@CKC
Thanks for that link. Here are some points.
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MHRA - NICOTINE CONTAINING PRODUCTS - QUESTIONS AND ANSWERS
PDF here:
http://www.mhra.gov.uk/home/idcplg?...111572&RevisionSelectionMethod=LatestReleased
also at:
NICOTINE CONTAINING PRODUCTS
From Q1:
"The responses to consultation suggest there is clear support for MHRA regulation,......."
Yes - everybody wants to see regulation of some kind. In fact we already have regulation, very efficiently carried out by the Trading Standards bodies.
Due to the fact that the MHRA were seen to lie to people during the consultation process, telling them that e-cigarettes were not regulated, it is not surprising that many respondents asked for regulation. It's already in place. Once the trade association has a materials quality approval system in place, no additional regulation will be needed.
"The majority of importers and users of unlicensed electronic cigarettes were opposed to regulation by the MHRA, the latter fearing that this would mean an immediate ban on products currently available and that this could lead them back into smoking tobacco. Public health focussed organisations too raised concerns that an immediate move to medicines regulation would lead to potentially useful products being taken off the market and/or innovation being stifled."
Quite so - 99.9% of products would be removed from the market. The average vendor carries at least 4 e-cigarette models. There are more than 100 e-cigarette models available. Each would require licensing @ £28,000 per licence plus the research costs - £75,000-plus for each individual item if all e-cigarette models are to be treated as different. If they were not, then one licence will cover all e-cigarettes - and that is extremely unlikely to be allowed. Therefore the licensing cost for each e-cigarette model will be £100k plus, for each vendor. In some cases the items are the same - but mostly they are not as there are over 100 models available. A license covering a 510 atomiser model will not cover a 901, 801, or even a large-format 510 with a cartomiser (as both the battery and the end fitting are different and nothing is the same, only the thread system is the same). After this you come to mods of course - custom models that work exceptionally well and use generic batteries - and each one will need its own license.
Then we need to look at liquid refills. There are two basic types, PG and VG, although some vendors carry a third type, PEG. These can be combined or offered separately. Just taking the the two main types, that means there are three possible offerings, and the mixed type will have variable amounts of the two main components. The there is the question of flavorings - each flavour is a different chemical composition, so would require a separate license. Then there are the 6 main nicotine strengths offered, plus zero-nic.
The variety here means that just one vendor offers a possible 7,000-plus combinations. It is absolutely impossible that multiple differing liquid formulations will be able to share the same license as they have vastly different ingredients. If this were the case, one license would cover all e-liquids - which is not going to happen.
So let's say each vendor will need 4 hardware and 10 liquid licenses, if they restrict themselves to a tiny fraction of their current product line. That's 14 times £100,000 as a minimum - or £1.4 million.
As you can see, all vendors will be forced out of business except those who basically sell one hardware item (perhaps with a variant such as a larger battery) and one range of cartomisers, all with the same basic liquid formulation. And, as it happens, those are the companies who have already applied for a pharmaceutical license. All one or two or three of them - at most. Out of 30+ UK vendors.
"The consultation highlighted the need for evidence on the levels of nicotine that have a significant pharmacological effect,......."
This statement is utterly and completely ridiculous. It implies that all products having an effect on the human body require medical licensing. As far as we are aware tobacco, alcohol, coffee and tea do not need medical licensing, and until this changes neither will smokeless tobacco products.
From Q2:
"The MHRA has received legal advice that products which contain nicotine which appreciably affect metabolism in normal usage could arguably fall within medicines legislation in terms of their pharmacological action."
See above - many consumer products fall into this group and are obviously exempt from any kind of medical license. There is also a good base of legal argument that arose in the NJoy vs FDA case to support this. Ecigarettes are a smokeless tobacco product, and until tobacco, smokeless tobacco, alcohol and coffee are classed as medicines, they are likewise exempt. The MHRA's approach means they will eventually be able to license almost anything and everything as a pharmaceutical - creeping regulation gone crazy.
From Q3:
"Smoking is the greatest single cause of avoidable ill-health and death, accounting for 80,000 deaths each year in England alone. As such, it is important that we look critically at new developments and assess their potential impact on public health."
Indeed. But luckily, smokeless tobacco products are available that have around a 99% reduced risk compared to smoking. The government has lied to the public about the relative risks, and lied for decades - when will this lying stop?
If somebody wanted to reduce the smoking death rate the fastest, most efficient, and most morally correct way, then they would fast-track safer alternative smoking products into the marketplace. The medical solution has utterly and totally failed, and always will fail. 80% of illness is caused by lifestyle choices, as any doctor will tell you. Correct the lifestyle choices and stop trying to give a pill to fix the result. Stop lying to the public.
"If, after the further research, nicotine containing products were to be regulated as medicinal, this approach could make such products more widely available, supported by clear information for users and appropriate advertising."
