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The FDA, The MHRA and the Electronic Cigarette

February 6th, 2010 by admin

I recently suggested to Paul Bergen from the TobaccoHarmReduction.org programme that he and other scientists write an open letter to the UK government currently considering making e-cigarettes a medicine.

I got this reply:

Am going to give it a shot but wonder about an agency that uncritically puts in the FDA nonsense and disregards its own ASH … have the feeling that they have already made up their minds but will speak up…

The FDA and the Electronic Cigarette

The FDA tested the electronic cigarette last year.

They tested the ingredients of the electronic cigarette and found traces of four tobacco specific nitrosamines at “very low levels.”

“Very low levels” – that’s what the scientists said, but that’s a quote that was omitted in the FDA press release.

In fact, they didn’t report any levels, which was surprising as they measured them in parts per trillion.

Here are some interesting points about the levels of tobacco specific nitrosamines found:

The levels found were the same as the levels found in the nicotine cessation aids approved by the FDA. (Source: Siegel)

The levels found were 1400 times lower than those in Marlborough cigarettes. (Source: Siegel)

If we banned electronic cigarettes based on the levels of carcinogens found in them, we would also have to ban many food stuffs. (Source: Carl Phillips)

The Vapour not the Ingredients

The FDA couldn’t be bothered to test the vapour of the cigarettes. They left that to us.

Despite the fact that the FDA study proved beyond a doubt that the NJOY electronic cigarette was far safer than regular cigarettes, press misinterpretation of the FDA study (which included one newspaper stating that the e-cigarette contained 40 times as much nicotine as regular cigarettes!)* lead to over 100,000 dollars being spent on independent lab tests of the electronic cigarette.

The tests proved that the NJOY e-cg va pour has one tobacco specific nitrosamine in its vapour – and that one is non-toxic.

The FDA Has Been Discredited

Bear in mind that the FDA conducted this study and released the press release while being sued by two e-cigarette companies.

And they lost the case!

The judge strongly criticised the FDA’s action, stating:

“This case appears to be yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices.”

The judge also slammed the FDA’s argument that the e-cigarette was dangerous:

Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public.

Source: Reason

The MHRA and the FDA

Despite admitting that the electronic cigarette can save lives, the MHRA quotes the FDA report as a reason for regulating the electronic cigarette as a medicine (handing over control to big pharm?)

We know from work done by the Food and Drug Administration (FDA) in the United States that laboratory analyses of e-cigarette samples were found to contain carcinogens and toxic chemicals, against which general product safety legislation could not protect.

Source: Consumer Letter MLX p.4

Handing Over Control to Big Pharm?

Can scientists and bloggers be blamed for being suspicious?

After all, pharmaceutical companies already bankroll the organisations that have been campaigning against the electronic cigarette.

And the amount the MHRA wants from manufacturers is suspiciously large – a cool 1.4 million to be precise.

Enough to put off a few e-cigarette companies, but not enough to give a seconds thought to big pharm.

Are we being too suspicious? I hope so!

*When we pointed this out in an open letter, ASH US released a press release urging newspaper to continue to lie.

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Check it out for yourself: If you haven’t already guessed, we retail the Njoy electronic cigarette tested by the FDA!

UK Government: Electronic Cigarettes Save Lives & Money

February 5th, 2010 by admin

It’s official: non-regulated nicotine products such as the electronic cigarette save lives.

Or to be specific, it can extend smokers’ lives by 3.59 years.

The estimate is based on the assessed value of users making a successful quit attempt using the electronic cigarette.

The government assumes that the number of people quitting will be the same as for NRT products, i.e. around 5%.

It’s Safer

The MHRA document makes no specific statement that electronic cigarettes are safer than regular cigarettes.

However, it’s difficult to believe that the MHRA would consider licencing a product which they would believe to be as harmful as regular cigarettes.

Furthermore, the document links the aim of tobacco harm reduction to the need to have a licensed and regulated electronic cigarette on the market. Specifically, that nicotine products should have:

“an extension of use to include both substitution and partial substitution of smoking with NRT of smoking with NRT in those not currently intending to make a successful quit attempt.” (Consultation Letter MLX p.20.)

Translation: If you can’t or don’t want to quit nicotine, you should use an electronic cigarette (or something similar)!

This is a clear admission that electronic cigarettes are safer than cigarettes.

Saving Money

The same document also believes that licensing the products would save money for the NHS.

There will be additional benefit to the NHS as smoking reduction and quitting will see a reduction in hospital admissions for smoking related illness. This will see a release of cash spent on these treatments and a reallocation of resource to other treatments that will have further health benefits. (Consultation Letter MLX p.28.)

i.e. E Cigarettes = more people quitting/cutting down = less money spent on smoking diseases

(The savings are nonsensical, unfortunately, because they don’t take into account cigarette taxes paid and the gainings from pensioners dying early.)

