RE: Time to come together - show your support
Dave's MHRA submission:
Quote:I shall be sending this to the MHRA
Electronic Cigarettes and Regulation
Existing Regulation
Poisons Act, Consumer Laws etc.
Existing Regulation
Nicotine containing products are already regulated under the Poisons Act, which requires concentrations of no higher than 7.5% and packaging in fully CHIP compliant methods. In stark contrast, the traditional nicotine containing product - tobacco - is available in whatever nicotine level manufacturers care to produce, and is not required to be packaged in such a way that children cannot ingest the entire contents of a pack. It is therefore entirely possible - and desirable - that Trading Standards can, and should, police this aspect of both “e-liquid” (the “fuel” for electronic cigarettes) and other NCPs
Fitness for purpose.
Already existing legislation protects consumers from products which do not live up to their claims. That is to say, if e-liquid is advertised as being of 24mg/ml concentration, then it should be at that level (within limits) else it is not as described and a complaint can be made. Again, this is a matter for Trading Standards.
Ingredients.
UK manufacturers of e-liquid already produce full independent reports of the contents of their e-liquids. As smoking, and, by extension, electronic cigarette usage is a “user choice” matter it is entirely at the user’s discretion as to whether s/he wishes to use either tobacco or electronic cigarettes. Since all ingredients (with the exception of Nicotine) in e-liquid are generally recognised as safe, then it is a matter for consumers, and not regulators.
Safety
In MXL 364, MHRA states “With regard to safety, toxic elements may be included and unexpectedly high doses of Nicotine could produce adverse effects...” It is generally recognised that smokers self-titrate, and that they build up a tolerance for nicotine over time. It is almost impossible to overdose on nicotine using any inhalation method of delivery, in stark contrast to patch usage, where there have been numerous instances of people and children becoming very ill due to having too many patches applied at one time.
Much has been made of the notion that electronic cigarettes, in particular in non-tobacco flavours, might appeal to children. In all cases, electronic cigarettes look like what they are. The same cannot be said of, say, Nicotine gum, which is flavoured in child-friendly flavours, and looks exactly like many other non-nicotine bearing gums on the market, and patches have already been mistaken for sticking plasters on more than one occasion. Absolute safety does not exist for any product, and in this regard, electronic cigarettes are no different. However, weighed against the traditional method of nicotine delivery - tobacco - they have been rated as orders of magnitude safer as a switch product.
The FDA analysis. MXL 364 mentions the much publicised FDA analysis of a sample of sixteen nicotine cartridges from two manufacturers, and cites “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 against which general product safety could not protect”. Firstly, the levels of carcinogens found in those samples were below the levels of the same carcinogens found in already authorised nicotine patches, and the toxic chemicals - which one must assume refers to Di-ethylene glycol - were at the threshold of detection and in only one cartridge. Bringing currently unlicensed e-liquids under regulation would do nothing to eliminate these issues at all - UK manufacturers are already using the exact same sources for their products as Pharmaceutical companies producing licensed NRT, and thus far, the MHRA and its associated bodies have provided no scientific evidence to show that their products are in any way dangerous.
Regulation by Function
A catch-all
The MHRA states that “Recent legal advice is that all products which contain nicotine which appreciably affect metabolism in normal usage my be within medicines legislation in terms of pharmacological action (medicinal by function)”. If this definition is rigorously applied, then, logically, tobacco products must be included. There can be no escape from this. A cigarette has no other function than to deliver a dose of nicotine, which will appreciably affect metabolism. That fact is inescapable, and if the MHRA wishes to press the point, there is a wealth of evidence to back it up.
Electronic cigarettes are designed to mimic tobacco cigarettes in function - that is to be used the same way, with similar levels of tactile feel and nicotine delivery, but with minimal levels of carcinogenic and debilitating chemicals being delivered. Their prime intent is not to assist the smoker to quit the habit, but to switch the mechanism to one which is demonstrably less dangerous, not only to him, but also to those around him.
