Intellicig response to HM Government proposals

[Shining Wit]

RESPONSE TO:
HM Government
A SMOKEFREE FUTURE
MHRA Consultation Letter MLX 364
THE REGULATION OF NICOTINE CONTAINING PRODUCTS

From Intellicig, UK manufacturer and marketer of electronic cigarettes.

Media release 05.02.10 For immediate use.

Electronic cigarette manufacturer backs Government call for
regulation but warns against forcing quitters back to deadly habit.

Intellicig, a leading and pioneering supplier of ‘electronic cigarettes’ – nicotine delivery
devices – has backed MHRA calls for industry regulation and licensing and is supporting the
Department for Health’s ‘A Smokefree Future’ policy document issued on Monday.
‘A Smokefree Future’ calls for a radical and innovative approach to providing safer nicotine
products so that addicts can limit their exposure to the proven health risk of tobacco smoke
with the use of NCPs (Nicotine Containing Products).
However, Intellicig, believes MHRA proposals, for distributors to cease marketing within 21
days of their final decision, which is due this summer, as counter-productive to achieving
‘A Smokefree Future’.
With 20,000 regular UK customers of its own, and an estimated 200,000 in total, Intellicig
director David Newns has evidence that a significant proportion will have no option but to
return to regular cigarettes and other tobacco-based nicotine products - with all their proven
health and social damaging effects - if electronic cigarettes are forced from sale at short
notice.

MHRA, in its Consultation Letter MLX 365, ‘The Regulation of Nicotine Containing Products’, is
seeking views from more around 200 organisations on its next move and has offered three
options:

· Option 1: Whether NCPs should be considered by MHRA as medicinal and, if so, whether
all products should be removed from the market in 21 days. [Note: This is the MHRA
state preferred option]

· Option 2: Whether NCPs should be considered by MHRA as medicinal and, if so . . . all
marketing must cease by a certain date, eg June 2011. [Note: Option supported by
Intellicig]

· Option 3: Do nothing. Allow market to continue unregulated.

The Government / MHRA stated preferred solution is Option 1, but David Newns believes this
will force thousands of quitters back to their deadly tobacco habit and urges the adoption of
Option 2.
Intellicig has testimonials from users, doctors, nurses and other health professionals, stating
their products have reduced dependency on tobacco and, therefore, transformed lives.
David Newns said: “The industry has been operating in the UK for more than four years and
no significant adverse reactions have been reported. “This suggests that, although current research
relating to electronic cigarettes is in its infancy, the thousands of user success stories provide a
substantial case for its contribution to ‘A Smokefree Future’.
“MHRA ultimately wants manufacturers to license their products as medicine, which can be a
lengthy and costly exercise. “We support this, because we want Intellicig to be viewed as a
safe and reliable product which helps people reduce their reliance on tobacco. We have invested
heavily in research and were the first company to manufacture our own nicotine cartridges for
electronic cigarettes - EcoPure is British designed, tested and produced in our own UK laboratories.
We are, as requested in A Smokefree Future, providing a radical and innovative alternative
to smoking. It is in our interests that the safety and quality of all electronic cigarettes on the market is
assured.”

However, Newns is keen that an option is endorsed following the consultation period
announced this week – but one that does not lead to an instant effective ban forcing
thousands of existing user to return to regular cigarettes.
He added: “We believe Option 1 will certainly stifle and possibly destroy our opportunity to
achieve licensing, since to cease trading immediately will mean our research and testing will
also have to end. This is currently cited as the MHRA’s preferred option in the consultation
paper. Selecting Option 1 will mean that the vast majority of our 20,000 customers will probably
return to tobacco usage in the form of regular cigarettes, in effect making thousands of
people start smoking tobacco again. The Government needs to support smokers to quit,
not take away an effective solution that in their own words is,
’considerably safer than smoked…tobacco products’.” (p3 consultation letter)
“Of the options proposed, we urge the MHRA, Government and the industry to back Option 2,
allowing time for further research,testing and innovation in the NCP sector.”

