FDA Vaping Regulations: An Absurd Perverse Government Failure Ron Kaufman Ron Kaufman

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Doctors Attack E-Cigarette Taxes, Tell FDA To Focus On Benefits Of Vaping

Jason Fourmont (R) exhales vapor from his e-cigarette before attending a city council meeting that will address the legality of indoor use of the device in New York December 19, 2013. The New York City Council on Thursday will vote on a bill that would add electronic cigarettes to the city

A collection of scientists and researchers are urging the Food and Drug Administration (FDA) to focus on the benefits of e-cigarettes and warn heavy taxation would be bad for public health.

Seven leading tobacco control experts took to the pages of the journal Addiction to examine the evidence on e-cigarettes. They found the devices cut smoking overall and could slash the number of deaths from tobacco.

“We’re concerned the FDA, which has asserted its right to regulate e-cigarettes, will focus solely on the possibility that e-cigarettes and other vapor nicotine products might act as a gateway to cigarette use,” says David Levy, professor in the department of oncology at the Georgetown Lombardi Comprehensive Cancer Center.

“We believe that the discussion to date has been slanted against e-cigarettes, which is unfortunate because the big picture tells us that these products appear to be used mostly by people who already are or who are likely to become cigarette smokers,” adds Levy.

The FDA is set to announce the regulations which could require all vapor products released after Feb, 15, 2007, (predicate date) to go through the onerous Pre-Market Tobacco Applications process.

The vast majority of e-cigarette businesses will not be able to bear the cost of this regulation and as much as 99 percent of products could disappear from the market if the rules are not altered.

An amendment to the spending bill from Reps. Tom Cole
40%
and Sanford Bishop, which passed the House Committee on Appropriations 31-19, would alter the predicate date and save most products on the market. A vote by the House on the spending bill has not been scheduled. (RELATED: Vapers Win Big: House Committee Passes Amendment To Save E-Cigarettes)

“We don’t want to encourage e-cigarette use by youth and young adults who would not have otherwise smoked. However, the primary aim of tobacco control policy should be to discourage cigarette use while providing the means for smokers to more easily quit smoking, even if that means switching for some time to e-cigarettes rather than quitting all nicotine use,” the authors write in Addiction.
They also agreed with policy experts that slapping e-cigarettes with taxes equal to those of regular cigarettes will discourage smokers from switching to e-cigarettes, which are 95 percent safer. (RELATED: Utah’s E-Cigarette Tax ‘Boggles The Mind’ And Could Prevent Smokers Quitting)

“Increasing e-cigarette prices by taxing them the same way as cigarettes will discourage youth VNP use, but also discourage use by smokers, especially those of lower socioeconomic status, who are trying to quit,” says Levy.

The authors of the article include David T. Levy, Ph.D, of Georgetown University; K. Michael Cummings, Ph.D, MPH, of the Medical University of South Carolina; Andrea C. Villanti, Ph.D, MPH, Ray Niaura, Ph.D, and David B. Abrams, Ph.D, from Truth Initiative; Geoffrey T. Fong, Ph.D, of the University of Waterloo in Canada; and Ron Borland, Ph.D, of Cancer Control Victoria, in Australia.

Bluffer’s guide to FDA regulation of tobacco and nicotine products

FDA puzzle

If you aren’t American, or even if you are, the regulation of tobacco, nicotine, and vape products in the United States can seem bewildering but somehow important. And big decisions could be coming out any time now. So if you want to be on it, here’s my bluffer’s guide to the United States Food and Drug Administration (FDA) and its approach to tobacco and nicotine products.

