What the MHRA say

[Kate]

These are some of the messages between the MHRA and myself so far:

Quote:Please could you help me with a couple of questions about the nicotine ban.

Could you tell me what defines nicotine as a medicine; and is there any evidence to show that those properties are present in inhaled vapour from dilute liquid nicotine but not in any non-medical products remaining on the open market?

As the proposal is closure of the commercial market for nicotine products does that mean it is being made a controlled substance?

Thanks

Quote:Thank you for your email about the consultation on proposals to regulate nicotine containing products.

Recent legal advice is that nicotine falls within medicines legislation because of its pharmacological action - it appreciably effects metabolism in its normal usage. There is separate legislation that regulates tobacco products and tobacco does not have a medicinal use.

The proposals set out in the consultation document do not seek to make nicotine a controlled substance.

Kind regards


Amanda Bryan

Quote:Thanks very much for your speedy reply to my questions.

I'd be grateful if you would clarify for me what 'normal usage' means and the legal definition of 'metabolism'.

Is caffeine thought to affect metabolism?

Thanks very much

Quote:Thank you for your email.

We are unaware of any legal definition of metabolism but a general accepted definition in respect of medicines would be 'processes for the synthesis, modification, and breakdown of molecules within a living organism '.
We consider "normal usage" to mean when used at therapeutic doses and via an appropriate route.
Caffeine does affect metabolism and some products containing caffeine are licensed as medicines.

Kind regards

Amanda Bryan

Quote:thanks again for your patience. I've heard that you might have been getting a lot of requests for information and apologise for adding to your workload. I have a few more questions please if you wouldn't mind helping me.

I think you're saying that sometimes caffeine appreciably effects metabolism when used at therapeutic doses and via an appropriate route and in those particular cases the products would be licensed as medicines.

Please could you tell me how you determine the threshold for 'appreciably' effecting metabolism and how you establish the measurements in the case of a particular product. Do you do your own lab tests and clinical studies?

My main interest is if nicotine is banned from the open market yet this chemical is similar in action to caffeine, then why would one qualify for complete restriction and not the other. Presumably you won't be banning nicotine containing foods such as tomatoes and potatoes and the current regulations in the Poisons Act 1972 allow concentrations of nicotine up to 7.5% on the commercial market. So what threshold have you determined?

In response to the concerns mentioned in the consultation document about safety, the current applicable regulations are The General Product Safety Regulations 2005 - http://www.berr.gov.uk/files/file22713.pdf Why are those regulations thought to be inadequate?

Thanks for your help

[Kate]

12 February 2010

Quote:From the published data available we have not been able to ascertain the lowest dose of nicotine that appreciably affects metabolism. In applying for a marketing authorisation manufacturers would need to demonstrate that nicotine concentrations shown to be effective are attained with their product.

Unlicensed nicotine containing products (NCPs) have not been assessed for safety, quality and efficacy and therefore there is potentially a risk to public health if these products are left on the market unregulated. We know from work done by the FDA that laboratory analyses of e-cigarette samples were found to contain carcinogens and toxic chemicals. Bringing all current unlicensed NCPs into regulation would eliminate these issues and ensure that smokers had products of the requisite quality, efficacy and safety to eliminate or reduce the harm from smoking.

Kind regards

Amanda Bryan

Quote:Hi Ms Bryan

What does effective mean in terms of a commercial nicotine product? If no metabolic claims are made by manufacturers then what is there to prove? Why should you expect tests proving quality ans efficacy, you don't regulate coffee in that way?

Safety of unlicensed nicotine products is currently covered by at least the following regulations so for you to say they are unregulated and potentially unsafe is simply not the truth and will not stand up in court:

CHIP - refers to the Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 - http://www.hse.gov.uk/chip/index.htm
The Poisons Act 1972 - http://www.opsi.gov.uk/RevisedStatutes/A...20066_en_1
CE certification requirements - http://www.berr.gov.uk/whatwedo/sectors/...11646.html
The General Product Safety Regulations 2005 - http://www.berr.gov.uk/files/file22713.pdf

In fact, it appears that the TSI would rather close the market than establish standards of acceptable levels of toxicity and contamination. The FDA report has been discredited, I suggest you find proper evidence if you have reason to believe you have valid concerns.