DAVID NEWNS IS AVAILABE FOR INTERVIEW
Contact via Slater PR



1. Background reading:
Consultation Letter MLX 364 The Regulation Of Nicotine Containing Products
Issued by MHRA
February 1, 2010
MLXs: Medicines consultation letters : MHRA
A Smokefree Future
Issued by HM Government
February 1, 2010
http://www.dh.gov.uk/dr_consum_dh/gr...ments/digitala
sset/dh_111789.pdf
2. Keynotes from Consultation letter MLX 364:
· The Consultation Letter MLX 364 seeks to provide a regulatory framework for NCPs (nicotine
containing products).
· Regulation is sought to ensure the safety and quality of NCPs.
· Among these products are electronic cigarettes.
· The letter seeks a response to one of three options.
Option 1: Whether NCPs should be considered by MHRA as medicinal and, if so, whether all
products should be removed from the market in 21 days.
Option 2: Whether NCPs should be considered by MHRA as medicinal and, if so . . . all
marketing must cease by a certain date, eg June 2011.
Option 3: Do nothing. Allow market to continue unregulated.
· Option 1 is the Government / MHRA preferred option.
· Manufacturers will need to go through the process of licensing products as medicines to
secure an MA (marketing authorisation) or cease marketing in the UK.
· Paragraph 22: “It is assumed that with the new strategy, ‘A Smokefree Future” and the
licensing of these products that number of quitters should increase.”
3. Keynotes from A Smokefree Future:
4.28 It is important to recognise that millions of smokers who want to quit . . . will choose to go
cold turkey, the least successful approach to quitting. We also know that many tobacco users are
keen to find safer alternatives to cigarettes, either to help manage their addiction or as a route to
quitting.
4.29 To meet this demand, this strategy introduces a radical approach to quitting and opens more
routes to quitting which we believe will help thousands more smokers to quit successfully. The
new routes will encourage smokers to break their depndance entirely and wil support smokers to:
- Manage their nicotine addiction using a safer alternative product
- dramatically reduce the harmful effects by using a safer alternative to smoking
4.30 Delivering this new approach will require innovation in the regulation of nicotine delivery
medicines.
4. Background on Intellicig
Lancashire-based electronic cigarette manufacturer, Intellicig, has enjoyed an incredible first
year and is looking ahead to add to their growing list of accomplishments.
Having established its manufacturing base in Accrington, Lancashire, just last year, Intellicig
has already registered £1 million in sales worldwide, is available in every pharmacy in Greece
and has become the subject of a lower insurance premiums deal in South Africa.
As part of a nationwide health kick campaign, Intellicig is the only electronic cigarette
company to be given the official seal of approval by the Egyptian Government to sell Intellicig
products in all of the 30,000 pharmacies in Egypt.
Producing the safest, cleanest and most reliable products on the market is Intellicig’s mission
and it is this longstanding commitment which has enabled the company to get to where they
are today.
Intellicig has been accepted into one of the world's top centres for biomedical research which
is another positive step forward in the development of their products.
By working in partnership with the University of Manchester Incubator Company (UMIC),
Intellicig has access to state-of-the-art laboratories fully accredited for bioscience and biotech
developments and in-house mentoring and professional services.
Intellicig has already invested heavily in producing their own brand of nicotine liquid ‘e-liquid’
right here in the UK, the only company currently doing so.
ECOpure has been achieved through intensive research, testing and stringent quality control
and is distinct from their competitors, who use e-liquid imported from abroad containing
unmonitored chemicals.
Taking up residence in the 86,500 square feet UMIC laboratory will enable the company to
further develop their nicotine solution by performing their own clinical trials on the products.
It is because of their commitment to reinvestment that has seen Intellicig clinch an exclusive
deal which will see their products stocked in more than 10,000 retail outlets nationwide.
Intellicig is the first electronic cigarette company to partner with sales and distribution
experts Innzone Ltd who work closely with major newspaper wholesalers Menzies Distribution
and Smiths News to get upcoming products on the shelves in convenience stores.
Innzone chose Intellicig above their competitors for one reason; they know exactly what is in
an Intellicig electronic cigarette.
This is the same reason why health experts have praised the smoking alternative and is being
suggested to those wanting to quit smoking and have a healthier lifestyle.
By running on ECOpure alone, a mix of just the four ingredients ethyl maltol, glycerol,
deionised water and nicotine, Intellicig becomes a healthier smoking alternative that allows
smokers to again enjoy the freedom to smoke in public places.
A report conducted by Salford University showed that the three raw materials used in
Intellicig’s e-liquid has a minimum purity of 99%, a figure that smokers can trust.

