Phone Call to the MHRA....

[smokindeuce]

Okay, just got off the phone from a call to the MHRA:

The person who I spoke to was nice and stressed that at this stage the proposal is very open to consultation.

This means that all options 1,2 or 3 are very much open depending on the kind of response they get. She also did not rule out option 3 but said that it would depend on the response they got.

My conversation (doing this from memory so not necessarily exact wording - responses in red):




Smokindeuce: I’ve recently been made aware of a new policy that the MHRA are putting forward on the regulation of unlicensed nicotine products or NCP’s and had a few questions for you if you wouldn’t mind.

We currently market and sell a tobacco alternative called the electronic cigarette and I would like to know a few details.

First of all, how would these proposals potentially affect us in the long run.


MHRA - It would depend on the outcome of the consultation.

Me: I gather that you are pushing for option 1 is this the case?

MHRA -no not at all - that is the point of this consultation.

Me: To give you a background, the liquids we sell are all UK produced and all to CHIP (Chemicals (Hazard Information and Packaging for Supply) regulations in terms of labelling and child proofing whereby satisfying trading standards. One of the liquids has also had a laboratory report analysis.



Would these factors be acceptable to continue sales as we are to my mind already fulfilling what has been asked from us?


MHRA -as long as licensing is applied for and accepted in terms of showing evidence of general safety and ethics




I would also like to know (if you will potentially be regulating all nicotine products), why nicotine containing tobacco products are not included in your proposal?


Tobacco already has many regulations. We are looking specifically at nicotine in a medicinal sense.


So why then would electronic cigarettes have to be regulated as a medical product if we are marketing it as a tobacco alternative NOT a cessation device?


MHRA: We are considering any product that comes to market which contains nicotine.


Me: But not tobacco?
It just seems a little hypocritical..... there are many people up in arms about this - these devices have been on the market for well over two years now.


There are a lot of livelihoods riding on this product for both users and vendors alike, cutting supply will upset an awful lot of people.



If this product is banned, people will still use this product, but instead they would get it in an unregulated form direct from China - it doesn't make any sense.


There must be a middle ground that the electronic cigarette can fall under somewhere between a tobacco product and NRT.... it is a unique device and nothing else has been made like it and nothing will follow - surely having it's own set of regulations is a possibility isn't it?


MHRA: That's the point of this consultation to get as much feedback and consider all the options.



The FDA recently did test on some of the liquids and the quality was .....


Me: Yes but did you also see the [FONT="]The FDA recently took a similar stand on the electronic cigarette as the MHRA and were taken to court where the judge ruled in favour of the electronic cigarette saying the FDA had no jurisdiction over the product. Do you think maybe the electronic cigarette could potentially be outside your jurisdiction?[/FONT]

MHRA: The FDA/US has a different set of rules and approach to the UK.



Me: Okay so what you are saying is that you will assess the response via the public consultation and all of the options will be considered.

And for us to continue to sell e-liquid we have to apply for a license.

MHRA: Yes

Me: Thanks, bye

MHRA: Bye

 

[smokindeuce]

What this means guys is every member of this forum must submit a response on their website here:

MLXs: Medicines consultation letters : MHRA


Whether you're from the US or Outer Mongolia...... Just do it......

 

[smokindeuce]

Everyone push for option 3!!!!!!!!!!

 

[smokindeuce]

I was also going to add that anyone considering phoning the MHRA do bear in mind we want these guys on our sides - the last thing that we need is an angry mob ringing up and getting their backs up.

Remember they are (in theory) coming at this from a sympathetic angle and the fact that they've even shown us options is a real plus.

So ring by all means - but try and keep it short, sweet and to the point, and leave your emotions at the door.

In fact by far the most effective action IMO, will just be to get as many of those response forms in as possible before their June deadline... keep on spreading the good word!

MLXs: Medicines consultation letters : MHRA

 

[Caesarea]

Cool, calm, collected and convincing. Is what we need.

thanks Smokindeuce!

 

[smokindeuce]

Thanks, C!

I realised after the call that I could have really done with recording the call as some of the details were lost in the moment. Still the general gist was and still is:


Send those response forms - option 3 for our freedom of choice:
MLXs: Medicines consultation letters : MHRA

 

[PlanetScribbles]

Good. I will be pushing for option 3 then. If it is on the table then it is the most logical choice, given that nic is already regulated under the poisons act.

 

[smokindeuce]

Good call Scribbles - we need to aim high on this one to keep our freedom of choice......

Smokefree? VOTE OPTION 3:

MLXs: Medicines consultation letters : MHRA

 

[deewal]

The FDA recently did test on some of the liquids and the quality was .....


Me: Yes but did you also see the [FONT="]The FDA recently took a similar stand on the electronic cigarette as the MHRA and were taken to court where the judge ruled in favour of the electronic cigarette saying the FDA had no jurisdiction over the product. Do you think maybe the electronic cigarette could potentially be outside your jurisdiction?[/FONT]

MHRA: The FDA/US has a different set of rules and approach to the UK.

