Quote:One of our lovely members, Lolli, is doing a live radio broadcast, about the e-cig's propsed ban, tomorrow morning with her local radio station BBC RADIO SOLENT 96.1 FM 103.8 FM at about 7.30 am.

Please come & give her loads of support in this thread :

http://allaboute-cigarettes.proboards.co...thread=289

You can hear the broadcast online live or listen again via :

http://www.bbc.co.uk/iplayer/radio/bbc_radio_solent/

You can also either email the show or ring in with your comments on the e-cig

Thanks in advance everyone for any support.

Chrissie

Quote:I have just emailed Lord Mandelson as I thought another angle to take against MHRA is that it must be unprecedented for a regulator to be able to abritrarily shut down a whole industry. Have copied letter below ... will let you know if I get a response

Dear Lord Mandelson
I would like to know if you are aware of the current consultation by MHRA on the regulation of nicotine containing products. It appears that the preferred option of MHRA is to bring all nicotine containing products under the medical licencing regime and to ban sales of any nicotine containing product that is not licenced in June of this year.

Electronic cigarettes vapourise liquid nicotine and are an alternative to smoking tobacco. The product is already regulated under the following regulations/legislation: CHIP - Chemicals (Hazard Information and Packaging for Supply) Regulations 2009, The Poisons Act 1972, CE certification requirements, The General Product Safety Regulations 2005.

There are many arguments against the need to bring nicotine into medicines licencing, but I want to know, as Business Secretary, what your view is on a government regulator arbitrarily regulating a product without sufficient evidence against it, and without giving sufficient notice for companies to obtain the necessary licences to comply with such swiftly imposed regulation. The result if MHRA go with their stated preferred 'Option 1' will be the immediate and complete destruction of the fledgling and innovative e-cigarette industry. Surely this must be unprecedented and seems a bizarre action to take to destroy a growing industry at a time when this country is struggling to pull itself out of recession.

I do not believe the consultation will be fair either. The list of organisations it has sent the consultation out to appears to be heavily weighted to pharmecutial organisations who will clearly have a vested interest in removing an alternative nicotine delivery product from the market. Smoking tobacco, proven to be harmful, should not be the only method to take nicotine recreationally. E-cigarettes now provide a healthier alternative and it would be to the detriment of the nation's health and wealth if this alternative was taken away from consumers.

Quote:Proposed ban of e-cigarettes
Many thanks for your email to Lord Mandelson dated 13 February 2010 regarding e-cigarettes. I am replying as I am the senior lead official within BIS for health and social care matters.
As you say this matter is currently subject to a public consultation that closes in May. The matter has been on my radar and I am genuinely undecided at this time what advice I should give to my Secretary of State. The [limited] evidence presented in the consultation document is strong in its own right but as it is so limited I am keen to hear what others have to say. To that end your email is most helpful. Can I urge you to ensure that you write formally to MHRA to the same effect so that your views are taken into account when the MHRA comes to asses the consultation responses?
Without prejudice, I have to say that at this time my instinct is to view option 2 as being the most consistent with better regulation principles; it is clear that if e-cigarettes can be designed and shown to deliver nicotine safely in a similar way to patches and gum then they might well form part of an overall NRT package.
On the 'fairness' of the consultation, part of BRE's role (where I sit) is to ensure that public consultations are undertaken transparently and that all responses are properly taken into account in determining next steps. If you can tell me of others (especially those manufacturing or retailing e-cigarettes) that you believe MHRA should have targeted I will happily raise this with them. I know that they will see their interests being best served by ensuring that all interested parties contribute their views through the consultation.
Please do submit your views formally to MHRA and feel free to contact me again directly after the public consultation closes. For your information, the Government [in practice the Department or Agency leading the consultation] is required to publish a response no more than 3 months after a consultation closes.
Regards
Graeme
Graeme Sandell
Assistant Director (Health & Social Care)
Domestic Affairs & Public Sector Team
Better Regulation Executive
Department for Business, Innovation & Skills
1 Victoria Street, London, SW1H 0ET
Tel: 020 7215 0814
Mob: 07973 600556
Email:graeme.sandell@bis.gsi.gov.uk

http://www.betterregulation.gov.uk

Quote:Can I suggest others write to this chap as he says he is keen to hear others views? I think he is looking at this as a NRT product so maybe we need to emphasise the point this is used as an alternative recreational use of nicotine?

Quote:Please could you help me with a couple of questions about the nicotine ban.

Could you tell me what defines nicotine as a medicine; and is there any evidence to show that those properties are present in inhaled vapour from dilute liquid nicotine but not in any non-medical products remaining on the open market?

