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Archive for February, 2014

The Bluetooth e-cigarette

23 Feb, 14 | by Becky Freeman, Web Editor

By Stan Shatenstein

There are so many spoof sites on the Internet, you have to think carefully before sharing news of an airline that provides in-flight shisha lounges. But a Bluetooth e-cigarette that lets you receive calls and listen to music? Oh, that one’s for real.

On the Dutch-based Supersmoker’s UK site, the Bluetooth e-cigarette is depicted in all its orchestral complexity, with its speaker, microphone, volume control and Bluetooth buttons – and a few musical notes for illustrative purposes.

For just 79 Euros (US$108), you will be able to stream music from Spotify or YouTube through the built-in speaker. The e-cigarette will buzz and vibrate on incoming calls, and it’s recommended you keep the microphone close when speaking, so you can look as suave as a latter-day Maxwell Smart speaking into his shoe phone.

No word if the song ‘Smoke Gets in Your Eyes’ will play if you’re stuck on hold.

Bluetooth E-cigarette

Will the UK government go ahead with standardised tobacco packaging or not?

16 Feb, 14 | by Marita Hefler, News Editor


 Deborah Arnott

Chief Executive, ASH UK

It seems like a straightforward question, but as is often the case there isn’t a simple answer. The UK parliament has passed primary legislation which allows it to introduce standardised packaging by regulation, but the government hasn’t yet made a decision to go ahead.

This primary legislation is a necessary but not sufficient step towards getting standardised packaging in place. The Government still has to decide whether to introduce the regulations which will bring standardised packaging into effect. The test that it has set itself is set out in the primary legislation and it is entirely appropriate, in line with that used by Australia.

Basically the legislation enables the Health Minister to make regulations for standardised packaging for tobacco products if s/he considers such regulations may be capable of reducing harm or promoting the health and welfare of children under 18. This can include potential benefits to children because of the impact of standardised packaging on adults, and the potential impact of the regulations either on their own or in conjunction with existing regulations on packaging and labelling.  The ways in which regulations might be capable of reducing harm or promoting health and welfare are defined as being any one of the following together or individually (the full amendment can be found here):

  • reducing smoking uptake
  • encouraging quitting
  • preventing relapse
  • reducing the appeal or attractiveness of tobacco products
  • reducing the ability of packaging to mislead consumers
  • reducing the ability of packaging to detract from the impact of health warnings, and
  • having an impact on attitudes, beliefs, intentions and behaviours towards smoking.

Because the UK Government said in spring 2013 that it wanted to see what the impact was in Australia, quite rightly it is carrying out a review before making its decision. That means that in making its decision it can take into consideration the most up to date information about the public health impact in Australia. Sir Cyril Chantler, an eminent paediatrictian, who is carrying out the review is visiting Australia to see for himself and then will report back to the Government by the end of March.

To quote the Health Minister Jane Ellison in parliament on Thursday 28th November 2013 after she had announced that the Government were bringing forward primary legislation on standardised packaging: “If, on receiving Sir Cyril’s review, the Government decide to proceed, that will allow standardised tobacco packaging to be introduced without delay. .. I have looked at the draft schedule, and if the Government were minded to go forward with this policy, I see no reason why it could not be put through before the end of this Parliament.” 

The decision will be taken once Chantler reports, and regulations could be in place if not implemented before the end of the Parliament in spring 2015 when the UK has its next general election. The primary legislation voted on last week was supported by not just the Coalition government but also the Labour opposition.  There was a massive majority; 453 MPs voted in favour with only 24 against. The governments in the devolved administrations of Scotland, Wales and Northern Ireland have also taken the necessary steps to ensure that regulations can cover the whole of the United Kingdom and not just England.

In addition in the same Bill the government has been given powers to introduce regulations to prohibit smoking in cars with children under 18. As with standardised packaging this was originally a backbench motion rather than a Government amendment. The Government allowed a free vote. The majority was 269, which compares with 200 for the UK smokefree legislation in 2006. Subsequently the prime minister’s spokespeople have made clear the government would like to go ahead with the necessary regulations to put this into effect before the next election.

The commitment of the UK parliament to take all measures necessary to reduce the harm caused by smoking is clear, and there is strong support from the public and the health community. We feel confident that after Chantler reports at the end of March the UK government will listen to the evidence and decide to go ahead with standardised packaging.

FDA moves to make e-cigarette research more difficult

10 Feb, 14 | by Becky Freeman, Web Editor

Below we republish a post by Stan Glantz from the UCSF Center for Tobacco Control Reserved & Education.

At a time when e-cigarette marketing, sales and use appears to be escalating, “real world” independent research is urgently needed. The FDA appears to be shutting down this important investigative channel.

