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

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Viewpoint: Are e-cigarettes really a menace?

Michael Mosley vaping

E-cigarettes, devices that give you a nicotine-hit by heating up a liquid which you then inhale, have become all the rage. But is the concern about them justified, asks Michael Mosley.

A few years ago they were a rarity, but now there are nearly three million e-cigarettes out there. Many people think that they are as bad for you as normal cigarettes. But are they?

I’ve recently spent a couple of months making a documentary about e-cigarettes, trying to find out truth behind the headlines. I took up heavy vaping (that’s what you do when you inhale vapour from an e-cigarettes). I have never smoked anything before and I wanted to see what effects inhaling nicotine in the form of an e-cig would have on a non-smoker. The results surprised me.

Everyone knows that smoking is bad for you and can lead to lung cancer. It also increases your risk of dying from a range of other conditions including heart attack, stroke and dementia. If you’re a man you might like to know (but then again you might not) that smoking is one of the main causes of impotence.

Fans of e-cigarettes say vaping can reduce the burden of smoking either by making it easier for smokers to quit or by providing them with a safer way for them to get a nicotine hit.

Michael Mosley and Hon Lik, the inventor of the e-cigarette
Image captionMichael Mosley and Hon Lik, the inventor of the e-cigarette

Critics, however, say that we are gambling with a technology we don’t understand and that there is no convincing evidence that e-cigarettes help people quit smoking. It may even encourage non-smokers to start.

Some countries have warily embraced e-cigarettes, while others have effectively banned them.

The UK has so far adopted a liberal approach, but on Friday new European legislation will come into force which will limit the size of refills and the nicotine content of the fluids. Vaping will become more restricted.

So, who’s right? Are e-cigarettes one of the greatest public health measures ever invented, with the potential to save millions of lives, or are they just another cunning way to keep us hooked on nicotine? I was keen to find out.

Well the scientific consensus is that vaping, at least in the short term, is a lot safer than conventional smoking. A recent study for Public Health England concluded that e-cigarettes are 95% less harmful than normal cigarettes.

To be honest when I took up vaping I wasn’t that worried about the short term health effects. What I was far more concerned about was getting hooked on nicotine. Yet as the weeks went by and I puffed away, nothing happened. When I leapt out of bed I didn’t feel a longing to reach for my machine. If anything I found it a bit of a chore.

Chatting to experts I discovered, to my considerable surprise, that although cigarettes are highly addictive, nicotine alone may not be. Although no-one knows for sure, research in animals suggests that nicotine is far more addictive when delivered in combination with the other chemicals found in regular cigarettes.

And nicotine in its pure form may have an upside. There’s evidence it can help patients with Alzheimer’s and Parkinson’s disease.

The National Institute on Aging in the US has recently funded a trial of 300 patients with mild cognitive impairment (a precursor to Alzheimer’s). The patients, none of whom are smokers, will be randomly allocated to either nicotine patches or placebo patches. Over the next few years they will have regular health checks, as well as memory and cognition tests.

Michael Mosley
Image captionEverybody agrees that smoking is bad for you

A similar, smaller study, published in 2012, found that non-smokers given nicotine patches saw improvements in memory, attention and reaction times.

But before you start slapping on the patches or firing up an e-cig you should aware that though nicotine may help people who already have impaired memory, there’s no evidence it will help the rest of us. Although I was tested before and after doing a month of heavy vaping, the nicotine didn’t enhance my brain, apart from a small improvement in my fine motor skills.

But the main health justification for e-cigarettes is that they can help those who are keen to quit smoking tobacco, quit. So do they?

There have been very few randomised controlled trials, but the ones that have been done suggest it does.

When Horizon conducted a small study where we randomly allocated a group of hardcore smokers to either e-cigs, nicotine patches or simply giving up (going cold turkey), we found the vapers and those who slapped on the patches were far more successful at abandoning their cigarettes.

E-cigs are not risk free and after a month of heavy vaping there were signs of increased inflammation in my lungs (which rapidly reversed when I stopped). Nonetheless I think that for smokers e-cigarettes could prove to be a game changer.

