations also require e-cigarette manufactures to submit premarket applications to the FDA in order to obtain federal approval for their products.  According to recent reports, the new requirements would force e-cigarette companies to complete a burdensome and costly application process.  Some manufacturers could spend more than 5,000 hours to complete an application, with a minimum cost of $330,000 per e-cigarette product, according to some estimates.  As a result of these expensive and time-consuming applications, many e-cigarette manufacturers—most of which are reportedly small businesses—could close down.

According to Christian Berkey, the Chief Executive Officer of Johnson Creek Vapor Company located in Hartland, Wisconsin, the FDA e-cigarette regulations would “extinguish a multi-billion dollar industry and put tens of thousands of people out of business.”  Mr. Berkey also stated that the new FDA rule would have more than just a burdensome impact on the e-cigarette industry, the effect of the rule would be “catastrophic.”  In its regulatory analysis, the FDA itself acknowledged that the cost of the rule “would be high enough to expect additional product exit, consolidation, and reduction in variety compared with the baseline.”

Unfortunately, the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences.  The costly impact the rule will have on e-cigarette manufacturers will stifle innovation and make it harder for e-cigarette companies to continue to offer products that serve as an alternative to smoking.  It is possible that without a cost-effective alternative, some consumers will resort to traditional cigarettes.

In order to assist the Committee in better understanding the FDA’s decision to expand its authority on e-cigarettes, I ask that you please provide the following information and materials:

1. The final rule notes that the FDA does “not currently have sufficient data about e-cigarettes and similar products to fully determine what effects they have on the public health.”  Further, the final rule states that “comments were divided on the safety and toxicity of e-liquids, e-cigarettes, and the exhaled aerosol.”

    1. Will the FDA issue a revised rule if there is sufficient data that finds that e-cigarettes are a safer alternative to traditional cigarettes?  Please explain.
    2. How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have “sufficient data” about e-cigarettes to determine the effects on the public’s health?

2. Some stakeholders claim that the FDA’s rule on e-cigarettes will stifle innovation and result in the closure of many small businesses that create and sell e-cigarette products.

    1. Did the FDA determine how many e-cigarette businesses will be affected by the rule?  If not, why?
    2. If so, please provide that data.
    3. Of the e-cigarette businesses that will be affected by the rule, how many of those businesses does the FDA predict will exit the market as a result of the new requirements?

3. Has the FDA considered the unintended consequences if decreased access to e-cigarettes leads to increased consumption of traditional cigarette and tobacco products?  Please explain.

Please provide this material as soon as possible but no later than 5:00 p.m. on May 31, 2016.  When delivering production sets, please produce to Majority staff in room 340 of the Dirksen Senate Office Building and to Minority staff in room 613 of the Hart Senate Office Building.

The Committee on Homeland Security and Governmental Affairs is authorized by Rule XXV of the Standing Rules of the Senate to investigate “the efficiency and economy of operations of all branches of the Government.”  Additionally, S. Res. 73 (114th Congress) authorize the Committee to examine “the efficiency and economy of all branches and functions of Government with particular references to the operations and management of Federal regulatory policies and programs.”  For purposes of responding to this request, please refer to the definitions and instructions in the enclosure.

If you have any questions about this request, please contact Scott Wittmann or Josh McLeod of the Committee staff at (202) 224-4751.  Thank you for your prompt attention to this matter.

Sincerely,

Ron Johnson

Chairman

Source: https://www.hsgac.senate.gov/media/majority-media/johnson-seeks-answers-from-fda-on-burdensome-e-cigarette-regulations

New clinical study shows exclusive e-cigarette use reduces exposure to harmful chemicals similar to complete smoking cessation

London, 13 July 2016 – New peer-reviewed research published today shows that smokers who completely substitute conventional cigarettes with commercial e-cigarettes experience dramatic reductions in exposure to harmful chemicals that are thought to contribute to tobacco-related diseases, not that dissimilar to complete smoking cessation.

The clinical findings, reported in the Journal of Toxicology Mechanisms and Methods, measured the changes in fifteen biomarkers of exposure to harmful and potentially harmful constituents (HPHCs) – reported by FDA to be significant contributors to smoking-associated disease risks, including carbon monoxide, aldehydes, and tobacco-specific nitrosamines – in the urine, blood and exhaled breath of 105 adult smokers during a five-day controlled trial.