In other words, an electronic cigarette is a cigarette in all but those constituents of smoking that are known to cause death and debility. The two delivery methods perform exactly similar functions, and one cannot be considered without considering the other.
“appreciably affects metabolism”. The MHRA has been unable to confirm absolute levels, methods of measurement or any limits for applying the term “appreciably affects metabolism”. For instance, it is well known that Aubergines contain significant quantities of nicotine, and it is not inconceivable that the nicotine contained in them may “appreciably affect metabolism”. Without hard and fast limits, or thresholds for the term, “appreciably affects metabolism” has no meaning. While it may take the equivalent of ten cigarettes to have an appreciable affect on person A’s metabolism, another person may only need to nibble a slice of Aubergine in order to experience some sort of nicotine-related effect.
In effect, then, the phrase “appreciably affects metabolism” means whatever the person using it at the time wishes it to mean, and it is, therefore, neither scientific nor a valid measure.
Impact Assessments
Currently affected users
It is estimated that in the UK there are anywhere between 100,000 and 200,000 users of electronic cigarettes. Should the MHRA succeed in forcing Option 1 upon us, those users will have two courses of action. One is to quit altogether, and the other is to return to smoking cigarettes. Since the vast bulk of users are using electronic cigarettes in their intended purpose - that is as a substitute for smoking tobacco - and have not and are not using them as a stop-smoking device, it is extremely likely that they will return to smoking cigarettes rather than quit altogether.
That is the nature of the product - it is not designed as a smoking cessation device, neither is it generally used as a smoking cessation device - it is primarily a switch product for those smokers who wish to lessen the risk, but who do not wish to quit what is, after all, a perfectly legal recreational activity, altogether.
Businesses
Of the distributors in the UK, only a very small number are actually manufacturers, and of those, two have the bulk of the market in UK-made e-liquid. Their offerings are not vast, but are significant in number. Their products are manufactured in facilities already producing approved nicotine-bearing products, and thus are already subject to the stringent quality controls those establishments have in place.
Should the MHRA force either Option 1 or Option 2 upon us, neither manufacturer would have the funding available to process all of their offerings through an application where each product is considered in isolation from the others. If they are considered as a “family” than option 2 is potentially feasible. However, to date, the MHRA has not responded to my requests for further information regarding costings.
That, therefore, means that it is entirely possible that either or both manufacturers would be unable to supply the market, thus forcing users back to tobacco cigarettes.
Small businesses
There is a significant number of small vendors who do not manufacture, but are re-sellers. Their businesses are small, and their profits not vast. They do, however, service a need, and imposition of either Option 1 or Option 2 would, in all likelihood, force them out of business - certainly Option 1 would. Option 2 would give them time to re-structure their buying regimes, assuming that approved UK and EU manufactured product could be sourced in a timely fashion. The knock on effect to their customers is as has already been stated - they will be likely to return to smoking cigarettes if Option 1 is enacted.
Conclusion
Health Benefits
The research that is available points out that electronic cigarettes are orders of magnitude safer for both the smoker and the bystander when compared to tobacco cigarettes. It therefore makes no sense to, effectively, ban them from the 100,000 or more users currently in the UK and force them back to smoking tobacco cigarettes.
Regulation
Existing legislation already covers electronic cigarettes in terms of safety and quality, and since they are used as a substitute for tobacco smoking, and are growing in popularity, their efficacy is demonstrable. Therefore regulation by the MHRA is neither necessary nor desirable, but, if it should be enacted, logic dictates that tobacco cigarettes should be similarly regulated. In short, as long as tobacco cigarettes remain on the market, there can be no justification for MHRA regulation of electronic cigarettes by function.
Regulation by presentation is, of course, as now, an entirely different matter, and should remain as it is.
It is therefore my opinion that Option 3 be the option which the MHRA pursues - there is nothing which needs to be done, other than to ensure that current legislation is adhered to.
http://ukvapers.com/showthread.php?t=619
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