  1. What law gives the FDA the power to regulate tobacco or nicotine? For tobacco, FDA operates under the Family Smoking Prevention and Tobacco Control Act of 2009 – usually shortened to ‘Tobacco Control Act’ (TCA)   This is primary legislation made by Congress and it governs the institutional framework and regulatory regime for tobacco products.   The TCA actually amends the Federal Food Drug and Cosmetic Act to create Chapter IX on tobacco products. For pharma nicotine, medical regulation under Chapter V applies.
  1. How is the FDA set up internally to deal with tobacco? The TCA set up the Center for Tobacco Products (CTP) as the main regulatory body within the FDA, and this is currently headed by Mitch Zeller. Mr Zeller has made enouraging public statements indicating that he recognises that different tobacco products have different risks and should be regulated accordingly. However, we cannot assume that the FDA-CTP will act consistently with that view – it will be confined by law, by its interpretation of science, and by how others in FDA want to approach the issue.

zeller

  1. Why is the FDA regulating vaping nicotine products as if they are tobacco products? Like the UK and EU, the FDA originally tried to regulate e-cigarettes as medicines, which would have been a disaster.  Thankfully, FDA was defeated in the appeal courts in 2010 in the ‘Sottera case‘ in which the court found that unless a product derived from tobacco is marketed for therapeutic purposes, the FDA may regulate it only under the provisions of the Tobacco Control Act. This is because the TCA defines ‘tobacco product’ to mean ‘any product made or derived from tobacco that is intended for human consumption‘ – and the nicotine in e-liquids is derived from tobacco.
  1. What does “deeming” mean and how is the FDA getting control of vape products?The Tobacco Control Act does not currently cover e-cigarettes, so in April 2014 FDAannounced it was initiating the process of ‘deeming’ e-cigarettes (as well as a several other tobacco products such as dissolvable tobacco, hookah, little and big cigars, and pipes) to be tobacco products under the definition used in the Act – and that process has not yet completed, but it’s how FDA asserts it has powers over vape products.  So you will hear people talking about the ‘deeming regulation’ to refer to the process of bringing e-cigarettes and liquids under the TCA. Once deemed a tobacco product the FDA will start more formally the process to develop a more concrete regime with which to regulate e-cigs and liquids. Under the proposed deeming rule, the FDA will require age restrictions, a warning label, and registration, as well as mandate a pre-market approval process for e-cigarettes (see 6 below) from the outset.
  1. What FDA is proposing sounds terrible, why can’t they do something sensible?Because it is operating under the Tobacco Control Act, FDA can only do what the TCA allows or requires, and no more or less. But the TCA was created when no-one had any idea about e-cigarettes. The TCA was designed with a couple of purposes in mind – to stop innovation in cigarette design on the basis that it might be harmful, and to create a very high bar for demonstrating ‘reduced risk’ products in case these mislead smokers into false sense of security. But these are objective applied to products that are likely to be at least 95% lower risk than smoking amount to a stranglehold on the vastly improved alternative – the opposite of what a sensible regulator would want.
  1. What are the ways that vape or tobacco products can get on to the market?  The TCA allowed any product on the market on 15 February 2007 to remain on the market (this is called ‘grandfathering’.  The vast majority of cigarettes on sale now were waved through because they were on sale in 2007.  For new products or variations on old products made after 2007, the TCA (and hence FDA) provides four routes to market:

6.1 Substantial equivalence. This is a supposed to be a straightforward route to market for products with characteristics that are ‘substantially equivalent’ to a ‘predicate product’ that was on the market at 15 Feb 2007. It might mean some change in formulation, packaging, colour etc. but essentially has same characteristics and doesn’t raise new public health questions. Products announced before 22 March 2011 can stay on the market provided they have made a substantial equivalence application until FDA completes the evaluation.  Given many tobacco products have changed in some way since 2007, there have been over 3,600 applications and there is now a large backlog, casting doubt on whether FDA has regulatory capacity to deal with new categories, like e-cigarettes.

6.2 Exemption from substantial equivalence. For minor changes to existing products.

6.3. Pre-Market Tobacco Application (PMTA). This is for products that are not substantially equivalent. To issue an order, FDA must evaluate that product based on a public health standard that considers the risks and benefits of the product on thepopulation as a whole, including tobacco product users as well as non-users. Note that this has to be done before the product is allowed on the market – and requires an assessment of the positive or negative impact on cessation and initiation.

…the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account–

(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and

(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products

Just imagine what you would have to know to be able to answer this question. The test is virtually impossible to meet for a product that has never been on the market – so models are created to try to show what will happen.  A much better way in my view would be to allow products onto market based on their individual risk, and then monitor for adverse population effects – but that is not what the TCA says.