As the proposal is closure of the commercial market for nicotine products does that mean it is being made a controlled substance?

Thanks

Quote:Thank you for your email about the consultation on proposals to regulate nicotine containing products.

Recent legal advice is that nicotine falls within medicines legislation because of its pharmacological action - it appreciably effects metabolism in its normal usage. There is separate legislation that regulates tobacco products and tobacco does not have a medicinal use.

The proposals set out in the consultation document do not seek to make nicotine a controlled substance.

Kind regards


Amanda Bryan

Quote:Thanks very much for your speedy reply to my questions.

I'd be grateful if you would clarify for me what 'normal usage' means and the legal definition of 'metabolism'.

Is caffeine thought to affect metabolism?

Thanks very much

Quote:Thank you for your email.

We are unaware of any legal definition of metabolism but a general accepted definition in respect of medicines would be 'processes for the synthesis, modification, and breakdown of molecules within a living organism '.
We consider "normal usage" to mean when used at therapeutic doses and via an appropriate route.
Caffeine does affect metabolism and some products containing caffeine are licensed as medicines.

Kind regards

Amanda Bryan

Quote:thanks again for your patience. I've heard that you might have been getting a lot of requests for information and apologise for adding to your workload. I have a few more questions please if you wouldn't mind helping me.

I think you're saying that sometimes caffeine appreciably effects metabolism when used at therapeutic doses and via an appropriate route and in those particular cases the products would be licensed as medicines.

Please could you tell me how you determine the threshold for 'appreciably' effecting metabolism and how you establish the measurements in the case of a particular product. Do you do your own lab tests and clinical studies?

My main interest is if nicotine is banned from the open market yet this chemical is similar in action to caffeine, then why would one qualify for complete restriction and not the other. Presumably you won't be banning nicotine containing foods such as tomatoes and potatoes and the current regulations in the Poisons Act 1972 allow concentrations of nicotine up to 7.5% on the commercial market. So what threshold have you determined?

In response to the concerns mentioned in the consultation document about safety, the current applicable regulations are The General Product Safety Regulations 2005 - http://www.berr.gov.uk/files/file22713.pdf Why are those regulations thought to be inadequate?

Thanks for your help

LaceyUnderall;194127 Wrote:Posted this at ECF and thought it might be helpful to you Kate. I have had it for awhile now... was not quite sure what to do with it... but none-the-less...

http://www.e-cig.org/pdfs/pml_submission...ontrol.pdf

I found a very interesting paper written by Philip Morris Limited in 2008, presented to the UK Department of Health

This was presented to the DH in early September of 2008 and if you cite the grand timeline... a week or so later the WHO made their statement regarding not marketing the ecig as a smoking cessation device. According to the July 2009 PR from US FDA, they apparently became "aware" of the electronic cigarette in July of 2007.

Page 42 is the first mention of the ecig and you will also find:

8.25. Our [Philip Morris's] support of pharmaceutical regulation for products such as electronic cigarettes is not intended to place unreasonable or undue regulatory burdens on the marketing of legitimate smoking cessation products or products that have the potential to offer consumers safer alternatives to cigarettes. However, it is not tenable to permit products that deliver nicotine – whether marketed with or without claims - to be sold without any regulatory oversight. page 46.

They then go on to blab about how regulations on snuss should be lifted. It is very clear that their intentions are to make available any product they produce, but not allow a competitive industry into ANY of their markets. Period.

Very interesting read! I don't know if any of this will help in the UK fight, but it certainly does put into perspective where the DH might just be coming up with their ideas... cough cough... big tobacco perhaps?

I have forwarded this on to several anti-smoking, yet pro-tobacco harm reductionists and they were lets say, shocked, as they had never seen this document before. Interesting what you can find on the good ole interweb eh?

Quote:I'd like to make a formal complaint about the treatment I've received while making queries to the DH.

A record of the correspondence is below and I still don't know what DH policy is on ecigs:




FAO
Mr Oliver Smith
Deputy Director, Tobacco and Health & Wellbeing Policy
Department of Health
Wellington House


Hi Mr Smith

Please would you have a look at this discussion and feel welcome to join in if you'd like - http://vapersnetwork.org/forum/showthread.php?tid=115

I'd be most grateful if you would let me know what you think would be the best way to deal with this situation.

Ecigs promise to revolutionise the habits of smokers and are considered many times safer than smoking. Please help us to keep this life saving product available and effective. Regulations could harm people by discouraging use and making a most effective device as useless as NRT.