There is a huge amount at stake. A billion people worldwide spend around £500bn a year on cigarettes and around half of them will die of smoking related diseases. In the UK alone smoking kills around 100,000 a year. Anything which gets people off cigarettes is going to save a lot of lives.

Smoking, cigarettes and vaping: Everything you need to know about the new laws

Cigarettes

New laws are coming in tomorrow which will change the lives of smokers and vapers across Europe.

According to Action on Smoking and Health (ASH) there’s around 10million smokers in the UK and a further 2.6million are puffing on e-cigarettes.

But new rules will be enforced under the Tobacco and Regulated Products Regulations 2016 in the hopes of slashing the number of nicotine addicts by 2.4million.

New laws are coming in tomorrow which will change the lives of smokers and vapers across Europe.

According to Action on Smoking and Health (ASH) there’s around 10million smokers in the UK and a further 2.6million are puffing on e-cigarettes.

But new rules will be enforced under the Tobacco and Regulated Products Regulations 2016 in the hopes of slashing the number of nicotine addicts by 2.4million.

The change affects cigarettes, hand-rolling tobacco and e-cigarettes manufactured for sale in the UK.

All products will have to comply with the regulations from 20 May 2016 but there will be a one-year transitional period while old stock is sold off.

Here’s everything you need to know about the new rules:

CIGARETTES

Standardised plain packaging

In a bid to discourage smokers from being attracted to pretty packaging, all cigarette boxes and rolling pouches will be standardised.

You will no longer be able to spot a pack of Pall Mall from Marlboro and all packets will have the same olive-green colour, opening and font styles.

This means “lipstick-style” packs aimed at women, such as Vogue cigarettes, will also be outlawed.

New cigarette packet design

Graphic health warnings

At least 65% of the packaging on show must be covered with public health warnings, graphic photos and text to demonstrate the damage that smoking does to your health.

On top of the warnings, there’ll be a ban on promotional statements such as “this product is free of additives” or ”is less harmful than other brands”.

Other misleading descriptions such as “lite”, “natural” and “organic” will no longer be allowed.

Ban on 10-packs of cigarettes

All packs must contain a minimum of 20 cigarettes to make room for the health warnings.

Small bags of rolling tobacco will also be banned – with pouches forced to weigh at least 30g while the current smallest pouch size is 8g.

Menthol and flavoured tobacco to become illegal

It’s very bad news for menthol fans because the flavoured fags will be phased out from tomorrow before becoming completely illegal by May 20 2020.

Other flavours which will become extinct in the next four years include fruit, spice, herbs, alcohol, candy or vanilla.

 

Cigarettes

WARNING: All packs will be plastered with health advice

E-CIGARETTES AND VAPING

Smaller, weaker containers

While there’s currently no limitation on the size of refill containers, it will now be capped at 10ml and 2ml for disposable e-cigarettes, cartridges and tanks.

This rule change could have a knock-on effect on the price of each container, as vaping fans will no longer be able to buy in bulk.

Secondly the maximum strength of a vile of vaping liquid will drop to 20mg per ml of nictotine, down from 24mg.

Zero nicotine products are not included in the legislation change.

 

Woman vaping

VAPING: The changes will also affect e-cigarettes

Packaging with health warnings

Similar to cigarettes, electronic fag packaging will also require health warnings.

Around 30% of the packet should be plastered with advice, stating: “This product contains nicotine which is a highly addictive substance.”

E-cigarettes must be childproof

The vaping liquid is potentially dangerous if it’s ingested so new rules state e-cigarettes must be childproof and tamper-proof.

Adverts will change

Under the new laws, e-cigarette companies won’t be able to claim that vaping is beneficial to peoples’ health.

This means they can’t draw comparisons between vaping versus smoking tobacco either.

Celebrities will be banned from endorsing e-cigarettes and free samples won’t be allowed to be given out in promotional campaigns.