6.4. Modified Risk Tobacco Product (MRTP). This is the route used if the manufacturer wants to make a claim of reduced risk in some way. This is like the PMTA but with the added burden of showing that the health claim is true and won’t have unintended consequences.  There is only one product that has attempted this – Swedish Match has submitted 130,000 pages of evidence to show that snus is less harmful than smoking – something everyone knows.  The main aim of SM is to get warnings removed for which there is no evidence and to change the generic warning:

Current label
Warning: this product is not a safe alternative to smoking

Requested
Warning: no tobacco product is safe, but this product presents substantially lower risks to health than cigarettes

Amazingly, this change is totally opposed by the US public health establishment and FDA’s ‘independent’ Tobacco Products Scientific Advisory Committee (TPSAC) and there is a legal consortium that has vowed to challenge it.  In my view, the MRTP approach is nuts: it means consumers only get realistic risk information if a tobacco company finds it commercially worthwhile to go through this process, and then public health will always it. Nothing is done to check whether the existing warning is misleading or causing harm. It’s nuts!

  1. And the problem for vape products is…? The problem with this framework is that e-cigarettes barely existed in 2007 – so the substantial equivalence route is closed. That leaves them with PMTA.  Consumer advocates argue that this route is so onerous and costly in terms of its evidence and paperwork requirements and compliance costs that it will wipe out almost every product in the US market – see CASAA’s most recent statement  or for those with an iron will, Bill Godshall’s comprehensive case. They are also concerned about the FDA focusing (i.e. banning) flavours and possibly internet sales – or making it difficult. Others argue that FDA did a lot of signaling in their proposed deeming rule that FDA was seeking input on varying pre-market burdens according to inherent product toxicity. But until the final deeming rule is issued, this issue will remain unresolved.
  1. Does anyone have a game-plan? Advocates are trying various ideas – getting an amendment to the 15 Feb 2007 grandfathering date added to a Bill going through Congress (e.g. HR2058); suggesting easing off on enforcement (the proposed rule already included a 24-month delay in enforcement of the PMTA requirement); and hoping that the regulatory scrutiny will stop it somehow (see 9 and 10 below).  Some experts close to the FDA claim they have more flexibility and discretion than appears at first sight. Maybe this is right, but there is little sign of much flexibility so far – and it will be partly hemmed in by threats of legal action and political pressure from every direction.
  1. Where are we in what seems like a never-ending process? The process of regulatory scrutiny is very demanding in the US – and the FDA treads very carefully because it expects legal challenges and needs watertight decisions (nothing like the EU!).. The deeming regulating and final rule is now in stage-8 of that 9-stage process.

FDA process

In October 2015, the regulation was sent to the Office of Information and Regulatory Affairs(OIRA) at the Office of Management and Budget (OMB) for review – these are the best thought of as the President’s ‘enforcers’ on good quality regulation and sensible spending.

  1. What does OIRA/OMB do and why is it taking so long? It is possible (I have no inside knowledge) that the announcement is imminent or that the FDA is having  trouble in clearing OMB/OIRA.  In other words, OMB/OIRA might be agreeing with e-cigarette advocates’ concerns that costs and detriments will vastly exceed the benefits.  It is supposed to apply the criteria in two presidential executive orders to decide if this is good regulation. These are:

Executive Order 12866, “Regulatory Planning and Review” 1993 establishes and governs the process under which OIRA reviews agency draft and proposed final regulatory actions. It requires an analysis of the costs and benefits of rules and, to the extent permitted by law, action only on the basis of a reasoned determination that the benefits justify the costs.

Executive Order 13563 “Improving Regulation and Regulatory Review” 2011 updates this, but does not fundamentally change the underlying principles: it points to the need for predictability and for certainty, and for use of the least burdensome tools for achieving regulatory ends. It indicates that agencies “must take into account benefits and costs, both quantitative and qualitative.” It asks agencies “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” It also authorizes agencies to consider, and discuss qualitatively, “values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts.”

These ought to be enough to stall or scupper the rule if it is bad as advocates say – but there is inevitably politics behind this. I’m advised not to believe any rumours:  as one expert put it, “anyone who knows isn’t talking and anyone talking doesn’t know”.

