By Lydia Wheeler – 10/23/15 02:44 PM EDT
The Food and Drug Administration (FDA) has sent its final rule to regulate additional tobacco products, including electronic cigarettes and cigars, for White House review.
The rule, which was first proposed more than a year ago, was sent to the White House Office of Management and Budget’s Office of Information and Regulatory Affairs on Monday, but it could be weeks before the rule is actually released.
FDA spokesman Michael Felberbaum said the Office of Management and Budget is required to review all significant regulatory actions and has 90 calendar days to do so.
“However, this timeframe can be extended to allow for additional interagency discussion,” he said. “At this time, the FDA cannot provide any further comment until the final rule is published.”
The American Lung Association is hoping for an expedited review.
“We remain deeply troubled that it’s taken 18 months from the time the proposal was released to now,” said Erika Sward, the group’s assistant vice president of national advocacy. “We need to move forward in protecting kids and public heath.”
Sward said the lung association is hoping the final rule will give FDA the authority to truly regulate all tobacco products. Under the proposed rule, she said, there was a loophole for certain “premium” cigars.
“There’s no such thing as a safe tobacco product and certainly not a safe cigar,” she said. “FDA needs to have the basic authority over all tobacco products to make sure kids aren’t buying them and warning labels are required.”
E-cigarettes are used by millions in the UK, but information about them is sometimes conflicting. So what is the current evidence on them?
The panel was unanimous: e-cigarettes may not be the key to reducing smoking, but they are certainly an important part of the solution. Photograph: Yui Mok/PA
It has been described as a ‘disruptive technology’ potentially capable of breaking our fatal relationship with tobacco. So the setting for a public debate on e-cigarettes – a museum part-funded by the tobacco industry, in a city home to the global headquarters of one of the largest tobacco manufacturers – was perhaps ironic. Yet on Wednesday evening, I found myself at the M-Shed in Bristol, watching just that: a debate about whether e-cigarettes could be part of the solution to the tobacco epidemic.
To mark the launch of a new Integrative Cancer Epidemiology Programme, linked to the Medical Research Centre Integrative Epidemiology Unit at the University of Bristol, Professor Marcus Munafò (Professor of Biological Psychology at the University of Bristol) and Professor Linda Bauld (Professor of Health Policy at the University of Stirling), both collaborators of mine, discussed e-cigarettes. Professor Gabriel Scally (Public Health Doctor and former Regional Director of Public Health for the South West of England) chaired the discussion.
Billed as a debate about whether e-cigarettes might be ‘the key to reducing smoking’, some in the audience may have expected a heated discussion. However, with this line-up of academics, influential in the fields of public health, tobacco and addiction, the discussion was evidence-based and measured. As for the motion of the debate, the panel was unanimous: e-cigarettes may not be the key to reducing smoking, but they are certainly an important part of the solution.
This may be surprising to some, given ongoing discussions surrounding e-cigarettes in the media. So what is the current evidence on e-cigarettes?
Although we don’t know the long-term health effects of e-cigarette use, they’re less harmful than cigarettes
Pretty much everything is safer than cigarettes. There is no other consumer product, which, when used as the manufacturer intends, kills every other user, taking from them an average of 10 years of healthy life.
It’s been said that “people smoke for the nicotine, but die from the tar”. E-cigarettes present a solution to this problem by providing a ‘clean’ (or cleaner) method of nicotine delivery. They deliver nicotine in a similar way to a cigarette (and much faster than other forms of nicotine replacement therapy; NRT), but don’t contain the other chemicals that ultimately kill cigarette users.
A recent Public Health England report stated that e-cigarettes are 95% less harmful than cigarettes, a controversial figure. However, as Linda pointed out, it’s almost irrelevant whether e-cigarettes are 95%, 90% or even 80% less harmful than cigarettes. What’s important, is that they are less harmful.
There’s no evidence e-cigarettes are as harmful as smoking
Yes, there are still some concerns about e-cigarettes and increasing levels of confusion and misinformation among the public around them. Evidence suggests that both adults and teenagers are more likely to report that e-cigarettes are equally harmful as cigarettes today, than they were a few years ago. Both Marcus and Linda speculate that these views may have been shaped by media reports fueled by disagreements between academics.
