UK Department of Health - think nicotine is tobacco or smoking

[Kate]

Quote:... This new tobacco control strategy establishes a vision of eradicating tobacco harms, describing aspirations and evidence-based policies under three objectives to deliver the vision:
1. To stop the inflow of young people recruited as smokers.
2. To motivate and assist every smoker to quit.
3. To protect families and communities from tobacco-related harm.
Delivering these objectives will create a smokefree future ...

http://www.dh.gov.uk/dr_consum_dh/groups...111748.pdf


It sounds like they want prohibition of smoke and tobacco but don't want independent (non medical) and effective smokeless or tobacco free products to be developed. They appear to want to regulate nicotine as a medical treatment.

[Kate]

Quote:...
Innovation in the use, design and regulation
of nicotine delivery medicines
4.31 The Medicines and Healthcare products
Regulatory Agency (MHRA) regulates nicotine
delivery medicines, and so will invite applications
for licences to cover the new routes to quitting.
4.32 Nearly a fifth of smokers use NRT, bought
from a retail outlet, to assist their quit attempt
by cutting down in certain situations. However,
feedback from smokers suggests that NRT is
not easily accessible (unlike tobacco) and can
be expensive (which introduces a disincentive to
use it).16
4.33 The MHRA will encourage manufacturers
to develop and market new and improved
products. At the same time, the Government
will work with the pharmaceutical industry
and retailers to encourage the development
of improved pack information, guidance and
training packages for retailers on the use of
nicotine delivery medicines, so that smokers
can be better informed and retailers feel more
confident in talking to their customers about the
products.
4.34 The Government will also work with the
pharmaceutical industry and other partners to
dispel the myths surrounding the harms from
nicotine. While it is the nicotine within the
tobacco that the smoker craves and is addicted
to, it is the tar and the carbon monoxide in
smoked tobacco that are the causes of smoking related
disease and death.
4.35 We believe that these actions will
encourage innovation in the use, design and
marketing of nicotine delivery medicines.
However, over the past year, we have already
seen the emergence of many different forms of
nicotine delivery systems, including e-cigarettes
and nicotine hand gels. These products
are unregulated and their safety remains
undetermined.
4.36 Given the pharmacological action of
nicotine, the Government will create a level
playing field by regulating all products that
contain nicotine (apart from tobacco, which is
regulated by specific tobacco legislation) under
medicines safety legislation. This will mean that
any producer of a nicotine-containing product
or nicotine delivery medicine will need to meet
certain requirements for safety, quality and
efficacy, in order to protect the public. The first
step towards the creation of this new regulatory
scheme for nicotine-containing products will be
a public consultation, to be undertaken by the
MHRA and launched alongside this strategy.
4.37 The Government will ensure that no
nicotine-containing products or nicotine delivery
medicines can be marketed in a way that
promotes or encourages tobacco use. We will also
keep nicotine delivery medicines under review.
In particular, we will monitor the impact of the
medicines’ availability on quit rates at a national
level, the safety implications of long-term use of
the medicines and the potential for their abuse....

This appears to say that nicotine has been classed as medicine and will only be available under medical regulations - apart from tobacco products.

[Kate]

So it turns out that MHRA and NICE also want to take recreational nicotine off the market.

http://www.mhra.gov.uk/Publications/Cons.../CON065617

http://www.nice.org.uk/getinvolved/patie...omment.jsp

Triple whammy today.

[iStormUK]

Man, this is starting to look worrisome, what do you think the ETA is going to be on regulated liquid nicotine? Governments are, thankfully, not very fast in implementing legislation, except when it comes to cyber crimes anyway, so we looking at 5 years, ten? Less? Can't seem to find info on this sadly.

[Kate]

This is from the MHRA consultation letter:

Quote:... Option 1 – Whether products containing nicotine should be considered by the Agency to be medicinal products by function and, if so, whether all unlicensed NCPs should be removed from the market within 21 days. Currently, MHRA operates a strict practice regarding the period of notice operators are allowed to comply with under the Marketing Authorisation Regulations following the classification of a product as medicinal. Given that these Regulations do not make explicit provisions for a staged withdrawal from the market of an unlicensed medicinal product, immediate cessation of the sale or supply is usually required by the Agency, with written confirmation of the same within 21 days.
Option 2 – Whether products containing nicotine should be considered by the Agency to be medicinal products by function and, if so, whether a notice should 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 not holding an MA for any such product on the market. This would effectively allow manufacturers a year from the end of public consultation to produce relevant evidence to support an application for an MA, submit it to the MHRA for approval and get the newly licensed products on to the market.
Option 3 – Do nothing and allow these unregulated products containing nicotine that have not been assessed for safety, quality and efficacy to remain on the market.
19. The MHRA’s preferred option is option 1, which is in line with current practice...

[Kate]

This is from the MHRA consultation letter too.

Quote:... Recent legal advice is that all products which contain nicotine which appreciably affect metabolism in normal usage may be within medicines legislation in terms of pharmacological action (medicinal by function)...

I wonder if they're going to use that argument to take regulatory control of all substances that appreciably affect metabolism or maybe dopamine?

Caffeine, sugar and dangerous sports could all have to be medicines.

[Kate]

Quote:... The effects of nicotine itself are similar to that other popular drug, caffeine. See our (nicotine reading list.) There is no evidence that nicotine causes any substantial risk for cancer, and the research shows that the risk for cardiovascular disease is minimal. The confusion about nicotine comes from anti-smoking activists talking about nicotine and smoking as if they were the same. While it is true that people smoke mostly because of nicotine; nicotine users die mostly because of the smoke.

Neither nicotine nor coffee are completely benign (in particular, both cause a short-term increase in your blood pressure and pulse rate when you use them, which could affect your health). A lot of evidence shows that coffee drinking causes very little health risk. Studying nicotine is a bit harder, because most nicotine users smoke, and the smoking is quite bad for you. But there is some good evidence: If nicotine were very bad for you then smokeless tobacco, which provides nicotine, would be very bad for you. As we've shown elsewhere, that is not the case.

Though nicotine is relatively safe for most individuals, it may have a negative effect on fetal development and as such should be avoided during pregnancy...

http://www.tobaccoharmreduction.org/faq/nicotine.htm



I'm just looking for an article about Swedish snus. These were banned in the EU because they're not pharmaceutical products but in Sweden they've been something like 30% effective for smoke quitters - compared with 5% for approved pharmaceutical nicotine products. The banning of snus was a big public health disaster and it looks like ecigs are going to go the same way to protect pharm and tobacco companies monopoly.

[Rusty]

I'm really taken aback by today's developments and I cannot even crack a joke!

[Kate]

Yeah, it's kind of sickening and totally counter productive from what I can see. I bet nobody has bothered to carry out an impact assessment or anything sensible, it's all about forcing an agenda on smokers and people who dare to enjoy nicotine.

If anybody wants to take action you can:

Sign the UK petition - http://www.petitiononline.com/vaping/petition.html
Write to the consultation committee at NICE
Write to the MHRA on their consultation
Write to your MP - http://www.writetothem.com/
Pass on the news and links to people you know so they can become involved too

Any other ideas gratefully received.

[Jackie]

I'll definitely be starting to write letters I think, todays news is extremely worrying for us!

I wish I knew the right words to put in a letter, it's a shame we don't have any vapers that are solicitors.