  1. When will this all actually affect the businesses and products?  When and if the rule is published, there will be probably two years until it comes into effect (2018) – but we won’t be sure about that until it’s out. In other words, it will have taken 10 years to make any meaningful regulations about e-cigarettes. And there may be legal challenges or even political changes of direction that could take longer.
  1. Is there a better way?

12.1 Do nothing. The status quo would be an enormous improvement on everything under consideration. That is because there isn’t a serious problem for regulators to address and benefits of the products are large. How about simply never publishing the deeming rule?

12.2. Consumer protection framework. A variation on ‘do nothing’ is to regulate vape products as consumer products, at least until Congress had provided FDA a legal framework fit for purpose, which the current TCA isn’t. This would have meant no deeming regulation and supervision by default by the Consumer Products Safety Commission, which has general product safety responsibilities – and could deal with electrical, mechanical, and thermal safety, child resistent containers, warning labels etc.

CPSC is charged with protecting the public from unreasonable risks of injury or death associated with the use of the thousands of types of consumer products under the agency’s jurisdiction. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $1 trillion annually. CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard.

12.3. Give FDA new law fit for purpose? In an ideal world, health advocates would have lobbied Congress for a purpose built legislation that would have securred a framework for proportionate and non-discriminatory risk-based regulation that wouldn’t wipe the industry out as part of trying to make it safer – see my notes on regulating new and disruptive technologies. Instead, I think they like FDA regulation under the TCA precisely because it is so damaging. In that mindset, heavy regulatory burdens are a benefit, not a cost.

12.4. Same law but FDA is smarter with it. Optimists claim that FDA can do it all under the TCA, just by ‘being smarter’ and finding a legally watertight way to reduce the pre-market burdens to some acceptable proportional level.  In theory OIRA/OMB should require that from FDA, so perhaps that is a better option than FDA critics recognise.

In all scenarios, CDC and its state-level equivalents should stop deceiving the American public and start communicating relative risk honestly – something they could learn from England.

  1. Can you just summarise all that? The basic problem is that the Tobacco Control Act was set up to do something completely different – opposite in fact – to what consumers and public health need for e-cigarettes. The FDA has to apply it and can’t do that much with it – even if it wanted to, which is far from clear. This form of regulations creates really high barriers to entry (suits the cigarette trade); puts a brake on innovation (suits the cigarette trade); will dramatically reduce competition in the e-cigarette industry (suits the cigarette trade); and favours the e-cigarette business model favoured by the tobacco industry – bricks and mortar high volume simple products (suits… ).

E-quitting

e-cigarette.web

A five-year, first-in-Canada study, led by McGill cardiologist Dr. Mark Eisenberg, is exploring whether vaping really is the magic ticket to finally breathing free and easy.

By James Martin

Although the holidays may seem like a distant memory, statistically speaking, most of us are still sticking with our New Year’s resolutions. (For now. Let’s not talk about how many of us last until July.) For many, that means quitting smoking — and they’re hoping that electronic cigarettes will help. According to the U.S. Centers for Disease Control and Prevention, nearly half of all American smokers have tried e-cigarettes to help them kick the habit. But Dr. Mark Eisenberg wants to know: Is vaping really the magic ticket to breathing free and easy?

Dr. Eisenberg is passionate about getting people to butt out. He gives a lot of smoking cessation talks — just last month, he spoke at the Jewish General Hospital, where he is staff cardiologist — and has noticed that, invariably, reformed smokers come up to him afterward to sing the praises of e-cigarettes, those increasingly popular handheld battery-operated vaporizers that mimic conventional cigarettes.

“This is just a first step," says Dr. Mark Eisenberg of his five-year study." But the fact is that smoking is still the single most reversible cause of mortality in Canada — so it’s an important first step.”

“They say, ‘I smoked for decades and I’ve tried everything — nicotine gum, patches, Zyban, Champix — and I couldn’t stop. Then I picked up an e-cigarette and I never smoked again,’” recalls Eisenberg, who is also a professor in McGill’s Faculty of Medicine and director of the Joint MD/PhD program. “Anecdotally, we have many, many cases like this.”