 

[deewal]

Sorry John. I think your wrong. It should be Option 3: Do nothing. Allow market to continue unregulated.
Nicotine cannot be a Medicine in an E-cig which is the healthy option but a recreational drug unregulated in a Killer Tobacco Cigarette. It flies in the face of Reason and Sanity.
This only proves to me that The Government / MHRA do not care about Health. They only care about Wealth. They are condemning thousands to Death with this unnecessary and misguided Policy. E-Cigs have been in use for at least 4 years without a single case of Harm reported anywhere. If my own Doctor tell's me that my health has improved and that my Blood Pressure is reduced to the point where he has cut down my Medication then that should speak volumes. The Health and Safety Standards Aspects have been met by most of our Reputable Suppliers and that should be enough.
To quote from the Consultationl letter " 4.29 To meet this demand, this strategy introduces a radical approach to quitting and opens more
routes to quitting which we believe will help thousands more smokers to quit successfully. The
new routes will encourage smokers to break their depndance entirely and wil support smokers to:
- Manage their nicotine addiction using a safer alternative product
- dramatically reduce the harmful effects by using a safer alternative to smoking"
Well, we already have the safer alternative product. Your selling it yourself.

"4.30 Delivering this new approach will require innovation in the regulation of nicotine delivery
medicines."
The most innovative and succesful nicotine delivery method is here. Your selling it yourself.

What the Government is saying is "We want control of it and we want the Profits from it and we want control of you"
If i can use Nicotine in an unsafe and deadly delivery device it should be my right to use it in a Harm Reduction delivery device.
I do not wish to be weaned off Nicotine or Caffeine or Fish and Chips or Pizza or Chocolate which will be their next target.

 

[Adik Ted]

If the idea is to save lives then having e-cigs available free or obtainable over the counter (in the same way other NRT products are) would be the way to go. Somehow I doubt that's the intention though. It's not like we've got a Nye Bevan in government. I suspect current NRT is a means of paying lip service to health while knowing it will do little to harm tax revenues from smoking in the long run.

 

[PlanetScribbles]

Sorry John. I think your wrong. It should be Option 3: Do nothing. Allow market to continue unregulated.
Nicotine cannot be a Medicine in an E-cig which is the healthy option but a recreational drug unregulated in a Killer Tobacco Cigarette. It flies in the face of Reason and Sanity.
This only proves to me that The Government / MHRA do not care about Health. They only care about Wealth. They are condemning thousands to Death with this unnecessary and misguided Policy. E-Cigs have been in use for at least 4 years without a single case of Harm reported anywhere. If my own Doctor tell's me that my health has improved and that my Blood Pressure is reduced to the point where he has cut down my Medication then that should speak volumes. The Health and Safety Standards Aspects have been met by most of our Reputable Suppliers and that should be enough.
To quote from the Consultationl letter " 4.29 To meet this demand, this strategy introduces a radical approach to quitting and opens more
routes to quitting which we believe will help thousands more smokers to quit successfully. The
new routes will encourage smokers to break their depndance entirely and wil support smokers to:
- Manage their nicotine addiction using a safer alternative product
- dramatically reduce the harmful effects by using a safer alternative to smoking"
Well, we already have the safer alternative product. Your selling it yourself.

"4.30 Delivering this new approach will require innovation in the regulation of nicotine delivery
medicines."
The most innovative and succesful nicotine delivery method is here. Your selling it yourself.