“To provide comparative information for this study, we split participants into three groups. Importantly, we requested the first group abstain from tobacco and vaping entirely to give us a benchmark for the maximum achievable exposure reductions. The second group used e-cigarettes exclusively and the third used both e-cigarettes and their usual brand of tobacco cigarettes,” explained Dr. Grant O’Connell, Vice President of Corporate and Regulatory Affairs. “Encouragingly, in eight out of the nine urinary biomarkers we studied, the reductions in levels of HPHCs following exclusive use of e-cigarettes were almost indistinguishable from reductions in smokers who stopped altogether during the same time. The obvious exception was nicotine.”

In the blood of both e-cigarette users and smokers who quit, levels of carbon monoxide were reduced by over 75 percent. Levels of volatile organic compounds such as acrolein, benzene and 1-3-butadiene were reduced by over 80 percent in both groups. Similarly, levels of tobacco-specific nitrosamines were reduced by 66 to 98 percent in the cessation group, and 62 to 93 percent in the e-cigarette group.

“Interestingly, when it came to the dual use group who halved their self-reported daily cigarette consumption of tobacco cigarettes by using e-cigarettes, we also saw reductions in exposure to HPHCs that were broadly proportional to the reduction in number of cigarettes smoked,” said O’Connell. “The findings support earlier research conducted by Fontem Ventures which showed that e-cigarette vapour is over 95% less toxic than smoke from a cigarette, contains over 95% less HPHCs, and does not negatively impact indoor air quality, unlike conventional cigarette smoke.”

“We are committed to making a valuable contribution to the science around vaping,” said Marc Michelsen, Senior Vice President of Corporate Affairs and Communications. “And these latest findings are encouraging in that they support the results of other third party studies, which conclude that e-cigarettes offer smokers a less harmful alternative to tobacco.”

Fontem Ventures is currently conducting – and will continue to conduct – further clinical and scientific research to understand whether or not reduced exposure to HPHCs translates into changes in some of the short-term health indicators associated with being harmful, or potentially harmful, to human health.

Abstract

Changes in fifteen urine, blood, and exhaled breath BoEs of HPHCs representing classes of compounds reported by FDA to be significant contributors to smoking-associated disease risks were measured in 105 clinical-confined subjects following randomization and a five-day forced-switch from usual brand conventional combustible cigarettes to: (i) exclusive commercial e-cigarette use; (ii) dual-use of commercial e cigarettes and the subject’s usual cigarette brand; or (iii) discontinued use of all tobacco or nicotine products. Levels of urinary biomarkers in subjects that completely substituted their usual cigarette with e-cigarettes were significantly lower (29%-95%) after 5 days. Percent reductions in eight of nine urinary BoEs were indistinguishable to smokers who had quit smoking, except for nicotine equivalents, which declined by 25%-40%. Dual users who halved self-reported daily cigarette consumption with e-cigarettes exhibited reductions (7%-38%) in eight of nine urinary biomarkers, but had increases (1%-20%) in nicotine equivalents. Reductions were broadly proportional to the reduced numbers of cigarettes smoked. Dual user urinary nicotine equivalents were slightly higher, but not statistically significant. After 5 days, blood nicotine biomarker levels were lower in the cessation (75%-96%) and exclusive use groups (11%-83%); with dual users experiencing no significant reductions. All subjects experienced significant decreases in exhaled CO. Decreases in the cessation and exclusive groups ranged from 88%-89% and 27%-32% in dual users. Exhaled NO increased in the cessation and exclusive groups (46%-63% respectively), whereas the dual users experienced minimal changes. Overall, smokers who completely or partially substituted conventional cigarettes with e-cigarettes over five days, experienced reductions in HPHCs.

 

Source: http://www.eurekalert.org/pub_releases/2016-07/ac-eeu071216.php

Watch BBC Horizon – E-Cigarettes: Miracle or Menace?

Michael Mosley addressed his questions regarding e-cigarettes, the questions public asks about e-cigarettes, to several experts among which Dr Marcej Goniewicz and Dr Mark Travers (Roswell Park Cancer Institute, USA) or Dr David O’Reilly, who granted BBC access to the British American Tobacco scientific department that he is leading.

BBC’s documentary is accessible (depending on your location) on this page : http://www.bbc.co.uk/programmes/b07c6ll4

If you’re not able to play the video from the BBC’s website, a user (outis110) on Youtube made it available :

Does the e-cigarette really help smokers to quit?

Yes, says the expert. It can be seen as a “fancy NRT” that may help combat urges to smoke.

Volunteers, all smokers, made an attempt to quit smoking. Seven of them attempted quitting cold turkey (success: 2/7), an identical amount with NRT (success: 7/7) and the same with e-cigarettes (success:7/7). The conclusion of this test was that even if the success can also be due to chance given the small sample considered, the physiological tests do reveal an overall enhancement of health after only 4 weeks of abstinence. A glance of hope for smokers who are concerned by their health.

