MHRA have decided to try and classify nicotine containing products as medicinal / pharmaceutical in nature .
That's pretty much the issue. At the moment they only have the authority over products that make health claims.
What they want to do is classify everything that contains nicotine (excluding tobacco products) as medicines even if they don't make health claims. Paragraphs 13, 14, and 15 (MLX 364) is where most of that is covered.
They (MHRA) have offered 3 choices in their consultation document.
1 - Its a medicine,
2 - Its a medicine ,
3 - It is not a medicine
So already its a loaded vote of 2:3 in favour of it being a medicine.
I personally would have assumed they initial consultation would have tried to prove guilt first then pass sentence if guilty.
Technically, 2:1 or 2/3, but that's me nit-picking on something that isn't important.
Using the precautionary principle, they don't need scientific proof that something is harmful if there is a cause of concern about its safety. Paragraphs 15, 16, 17, and 18 (MLX 364) give their reasoning: "quality, safety, and/or efficacy".
Thus for many (including myself) option 3 would be ideal solution and end to the matter, for the time being though do not count out further legislation as to "nicotine concentrations allowed for human use", bottle sizes, etc bought in by trading standards.- but thats for another day.
Option 3 is misleading. Some manufacturers and suppliers have already removed anything that may be mistaken as a health claim from their sites. The MHRA already have the authority over products that make health claims.
The Poisons Act, General Product Safety legislation, consumer protection legislation (Sale of Goods Act, Distance Selling regulations, etc), and other legislation should already cover all e-liquid and devices. Instead of testing any e-liquid themselves, they cite the FDA's "test" as a reason for all nicotine products to go through medicine licensing to ensure "safety".
If the loaded vote works in the MHRA's favour would I be right in assuming the following.
The MHRA have only given 1 definite timescale of 21 days for option 1. Option 2, has no timescale, but could in theory be as little as 22 days. ie longer than option 1.
Yes, although they do give a year as a suggested time-scale for Option 2.
Suppliers would need Marketing Authorities (MA) to continue selling their products. and the MA is the safety certificate of a whole host of phased clinincal trials. - the costs of which are incurred by the applicant(s).
...
Nicotine would be classed as the main active ingredient. ( different flavourings could also introduce extra active ingredients)
and with nicotine being both toxic and addictive in nature and with current e-liquid strengths could the MHRA actually then even classify it as presciption only?
I've only skimmed through the procedure of medicine legislation in the UK, but it did look like it is the main 'active' ingredient in a medicine that counts. I've tried to get my head around "pharmaceutical equivalence" but would prefer the MHRA or someone to actually explain it to me.
Assuming varied dosages (e.g. nicotine strength) would be considered the same medicine, and different mixes and flavours are pharmaceutically equivalent, it is possible that the e-cig industry only requires one MA that covers all e-liquid, and all the other manufacturers only need a manufacturers license and a generic/piggy-back license.
The problem with that, however, is whether something that is pharmaceutically equivalent needs to undergo tests and trials to prove it has the same effect.
I don't see e-cigs or e-liquid becoming prescription only, or at least not on NHS prescription. My GP would rather I vaped than started smoking again so he'd make sure I was able to get enough liquid (and I can't see any doctor wanting to sign scripts for a third of their patients every week).
Also, a pre-payment certificate for £104.00 gives unlimited prescriptions for a year. I can't see us getting e-liquid for 2 quid a week being economical at all.
As for nicotine being addictive and toxic, there are plenty of medicines already authorised that are addictive (and can kill if someone O/Ds on them).
The clinical trials would have to cover all the variations of the e-liquids. ie strength, flavours, packaging ,dosage and dosage control . This could take many years couldn't it? ( eg just phase III trials on humans can vary from 3 months to several years)
Unfortunately my knowledge is severely limited in this area. I did see a figure somewhere that the average cost of getting a medicine to market is $359 million, though.
John.
(not that they have plans to do that...yet)