Horror stories of children drinking the liquid nicotine (a problem which can be alleviated by having stricter controls on safety caps) and fires and accidents caused by exploding devices (the frequency of which is still far lower than the risk of fire posed by cigarettes) have been reported in the media. There are ongoing concerns about the chemicals produced when e-cigarettes are used, some of which are the same as the dangerous chemicals found in burning cigarettes (although the amount of these chemicals is a tiny fraction of the amounts found in cigarettes). Finally, we can’t yet be certain about the long-term health consequences of vaping, simply because people haven’t been using them for long enough to know (just like we didn’t know for decades that cigarettes definitely caused lung cancer).
For these reasons, we should be careful to ensure that children and non-smokers don’t start using e-cigarettes – currently there is very little evidence that these groups are regularly using the devices. However, most academics and public health officials are in agreement that for current smokers, e-cigarettes are a safer alternative to smoking.
E-cigarettes can be an effective method of stopping smoking
Linda presented evidence on the effectiveness of e-cigarettes for smoking cessation. E-cigarettes seem to be somewhere in the middle of the range when it comes to helping smokers quit. Some studies show that they are more effective than either willpower alone or NRT bought over the counter, but less effective than behavioural support.
The type of e-cigarette used matters too. The early models (‘1st generation’ or ‘cigalike’ models) don’t seem to be very effective methods of smoking cessation – interestingly, these are predominantly the models being bought up by the tobacco industry. The 2nd generation e-cigarettes and tank models (which can be refilled with liquids) seem to lead to higher levels of quitting success.
The sheer reach of e-cigarettes is their most powerful weapon. While behavioural support for cessation, combined with NRT or varenicline, has been underused by smokers wanting to quit, the rise of e-cigarette use over the past five years has been unprecedented. There are now an estimated 2.6 million vapers in the UK. With such a large numbers of users, even modest levels of smoking cessation success from their use will have a large impact on cessation rates.
E-cigarettes are a consumer-led revolution
The speed of the e-cigarette revolution and its ability to galvanize a whole community of individuals who now define themselves as ‘vapers’ is impressive. Never before has a route out of smoking garnered as much support from its users. As far as I know, there are no online forums for nicotine patch users to discuss optimal patch placement, no celebrity endorsements for nicotine lozenges and no users of nicotine nasal sprays challenging European Union Directives.
Many vapers feel passionately that e-cigarettes have enabled them to quit smoking. Indeed, a passionate crowd was in attendance at the debate. When asked at the beginning to raise their hands if they had ever tried an e-cigarette, over half of the audience did so. This is in comparison to population surveys that report 1.5%, 16.5% and 58.5% rates of ever use among non-smokers, ex-smokers and daily smokers respectively.
The last question in the debate came from a member of the public who defined himself as a ‘vaper and ex-smoker’. He expressed his dismay that new the EU Tobacco Products Directive (TPD – due to come into force in May 2016) will impose strict regulations on e-cigarettes, including bottle sizes, tank sizes and nicotine strength. In order to continue selling e-cigarettes not meeting these new regulations, retailers can instead apply for their products to be registered as medicines. But this is an extremely costly route, likely to be impractical for the majority of e-cigarette retailers other than the incredibly wealthy tobacco industry. The TPD is currently being challenged by one e-cigarette retailer. However, if it goes ahead, there are concerns from vapers and those in the public health community, that it may mean the end of vaping as we know it.
Arguably one of the reasons why e-cigarettes are so popular is that they reflect a consumer-led revolution, built from the ground up. Users can personalise their product, and many see vaping as a lifestyle choice rather than a smoking cessation aid or a medicine. If strict regulation means fewer smokers switch to using e-cigarettes, this could be a huge public health opportunity missed.
Olivia Maynard is a tobacco researcher at the University of Bristol. You can find her on twitter @oliviamaynard17.
A group of researchers may have cooked the books to show that vapor exhaled from e-cigarettes is more dangerous than it actually is.
A paper published in the Current Environmental Health Reports found that “secondhand” exposure to exhaled e-cigarette vapor is toxic because it contains particulate matter, which can pose a risk to the respiratory system.