Greater government scrutiny

Vaping giants will have to submit information to the government detailing exactly what their products contain before they are allowed to sell them in the UK.

It’s about to become illegal to advertise e-cigarettes

It's about to become illegal to advertise e-cigarettes

It will soon become illegal to advertise most e-cigarettes.

The new law is being brought in as part of the EU’s Tobacco Product Directive, which is coming into force on Friday.

According to new laws being brought in to regulate tobacco sales, any promotion, sponsorship or advertising of e-cigarettes or their refill containers will be prohibited.

The ban will apply to most mainstream media platforms – including the internet, television and radio.

For now adverts on outside posters and on the sides of buses are still allowed, as long as the bus isn’t leaving the UK.

And where ads are permitted, they won’t be allowed to make claims about e-cigarettes helping people to give up smoking.

People say e-cigarettes can help people quit smoking (Picture: Getty Images)

However, there are a couple of exceptions.

Zero nicotine e-cigarettes – for example, 100 per cent herbal vapes – are not covered by the new laws because they’re not tobacco products.

On the other end of the scale, if an e-cig contains more than 20mg/ml of nicotine then, under the TPD, it will need to be medicinally licenced.

Because of this, high-nicotine e-cigs will be regulated by the Medicines and Healthcare Products Regulatory Agency instead, and are subject to the same advertising regulations as over-the-counter medicines.

This means e-cigs with higher than 20mg cannot be endorsed by celebrities, given out as free samples, or marketed to children.

Where can’t I advertise e-cigs?

It will be illegal to advertise e-cigarettes…

  • On broadcast TV as an advert or sponsorship
  • As a product placement on broadcast TV
  • On the radio as an advert or sponsorship
  • On on-demand TV as an advert, sponsorship or product placement
  • In newspapers, magazines and periodicals, except for trade publications and non-EU publications
  • With internet display adverts, over email or by text messaging, except for trade and non-EU publications
  • As an ad or promotion on a company’s own website or on any other non-paid-for online space under their control – however, strictly factual ‘how to’ videos are permitted

Some in the industry think the new regulation on advertising will be excessively restrictive.

Richard Hyslop, chief executive of the Independent British Vape Trade Association, told Metro.co.uk: ‘There is never a situation where it is better to smoke than it is to vape.

‘Vaping is now recognised by the UK Government as the most popular form of support to stop smoking.

‘However, with virtually all forms of advertising for vape products being banned how are smokers to be exposed to vaping?

‘This advertising ban can only result in a situation where fewer smokers make the switch the vaping – a significantly less harmful alternative.’

Where can I advertise e-cigs?

It will still be permitted to advertise e-cigarettes…

  • On blogs, in tweets, or in other independently compiled, non-paid-for reviews
  • In the e-cigarette trade press and in trade-to-trade communications
  • At the cinema
  • In faxes
  • On posters on the sides of buses that are not travelling outside of the UK
  • On leaflets
  • In direct, hard-copy mail

However, others are welcoming the law change.

Brett Horth, CEO of e-liquid manufacturer Vapour Labs, told Metro.co.uk: ‘Whilst the TPD regulations may seem strict to some, we feel it is hugely positive for the industry and we encourage its enforcement today.

‘TV, radio and online advertising has been banned, however outdoor advertising – such as on vehicles or billboards – is still allowed, which provides us with an all-new opportunity!’

 

Smoke and mirrors: the truth about vaping

vaping-thetimes-160517

Horizon: E-Cigarettes: Miracle or Menace?

BBC Two – 9.30pm on Sunday 22nd May 2016 

When the editor of the BBC science series Horizon asked me if I fancied making a programme about e-cigarettes that would involve “vaping” (inhaling nicotine-laden vapour) for a month my initial reaction was: “Hell, no.”

Then I thought about it a bit. I was worried that if I took it up I might get addicted (I’d never smoked), but I was also curious. What would it be like? What effect would it have on me? There has been a huge surge in the use of e-cigarettes over the past couple of years, yet very few studies on the effects of vaping on non-smokers. Time, I decided, to do one, with me as the subject.

