This is my first response.
More may follow as I digest and consider your proposal.
Also I would like to declare an interest as both a user and retailer of electric cigarettes and nicotine liquids.
My first concern is with paragraph 1.
You want to bring nicotine containing products (NCPs) within the medicine licensing regime. So therefore it follows that you feel nicotine should be classed a medicinal substance.
Yet in the very same paragraph you state that tobacco and tobacco products would be exempt from this new regime. Why would this be ? Cigarettes, Cigars, Rolling Tobacco (NCPs) all serve a purpose to deliver nicotine to the user. Is this nicotine in tobacco so manifestly different to the nicotine in the targeted NCPs that it should be treated differently, not as a medicine. No it is the same chemical. (although it is known that tobacco companies add ammonia to some cigarettes to convert part of the nicotine to its base form, more readily absorbed, think nicotine crack)(1)
The only logical reason to exempt tobacco and tobacco products is due to the fact that these products have already been proven to be safe. I see a hole in this logic.
You need to explain why tobacco and tobacco products are exempt. Not just state that they are!
What is so special about them as NCPs and nicotine delivery devices, apart from the fact that they are such effective killers.
The immediate effect of your proposed legislation will be to drive many of the thousands of people who have stopped using smoked tobacco as a nicotine delivery device, through the use of electric cigarettes and nicotine liquids, straight back onto smoked tobacco.
I thought the MRHA's remit would be to improve / safeguard the public's health. This legislation will without any doubt damage it.
From your “About us” page.
“No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.”
Please take time to explain the robust and fact-based judgements that led you to decide that tobacco would be granted a automatic exemption from this legislation.
Please publish any risk assessments on tobacco that helped you reach this decision.
Please also publish any risk assessments on electric cigarettes that caused you to decide they would not also be exempt.
If you set out to design the best possible delivery system, with regards to damaging health, for delivering nicotine into a human body then I don't think you could come up with anything better than delivery by inhaling the smoke from burning tobacco, excepting intravenous injection.
One word to describe your proposed legislation exempting tobacco.
Madness.
Paragraph 14
You state “Recent legal advice is that all products which contain nicotine which appreciably affect metabolism in normal usage may be within medicines legislation in terms of pharmacological action (medicinal by function). ”
First of all legal advise from whom ? What is normal usage ? And yet again how does tobacco find itself exempt from the “All products” mentioned in the paragraph.
All plants from the Nightshade family (Potato, Tomato, Chilli Peppers and capsicums and Aubergines among many others)contain nicotine in varying amounts. I would like you to publish the documents you have which state eating these under normal usage does not appreciably affect metabolism. Because there is a wealth of published information which says otherwise.
Or do you intend that these vegetables will come under the legislation ?
You don't give them an exemption as with tobacco and logic would indicate they would have to be included ?
Paragraph 15.
You state “Because of their “legal status”, it is difficult to get information on quality, safety and/or efficacy of these NCPs, and to know whether the clear benefit to risk that has been established for NRT products can be attributed to them. ”
As for the quality and safety, at present it NOT difficult to get information. You have UK retailers working out in the open. I have had my nicotine products tested and analysed by my local trading standards office. The conclusion was that they were deemed safe.
I know most other UK retailers of NCPs (of the electronic variety) have had there products subjected to similar tests.
At any-time trading standards can request more samples to test, ensuring that the quality has been maintained.
If this legislation goes through then the market for nicotine liquids will go underground.
The retailers you currently have out in the open will withdraw from the market to be replaced by unscrupulous sellers selling god only knows what. History has shown only too well that when the public want a product they will get a product. But where the product is illegal criminals will supply an completely uncontrolled, and possibly contaminated, product.
You will undoubtedly have some users of electronic cigarettes who will attempt there own 'kitchen' extraction of nicotine from tobacco..
Who is going to ensure to quality and safety of these underground or home made NCPs.
No one is.
As for the efficacy. The uptake of electronic cigarettes would not have been as it has if they did not work for many people. By all means do more studies but you seem to be stating “they might not work so we're banning them” “oh and by the way we know tobacco kills so that's exempt”.
Paragraph 16.
You state
“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 .”
Can you publish these analyses please. I seem to remember only one sample out of many was bad ?
Even better could you collate all the tests done in this country by our own trading standards and publish how many bad samples were found.
Of course tobacco must have been given its exemption, in part, because exhaustive testing has found no carcinogens or toxic chemicals in its smoke. No wait that's not quite right !
Paragraph 17
You know that your favoured option, option 1, would not give time for the fledging UK electronic cigarette industry to gain a license. Effectively destroying it. In my opinion that is the aim of the legislation.
You state “ This, however, needs to be weighed against the (unknown) risk to public health of the continuing availability of products”
How about weighing the (known) risk to public health by the removal of electric cigarettes from the market. Many people will go back to inhaling tobacco smoke. They will die younger. I'm sad to say I again think this is another (twisted) purpose of this legislation.
I chose Option 4
You didn't include an Option 4 so I've written my own:
Option 4 – Do nothing and allow these unregulated products containing nicotine that have
not been assessed for safety, quality and efficacy to remain on the market. But do conduct studies on them and where they can be found to have a dire effects on human health ban them.
Where studies already exist which show dire consequences to human health i.e. Tobacco intended for combustion and inhalation, ban them.
I've tried to remain calm whilst writing this but it has not been easy.
Yes if enacted the legislation would have a huge impact on my business. But that is truly not my main concern. My main concern is for for my customers, and all other electric cigarette users, long term health.
That should be your main concern but the exemption of tobacco from this legislation proves that this is not the case.
You should be ashamed of yourselves as an organisation.
Lee Harris
ecigsoutlet
19 Western End
Newbury
RG14 5NT
(1)http://biopsychiatry.com/nicotine/freebase-nicotine.html