What doctors don’t have, however, is hard data to back it up. That’s why, this month Eisenberg will start a five-year clinical trial to look at how effective e-cigarettes are at aiding smoking cessation. It’s not just smokers and physicians who are interested in such clarity — so are lawmakers. Under Canada’s Food and Drug Act, e-cigarettes containing nicotine cannot be imported, advertised or sold without Health Canada’s approval; nicotine-free e-cigarettes are not restricted. Although Health Canada has yet to grant such approval, nicotine-loaded e-cigarettes are nevertheless widely and openly available in Canada.

The study, which is funded by the Canadian Institutes of Health Research (CIHR), will follow 486 outpatient smokers at 19 sites across Canada. The smokers will be randomized into three groups. One group will be given e-cigarettes that contain nicotine and counselling. The second group will receive e-cigarettes that do not contain nicotine, and counselling. The third group will only receive counselling. The researchers will supply the smokers with e-cigarettes for 12 weeks, and then follow up with them after six months and a year, observing whether they graduate to total non-smoking, continue with the e-cigarettes, or return to conventional cigarettes. Although some reformed smokers may fall off the wagon after a smoke-free year, Eisenberg clarifies that “statistically significant results at 12 months would still be important evidence” for the efficacy of e-cigarettes as a cessation aid. All 486 patients will not be enrolled simultaneously, with the study expected to roll out over the course of five years.

“The ultimate goal is to use the e-cigarette as a transitional tool in going from smoking conventional cigarettes to not smoking at all,” says Eisenberg. He notes that, at least in the early stages, e-cigarettes are about “transferring the addiction. You’re getting people onto something else that is giving them their nicotine, so they may never quit. E-cigarettes also provide other physical and social aspects because they feel like a cigarette; a pack-a-day smoker makes that hand-to-mouth motion more than 70,000 times a year, for example. That’s a difficult thing to break away from, and a nicotine patch doesn’t provide it.

“We have great hopes that e-cigarettes will be helpful for people trying to quit smoking,” he adds. “Even if they just switch to smoking e-cigarettes that would be better than continuing to smoke conventional cigarettes for decades. I’m not saying that e-cigarettes are safe, but they’re much safer than conventional cigarettes. They’re not going to give you lung cancer. They’re not going to give you heart disease. They’re not going to give you emphysema.

“But what we’re really hoping for is that e-cigarettes lead people to not smoking altogether.”

(This particular study, Eisenberg notes, is not designed to investigate safety concerns, such as whether e-cigarette vapour contains trace elements of harmful substances. Other than their smoking habits, the trial’s participants are healthy, he explains, “so the chances that they’d have adverse effects over a short time like the course of one year are quite low.” The researchers will, however, track whether the smokers are hospitalized for any cardiopulmonary issues. They will also gather data about benign side effects, such as throat irritation.)

E-cigarettes are already big business, ringing up an estimated $500-plus million in sales in the U.S. alone — and that’s without being able to make any claims about helping smokers kick their habits. Eisenberg says that the e-cigarette industry itself isn’t clamouring to make such claims: “They don’t want to be regulated by the Food and Drug Administration [in the U.S.] and Health Canada, so they don’t want to support clinical trials,” he says. “And they don’t need to: Smokers are voting with their feet by buying e-cigarettes to help them quit smoking.” Governments, however, want more than anecdotal evidence.

“This study alone would not be enough for Health Canada to allow companies to market e-cigarettes as smoking cessation aids,” explains Eisenberg. “That said, if this trial shows that there is a substantial reduction in smoking traditional cigarettes, then Health Canada will have to rethink their policy.

“This is just a first step. Then we would need multiple big trials in multiple populations. We would need to use tapering [of nicotine levels] studies, and we would need to use interventions that are longer than 12 weeks. But the fact is that smoking is still the single most reversible cause of mortality in Canada — so it’s an important first step.”

Posted on Wednesday, February 3, 2016

Do e-cigarettes make it harder to stop smoking?

File picture taken on May 25, 2009 in Beiijng shows the inventor of the electronic cigarette, Hon Lik

People trying to give up smoking often use e-cigarettes to help wean themselves off tobacco. Most experts think they are safer than cigarettes but a surprising paper was published recently – it suggests that people who use e-cigarettes are less successful at giving up smoking than those who don’t.