I hate cigarettes, really hate them. I’ve never smoked, partly because when I was young I didn’t see the point, but mainly because when I was about 12 my dad offered me £100 if I didn’t smoke before the age of 18. I can’t remember if he ever paid me.

If I was even a little tempted to smoke, going to medical school put me off. One of the first patients I saw was Sarah, a 65-year-old woman who was dying of emphysema, a very common disease of the lungs caused by smoking. Even with an oxygen mask she struggled for breath. She’d been smoking 40 a day since she was 15 and she reckoned that she’d spent about £90,000 on cigarettes (at today’s prices it would be more like £290,000).

I also remember a young man called Alex with Buerger’s disease, a relatively rare condition where you get inflammation and clotting in your arteries and veins. Almost everyone who has Buerger’s smokes, and quitting smoking is the only way to stop it progressing. Despite knowing the risks Alex just couldn’t stop. He eventually developed gangrene and had to have a limb amputated.

Fans of e-cigarettes claim that vaping could help people like Alex and Sarah, either by making it easier for them to quit or by providing a safer way for them to get a nicotine hit. It is said that smokers smoke for the nicotine but die from the tar, so why not give them one and not the other?

Critics, however, say that we are gambling with a technology we don’t understand and that there is no convincing evidence that e-cigarettes help people to quit smoking. It may even encourage non-smokers to start.

There is a huge amount at stake. A billion people worldwide spend about £500 billion a year on cigarettes and about half will die of smoking-related diseases. In the UK alone smoking kills about 100,000 a year. If e-cigarettes take even a small fraction of the cigarette market, that is a lot of money and a lot of lives.

Some countries have warily embraced e-cigarettes, while others have effectively banned them. The UK has so far adopted a liberal approach, but in a few days’ time there will come into force European legislation that will limit the size of refills and the nicotine content of the fluids. Vaping will become more restricted.

So who’s right? Are e-cigarettes one of the greatest public health measures invented, with the potential to save millions of lives, or are they just another cunning way to keep us hooked on nicotine? I was keen to find out.

I started by having a range of physical and mental tests, including cognitive tests such as reaction times, then headed for my nearest e-cigarette shop. They come in lots of different shapes and sizes but all work on the same principle: there’s a battery that powers a heating element, a coil. There’s a chamber into which you pour your “e-liquid” which usually, but not always, contains nicotine. The heat from the coil turns the liquid into vapour, which you then inhale. There’s no burning and therefore fewer noxious chemicals involved. The e-liquids come in many flavours, from pina colada to menthol. I went for mint.

I bought a nice, geeky-looking device, with a big, shiny canister and lots of buttons. Then I went home to start vaping. I’d been given a schedule that began gently, then rapidly built to the point where I was taking about 120 puffs a day at a moderately high nicotine dose (the equivalent of a heavy smoker trying to give up). The plan was to do this for a month.

Initially I did a lot of coughing and found the head rush unpleasant, but after a while I started to enjoy the experience. It was a bit like having a very strong cup of coffee, except the effects were almost instantaneous. Blowing smoke was also fun, in an adolescent sort of way, though my friends and family were not impressed.

What was vaping doing to my body, though? According to some scientists, quite a lot of damage. In a recent widely reported study ominously titled Electronic cigarettes induce DNA strand breaks and cell death, researchers found evidence that e-cigarettes are “as harmful as tobacco”.

Addictive or not, it seems nicotine by itself is not that bad for you They took human epithelial cells, the sort that line your mouth, trachea and lungs, and exposed them to vapour from e-cigarettes. Some of this vapour had nicotine in it, some didn’t. When they examined the cells afterwards they found DNA damage and cell death. Although there was more damage in the cells exposed to nicotine-laden vapour, it was still detectable in the nicotine-free vapour. This was the sort of damage that, according to the report, can “set the stage for cancer”. Scary stuff. The lead researcher was quoted as saying that e-cigarettes “are no better than smoking regular cigarettes”.