They must think we're a bit daft because in CONSULTATION LETTER MLX 364.pdf which is the Full Consultation with what they have called a "Impact Assessment which is NOT a Risk Assessment of the product because they say "they do not have enough evidence" they make a point of quoting the now discredited, infamous FDA's Press release as Evidence quoting.....

[FONT=Arial,Arial][FONT=Arial,Arial]"at this time the agency has no way of knowing, except for the limited testing performed, the levels of nicotine that may be delivered to the user. The lab analysis of 2 leading brands identified the following [/FONT]
[FONT=Arial,Arial]• The electronic cigarette labelled as containing no nicotine had low levels in all samples except one [/FONT]

[FONT=Arial,Arial]• 3 different e-cigarette cartridges with same label emitted markedly different amounts of nicotine/puff (2.68 to 43.2 mcg/100mL puff) [/FONT]

[FONT=Arial,Arial]• One high-nicotine cartridge delivered twice as much nicotine to the user than came from a FDA approved device authorised for smoking cessation. [/FONT]


[/FONT]

Impact Assessment​

[FONT=Arial,Arial][FONT=Arial,Arial]22. You are also invited to comment on the possible impact on business of the proposals and options and a draft partial IA is attached. [/FONT]

[FONT=Arial,Arial]So they are using the FDA's discredited Lab Analysis as their Risk Assessment which has been clearly dismissed by Judge Leon. [/FONT]
[/FONT]

 

[Caesarea]

Good call Scribbles - we need to aim high on this one to keep our freedom of choice......

Smokefree? VOTE OPTION 3:

MLXs: Medicines consultation letters : MHRA

Agreed,

C.

 

[ChrisK]

smokindeuce said

'In fact by far the most effective action IMO, will just be to get as many of those response forms in as possible before their June deadline...'
Actually the consultation deadline is 4th of May.

I'd strongly suggest option 2. There is no way e-cigs are going to survive without some sort of regulation. It should also clear up once and for all our right to use these in public places. Until the government are behind these devices the rest of the population won't be. The management of public buildings who do not know what you are using will err on the side of caution and ask you to leave.
Those of you who think that the liquids you ingest have no need for regulation consider the tainted toddler's milk in China and think again.
Stuff that goes into your body needs to be tightly regulated, for your sake.

 

[smokindeuce]

Thanks for pointing out the deadline is in fact 4th May....

We currently make sure all our bottles adhere to CHIP regulations in order to satisfy trading standards..... as far as I'm concerned the liquid is regulated, just not by the MHRA.

This means child proofing, appropriate labelling..... both of our main liquid brands are produced in a laboratory here in the UK, and so I have no doubt as to it's purity.

So yes I would prefer option 3 because we are not advertising this as a cessation/medical device and we already satisfy what current regulations there are for us.

QUOTE
'Stuff that goes into your body needs to be tightly regulated, for your sake. '

That begs the question of whether they'll ever regulate cigarettes more tightly...... 'for our sake'.......

 

[JollyRogers]

I submitted option 2. I buy my fluid from TW, because I know they test it. I used to smoke Marlboro's and all the crap they put into the analogs is crazy. However, for some reason when I decided to try this, I kept thinking about what was in the fluids. Sorry about not voting Option 3, it's just that I don't like the idea of somebody making fluid in their garage and selling it without any process control etc.

 

[deewal]

Those of you who think that the liquids you ingest have no need for regulation consider the tainted toddler's milk in China and think again.
Stuff that goes into your body needs to be tightly regulated, for your sake.

Quite right too. Fancy a McDonald's ? Let's drive to one in a Toyota.

Hell of a first post ChrisK. You could use Liquid manufactured in the UK.
I don't think TW or Intellicig use Bathtubs or make Toddler's milk.
If they Regulate the E-Cig in the UK then you can bet your ar*e we'll be getting Liquid made in Bathtubs because they'll regulate it out of existence.
Hey, Benson and Hedges do a nice Nicotine Delivery Device. Totally Harmless too.
Now i'm off for a pint of Whiskey. The Famouse Grouse. If this does'nt rot your Liver, we'll give you your money back.

 

[Starlight]

VOTE OPTION 3

Here here. Or even Option 4, as has been suggested on another forum

Talking of "voting": if you're writing to your local MPs as well (which I hope everybody is), ask them what their intentions are when it comes to voting on it, as MPs have to reply to you (by law, I believe) if you write to them. That will help attempt to ensure they DO read about it rather than fob it off and then give you a nebulous reply.

