FDA Announcement: What Does it Mean?

When I finally finished reading all the articles on the announcement from the FDA, I found it difficult to tally what I’d read with the celebrations of vapers. Don’t get me wrong, there’s a lot to be hopeful for from the announcement. But that’s all it is. Hope.

We’ve had that before haven’t we? Just recently the lawsuit against the FDA brought by Nicopure Labs went against Nicopure. That was probably one of the main attempts – recently – to challenge the Deeming Rule and maybe give the industry some much needed breathing room. It wasn’t to be.


Again the EU is told No

Regular readers will of course remember fondly that the EU held another “public consultation” recently, with the closing date of last month. This so-called public consultation was all about the taxation of manufactured tobacco products. Of course, being the EU and with the shiny new Tobacco Products Directive it just had to include the humble e-cigarette, despite (of course) neither the devices themselves, nor the liquid refills containing any actual manufactured tobacco at all – natch.



EU Trolling Us?

The hypocrisy is rife within the EU (not such a great shock it has to be said), but it is such a glaring “we don’t know what the fuck we are doing” type that I simply couldn’t resist putting finger to key. Ya see, as any business knows, distance selling is one of many keys to success. More often than not, products and services are sold to other territories. This takes distance selling to a different pot. Cross-border. Businesses aren’t just having to apply local laws and so forth, once their product crosses an international border, it has to comply with the destination laws too.

This is one of those times when, fundamentally the Single Market™ is a benefit. That is, the Single Market without all the political rubbish that goes with it. The vast majority of EU diktat has in it somewhere “to harmonise the operation of the internal market” – I’d go as far as saying that they all do. After all, the Single Market (for all its flaws) is in fact a useful benefit to the EU in general – it does not outweigh the negatives associated with the Commission, Parliament or Council. (more…)

Time to talk Tax

There is a strap-line from HM Revenue & Customs – “tax doesn’t have to be taxing” – yet despite their best efforts, if you really want to wade through the system, you are going to have to employ someone with letters after their name. The proles don’t really stand a chance of navigating the endless forms, cross referencing and waiting. Not to mention there are certain rules that need to be followed with regards to things like wage slips, P60 (end of year stuff for UK employees). Yet I’d be willing to bet that many folks don’t wholly realise how much tax they actually pay. Especially when it comes to tobacco. (more…)

Open Letter to all my Representatives

This letter is intended for all MPs, MEPs and Lords.

Thank you for your varied replies to my correspondence, it is appreciated that you take time out of your busy schedules to read and reply.

Unfortunately I am dismayed at the wide variety of those responses, not to mention the boilerplate responses which are intended to say very little other than provide some limited platitude. Those boilerplate responses did not address any of the concerns I had raised. It is a classic fobbing off and I am incredibly disappointed that you have felt it necessary to do that, to put it mildly.

This issue is important, not just for me but for 2.8 Million current vapers and for 9.6 Million current smokers. This issue has arisen due to unnecessary interference from the EU and will now be considered a factor by many in the upcoming Referendum.

The Tobacco and Related Products 2016 legislation that has been transposed from the EU Tobacco Products Directive (2014/40/EU), specifically the sections related to Article 20 of the Directive, will have far reaching consequences that have not been considered in the Impact Assessment[1] considering that one of the stated aims of the Directive is “to harmonise the EU market” – a noble idea with one fatal flaw – at least 15 Member States have no implementation of the Directive, some Member States have “gold plated” the Directive – specifically, banning cross border sales, which is against one of the stated aims:

To reduce obstacles to trade in tobacco and related products within the EU by reducing differences between the regulatory regimes in different EU Member States.

Further to the UK Government’s own Impact Assessment, Action on Smoking & Health[2] and their own commentary on certain aspects of the legislation[3] specifically related to the limitations on nicotine strength available under this legislation ignores one of the key reasons why electronic cigarettes (e-cigarettes/vapourisers) have worked for so many (2.8 Million UK users) – the pleasure principle[4], and grossly underestimates the effect that the nicotine strength limits will have[5].

I am one of that 2.8 Million that will be negatively impacted by this legislation, because I made a choice on June 11th 2014 to switch to vaping, but this isn’t about me. This is about the 9.6 Million adult smokers in the UK[6] and giving them the choice to switch to an alternative to smoking. Both Public Health England[7] and the Royal College of Physicians[8] have released reports on this subject, and both are proposing that e-cigarettes are part of a harm reduction strategy:

However, in the interests of public health it is important to promote the use of e-cigarettes, NRT and other non-tobacco nicotine products as widely as possible as a substitute for smoking in the UK.

The limitations being imposed by the transposed Directive – the 10ml refills, 2ml tank size and limits on nicotine strength will have serious negative consequences for recent and new switchers. It is a matter of record that the research the EU used to draft these limitations was grossly misinterpreted[9], and sadly the science continues to be misinterpreted, or worse ignored.

It has become astonishingly clear that some are intent on keeping this legislation in its entirety despite the furtherance of research into the subject of vaping. Recently a Fatal Motion in the House of Lords had been proposed for debate, now that Motion has been changed to a “Regret” motion alongside two other motions[10] and an urgent debate under Standing Order 24 in the House of Commons has been deemed “not proper” to be discussed under So24[11], yet a debate on this subject is exactly what is needed.

The legislation, as it stands – and specifically the transposition of Article 20, is in a vital time where the portion directly related to e-cigarettes could have been nullified by the House of Lords thereby opening the way to regulating these products in a far more proportionate manner, allowing new users to switch if they wish and allowing existing users – both experienced and recent switchers – to continue using these devices to remain smoke free.

I urge you, my elected representatives, to open urgent debate, be open to both sides and give 9.6 Million smokers the same choice I myself made almost two years ago,  and 2.8 Million vapers the opportunity to continue to choose the alternative to smoking.

Paul Barnes

1 – https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/440994/TPD_IA.pdf

2 – http://ash.org.uk/files/documents/ASH_1011.pdf

3 – http://www.ash.org.uk/media-room/press-releases/:new-eu-rules-on-nicotine-strength-not-a-problem-for-most-vapers

4- http://nnalliance.org/blog/39-the-pleasure-principle

5 – http://londoneconomics.co.uk/wp-content/uploads/2014/02/High_nicotine_e-cigs_ban-Feb14.pdf

6 – http://www.ash.org.uk/files/documents/ASH_93.pdf

7 – https://www.gov.uk/government/publications/e-cigarettes-an-evidence-update

8 – https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0

9 – http://ecigarette-research.org/research/index.php/whats-new/whatsnew-2014/147-misinterpreted-research

10 – http://www.publications.parliament.uk/pa/ld/ldordpap.htm#motdeleg

11 – http://www.theyworkforyou.com/debates/?id=2016-06-08a.1204.9

Another TPD Implementation

As the date draws closer for actual implementation of the voted-in Tobacco Products Directive, EU Member States are producing their interpretation of the Directive. Unlike the UK which has been decidedly light-touch, though how light-touch remains to be seen, Member States have taken to adding a bit extra – i.e. “Gold Plating” the Directive which only serves to make it worse. Belgium are going to be charging 4,000 Euro per notification which is a disastrous amount for smaller businesses to bear. Finland is being downright stupid and now we have Hungary. (more…)