“E-cigarettes WON’T help you quit,” reported the Daily Mail. “Smokers using vapers are ‘28% less likely to ditch traditional cigarettes,'” read the paper’s headline.

The story was reported on many other websites around the world, including CBS: “Study: E-cigarettes don’t help smokers quit,” it said.

The study causing the fuss was written by researchers at the Center for Tobacco Control Research and Education at the University of California, and published in one of the Lancet’s sister journals, Lancet Respiratory Medicine.

It is a meta-analysis, which means the authors reviewed the academic literature already available on the topic. They sifted out the weaker papers – ones that didn’t have control groups, for example – and were left with 20.

E-cigarettesImage copyrightiStock

The conclusion? Smokers who use e-cigarettes have a 28% lower chance of quitting than smokers who don’t use them, according to Prof Stanton Glantz, one of the authors.

But while the conclusion is surprising, so is the number of academics who have criticised the paper.

One was Ann McNeill, professor of tobacco addiction at Kings College London, whose own research is included in Glantz’s analysis.

“This review is not scientific,” she wrote on theScience Media Centre website.

“The information… about two studies that I co-authored is either inaccurate or misleading… I believe the findings should therefore be dismissed.

“I am concerned at the huge damage this publication may have – many more smokers may continue smoking and die if they take from this piece of work that all evidence suggests e-cigarettes do not help you quit smoking; that is not the case.”

Prof Peter Hajek, director of the Tobacco Dependence Research Unit at the Wolfson Institute also called the findings “grossly misleading”.

e-cigarettesImage copyrightiStock

The critics are making three main points. First, the definition of e-cigarettes is a bit loose. There are many different types – some look like cigarettes, others have tanks for the vaping liquid, some are disposable and other are multi-use. They all deliver different doses of nicotine. Many of the papers included in the analysis don’t specify which type people are using, according to Linda Bauld, professor of health policy at the University of Stirling.

Another point is that the studies vary in the way they measure how often people use e-cigarettes. “Some only assessed whether a person had ever tried an e-cigarette or if they had tried one recently, not whether they were using it regularly or frequently,” Bauld says.

Even the paper’s author admits it’s possible that in some of the studies e-cigarettes may only have been used once, which he says would not be a good predictor of whether they had affected people’s ability to stop smoking.

And there is another problem. You might expect, if you were going to draw conclusions about how useful e-cigarettes are in helping people quit, to focus on studies looking at people who are trying to give up.

Prof Robert West, who heads a team at University College London researching ways to help people stop smoking, says this analysis mashed together some very different studies – only some of which include people using e-cigarettes to help them quit.

Vape Lab employee uses an e-Cigarette while workingImage copyrightGetty Images

“To mix them in with studies where you’ve got people using an e-cigarette and are not particularly trying to stop smoking is mixing apples and oranges,” he says.

Some of the studies track smokers who use e-cigarettes for other reasons – perhaps because smoking a cigarette in a bar or an office is illegal and they want a nicotine hit.

“With the studies where people are using electronic cigarettes specifically in a quit attempt the evidence is consistent,” says West, referring to two randomised control trials.

Both are quite small and one was funded by the e-cigarette industry. They took two groups of smokers, and gave one real e-cigarettes, and the other a placebo. The studies reach a broadly similar conclusion to a large, real-world study called the Smoking Toolkit run by West.

West’s investigation follows people in their daily lives and assesses how successful various methods of giving up smoking are – this includes nicotine patches, medicines and going cold turkey.

These studies suggest that people using e-cigarettes to help them quit are 50% to 100% more successful than those who use no aids at all.

In his paper, Glantz acknowledges there are limitations to the research that he analysed. He agrees there are problems with the way the use of e-cigarettes is measured and accepts it’s not clear which devices people are using. But he is sticking by his analysis because he believes he has taken these factors into account.

The editor of Lancet Respiratory Medicine, Emma Grainger, defends the article too. She says she does not see a problem with the paper and that it has been through the normal peer-review process.