By the way, Tim, thanks muchly for all your efforts and hard work - it's much appreciated!. Good to see at least one of the smaller independent UK suppliers posting about it at length and discussing it here

 

[smokindeuce]

I submitted option 2. I buy my fluid from TW, because I know they test it. I used to smoke Marlboro's and all the crap they put into the analogs is crazy. However, for some reason when I decided to try this, I kept thinking about what was in the fluids. Sorry about not voting Option 3, it's just that I don't like the idea of somebody making fluid in their garage and selling it without any process control etc.

Like TW, our Ecopure liquid has also been tested in a laboratory for purity. This is also something that is on the cards for the OhMG liquid we sell.

Both of these liquids are made in a UK laboratory, and satisfy CHIP regulations. Both liquids utilise minimal ingredients to maintain purity.

It is of course your choice which option (1,2,3) you vote for so no need for apologies..... you also have the choice of where you buy your liquid from.... voting with your pocket if you like.

If option 2 were to be settled on, of course regulations would be tighter which would have its advantages no doubt, but price will be pushed up in the process and choice will be limited on a local level.

Then you have to consider that people will still be able to get the unregulated stuff through customs from China/India/US etc. so does choosing either option 1 or 2 even achieve anything in the long run?

At least with the way things are currently, there are some quality controlled UK produced e-liquids on the market at affordable prices. If option 1 or 2 are the way things go in June, you can most likely say goodbye to variety, fair pricing and ultimately freedom of choice will disappear from the local supply chain.

 

[smokindeuce]

Take a look at this link if you haven't already:

Study: 'Electronic cigarettes' don't deliver - CNN.com


If this research is published in advance of the MHRA decision being made, this evidence could potentially rule out ELIQUIDS from even requiring regulation.


Laugeson has also mentioned in studies that inhaling an ecig provides around 1/10th of the nicotine you get from cigarette smoking.....

 

[frogbmth]

I agree, produce a commercial e-liquid with good flavour and throat hit and you're on a winner. The amount of nicotine absorbed from these things is way below that required to sustain true addiction.

 

[PlanetScribbles]

Harsh regulation of an already comparatively safe product will drive it underground, effectively creating an unsafe product. It's madness to force vapers to buy a reduced harm product from overseas.
The fact is that I will continue to vape whether they 'ban' it or not. They can stick their ban where the sun doesn't shine.

 

[Shining Wit]

Like TW, our Ecopure liquid has also been tested in a laboratory for purity. This is also something that is on the cards for the OhMG liquid we sell.

Both of these liquids are made in a UK laboratory, and satisfy CHIP regulations. Both liquids utilise minimal ingredients to maintain purity.

It is of course your choice which option (1,2,3) you vote for so no need for apologies..... you also have the choice of where you buy your liquid from.... voting with your pocket if you like.

If option 2 were to be settled on, of course regulations would be tighter which would have its advantages no doubt, but price will be pushed up in the process and choice will be limited on a local level.

Then you have to consider that people will still be able to get the unregulated stuff through customs from China/India/US etc. so does choosing either option 1 or 2 even achieve anything in the long run?

At least with the way things are currently, there are some quality controlled UK produced e-liquids on the market at affordable prices. If option 1 or 2 are the way things go in June, you can most likely say goodbye to variety, fair pricing and ultimately freedom of choice will disappear from the local supply chain.

Tim, I hope you don't mind me posting here as I had no objection to you posting on our forum (we are supposed to ask each other's permission).
We believe our liquid to be safe as you do too, but that is not enough, it has to be proved to be safe which is what we are doing. Citing other unregulated substances as reason for not regulated Nicotine liquids is not good enough for us.

Many years ago I wa a taxi driver and had the unpleasant job at 3 am one morning of driving a young girl to hospital; she was unconscious but apparently having fits or some kind of seizures. The unmistakable smell on her told me she had been using 'Poppers', a 'recreational' drug that has been popular in the UK since the 1970s and which has somehow avoided being regulated. Amyl Nitrate is what she had been 'enjoying' and it caused a heart seizure followed by fits. The doctors managed to save her but she needed a lot of rehabilitation both physically and mentally and never fully recovered. She was 17 years old.

So, do we ask that all Nicotine liquids be given this same immunity from the law as Poppers? That is what option 3 would mean, no regulation. CHIP only means that the labeling and packaging have to be specific and child resistant, there is no requirement for testing and that is why it will be regulated whether we like it or not and regardless of protest. Without regulation, anyone can mix up a liquid in their kitchen/bathtub/wherever and sell it. What if they made a mistake with their sums and put too much Nicotine in it? Who would be responsible, legally and morally? Regulation would insist all liquids on sale are safe and a banning order on unregulated imports is not hard to imagine.

Regulation doesn't necessarily mean price increases if companies are commited with a passion to what they believe in. Regulation is scaring some people because they are riding the gravy train and not putting anything back into the system; we are investing huge amounts and yes it is a gamble, just like crossing a busy road.
Cheers.
John.