Passive Smoking

The document also suggests there would be an additional health benefit of reduced passive smoking if the electronic cigarette were legalised.

If additional people use smoke-free licensed NRT products there is more chance of a successful quit attempt and this will reduce those exposed to smoke; passive smokers. This will bring about additional benefits to the NHS and using the Value of Preventing a Casualty, we can estimate an additional benefit in avoiding a life lost from passive smoking at approximately £1,500,000. (Consultation Letter MLX p.28.)

i.e. Electronic Cigarettes = More People Quitting = Less People Dying of Passive Smoking

(Incidentally we at the Ashtray blog are not convinced about the dangers of passive smoking.)

Concerns

There are a number of worries people have. We are particularly concerned with one and two below.

1. Availability will become limited – possibly only available in pharmacies.

2. Making something that smokers enjoy a medicine. If smokers are allowed to use the vastly more dangerous cigarettes why should the nanny state tell them they are not allowed to use it recreationally?

3. That this represents a sneaky attempt to pass control of the e-cigarette market to pharmeceutical companies. (UK Moves To Give Electronic Cigarettes to Pharmaceutical Industry)

4. Choice will become limited. (Is Britain about to ban the e-cigarette? on Smokles.)

5. That electronic cigarettes will be banned. (E Cigarettes could be taken off the market on Velvet Glove Iron Fist – points out that Snus, the safest form of chewing tobacco, is illegal in the UK despite huge evidence that it has cut cancer rates in Sweden.)

Let us know if you have any more concerns!

And let the government know what you think too – click here to leave your feedback on the MHRA website.

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Act now to save electronic cigarettes in the UK!

February 4th, 2010 by admin

The government is currently trying to decide what to do about the electronic cigarette.

And they are inviting the public’s views.

By letting them know, you can decide the fate of the electronic cigarette.

What could happen:

1. The government could ban the e-cigarette.

2. The government may only allow it to be sold as a quit smoking aid.

We invite regulation that will help safe electronic cigarettes, but ask that smokers be allowed to enjoy an alternative to smoking that contains no tar or tobacco, and which (for some models) has been tested free of toxins.

Professor Michael Siegel recently said (in a comment on the FDA in America):

To deprive them [the public] of the choice to continue vaping and instead, force them to return to smoking, would severely harm their health. I simply do not see the public health protection resulting from a policy of forcing thousands of vapers to return to cigarette smoking.

Please click here to comment – and stop them from depriving smokers of the electronic cigarette!

http://www.mhra.gov.uk/Publications/Consultations/Medicinesconsultations/MLXs/CON065617

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UK Regulation of Electronic Cigarette: Good or Bad?

February 3rd, 2010 by admin

The MHRA is proposing to licence Electronic Cigarette manufacturers in the UK. Their consultation document suggests that this will reduce the number of manufacturers by 50%.

To be precise, the MHRA document suggests:

“…all NCPs [Nicotine Containing Products] should be classified as medicinal products and all unlicensed NCPs be removed from the market within 21 days”

It is proposed that licensing will cost around GBP5,000 – 6,000 a year, with similar annual costs for inspection and registration, resulting in approxiamtely 12 manufacturers remaining, who will have complied with the required regulations.

Now our first reaction is that this a good thing because it will:

  • put in place quality control
  • legitimise the industry
  • remove cowboys
  • ensure consistency
  • save lives, as suggested in the final paragraph
    “If additional people use smoke-free licensed NRT products there is more chance of a successful quit attempt…..”

However, Kate from the Vaper’s Forum has also raised some concerns which we’ll also mention later.

Quality Concerns

One of the concerns with the electronic cigarette is quality.

It’s not a concern we have about the NJOY, which has just been proven toxin free by the testing lab Analyze and which is manufactured under strict supervision.

However, we are concerned about cheap alternatives. As Jim Palasota of NJOY told us, many companies are not concerned about quality, they are only concerned about buying the cheapest e-cigarette so that they can be the cheapest on the market. As these companies are often under funded, they do not have the means to have independent lab tests carried out or inspect the factories in China.

Jim is not the only one to have concerns about the quality of the products. When we interviewed Professor Carl Phillips, his only real concern over the electronic cigarette was the possibility of contamination:

Cowboys

We also think the move will remove some of the cowboys.

We’ve posted before about electronic cigarette scams.

These involve selling “free” electronic cigarettes and then charging a fortune for refills sent monthly, and refusing to cancel such standing orders.