What the Government is saying is "We want control of it and we want the Profits from it and we want control of you"
If i can use Nicotine in an unsafe and deadly delivery device it should be my right to use it in a Harm Reduction delivery device.
I do not wish to be weaned off Nicotine or Caffeine or Fish and Chips or Pizza or Chocolate which will be their next target.

This is how the system is tipped in the establishment's favour. They give three choices, one which is impossible to achieve, one that is not satisfactory, and a third that is completely unacceptable. You are expected to vote for the lesser of the two evils, knowing full well that the best option will never happen.
It's a loaded dice, that you have no choice but to play

 

[Redcoat]

would it be possible-unless Option 1 is what you are really after- to at least e-mail your 20,000 customers and ask if they would respond to the no. 10 petition?
even if you do favour option2.

 

[Shining Wit]

Everything so far will be considered tomorrow at our board meeting.
Thanks.
John.

 

[Perfectionist]

VERY smart move by IntelliCig !!

Instead of throwing a tantrum like some petulant child or acting like a naive teenage rebel whose watched Braveheart one too many times (FREEEEEEEDOM!) ...... they are being pragmatic by getting on with complying with and adapting to, the new "business environment" ...... not only will this be a major step forward in making e-cigs "mainstream" ...... it would also be a Licence for them to print money !! (if, as I suspect they are one of few, or even the only, Licensed supplier!)

I wish them every success (as long as they offer competitive prices!) and have no doubt they'll be laughing all the way to the bank, while merrily sticking it to the Tobacco Industry !! (Well, until one of the Tobacco companies decides to enter the e-cig market and offers them a mountain of cash to buy their brand!)

Let the rest of the Industry run around like headless chickens under the delusion that they've suddenly become qualified Barristers and can fight the Governmentals, in a futile attempt to get e-cigs treated with the same leniency that Tobacco enjoys ...... last time I checked, e-cigs didn't generate TEN BILLION in annual Tax Revenue !! 8-o

 

[monkeyuk]

This looks interesting too....you can have your view at the public consultation by filling in an online document as Toby at iVapour UK says in his sticky:


Sticky: E-smoking in the UK is under serious threat

 

[deewal]

instead of throwing a tantrum like some petulant child or acting like a naive teenage rebel whose watched braveheart one too many times (freeeeeeedom!) ...... (if, as i suspect they are one of few, or even the only, licensed supplier!)

let the rest of the industry run around like headless chickens under the delusion that they've suddenly become qualified barristers

troll alert

 

[Perfectionist]

troll alert

Thinking that Intelli have the right approach, makes me a Troll does it ??

Much (not all) the melodrama being orchestrated by most of the other e-cig companies is amateurish and facile ...... and worryingly, may well be doing more harm than good ......

Get a top Legal Firm and some independent Medical Professionals involved and the efforts would be productive ...... but having Vendors (with obvious vested interests) openly mocking Government Policy and using their layman skills to nitpick with Regulators, all while encouraging their customer base to start a mini-revolt, is a recipe for trouble ...... that will be seen as insulting and a cynical attempt to deliberately force their hand ......

But that's only in my humble opinion, what do I know ......

 

[Shining Wit]

