OK, I've written up my thoughts here: UK's MHRA to regulate electronic cigarettes as medicines - ECF InfoZone
Depressing.
Depressing.
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A thoughtful piece, SJ. Many thanks. Now that a fairly sizeable fly has settled into the ointment, how do we extricate it?
- Apr 2, 2009
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By announcing a three year delay before the ban (er regulation) goes into effect, it appears that MHRA officials are just kicking the can down the road until they can hire someone who has enough competence to deal with this.
If e-cigarette sales continue to double annually (as they have since 2009), there will 8 times more e-cigarettes sold and likely 8 times more e-cigarette consumers than now.
MHRA's decision is likely to further increase vapor products sales during the next several years as some vapers in UK will begin stockpiling for future years.
Nothing like declaring a war three years in advance against folks whose ranks continue to grow exponentially. Such stupidity.
A likely silver lining in MHRA's announcement is that BAT and perhaps several large e-cigarette companies will begin spending lots of money to get their e-cigarette brand(s) approved by MHRA as medicine.
Once MHRA approves the first e-cigarette brand as medicine, it will be a huge international news story that will inform the world (including all e-cigarette prohibitionists, health agencies, smokers and nonsmokers) that e-cigarettes help smokers quit smoking.
But very few smokers would go out and buy the far more expensive e-cigarette brand that was approved by MHRA.
Rather, smokers will buy less expensive e-cigarette products to save money.
I can already hear MHRA, DOH and NICE officials (and ASH UK) complaining in 2016 that their new e-cigarette prohibition has sharply increased black market sales of e-cigarette brands that aren't approved by MHRA as medicine.
If e-cigarette sales continue to double annually (as they have since 2009), there will 8 times more e-cigarettes sold and likely 8 times more e-cigarette consumers than now.
MHRA's decision is likely to further increase vapor products sales during the next several years as some vapers in UK will begin stockpiling for future years.
Nothing like declaring a war three years in advance against folks whose ranks continue to grow exponentially. Such stupidity.
A likely silver lining in MHRA's announcement is that BAT and perhaps several large e-cigarette companies will begin spending lots of money to get their e-cigarette brand(s) approved by MHRA as medicine.
Once MHRA approves the first e-cigarette brand as medicine, it will be a huge international news story that will inform the world (including all e-cigarette prohibitionists, health agencies, smokers and nonsmokers) that e-cigarettes help smokers quit smoking.
But very few smokers would go out and buy the far more expensive e-cigarette brand that was approved by MHRA.
Rather, smokers will buy less expensive e-cigarette products to save money.
I can already hear MHRA, DOH and NICE officials (and ASH UK) complaining in 2016 that their new e-cigarette prohibition has sharply increased black market sales of e-cigarette brands that aren't approved by MHRA as medicine.
I'm not suggesting that we do. That is, however, the second time you've missed the point in as many posts. If the Reuters article is to be believed, it may well not be any more difficult for us to get hold of vaping equipment and supplies than it is at the moment. Unfortunately, all manufacturers of NCPs will have to obtain a license in order to sell those products, and that is likely going to come at a significant cost - a cost which will be passed onto us (the consumer). There are many other potential implications - most of which were raised during the ENVI workshop in May:
1. Medical regulation is not (nor should it be) applicable to hardware - and, indeed, none of the hardware on the market at the moment meets the requirements of current medical regulation.
2. Tobacco is not classed as an NCP or a medical product - why are e-cigarettes being treated differently? This gives the EU carte blanche to impose over zealous and punitive regulations whilst traditional tobacco reamins freely available and is largely unaffected.
3. Flavorings will not be allowed.
4. Potential restrictions on the amount of nicotine cotained in e-liquids.
5. Hefty administrative burden for manufacturers and vendors.
EDIT: In the time I spent typing that reply both Bill Godshall (Post #37) and SmokeyJoe (Post #41) have posted some thought provoking and insightful links - which are much more informative than anything I could come up with on my own.
JJ
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Anyone who believes ecigs would reamin in the free market without any regulations or licensing are living in a delusional fantasy.
Ecig manufacturers, suppliers and retailers need to position themselves to obtain licensing for these products in the future to maintain consumer sales.
Ecig manufacturers, suppliers and retailers need to position themselves to obtain licensing for these products in the future to maintain consumer sales.
Well, the good news is they didn't ban candy flavorings.........
If you're in the UK, see the DIY section.
If you're in the UK, see the DIY section.
Bill, my reading of what the MHRA have just done is that they didn't have a choice, or at least their lawyers felt they didn't.
From memory, the whole crux of the meeting I attended 3 years ago was that they had been informed (by their lawyers) that they needed to act on e-cigarettes. The fact that it's taken 3 years to announce this is a testimony to those who've been campaigning, including all the vapers who contact them during the consultation, and the fact that they obviously had information that it was going to be legislated on by the EU.
Do you, Bill, have any updates on when the FDA are going to announce their 'deeming' proposals?
From memory, the whole crux of the meeting I attended 3 years ago was that they had been informed (by their lawyers) that they needed to act on e-cigarettes. The fact that it's taken 3 years to announce this is a testimony to those who've been campaigning, including all the vapers who contact them during the consultation, and the fact that they obviously had information that it was going to be legislated on by the EU.
Do you, Bill, have any updates on when the FDA are going to announce their 'deeming' proposals?