Closing the commercial nicotine market will remove effective harm reduction strategies for smokers and those products are unlikely to be approved by you before many more lives are lost, if they ever are. Nicotine might never be proven to have therapeutic properties or be effective at smoking cessation. Current evidence suggests that NRT does not work in at least 95% of cases yet you regulate it as if it works. That is scandalous and there should be an enquiry about how you can endorse products that cost so much and deliver so little. Basically you will be putting a monopoly on nicotine which is similar to taking caffeine off the market to protect the interests of pharmaceutical and tobacco companies. The nicotine market is extremely valuable and there is no excuse for removing properly regulated (see current applicable laws mentioned above) competition, that amounts to murder of people who have or could have found satisfying alternatives to smoking.

You don't even have any measure of what is acceptable and that means you'll have to regulate tomatoes, potatoes and many other nicotine containing foods as medicines.

It's my belief that you have no authority to carry out the restrictions you propose without approval from parliament. Please could you tell me what gives you atuthority?

Thanks

[Jackie]

Great letters Kate, especially that last one. Thanks very much for sharing.

Honestly they are on very shaky ground with this, I really hope it's shaky enough to make them reconsider. I'm pretty sure we'll win this battle given the various responses they've had. Maybe not the war, but the first battle at least.

[Kate]

Hopefully the MHRA will tell me what authority they have to declare nicotine a medicine soon. I've been thinking about this a bit and am pretty certain that they don't really have justification for the definition anyway. This is what they say defines nicotine as medicine:

"... nicotine falls within medicines legislation because of its pharmacological action - it appreciably effects metabolism in its normal usage..." but "... tobacco does not have a medicinal use"

Does that mean that if something has no medicinal use then it is not 'medicine'?

Vaping has no proven medical use so I wonder what evidence they have to say it's medicine. I think we need to know what proven medical use nicotine has. That should be interesting because of the NRTs they license that don't work.

[moog]

It says "tobacco does not have a medicinal use", but if it contains nicotine which it does then what is the difference apart from it having many bad side effects...Many "medicines have bad side effects" so what is so special that exempts tobacco.

[Kate]

It looks like I'm going to have to find out how Freedom of Information requests work.


16th Feb 2010

Quote:In addition to the questions I've already asked you below I'd be grateful if you would help me with another couple please.

... current applicable [safety] regulations are The General Product Safety Regulations 2005 - http://www.berr.gov.uk/files/file22713.pdf Why are those regulations thought to be inadequate?

What does effective mean in terms of a commercial nicotine product? If no metabolic claims are made by manufacturers then what is there to prove? Why should you expect tests proving quality ans efficacy, you don't regulate coffee in that way?

It's my belief that you have no authority to carry out the restrictions you propose without approval from parliament. Please could you tell me what gives you authority?


These are my additional questions:

You say that "... nicotine falls within medicines legislation because of its pharmacological action - it appreciably effects metabolism in its normal usage..." but "... tobacco does not have a medicinal use". Does that mean that sometimes nicotine has no medicinal use and that depends on how it's delivered?

Please could you tell me what evidence there is to show that nicotine has a medical use?

Quote:Thank you for your further emails dated 12 and 16 February.

As I am sure you will appreciate we are currently coordinating and reviewing a large number of responses to the consultation exercise (we have received over 400 to date). I have already responded to three previous emails from you and to enable us to deal with the responses received to the consultation the MHRA cannot enter into protracted correspondence about these proposals . I will, however, ensure your comments and questions are considered as part of the consultation exercise.

Kind regards

[Kate]

Well, this seems to be how it works - http://www.justice.gov.uk/guidance/foi-p...l-what.htm

So I've sent this:

16th Feb

Quote:Sorry to hear that you are so busy with this consultation, I guess a lot of people feel that their interests need to be taken into account.

I'd like to make a request for information under the Freedom of Information Act.

Please provide details that outline your authority to ban nicotine from the commercial market.

Please provide information to show that nicotine actually has a medicinal purpose (and therefore should be removed from the provisions of the Poisons Act 1972).

Please reference for me the legislation that exempts nicotine in tobacco from falling within medicines legislation even though its pharmacological action may appreciably effects metabolism in its normal usage.

Thanks

[paxes]

Great Work Kate,
Ive only just found this site as been quite busy with other projects but will be keeping abreast of this thread and recommending this site to my fellow vapers

[Kate]

Hi Paxes, welcome, glad you found us


This is the latest I have from the MHRA, from 17th Feb:

Quote:Dear Ms ****,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 17th February 2010.


I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.


Yours Sincerely

[moog]

Maybe it will come back heavily redacted with just Dear Ms ****...