Originally Posted by deewal comments in blue.
Sorry John. I think your wrong. It should be Option 3: Do nothing. Allow market to continue unregulated.
In the interests of Public Health that would be unacceptable. If it's safer. then you have to go the whole ten yards and prove it. To allow anyone to come along and manufacture/sell without regulated safety checks would be immoral.
Nicotine cannot be a Medicine in an E-cig which is the healthy option but a recreational drug unregulated in a Killer Tobacco Cigarette. It flies in the face of Reason and Sanity.
We have to deal with the reality of the situation.
This only proves to me that The Government / MHRA do not care about Health. They only care about Wealth. They are condemning thousands to Death with this unnecessary and misguided Policy. E-Cigs have been in use for at least 4 years without a single case of Harm reported anywhere. If my own Doctor tell's me that my health has improved and that my Blood Pressure is reduced to the point where he has cut down my Medication then that should speak volumes. The Health and Safety Standards Aspects have been met by most of our Reputable Suppliers and that should be enough.
Which Health and Safety Standards Aspects are you referring to?
'most' is not enough, it has to be all.
How would option 2 condemn thousands of people to Death?
To quote from the Consultationl letter " 4.29 To meet this demand, this strategy introduces a radical approach to quitting and opens more
routes to quitting which we believe will help thousands more smokers to quit successfully. The
new routes will encourage smokers to break their depndance entirely and wil support smokers to:
- Manage their nicotine addiction using a safer alternative product
- dramatically reduce the harmful effects by using a safer alternative to smoking"
Well, we already have the safer alternative product. Your selling it yourself.
Proof is what is required to be taken seriously.
"4.30 Delivering this new approach will require innovation in the regulation of nicotine delivery
medicines."
The most innovative and succesful nicotine delivery method is here. Your selling it yourself.
Proof again.
What the Government is saying is "We want control of it and we want the Profits from it and we want control of you"
If i can use Nicotine in an unsafe and deadly delivery device it should be my right to use it in a Harm Reduction delivery device.
I do not wish to be weaned off Nicotine or Caffeine or Fish and Chips or Pizza or Chocolate which will be their next target.
Welcome to our world


We are working hard but we don't publish everything we do for obvious reasons. In order to achieve what you want, availability of ecigs, we have to ensure we stay in business. It's called playing the game and hopefully we will continue to be successful.
Cheers.
John.

 

[rtbob]

I'm for option 3

 

[Shining Wit]

I'm for option 3

Please put forward a reasonable argument for choosing option 3 without mentioning tobacco or 'standard cigarettes'.
John.

 

[westcoast2]

Please put forward a reasonable argument for choosing option 3 without mentioning tobacco or 'standard cigarettes'.
John.

There are a number of regulations that can come into play. These include labeling, packaging, quality and safety.

It maybe that the e-cig is not fully covered by these regulations. I have no doubt the safety and quality of the e-cig could be brought within them Indeed, from what I have read, trading standards have checked some cartridges and made recommendations.

If there was a serious issue wrt H&S the MHRA could already have acted.
If this has not occured then it seems Public Health and safety is not the issue and neither is quality.

Option 1 & 2 are effectively the same option, regulation as a medicine. Option 3 is misleading, the e-cig is unregulated as far as being a medicine is concerned. Are you suggesting that there are no regulations affecting the e-cig, especially the e-juice? Indeed doesn't some hardware require a CE mark?

The distinquishing feature between a medicine and non-medicine is efficacy (Therapeutic benefit), isn't it?

What therapeutic benefit are you offering?
Has this benefit been shown by clinical trials?
Is it better than currently available methods? In what way?

Are you expecting a medical nicotine framework that is different to the MA process?
Have you determined the optimum medicinal dose?
How would your 'patients' be able to ensure they recieve a therapeutic dose if e-juice is involved?
Will the e-cig have a 'controlled dose'?
Are you aiming for a GPL (OTC sales)? Are the requirements more stringent?
Will the e-cig need to be PO for a time? What effect would this have on acceptance?

Have you determined whether the presentation of the 'device' is accepatable to the 'patient'?
Indeed would presentation as a medicine be more or less acceptable than the generaly available e-cig today?

I note you support the 'Smokefree' strategy promoted by HMG. Are you aware they suggest that 'cold turkey' is the least effeective method for quiting (pg 43, and and partly on pg 11)

This means that the other half are ‘unassisted (cold turkey) quits’, which have the lowest chance of success.

This is clearly inaccurate, as the Allen Carr method has a higher quit success rate than NRT

The NICE citizens council seems to have confused a 'Harm Reduction' strategy with a 'Nicotine elimination' Strategy. I was suprised to see that D Arnott did not advocate e-cigs as many took ASH (UK) to be in support. She said

NRTs were not actually very attractive.

Are you plannig on making the e-cig less attractive? D Arnott did not offer any support for e-cig as far as I can tell.