This is the most outrageous lie: 99.9% of products will be removed from sale.
If you want clearer information given to buyers and better results, then stop the Health Service backing useless NRT products with a failure rate of 93% or worse, and get them behind smokeless tobacco products, which have a 99% reduced risk and are 80% successful when used under mentoring.
Or is an easily-achievable 25% reduction in the smoking death rate not something you would like to see? And even a 50% reduction is certainly possible with full government support. Try looking at Sweden for example, where the use of smokeless tobacco products has resulted in the lowest male cancer death rate in Europe.
"........ NCPs would have a general sale legal status meaning they can be sold in general sale outlets such as supermarkets."
This is a clever obfuscation of the truth. By 'general sales product' they mean a pharmaceutical that is licensed for 'general sale', ie in an establishment where that is permitted, where the sales conditions are monitored, and of course if the product has a pharmaceutical license. It has nothing to do with the trading description and Customs & Excise classification General Sales Product, and is a deliberate attempt to confuse.
From Q4:
"Although regulating these products as medicines will have an economic impact on importers of these products, this does not necessarily mean there will be an increase in cost to the end user."
Again an outright lie. Even if one product alone had to be licensed, are they saying that the £100k-plus cost of licensing is insignificant to a small business? But since most vendors (all of them except the single-product carto model vendors) will have to obtain a minimum of 10 licenses, this whole area is a complete fantasy.
All vendors except single-line product sellers will go out of business. Those who manage to stay on, selling one hardware item and one extremely limited liquid range, will add their licensing costs to the product's selling price. Cost per unit has to go up, in an amount dependent on volume of business.
From Q5:
"Public health protection is the MHRA’s priority."
Perhaps, when it aligns with the pharamaceutical industry's agenda.
Otherwise, that statement is open to question. Is better public health the MHRA's sole objective - or is there another agenda?
The MHRA - skullduggery and corruption
Scientists and researchers who work for the FDA, the MHRA's equivalent in the USA, regularly complain in jointly-written, signed letters to the media about corruption in the FDA management that has resulted in numerous events that have had substantial negative impact on public health. The problem with the FDA is that they are funded by and work extremely closely with the pharmaceutical industry, and appear to promote the industry's agenda. Of course, it is entirely possible that the UK MHRA is managed in a different way. Unlike the FDA then, the MHRA would not be funded in various ways by the industry; would not have ex-pharma staff working for them; would not have ex-MHRA staff working in the industry; would not have staff mobility between the industry and the regulators; would not have senior industry positions available for retiring MHRA staff; would not be clearly seen to avoid any regulatory action that has a major negative effect on pharma income; would not be seen to encourage regulatory activity that increases pharma income at the cost of other interests; has no personnel who have ever benefitted in any way from pharma largesse; and so on. As stated, this is entirely possible.
"The forthcoming programme of scientific and market research will look at the impact on industry and the public health objective will be pursued in the least burdensome manner possible."
The 'least burdensome manner' would be to leave the hell alone and stay with the pill-pushers. When you have removed all the dangerous drugs that kill dozens every year, then come back and tell us how good you are at your job. Attacking e-cigarettes doesn't play, they haven't killed anyone yet and are unlikely to until someone drowns in a vat of the refill liquid in a factory; unlike the case for the quit-smoking drugs which have killed and will kill far more people than e-cigarettes - both by lethal side effects and by the fact people fail to quit and then return to smoking, which kills them.
Smokeless tobacco products are the smoker's choice of the future. They should be a valid and popular choice right now - if it wasn't for government's incompetence and immorality in this area.
It would be possible to reduce deaths from smoking by 25% in 5 years if you went about it the right way - by promoting consumer harm reduction choices, of course. Why is government so incompetent at tasks it claims it wants to achieve?
From Q6:
"The consultation highlighted the need for evidence on the levels of nicotine that have a significant pharmacological effect, and the need for further information on the impact of medicines regulation on public health and business. A period of further scientific and market research will therefore be coordinated by the MHRA with the aim of answering these important questions before a final decision on whether or not to regulate nicotine-containing products as medicines is made."
Materials that have a 'pharmacological effect' may or may not be medicines. Tobacco, alcohol, and coffee are not medicines. E-cigarettes are a consumer product like tobacco, smokeless tobacco, alcohol, coffee, or anything else that makes you feel better. Drugs are for illness, drinking coffee or using a smokeless tobacco product is not for curing an illness - the pressure of modern urban life is not an illness. It may be the cause of several, though.
Any research would need to find evidence of the occurrence of harm caused by e-cigarettes, or a very strong argument that large numbers of persons will be injured in some way.* This is unlikely to happen since after a global trial by millions of people for several years, there is not one single example of morbidity or mortality. Further, since all the ingredients are popular and safe consumer products, and/or are by themselves GRAS / Acceptably Safe, and are consumed in vast amounts by people everywhere, there is no indication they will cause harm or that combined they will be more harmful.