VapeCon International Expo in Riverside, CA (VC Official Recap)

Published on 22 Jan 2016

Vape Capitol’s Official Recap of VapeCon International in Riverside , CA.

Headlines about e-cigarettes don’t mean they’re ‘not safer than tobacco’

If your New Year’s resolution was to stop smoking, and you were looking for support to help you quit, then recent headlines suggesting e-cigarettes ‘aren’t any safer than tobacco’ might have raised an eyebrow or two.

Since Christmas, we’ve seen three sets of critical headlines about e-cigarettes, each looking at a different aspect of a device now used by millions across the UK.

But how accurately do these stories reflect the scientific evidence? What do we really know about how safe e-cigarettes are? Can they really help you quit? And do candy flavours attract kids?

If you were to go on the media reports alone, you’d be forgiven for being alarmed.

But as is so often the case in the reporting of science and risk, taking a deeper look behind the headlines reveals a very different story.

Just because they’re not “safe” doesn’t mean they aren’t “safer”

The first study to make the headlines suggested that e-cigarettes were ‘as harmful as tobacco’. After studying cells in the lab, the researchers found some indications of increased levels of DNA damage and cell death in those treated with e-cigarette vapour.

This led one of the researchers to tell the media, “I believe [e-cigarettes] are no better than smoking regular cigarettes.” (More on this statement below).

The most important thing to remember here is that this was a study looking at the effect of chemicals on cells in a lab. Although this can be useful, it obviously can’t give a clear idea of what the impact would actually be in your body. So any claims of impact on health based only on lab studies will always be far-fetched.

The study also looked at an extremely high concentration of vapour. As the researchers admitted at the time, “it was similar to someone smoking continuously for hours on end, so it’s a higher amount than would normally be delivered.”

It boils down to this: the study showed that it might be worse for your cells to be exposed to e-cigarette vapour than the air in a lab. So e-cigarettes might not be 100 per cent harm free. Andprevious studies have shown there may be some dangerous chemicals present in vapour – so this isn’t a surprise. And there’s little in life that really is ‘safe’ – even drinking too much water can kill you.

But here’s the big caveat. The researchers also treated some cells with tobacco smoke. These died within 24 hours. Those treated with e-cigarette vapour were still alive to experiment on 8 weeks later.

So, contrary to the headlines, this study actually suggests that using e-cigarettes may be far less dangerous than smoking.

You’d never believe that from the headlines though.

There were a few great critiques published shortly afterwards, (notably this one in the Guardian) and the press release was amended (more than a week later) to include the following correction:.

Contrary to what was stated or implied in much of the news coverage resulting from this news release, the lab experiments did not find that e-cigarette vapor was as harmful to cells as cigarette smoke. In fact, one phase of the experiments, not addressed in the news release, found that cigarette smoke did in fact kill cells at a much faster rate. However, because similar cell-damage mechanisms were observed as the result of both e-vapor and regular cigarette smoke, Dr. Wang-Rodriguez asserts, based on the evidence from the study, that e-cigarettes are not necessarily a healthier alternative to smoking regular cigarettes. As stated in the journal paper and the news release, further research is needed to better understand the actual long-term health effects of e-cigarettes in humans.

But we’re concerned that, as far as public perception goes, the damage may already have been done.

How can you tell if something helps people quit?

So the scientific evidence on e-cigarette vapour to date suggests it’s far safer than tobacco smoke.

But can e-cigarettes actually help you quit?

Here we come across the second set of unfortunate stories, after a systematic evidence review and meta-analysis published last week claimed that those using e-cigarettes seemed to be less likely to quit smoking than those not using the devices.

But, again, there are a number of serious problems with the review.

Systematic reviews and meta-analyses are usually extremely useful, because they pull together all the evidence in one area, to paint a fuller picture than one study alone.

However the relationship between this picture and reality depends entirely on the quality and relevance of the original studies that are included. In this case, since there haven’t been many high-quality trials exploring whether e-cigarettes help people quit smoking, the researchers included a range of different types of studies.

The gold standard of evidence is the randomised control trial, which, in this case, would compare a group of smokers trying to quit using a nicotine-containing e-cigarette, to a similar group using nothing (or an e-cigarette without nicotine). But here’s the problem – there have only been two published studies like that.