Thanks very much
Kate ***

**********************


DE00000470531

Dear Ms ***,

Thank you for your recent email to the Department of Health about electronic cigarettes (e-cigarettes). I have been asked to reply.

The Department has commissioned research through the Local Authorities Coordinators of Regulatory Services (LACORS) to test e-cigarettes to see if they comply with the law. This scientific research has found that e-cigarettes contain toxic levels of nicotine and that none of the products tested to date complies with product safety regulations. Local authority trading standards departments have accordingly been informed, and trading standards departments have already removed e-cigarettes from sale because they do not comply with product safety regulations.

Local authorities enforce the product safety regulations and the Department is working with them to protect the public from the dangers of e-cigarettes that contain toxic levels of nicotine.

E-cigarettes should not be sold as an aid to quitting smoking without authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) which, so far, has given no such authorisation.

I hope this reply is helpful.

Yours sincerely,

Cameron Gordon
Customer Service Centre


*****************************


This is my original message to DH:

FAO
Mr Oliver Smith
Deputy Director, Tobacco and Health & Wellbeing Policy
Department of Health
Wellington House


Hi Mr Smith

Please would you have a look at this discussion and feel welcome to join in if you'd like - http://vapersnetwork.org/forum/showthread.php?tid=115

I'd be most grateful if you would let me know what you think would be the best way to deal with this situation.

Ecigs promise to revolutionise the habits of smokers and are considered many times safer than smoking. Please help us to keep this life saving product available and effective. Regulations could harm people by discouraging use and making a most effective device as useless as NRT.

Thanks very much
Kate ***

Your reply is totally inappropriate. Please give me contact details for whoever deals with policy on electronic cigarettes.

LACORS got their measurements wrong, none of the samples contained over 7.5% by volume nicotine which is the limit set by the Poisons Act.

Thank you
Kate ***


************************************


Hi. Please could you send me contact details for the person responsible for policy on electronic cigarettes.

Thanks
Kate ***


***********************************


Dear Ms ***,

Thank you for your further email to the Department of Health about electronic cigarettes.

I have passed your original correspondence to the Department of Health’s senior policy manager for tobacco who has noted your comments, but confirmed that there is nothing to add to my previous reply.

I hope this clarifies the Department’s position on this matter.

Yours sincerely,

Cameron Gordon
Customer Service Centre


**************************************


Hi Cameron

I'd like to present objections to the letter sent to

Mr Oliver Smith
Deputy Director, Tobacco and Health & Wellbeing Policy
Department of Health
Wellington House

The Local Authorities Coordinators of Regulatory Services (LACORS), Trading Standards Institute (TSI) and The Chartered Institute of Environmental Health (CIEH) recently sent a formal letter to the Department of Health outlining changes they would like to see made to existing legislations so they includes electronic cigarettes.
http://esmokerdirect.com/blog/propos...onic-cigarette

These bodies apparently aren't enforcing existing consumer protection laws. The Poisons Law deals with levels of toxins allowed and other laws cover product safety - traders operating outside the law should be dealt with accordingly. What is the point of more legislation if we are not protected with the ones that exist?

Their call for legislation to categorise vapour as harmful smoke is not credible and is based on uncivilised control tactics. Please confirm if the DH is considering supporting this measure.

Thank you
Kate


**********************************


Dear Mr ***, [Note that I've now grown a penis]

Thank you for your further email about e-cigarettes.

It may be helpful if I explain the context and the substance of the letter to the Department of Health from the organisations, Local Authorities Coordinators of Regulatory Services, the Trading Standards Institute and The Chartered Institute of Environmental Health.

These organisations wrote to the Department of Health in September 2009 calling for the definition of 'tobacco products' to be reviewed with a view to including e-cigarettes and similar products, or for these products to be regulated by the Medicines and Healthcare products Regulatory Agency in the same way that they currently regulate nicotine delivery systems. They said in their letter:

Whilst Councils can continue to apply the General Product Safety Regulations and other safety legislation to these products, in the interests of consumer protection, it is considered that further products specific controls may be required.

You may be confusing the role of these organisations and the role of local authority trading standards officers. It is local authority trading standards officers who are the statutory enforcement officers for the laws to which you refer, in particular the consumer protection laws. Consumer protection laws are being enforced by local authority trading standards officers and that is why electronic cigarettes which do not conform with the relevant regulations have been removed from sale.

I am afraid that there is nothing further that the Department of Health can say on this matter.

Yours sincerely,

Cameron Gordon
Customer Service Centre



***************************************


Dear Cameron

You said:

These organisations wrote to the Department of Health in September 2009 calling for the definition of 'tobacco products' to be reviewed with a view to including e-cigarettes and similar products, or for these products to be regulated by the Medicines and Healthcare products Regulatory Agency in the same way that they currently regulate nicotine delivery systems.