Dilbert meets Kafka again: While FDA dallies on regulating e-cigs it moves to make it harder to do meaningful research on them

by Stan Glantz

Twiter: @ProfGlantz

In another Dilbert meets Kafka moment, the FDA, both directly and indirectly through NIH/NIDA, has been telling researches that they are planning to require researchers to get an “Investigational New Drug” (IND) approval for any studies of e-cigarettes.

What this means is that, at the same time that the FDA is sitting quietly while e-cigarettes are being aggressively marketed, including with unsupported claims that they are effective smoking cessation aids (which allows, even in the current legal environment, to regulate them as drugs right now),  and in the face of skyrocketing use by kids,  the FDA is poised to throw up roadblocks to independent research on the effects of e-cigarettes.

Not only will this substantially slow down research, but it will limit the scope of what is studied.  What we need is to understand the effects of e-cigarettes as used in the real world, not some highly stylized “research” e-cigarettes function.

Neal Benowitz has written an important letter to Mitch Zeller, head of the FDA Center for Tobacco Products.  His letter is worth quoting in full:

I understand that the FDA is considering requiring an ITP/IND prior to allowing federally-funded research on electronic cigarettes.   While such a request might make sense for e-cigarettes for which a therapeutic indication is being sought, it is a terrible idea for e-cigarette research more broadly.  My concerns are as follows:

1.            The use of e-cigarettes in the U.S. population is increasing exponentially over time.  Physicians and other health care providers and policy makers are seeking information on which to base advice for patients or the general public regarding use of e-cigarettes.  Any delays in generating any new research data would be highly detrimental to this process.

2.            Relatively few data are available on e-cigarettes by which to determine the risks vs. benefits of e-cigarette use in populations. Clinical and policy decisions should be made on the basis of data.

3.            More than four hundred e-cigarette products are currently on the market. These have widely differing designs, including variable liquid composition, different chamber size, different batteries, different nicotine and constituent delivery, and different particulate size and distribution.  It would be impossible to obtain the necessary data on manufacturing and safety of constituents for the various products to obtain an ITP/IND in a timely manner, if at all.

4.            NIDA could develop a prototype e-cigarette for research, but this prototype would take considerable time to develop and would be limited to one or a few design characteristics.  These limitations would result in a great delay in gaining information on e-cigarette pharmacology and safety and would have limited application to many products on the market now and in the future.

5.            There are critical unanswered questions related to use patterns, nicotine delivery, addiction liability and safety that can be studied in people using their chosen e-cigarette products.  Such research is not necessarily part of a research program to gain approval for therapeutic use.

6.            Requiring an ITP/IND or NIDA e-cigarette prototype will paralyze much of the research that has been funded (or submitted for possible funding) and which is critical to inform public health.

In summary, data on the addiction liability and safety of various e-cigarette products are desperately needed to inform public health decisions.  Requiring an ITP/IND for e-cigarettes would delay needed research and would be detrimental to public health. I strongly urge the FDA not to require an ITP/IND for e-cigarette research, other than that intended to support application for a therapeutic indication.

This letter has been bouncing around among researchers who care about e-cigarettes and generated a lot of support.

In response, Maciej L. Goniewicz, an Assistant Professor of Oncology in the Department of Health Behavior and the Division of Cancer Prevention and Population Sciences Roswell Park Cancer Center, who has done some of the best research on nicotine and carcinogen exposure from real e-cigarettes, observed that

For me current approach by FDA is currently blocking all my projects on >safety, toxicity and use of the products. None of this projects is a smoking cessation study. Since I got back to States I have prepared few projects and grant proposals on ecig safety.  And now FDA is paralyzing all my efforts. Recently, we got the opinion that even for  nicotine-free e-cigarettes we need IND.  We can’t monitor nicotine cravings, withdrawal system, even reduction in smoking in any of these studies because FDA claims this is “therapeutic indication”.  It looks like nowadays, the only research we can do are laboratory studies or studies on established users.

In short, the FDA is doing nothing to regulate e-cigarettes but is making it harder for independent researchers to collect the data needed to inform the public and policymakers (and the FDA) about the actual effects of e-cigarettes.

The IND process was established to allow pharmaceutical companies who want to test drugs or make therapeutic claims about them to collect the data they need to win FDA approval for those drugs or claims.  It would be appropriate for the FDA to require the e-cigarette companies (and researchers they support) to go through this process.  To date, none of the e-cigarette companies have done so.  And, from their perspective, why bother?  The FDA is doing nothing to regulate the therapeutic claims they are making.

But it makes no sense to require investigators studying the effects of e-cigarettes on the market to go through this process.

I urge other researchers who have been or will be affected by this decision to write Zeller and post their comments as replies to this blog post so that the whole community will have access to their thoughts.

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