What the press release that promoted this study didn’t mention, and what most of the headlines missed, was that the researchers had also exposed some cells to tobacco smoke. The results of this were nothing short of cataclysmic. Most of the cells exposed to tobacco smoke died within 24 hours. By contrast, the cells exposed to e-cigarette vapour survived for up to eight weeks.

As a cancer charity researcher quickly tweeted, instead of the headline “Vaping no better than smoking regular cigarettes”, they could have said “Cells can survive for eight weeks in e-cig liquid but only 24 hours in cigarette extract”. Not, perhaps, quite as catchy.

To be honest, when I took up vaping I wasn’t that worried about the short-term health effects. There have been a number of major reports, such as the one from Public Health England, that state that e-cigarrettes are “around 95 per cent safer than tobacco”.

What I was far more concerned about was getting hooked on nicotine. Yet as the weeks went by and I puffed away, nothing happened. When I leapt out of bed I didn’t feel a longing to reach for my machine. If anything I struggled to keep up with my schedule. Once the novelty had worn off it became a bit of a chore.

Chatting to experts, I discovered to my considerable surprise that although cigarettes are highly addictive, nicotine alone may not be. Although no one knows for sure, research in animals suggests that nicotine is far more addictive when delivered in combination with the other chemicals found in regular cigarettes.

Addictive or not, it seems that nicotine by itself is not that bad for you. A report put out by the Royal Society for Public Health last year said that though 90 per cent of the public think that nicotine is harmful, in fact it is “no more harmful to health than caffeine”. And, like caffeine, nicotine has potential health benefits. A natural plant alkaloid, it binds to and stimulates receptors in the brain that are important for thinking and memory. Dr Lynne Dawkins, an addiction expert, tells me: “There is emerging evidence that in certain conditions, such as Alzheimer’s and Parkinson’s disease, nicotine may have a cognitive-enhancing effect.”

To test this claim the National Institute on Aging in the US has funded a trial of 300 patients with mild cognitive impairment (a precursor to Alzheimer’s). The patients, none of whom are smokers, will be randomly allocated to nicotine patches or placebo patches that they will have to wear for 16 hours a day. Over the next few years they will have regular health checks as well as memory and cognition tests. A similar, smaller study, published in 2012, found that non-smokers given nicotine patches saw improvements in memory, attention and reaction times.

Yet before you start slapping on the patches or firing up an e-cig you should be aware that though nicotine may help people who already have impaired memory, there’s no evidence it will help the rest of us. Although I was tested before and after a month of heavy vaping, the nicotine didn’t enhance my brain, apart from a small improvement in my fine motor skills that could apparently make me slightly better at sewing.

The main health justification for e-cigarettes is not that they can help to improve your memory but that they can help those who are keen to quit smoking tobacco — but do they? A recent meta-analysis (comparing lots of different studies) concluded that they don’t. Surprisingly enough this paper concluded that vapers are less likely to give up smoking than those who try other methods. It led to headlines along the lines of “E-cigarettes don’t help smokers quit — they may actually have the opposite effect”.

Like so much of the evidence used to attack or justify vaping, this finding was hugely contentious. Critics, such as Professor Peter Hajek from Queen Mary University of London, described it as “grossly misleading”. Professor Robert West of University College London pointed out that if this were true then quit rates would be falling in countries such as the UK where e-cigarettes are taking off. This isn’t happening. If anything we are seeing the reverse.

When Horizon conducted a small study in which a group of hardcore smokers were randomly allocated e-cigs, nicotine patches or going cold turkey, we found the vapers and those who slapped on the patches were far more successful at abandoning their fags.

E-cigs are not risk-free, and after a month of heavy vaping there were signs of increased inflammation in my lungs (which reversed rapidly when I stopped). Nonetheless I think that e-cigarettes could prove to be a game-changer, one of the great inventions of the age. That said, I have no desire to ever take another puff again.

Horizon: E-Cigarettes: Miracle or Menace? is at 9.30pm on Sunday, BBC Two