But what does the e-cigarette do to non-smokers?

Michael Mosley, as a non-smoker but a devoted journalist, turned to vaping for the needs of the documentary, puffing on a third generation device supplied with nicotine e-liquid.

Beneficial effects of nicotine were found by researchers on certain groups, for example people with Alzheimer disease, who exhibited better performances under treatment with nicotine. But it is almost the only positive medical aspect of this molecule since almost no research has currently been carried out on this molecule among non-smokers.

Experts concede that the addictiveness of nicotine is exacerbated by its combination with other substances present in cigarette smoke and the action of smoking itself. Alone, in e-liquids, nicotine is much less addictive than in tobacco cigarettes and the journalist says that it won’t be hard for him to kick the habit of vaping after the end of the footage.

His second observation is that nicotine did not affect his overall performances in terms of responsiveness or for any other intellectual skills. No change compared to the base line. To explain the effect of nicotine, he suggests that lacking nicotine is like lacking caffeine: after a shoot, one feels better than before but not better than the others.

From a social aspect, he ironized that vaping is not as easy as it may appear, especially when there is a ban on vaping in working areas. Going outside the office to vape may reveal itself painful and, he noticed, leads to puff much more in a shorter period than under normal circumstances, if it had been authorized to vape at work, for example. A call to lift vaping bans indoors?

But there comes the problem of second-hand vaping.

Second-hand vapor is shown by the documentary to be very variable both in quantity and quality. Dr Mark Travers, for example, was surprised by the level of particles recorded in a test chamber occupied by experienced vapers using their Mods compared to what he is used to with vapers using disposable e-cigarettes for the same test. Hence, depending on which type of device is used, one cannot exclude second-hand vaping but compared to second-hand smoking, its level is much less, if nicotine concentration is considered, says the researcher.

Michael Mosley underwent medical tests in order to evaluate the potential benefit of vaping on himself. The most striking result was an increase in expired nitric oxide, a marker of the inflammation of his aerial tract. His inflammation was diagnozed by NO but confirmed by the presence of numerous macrophages in sputum samples, as the consequence of a stress that is induced by each puff on his device.

The journalist briefly explains that too many macrophages in the lungs are detrimental because they produce enzymes that may damage the lung itself instead of being used to protect the body from exogenic substances. Nevertheless, a return to normal is expected for subjects in good health, within a couple of weeks after they stopped vaping.

The specialist highlights the crucial need not to consider e-cigarette as a substitute for smoking in places where it is forbidden and to quit smoking altogether when starting vaping. It is a real health concern, he says, because it weakens human defense system to external agressions.

What conclusion can be made from this experience?

His conclusions are that whether e-cigarettes are good news or not, finally depends on how they are used and that it would be stupid for a non-smoker to start vaping. In turn, for smokers, it is something that may help them stop smoking, that has a low risk profile in the short term but whose long-term effects are not known.

Nevertheless, the documentary points out that if most smokers turned to become vapers, it would be a huge step forward for Public Health, saving lives of millions of smokers worldwide.

Source: http://www.vapingpost.com/2016/05/25/watch-bbc-horizon-e-cigarettes-miracle-or-menace/

New Logo, New Era: Innokin’s 5th Anniversary Celebration Begins!

New Logo, New Era: Innokin’s 5th Anniversary Celebration Begins!

Innokin is proud to celebrate our 5th year anniversary with the launch of a new company logo and the continued promise of our unwavering commitment to harm reduction through advanced vaping technologies and cutting edge designs.

The new Innokin logo represents powerful advanced technologies, safely contained within smart, streamlined designs. Our company vision has grown and by working closely with top designers from around the world, we will be bringing truly innovative new vaporizers and tanks to the market in 2016 & beyond.

Safety and quality have always been top priorities and Innokin will continue to stay true to its core vision of creating top quality advanced vaping technologies with innovative designs and standard-setting integrated safety protections. Our teams of experienced engineers and designers continue to push the envelope of new technologies and build products that are internationally renowned for quality, safety, innovation and focused power.

Innokin is a proud supporter of SEVIA-USA in the battle to protect the future of vaping in America and we will continue to stand behind research & responsible regulations in North America, Europe, and other emerging markets. With millions of success stories already on our side, the future of vaping is bright, and all of us at Innokin will continue to strive to bring the highest quality products to people all over the world.

Millions of vapers around the world rely on Innokin products and we are looking forward to the advances in vaping technology & design in the next 5 years and beyond. Thank you for joining us. Vape On!

Innokin Logo