These companies give the whole industry a bad name. They may also potentially stop smokers who would have switched to an electronic cigarette.

Legitimising the Industry

A third benefit is that an official licensing scheme would legitimise the industry.

Licensing would give more consumers more confidence in a new product, and a product which has been much maligned by American anti-smoking propaganda.

but…

Not everyone is happy with the move.

Here is a movie which Kate from the Vapers Forum sent me. (The video is excellent, btw, well worth watching whether or not you agree with it!)

As I understand it, Kate is concerned about the electronic cigarette only being licensed for use as a pharmaceutical aid.

Many e-smokers are using vaping as an alternative to smoking, and this should be their right.

If they want to enjoy nicotine safely, why shouldn’t they?

And indeed at the Ashtray blog, we also like to say, if smokers want to enjoy nicotine dangerously, it’s their decision, not the government’s!

(Smoking doesn’t cost the country! Despite the propoganda, cigarettes raises more taxes than the government spends on smoking diseases, and saves a fortune in pensions costs. We are not saying it is a good thing, only that it is a responsible adult’s legitimate choice. Oh, and the largest passive smoking study ever conducted found no evidence that passive smoking causes lung cancer.)

So, pluses and minuses here.

What’s your opinion?

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Major Change in UK Attitude to Tobacco Harm Reduction?

February 2nd, 2010 by admin

I’ve just had an email from Bill Godshall in which he applauds apparent moves by the UK’s NHS to approve a Tobacco Harm Reduction approach to smoking.

To the unitiated tobacco harm reduction involves getting smokers who can or can’t quit to use products which are vastly safer (usually 99% safer) than smoking.

You can learn all about tobacco harm reduction here: TobaccoHarmReduction.org (run by the University of Alberta).

For years, despite ASH’s initial enthusiasm, THR has been avoided in the UK.

Crazily, one of the safest products available, SNUS, has been banned in the UK while more dangerous forms of chewing tobacco which cause oral cancer are perfectly legal.

Anti-smoking fanatics have opposed tobacco harm reduction on the basis that anything which does not involve completely quitting smoking is bad, and also because of the fear that it might lead youngsters into smoking.

Now, according to Bill Godshall, UK attitudes to THR have changed:

In an historic first for public health, the National Institute for Health and Clinical Excellence (NICE) of the UK’s National Health Service overwhelming approved tobacco harm reduction as a key component in England’s ten year plan to reduce cigarette smoking by half. The US FDA should follow the UK’s lead. The announcement and a news excerpt are below, the press release is attached, and the full report “A Smokefree Future” is at http://www.dh.gov.uk/dr_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_111748.pdf

Bill Godshall

- – -

Citizens Council vote in favour of harm reduction in smoking

http://www.nice.org.uk/newsroom/news/CitizensCouncilVoteInFavourOfHarmReductionInSmoking.jsp

The Citizens Council, a group which brings the views of the public to NICE’s decision-making, has voted overwhelmingly in favour of the use of harm reduction as a way to reduce the dangers of smoking.

The 30 members of the Citizens Council met in October last year for three days to discuss the pros and cons of harm reduction. Whereas smoking cessation aims to help smokers quit smoking and break their reliance on nicotine completely, the idea of harm reduction involves reducing the harm associated with cigarettes for smokers who find it too hard to quit. This could include replacing cigarettes with a clean form of nicotine, or with cigarettes which intend to deliver lower levels of toxins.

Overall, the Citizens Council supported the use of harm reduction in smoking but the idea of considering harm reduction as a way to provide a less harmful alternative to smoking – while accepting that nicotine addiction continues – proved relatively unpopular.

Sir Michael Rawlins, Chair of NICE, said: “The concept of harm reduction conflicts with traditional smoking cessation as it does not necessarily seek to help people stop smoking altogether, nor does it treat nicotine addiction. What would this approach mean for the goal of having a smoke free society?

“The Citizens Council’s view will help guide our independent advisory committees, should they be required in the future to make recommendations about harm reduction in smoking.”

The findings from the Citizens Council come as the Department of Health launches a Tobacco Control Strategy for England which aims to halve the number of smokers, from 21 to 10 per cent of the population by 2020.

This latest strategy, A Smokefree Future, builds on the previous 1998 strategy and sets out to ensure that every smoker will be able to get help from the NHS to suit them if they want to give up. This includes introducing new approaches to reducing smoking such as harm reduction.

The Department of Health will also work with NICE to encourage alignment of the Quality and Outcomes Framework (QOF), so as to encourage more smokers to use the NHS Stop Smoking Services.