A 2014 meta-analysis of these found people using nicotine via an e-cigarette were more likely to successfully quit than those using e-cigarettes without nicotine.

Last week’s review included both of these randomised trials alongside a range of other ‘real-world’ non-trial studies of e-cigarette use. This is a big problem. Whatever their strengths individually, these studies didn’t use consistent measurements – neither of e-cigarette use, nor of whether people had actually quit – so the studies aren’t necessarily comparable. And so including them together in a meta-analysis is questionable, at best.

Even so, when the analysis only included studies where people were actively trying to quit (as opposed to using e-cigarettes for other reasons) the results became inconclusive – people who said they’d ‘ever’ used an e-cigarette weren’t any more or less likely to succeed.

Furthermore, some of the studies included only looked at current smokers and asked about e-cigarette use. This would exclude anyone who had used an e-cigarette but successfully stopped smoking.

Quitting smoking can be incredibly hard. Someone trying an e-cigarette once probably wouldn’t have any better chance than if they hadn’t. Whatever support aid is used it would need to be as part of a concerted quit attempt and used enough to deliver sufficient nicotine to wean yourself off tobacco, and preferably alongside specialist support from a Stop Smoking Service to get the best possible chance of quitting.

E-cigarettes aren’t a magic bullet, but that doesn’t mean they couldn’t be a useful weapon in our arsenal against tobacco. The evidence for quitters using these products both within the Stop Smoking Services and without points towards this being the case in the UK.

The impact of advertising and flavours on kids

Whether or not they’re ‘safe’, or help people quit, another big concern about e-cigarettes is that they could encourage children to start smoking – either by exposing them to nicotine (the ‘gateway’ argument) or by making smoking seem more normal again (the ‘renormalisation’ argument).

The first of these arguments isn’t supported by the evidence to date: surveys across the UK last year found that young people who hadn’t smoked weren’t using e-cigarettes.

But a small study published this week found young people rated printed adverts with flavoured e-cigarettes more appealing than those without flavours, leading to headlines suggesting children are being lured in with sweet flavours.

But when you dig into the detail, again it’s a more complex picture – the young people in this study, including those who saw the flavoured e-cigarette adverts, had negative views about e-cigarettes, and said they didn’t intend to buy them. And, perhaps more importantly, it didn’t find any evidence that e-cigarette adverts increase the appeal of regular cigarettes.

There are now measures in place to protect young people (e-cigarettes cannot be sold to under 18s, and further legislation heavily restricting advertising will come into force in May) but it’s still important to continue looking at how e-cigarette adverts might appeal to children, and to track use of both e-cigarettes and tobacco cigarettes to make sure there isn’t a negative impact from these products.

However, Linda Bauld, Professor of Health Policy at the University of Stirling (and our Cancer Prevention Champion), said the study “should provide some reassurance to those who say that e-cigarette advertising will result in a new generation of tobacco smokers.”

Where does this leave us?

When you look at the bigger picture, rather than the headlines, the evidence so far actually points towards a positive role for e-cigarettes in helping combat the biggest preventable cause of cancer. However none of the questions posed here – on safety, effectiveness and impact on children – have full answers.

As we’ve said before we need years of good quality science before we can definitively answer these questions, and at Cancer Research UK we are working towards that. But for now the evidence we have suggests e-cigarettes are far safer than smoking tobacco, they might help you quit and non-smoking children aren’t being lured into using them regularly.

While the evidence on e-cigarettes continues to accumulate, and the media controversy rages on, if you’re looking for evidence-based inspiration to quit smoking in 2016, speak to your GP or localStop Smoking Service, or check out our website… but maybe keep reading the headlines with an appropriate dose of scepticism.

Nikki Smith is a senior health information officer at Cancer Research UK

http://scienceblog.cancerresearchuk.org/2016/01/20/headlines-about-e-cigarettes-dont-mean-theyre-not-safer-than-tobacco/

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Another View: Taxing e-cigarettes will backfire on public health

A man exhales vapor from an e-cigarette in New York. There are moves in California to tax and regulate e-cigarettes the same as tobacco products.