MHRA announces 'Do Nothing' as an interim procedure until Spring 2013
The PDF with the decision contains no substantive decision or discussion regarding a decision, and instead attempts to avoid the issue entirely, merely mentioning in passing that 'more research will be done', and is available from the MHRA site, titled:
Outcome of consultation exercise MLX364 on the regulation of nicotine containing products (NCPs).pdf
This is a win for the consumer and the industry. In 18 months' time there will be little practical change in the situation - with the exception that an EU decision on the same topic may overrule UK law.
Now that the dust has settled we can look a little more closely at the implications of the MHRA's announcement of last Thursday.
The first thing to clarify is that the decision is 'none of the above' - it is not Option1, 2, or 3. The MHRA were defeated since their regulatory proposal was rejected by the RPC. However, they cannot let the matter rest there, and since there is probably no rule that says they cannot keep trying even if rejected, they are in effect stating that they are going for an additional route:
Option 4 - avoid any and all IA or RPC problems by making the matter a legal issue and thus immune to blocking by the RPC or anyone else.
The implications of the I.A.'s rejection
Because the Impact Assessment was not perhaps managed as efficiently as it might have been, and was rejected by the RPC (we don't know for sure as the decision process was not entirely transparent, but it would appear to have been given a Red rating), the attack will be repackaged in a different way. Since the RPC have proven troublesome and won't rubber-stamp the IA fantasy tale, and look to be difficult to budge, another route must be found.
The prime thrust of the attack this time will be to attempt to prove that nicotine is a licensable drug, since other arguments (anything health-based or finance-based) were shown to be untenable last time.
The MHRA hopes to circumvent and evade the RPC by legal means since it would appear that a logic and numbers-based argument cannot succeed - as there is no logic to their position and the numbers don't add up. But if, on the other hand, the courts can be persuaded to find that nicotine is a pharmaceutical, then the MHRA succeeds - the RPC will have been outflanked. No I.A. is needed and nothing else needs fixing: job done.
It seems that the only defence against this particular attack will be a legal one, to show that in fact nicotine is a consumer recreational substance like coffee, caffeine-containing drinks, or alcoholic drinks. Some groundwork on this has already been done by the US legal team that defeated the FDA on this very point.
However the main problem for us will be that a legal battle is expensive. We will be facing the might of the pharmaceutical industry, who will use their money and taxpayers' money to fund the attack.
We need to be very clear on one thing: the MHRA have already decided that they will license e-cigarettes as a pharmaceutical, and had decided that before the public consultation. What they have to do is to find a way to push that decision through.
Timescale
In one year's time (not 18 months) you can expect the MHRA to state they have evidence to show that nicotine is a pharmacological agent, and thus a drug that requires licensing. Many within the pharmaceutical industry will now be put to work to provide evidence for the MHRA to use, and you can be sure this work will be very well funded. They have a year or less to carry this out, and most likely have already started.
Only a legal defence can stop the attack. In this regard the UK situation will then mirror the US one. It does look as if they have chosen their ground well this time, learning from their first failure: a legal battle is expensive, and they hold all the cards. They have pharma money, and they have your money too.
In addition, if the attack should by some chance fail, the MHRA have an excellent excuse for their masters: we did our best but the evidence you provided us with, and/or the legal team, and/or the funding was just not enough - so it's your fault, not ours. Plus: now the courts have told us we have to leave this matter alone.
They failed last time, and managed to look a little foolish, because Goliath should not be defeated by a midget - but this time round they have an excellent get-out-of-jail-free card. Great news for all at the MHRA, because this time they can't really lose, whatever happens.
The unknown quantity in all this is the EU. Nobody knows what they will decide.
Option 1 – Whether all NCPs should be classified as medicinal products and all unlicensed NCPs be removed from the market within 21 days.
Option 2 – Whether all NCPs should be classified as medicinal products and notice be issued to manufacturers that all marketing must cease by a certain date e.g June 2011. After this date enforcement action would be taken against manufacturers of unlicensed products still on the market.
Option 3 – Do nothing However, they state that option 3 is not an option: "Option 3 warrants no further investigation as it is neither in the public health interest nor commercial interest to leave the current regulation of NCP/NRT untouched."
They also state that the government prefers option 1.
Evidence
The MHRA base their evidence for the need for regulation on the flawed FDA press release concerning electronic cigarettes. This press release mentioned the existence of nitrosamines without mentioning that they were at the same level as legally approved NRT products.
The issues has been further confused by a trading standards announcement which announced that the level of nicotine in e-juice was 20%, or almost three times that allowed in the UK poisons act. This appears to have been due to an elementary mistake in calculations which led to the level of nicotine being multiplied by 1000 percent; the actual level was 2%.
Conflict of interest
The MHRA is funded by the pharmaceutical industry, and according to a House of Commons select committee has a close and unhealthy relationship with the industry.
(See House of Commons Select Committee The Influence of the Pharmaceutical Industry)
MHRA Consultation
At an MHRA meeting the MHRA appeared surprised that e-cigarette traders present only sold the e-cigarette ,and that they did not claim it was an nicotine cessation aid.
The MHRA stated that there was a level above which nicotine effected the metabolism and at which it would have to be regulated. However, they did not know what that level was.
Implications
The electronic cigarette industry believe that the two weeks allowed for companies to gain the licensing (usually two years) and the £350,000 ($500,000) suggested licensing fee per electronic cigarette would represent an effective ban on the device, returning an estimated 60% of thousands of electronic cigarette users back to tobacco cigarettes.
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Directive 2001/95/EC(6) on general product safety applies in so far as there are no specific provisions with the same objective in other EC law. This directive provides for restrictive or preventive measures to be taken if the product is found to be dangerous to the health and safety of consumers.
Whether ecigs could be regarded as falling under Directive 93/42/EEC on medical devices depends on the claimed intended use and whether this intended use has a medical purpose. ”It is for each national authority to decide, account being taken of all the characteristics of the product, whether it falls within the definition of a medicinal product by its function or presentation.“ Link
Electronic cigarettes may fall under the definition of a medicinal product laid down in Directive 2001/83/EC, either if the product is presented as a remedy against nicotine addiction or if it is qualified as restoring, correcting or modifying physiological functions.
Member States might be allowed, in application of Article 36 of the Treaty on the functioning of the European Union, to adopt restrictive rules relating to the manufacturing and the marketing of electronic cigarettes in order to protect the life and health of humans. Such measures should be based on scientific and technical data regarding the harmfulness of these products and respect the proportionality principle. Link
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MHRA Decision