By going for Option 3 there is a chance to take a wider view, possibly a framework based on, for example, the Alcohol model rather than the Medicinal model. Options 1/2 are designed to narrow the choices just to the medicinal.

An aside, it seems that Food stuffs can be regulated as medicines and the medicinal use takes precedance, this could have implications for Tomatoes and Potatoes both of which contain Nicotine. The MHRA are trying to regulate all NCPs not just the e-cig.

Much of the consultation seens rushed, the impact and risk assesments incomplete. It is virtually impossible to come to a reasonable decision, that makes such a profound change, based on the information provided in the consultation.

Of course there are other, non medical concerns, employment for instance and the status of unlicensed products for example.

just some thoughts
----

 

[5cardstud]

Well it sounds like intellicig would be a good co. to boycott.

 

[HexKrak]

It should be regulated for public saftey. If the e-cig continues to grow, more fly by night companies will come in to exploit the market. If proper regulation is in play than you should be able to feel safe ordering from any compliant business.

Problem is that there's no neat place to regulate this product under. It's not going to be "food safe" due to the possibly lethal levels of nic in certain juices (if consumed rather than vaped), but it's not a traditional tobacco product. It's intent is also not always medicinal. So it'll need it's own set of regulations. Such actions shouldn't be hard, but due to bureaucracy and lobbying by gov't and tobacco entities it is made almost impossible.

 

[HexKrak]

Well it sounds like intellicig would be a good co. to boycott.

Sounds like intellicig is trying to do something to ensure the future of our products. I applaud them for that because doing nothing right now will ensure the elimination of the e-cig from the US and UK

 

[Shining Wit]

Sounds like intellicig is trying to do something to ensure the future of our products. I applaud them for that because doing nothing right now will ensure the elimination of the e-cig from the US and UK

Thanks HexKrak.

You can throw stones at their windows or you can sit round the table and negotiate. I know which is most productive in the real world.
If people wish to boycott us then that is their personal choice.
If people wish to buy from a company that is reinvesting hundreds of thousands of pounds (no exaggeration there) into ensuring they develop a product that will be fit and safe for the market and that will pass regulations, whether they are fair in or not in anyone's opinion, then they will exercise their personal choice.
We can only provide this incredible product by staying in business and we are obliged to do what we see fit in order to protect our business and the jobs of at least 25 people here in Accrington.
We are working as hard as anyone but we don't always advertise our plans to the world.
We do publicise our achievments which you can read about in following posts.
John.

 

[Shining Wit]

Well it sounds like intellicig would be a good co. to boycott.

Why is that?

John.

 

[Shining Wit]

UMIC’s gains Leading-Edge UKBI Inspire accreditation

UMIC’s Biotechnology Incubators achieve Leading-Edge standard in UKBI Inspire Assessment
UMIC has recently undergone an assessment against the UKBI Inspire monitoring, development and accreditation process, and is delighted to report it achieved a Leading Edge standard in recognition of its business incubation activities, reflecting ten years of hard work and significant sustained successes with our tenants.
Martino Picardo, UMIC’s Managing Director, said “We are absolutely delighted to have been accredited at this level. We have been able to maintain a steady balance of deal-flow (University and external spin outs and start-ups), across a broad and diverse selection of company types in the Bio-Health sector. We have had considerable success in graduating companies, identifying anchor tenants and preparing start-ups for tenancy. The nature and quality of our services is constantly seeking to improve, based on our customer feedback. The accreditation reflects the hard work of our staff to deliver world class futures, based on quality service delivery, on behalf of The University of Manchester.

Read the full article here.

*******************************************************



Intellicig have recently been accepted into the UMIC facility and the award only serves to reinforce that we are aiming very, very high and only the best will be good enough.
Our R&D department will be moving in very soon and the laboratory will provide the space and facilities to further develop both liquid and hardware. This is a must if we are to compete at the highest level with the big pharmaceutical companies.
We want to guarantee the availability of our electronic cigarettes and liquid for the future, if we don't then what hope is there for the small companies?
John.


Outside view of the Bioscience Facility

Pictures of our laboratory and office facilities at UMIC's Bioscience Facility