Wow! I hope you're not made to regret that post when the FDA rules on US regulation, or if the U.N. Arms Treaty turns out to be a sneak attack on US gun control. I'll be keeping my fingers crossed that it's good news on both counts, because we Brits are nice like that...
JJ
I hope this isn't our friends across the ponds saying "it could be worse".
Call your $##^!&!*@^# politician and start making noise. This is your freedom being snatched away.
Call your $##^!&!*@^# politician and start making noise. This is your freedom being snatched away.
Thank you for sharing that excellent blog. That is what I've said all along, the bad guy isn't BT, it's the Pharmaceutical Companies. They have the most income to lose.
- Apr 2, 2009
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Smokey Joe wrote
Government agencies like to hide behind their lawyers. I wasn't aware that anyone has sued MHRA for NOT imposing regulations on e-cigarettes. MHRA could have done what it should have done, nothing.
The proposed EU Tobacco Products Directive is not law, but rather is just a proposal (that is likely to be amended many times before it is approved, if its ever approved).
The US FDA has stated that it will first take action on the huge backlog of several thousand Substantial Equivalence applications before taking action on the "deeming" regulations. If FDA denies some SE applications (which is likely to occur), the aggrieved tobacco company(ies) may sue the FDA, and the case(s) may be given to Judge Leon for adjudication (since he's handled other lawsuits against FDA).
And if our campaign exposing and opposing the FDA "deeming" regulation continues to succeed (as it has since 2011), the FDA will NEVER propose (or at least won't issue a Final Rule for) the "deeming" regulation.
Government agencies like to hide behind their lawyers. I wasn't aware that anyone has sued MHRA for NOT imposing regulations on e-cigarettes. MHRA could have done what it should have done, nothing.
The proposed EU Tobacco Products Directive is not law, but rather is just a proposal (that is likely to be amended many times before it is approved, if its ever approved).
The US FDA has stated that it will first take action on the huge backlog of several thousand Substantial Equivalence applications before taking action on the "deeming" regulations. If FDA denies some SE applications (which is likely to occur), the aggrieved tobacco company(ies) may sue the FDA, and the case(s) may be given to Judge Leon for adjudication (since he's handled other lawsuits against FDA).
And if our campaign exposing and opposing the FDA "deeming" regulation continues to succeed (as it has since 2011), the FDA will NEVER propose (or at least won't issue a Final Rule for) the "deeming" regulation.
I'm not sure if I am Reading this correctly. But if the Fees for "licensing before the marketing of medicines" are what I think they are, it would seem that only BT and BP would be able to pay them
Marketing authorisations : MHRA
Maybe someone can click on the "Fees" in the above link and tell if I am reading this Correctly?
What would happen? I guess, if you want nicotine, you'd have to start smoking so you could then turn around and get a prescription???? lol.
What happens with cigs? Are they prescription only? No. But e-cigs are.
.....
What about NRT's in the UK? Prescription only?
Grrrrrrrrrrrrr
I would be quite happy if ecigs became prescription only, just buy an annual NHS prescription pass for £104 and let the non smoking taxpayers contribute to my ecig habit.
Zoid,
The last time I asked, a license fee for one product was £28,000. However the real cost is in the clinical research, documentation, and legal costs.
As an example, Intellicig estimated 2 years for the process and budgeted £95,000 for the MA (Market Authorisation, aka pharmaceutical license), for the licensed version of their ecig (called Nicodex). After 3 years and over £1m they have nothing. They had to sell the company not once but twice in order to avoid going bust: first for a cash injection of around £2m, then again to BAT for tens of millions (somewhere around £40m although we don't know the details).
BAT got a bargain there because an ecig with a medical license, as you can probably now see, is a license to print money. An MA costs far more than any small company can afford (we know that it cost £750,000 per product just for natural health supplements with 30 years' proven safe use history); but once you have it, you have an 'in' to the NHS. After that point, any doctor who prescribes NRTs (let alone varenicline) would be off their head - even a bad ecig with zero support will work at least three times better than any (current) pharmaceutical intervention for smoking cessation. That means Intellicig/CN Creative/BAT will make about £100m a year just to start with.
I'd call that good business.
The last time I asked, a license fee for one product was £28,000. However the real cost is in the clinical research, documentation, and legal costs.
As an example, Intellicig estimated 2 years for the process and budgeted £95,000 for the MA (Market Authorisation, aka pharmaceutical license), for the licensed version of their ecig (called Nicodex). After 3 years and over £1m they have nothing. They had to sell the company not once but twice in order to avoid going bust: first for a cash injection of around £2m, then again to BAT for tens of millions (somewhere around £40m although we don't know the details).
BAT got a bargain there because an ecig with a medical license, as you can probably now see, is a license to print money. An MA costs far more than any small company can afford (we know that it cost £750,000 per product just for natural health supplements with 30 years' proven safe use history); but once you have it, you have an 'in' to the NHS. After that point, any doctor who prescribes NRTs (let alone varenicline) would be off their head - even a bad ecig with zero support will work at least three times better than any (current) pharmaceutical intervention for smoking cessation. That means Intellicig/CN Creative/BAT will make about £100m a year just to start with.
I'd call that good business.
It does seem that the Cost would be Extremely Prohibitive to All but the Biggest Companies. Let alone a Large e-liquid retailer.
I don't want to read more into this than I should, but it seems like a Good Way to Allow e-Cigarettes to still be sold. But to ensure that Only BT or BP can reap the Profits from selling them.
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