Anti-smoking advocates, doctors and the American Vaping Association claim the report is totally bogus. According to the critics, the study found essentially no difference between the amount of particulate matter in a house with active vaping and homes that were both totally vape and smoke-free.
The observational study found that the home containing tobacco smoke had levels of PM2.5 60 times greater than the homes with and without vaping. The results showed that the home with vaping measured 9.88 micrograms per cubic meter of air.
Read more: http://dailycaller.com/2015/10/14/scientists-accused-of-cooking-the-books-to-produce-toxic-e-cigarette-study/#ixzz3pLrAgF1r
The two homes with no vaping or smoking at all recorded PM2.5 levels of 9.53 and 9.36. The house with tobacco measured PM2.5 of 572.52 per cubic meter.
Dr. Michael Siegel, Professor at the Boston University School of Public Health, wrote on Tobacco Analysis:
The truth is that exposure to the e-cigarette aerosol is no more ‘toxic’ than baseline exposure in a completely smoke-free, vape-free home. In other words, in terms of fine particulate matter exposure, secondhand vaping appears to represent no risk.
Siegel added that “it has the appearance that because the results didn’t come out the way the authors wanted it to, they misreported the conclusion to conform with what was apparently their predetermined conclusions against e-cigarettes.
Read more: http://dailycaller.com/2015/10/14/scientists-accused-of-cooking-the-books-to-produce-toxic-e-cigarette-study/#ixzz3pLru8YQS
It’s no secret that smoking tobacco isn’t great for your health. But when it comes to the world of insurance, it’s always been a little more complicated.
When you’re young, and buy your first life insurance policy, being a smoker can be costly. In fact, it’s likely to double your premiums. Same goes for any other kind of protection insurance – like critical illness cover or income protection.
But if you make it all the way to retirement as a smoker, it finally starts to pay back in your favour. Smokers can buy a better retirement income than their clean living peers.
The real reason my home insurance premiums jumped 23pc
As always, these prices are driven by statistics. Life insurance is more costly as a smoker because you’re more likely to die while your policy’s in force. And for exactly the same reason, pension companies will offer you more in retirement – because they expect to be paying it to you for fewer years than someone who doesn’t smoke.
But what about so-called “vaping” and electronic cigarettes? These have been the key to many heavy smokers giving up over the past few years – and a few months back, a UK government study even suggested it is 95% less harmful than smoking regular cigarettes.
So in the face of broadly positive press for e-cigarettes, why is it that the insurance industry has decided that they are just as bad for you as the real thing? What do they know that we don’t?
Take out a life insurance policy today and you’ll almost certainly be asked if you’ve “smoked any tobacco products over the past 12 months (including e-cigarettes)”. It’s a yes or no answer – and if you answer yes, your premium will be twice as expensive.
If the life insurers were able to base their decision in statistics – this decision may be more defensible. But given that they don’t even ask people to specify whether they vape or smoke – they don’t even have the data. Not to mention the fact that e-cigarettes have only been around for about a decade – which isn’t enough time to compile any meaningful results.
It’s hard to see this as anything other than a cynical ploy to pocket a few extra quid
This is not the only anomaly to be found in a life insurance application form. Insurers routinely ask questions about alcohol consumption, family health history, and even your waist line. These are fairly intrusive questions – but are perhaps fair enough in terms of the clear links between these factors and an individual’s mortality. But insurers also ask if you’ve ever suffered from “stress”. Anyone who answers no to that question is surely not being honest with themselves. But anyone who answers yes may find their premium pushed up – as they’re shoved into the mental health problems bucket.
It’s time for the regulator to take a look at the way insurers set their prices – not just in life insurance, but in all areas of insurance. There are too many areas where the evidence is simply not clear enough to justify the way that insurers choose to treat prospective or even existing customers. One of my greatest bugbears is an insurer’s right to put your car insurance premium up if you’re involved in an accident that wasn’t your fault. Regardless of whether the statistics justify their reasoning, it’s simply not fair play.
James Daley is the founder and managing director of Fairer Finance (fairerfinance.com), the consumer group and financial ratings website. He is also a regular pundit on the BBC One shows, Rip-Off Britain and Watchdog, and a former editor for the consumer group Which?. Follow him on Twitter @fairerfinance
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