I'd like to know if you intend to support the request to define vapour as smoke and/or recreational vaping as medical use? Will you be calling for tobacco regulations or medical regulations to apply to ecigs? How will you make ecigs fit the definitions of either?

The MHRA do not regulate snuff or other tobacco products so if you define ecigs as tobacco then the will not be appropriate as the only nicotine delivery systems they regulate are medically proven NRTs. In fact vaping has not been proven to be an effective NRT so cannot be claimed to be a health product. As the MHRA has no jurisdiction over non-medical use any health claims made by traders should be stopped by trading standards enforcement officers.

Defining vapour as harmful smoke appears to have no purpose other than to inconvenience and stigmatise smokers who would otherwise use this less harmful alternative to smoking.

Ecigs are neither tobacco or medical products. Vaping is a recreational activity that can involve the use of nicotine. There is no second hand smoke or risk for bystanders and there are no reported adverse health effects after over three years of wide commercial availability of this product.

I look forward to hearing from you.

Kate

*********************************


Dear Ms ***,

Thank you for your further email to the Department of Health about ecigarettes.

We have answered your questions on this matter several times and have explained the Government's position. As previously stated, the Department has nothing further to add on this issue and any further correspondence you send on this matter will be logged but will not receive a reply.

I hope this clarifies the Government's position.

Yours sincerely,

Cameron Gordon

***************************************



That's a lie. You did not answer any of my questions, you pumped out propaganda. The reason I had to ask you more than once was because you didn't reply.

Thanks for nothing

Quote:Dear Ms *****,

Thank you for your email of 15 January making a formal complaint about correspondence you have had with the Department regarding electronic cigarettes (e-cigarettes).

I am sorry to read that you feel the Department has not properly explained its policy on e-cigarettes. However, having reviewed the correspondence, I am satisfied that we have responded appropriately and helpfully to your requests, although I hope you will accept my apologies that we addressed you as ‘Mr’ in one of our emails.

I am afraid that there is therefore little I can add to previous replies, other than to emphasise that the Department is not in a position to promote these products. While claims are made on the Vapers Network site that e-cigarettes are considered many times safer than smoking and that they are life saving and effective, the Department is not aware of any peer-reviewed scientific research to support such claims. We would therefore suggest that consumers exercise caution.

You may be aware that the Medicines and Healthcare products Regulatory Agency (MHRA) has recently launched a public consultation on the regulation of nicotine containing products. Further information is available on the MHRA website at:
<a href="http://www.mhra.gov.uk/Publications/Consultations/Medicinesconsultations/MLXs/CON065617">http://www.mhra.gov.uk/Publications/...MLXs/CON065617

I appreciate that you will be disappointed with this reply, but I hope I have been able to clarify the Department’s position. If you remain unhappy, you can ask your MP to contact the Parliamentary and Health Service Ombudsman, who carries out independent investigations into complaints about Government Departments. The contact details are:
The Parliamentary and Health Service Ombudsman
MillbankTower
Millbank
London SW1P 4QP

Telephone: 0845 015 4033

Email: <a href="mailtohso.enquiries@ombudsman.org.uk">phso.enquiries@ombudsman.org.uk</a></div>

Yours sincerely,

Quote:I asked what the DH policy was and had no response. Your representative did not have a rational discussion but talked about irrelevant details as you have just done. It doesn't matter what Vapers Network thinks, I asked what DH policy was and was given no answer, just junk about Lacors etc.

Who asked you to endorse vaping?

Quote:... Expect to see freedom being one of the key battlegrounds of the election: but the key question for the mainstream parties is not whether our liberties should be curtailed, but how. The real challenge for those seeking to defend hard-won freedoms is to denormalise denormalisation.

Quote:... the document addresses is the challenge in the enforcement of Smokefree legislation in public places:

“The inability to easily distinguish between a normal and an e-cigarette leads to confusion and upset amongst the public which can give rise to complaints as they believe that breaches of the legislation are taking place, and they are being subjected to cigarette smoke whilst in a no-smoking area. The use of e-cigarettes in premises where the law prohibits smoking could well encourage people to smoke, either in the mistaken belief that the law does not apply or is not being enforced, or that the individuals concerned will not be noticed and reported. There is also real potential for public order offences being committed where individuals are approached and asked or told to stop and this is challenged.”

After this the organisations go on to comment that they believe that electronic cigarettes should be classified as tobacco products and subject to the relevant legislation...