The 30 members of the public that make up the Citizens Council are drawn from all walks of life, and provide NICE with insights into the public’s views on challenging issues that often involve values such as fairness and need. It meets twice a year and reports directly to NICE’s Board. Its recommendations inform a wide programme of work. When the Council was set up in 2002 it was the UK’s first advisory body made up entirely of members of the public.

The public is now invited to comment on the Citizens Council members’ views on the use of harm reduction in smoking, before the report is presented to the NICE Board. The report on the Council’s views is available for public comment, at www.nice.org.uk . Comments must be sent in by 5pm on Wednesday, 31 March 2010. http://www.nice.org.uk/getinvolved/patientandpublicinvolvement/opportunitiestogetinvolved/citizenscouncil/reports/CitizensCouncilReportSmokingAndHarmReductionWithInvitationToComment.jsp

1 February 2010

We’ll be writing more shortly on major ongoing developments in the UK regarding tobacco harm reduction, the MHRA and the electronic cigarette.

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Passive Smoking: A Risk Too Small to Worry About?

January 31st, 2010 by admin

I used to be a firm believer in passive smoking as a serious danger to health. Well, we were told this by people in positions of trust, by health organisations, by scientists and by doctors, so why would one think otherwise.

However, I was a bit surprised when I heard the very doctor who had discovered the link between smoking and lung cancer, Richard Doll, laughing at the idea of passive smoking being a serious risk when interviewed on desert island discs a few years before his death.

That quote is still preserved today. In an Independent article entitled Passive Smoking: Is there convincing evidence it exists? Sir Richard Doll is quoted as saying:

“The effect of other people smoking in my presence is so small it doesn’t worry me.”

Why wasn’t he concerned?

Well the clue could be in this second quote from the Independent article:

“Reputable research shows that a non-smoker inhales between a 500th and 1,000th of the toxins inhaled by the smoker himself…”

More on passive smoking tomorrow!

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The Electronic Cigarette and Smoking Cessation

January 30th, 2010 by admin

In this movie, the latest of our mini-extracts from our interview with Professor Carl Phillips from the TobaccoHarmReduction.org project, we get a scientist’s opinion on whether the electronic cigarette could potentially be used as a tobacco harm reduction tool.

Also see:

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Professor Slams BMJ Article on E Cigarette

January 29th, 2010 by admin

A second tobacco expert has come out and criticised an article in the British Medical Journal on the electronic cigarette.

To recap, the article concluded that the contents of the electronic cigarette were far safer than regular cigarettes but it should be banned anyway because the electronic hasn’t been studied enough. (In the process, as Paul Bergen of the TobaccoHarmReduction.org project pointed out, they ignored several studies that had been made.)

Now Professor Michael Siegel, who runs the tobacco analysis blog, has joined the critics.

Michael summarises the article as stating that water vapour from the electronic cigarette is no safer than regular cigarettes.

Such an assertion is beyond belief. It is completely inconsistent with everything we know about toxicology and pathology and there is no scientific basis for such a statement. It conflicts directly with even the stated conclusion of the article itself, which acknowledges that the levels of hazardous components in electronic cigarettes are likely much lower than in traditional cigarettes

See his full analysis of the BMJ article at the Tobacco Analysis Blog.

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The E-Cigarette and the FDA: A Scientist’s Response

January 29th, 2010 by admin

This is latest in our series of mini-extracts from our full interview with Professor Carl Phillips.

Also see:

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A couple of days ago we blogged about a health group

January 28th, 2010 by admin

A couple of days ago we blogged about a health group who admitted that the electronic cigarette was far better than cigarettes, but felt they had the right to deny this healthy alternative to the millions of smokers who will die from using cigarette because it too closely resembled smoking.

They’re not the only health group to do so.

We think ASH US (not ASH UK – we don’t agree with everything they say but we do have respect for their stance on tobacco harm reduction) are evil.

But at least they, like us, have pointed out the ridiculous position of the American FDA on the electronic cigarette, stating:

The principal dangers of e-cigarettes highlighted by the FDA — that they contain “known carcinogens and toxic chemicals” — appears overblown. Virtually all nicotine replacement products – e.g., nicotine gum, nicotine patches, nicotine sprays, nicotine inhalers, etc. — reportedly also contain tiny amounts of these known carcinogens because the nicotine used in the products is extracted from tobacco which contains these naturally-occurring chemicals.” (Source: PR Inside)

It proves once again that smoking groups are not attacking the cigarette because it causes harm (many now accept it is safer than cigarettes), but because of a moral objection to smoking.

Oh, and let’s not forget the funds they receive from the manufacturers of the cessation aids threatened by the electronic cigarettes.

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