* Medicines are allowed to kill large numbers of people, if the numbers who would otherwise die is greater. At least - that seems to be the generally accepted measure, as we have many medicines that do kill. Quit-smoking drugs for example have killed hundreds (possibly thousands, but the figures are hard to obtain for some reason).
From Q7:
"A decision has not yet been made on whether or not to regulate nicotine containing products under medicines legislation."
This is one of the more ridiculous statement in this document. Of course a decision to regulate the products has already been taken, otherwise this highly expensive and time-consuming exercise would not have been needed. In fact it is only needed at all because the regulations that the regulators must adhere to, stipulate that a 'public consultation' process must take place. If that regulation did not exist, e-cigarettes would already be subject to regulation.
And it does not of course have anything to do with public health. Public health would be best served by leaving e-cigarettes alone; by stopping the lies about the relative risks of smokeless tobacco products; and by promoting the sale of smokeless tobaco products as hard as possible. That's what a commitment to public health would require.
E-cigarettes represent a threat to pharmaceutical industry income since nobody would need NRTs. That is the only factor that needs taking into account.
From Q8:
"When will a decision be made on the regulation of NCPs as medicinal products?"
When the government changes and the regulate-everything-and-don't forget-my-bung socialists come back; or when the EU tells the UK that is what it has to do.
Until then it looks as if the huge costs to the country, the removal of 99.9% of products, the massive threat to public health, the removal of hundreds of jobs, the loss of a great deal of tax revenue that will then go to overseas operators, the complete removal of the current quality control regulations for e-cigarettes, and the creation of the largest black market the world has ever seen, may be a slight impediment to regulation.
From Q9:
"The safety and efficacy of the products as they are used has not been subject to the type of rigorous testing expected for medicines regulation."
A bit like coffee percolators, then. Although of course both coffee percolators and e-cigarettes are regulated - unless you are once again trying to suggest this is not the case?
From Q10:
"Should these products be left on the market until March 2013 if there are concerns over the safety, quality and efficacy?"
They will have to be left on the market as despite the MHRA fighting tooth and nail to introduce regulations, and thus ban them and please their paymasters greatly, the RPC pointed out that the IA consisted of total fantasy masked as a fatuous plea to protect public health. In the best traditions of propaganda it was exactly the opposite of the likely result, which would be a massive blow to public health.
"The consultation has highlighted a number of questions that need to be answered and the scientific and market research should help to answer these questions and enable a final decision to be made."
Those questions mainly consist of, "Will the EU come down against e-cigs and thus make our job a lot easier?", and "Am I really being paid enough to indulge in this real-world version of Second Life?", and "Can we rig the market research this time in a way that won't result in us being found out again?". These are indeed serious questions.
From Q11:
"Does this mean I can still buy electronic cigarettes?
Yes."
Read: Unfortunately we waited too long and the government changed, which scuppered the plans the pharma industry had for crushing this threat. Sorry boss.
From Q12:
"What about Nicotine Replacement Therapy (NRT) products? Has their status changed?"
"The licences for medicinal Nicotine Replacement Therapy (NRT) have now been extended to include a ‘harm reduction’ indication, which means smokers can now use these products if they choose, or are forced into, temporary abstinence (i.e. who do not wish to expose others to their second-hand smoke or cannot smoke because they are in a smoke-free area), or if they wish to reduce the number of cigarettes smoked without a specific intention to quit."
Read: We didn't want to grant this extension but as we messed up bigtime crushing e-cigs, we had to allow the pharma boys a way to compete with stuff that obviously works a whole lot better than their gear. Damn.
From Q13:
"The programme of research will include .............. modelling of the potential impact of bringing these products into medicines regulation on public health outcomes."
Actually this doesn't need modelling: basic logic tells us that if e-cigarettes become subject to licensing, it will be equivalent to a ban, since 99.9% of products will be removed from the market. As e-cigarettes are almost an order of magnitude more effective than NRTs in successfully allowing consumers to change to a less harmful nicotine supply, removing almost all e-cigarettes from the market and forcing people to either go back to smoking or to use the comparatively-useless NRTs (which is the same as forcing at least 93% to go back to smoking) means that the effect on public health would be severe.
From Q14:
"Why has it taken you so long to publish the results of consultation MLX 364?"
Read: We fought as hard as we could to bring in licensing. In the end, the people in charge just wouldn't go for our tales of fantasy. We don't know why.
From Q15:
"What is the position of nicotine containing products in other countries?"
"The regulation of nicotine containing products is being considered in other European Member States and by the European Commission."
Read: We hope to hell that the EU can be persuaded to call for e-cigarettes to be banned. Otherwise our job will be impossible, and our friends will be very unhappy indeed.
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