RE: What the MHRA say
21/04/2010
Quote:Dear Ms B***
I am responding to your e-mail of 23 March 2010.
I note that you describe your series of questions as a request under the Freedom of Information Act (FOIA). The FOIA relates to information or documents held by the Agency rather than responding to specific questions but I have sought to provide information on each of the questions you pose.
Nicotine containing products (NCPs) restoring, correcting or modifying physiological functions
The pharmacological action of nicotine affects many physiological functions. Nicotine is addictive as it activates the dopamine systems within the brain and dopamine is the neurotransmitter that is directly responsible for generating feelings of pleasure. It has a cardiovascular effect resulting in acute increases in heart rate and blood pressure, constricting the blood vessels to the heart and skin, and dilating those to the skeletal muscles. Additionally, there is a metabolic effect increasing the rate at which the body burns calories with concomitant appetite suppression. It also affects the endocrine system with the release of endorphins.
As stated in my letter of 23 March 2010, the MHRA is responsible for the regulation of medicines and medical devices, not foodstuffs such as tomatoes and potatoes. Deciding where products fit around the borderlines can, however, be very difficult and there are some foods which claim to modify physiological processes and these can fall within the definition of a medicinal product.
Applying for a marketing authorisation (MA)
If a company wishes to obtain a marketing authorisation (MA) for a NCP the efficacy data required will be dependent on several factors (including the specific formulation of the NCP) but in principle we are extremely unlikely to require a full data package with the following likely to suffice
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Data showing a comparison between the pharmacokinetic profile (plasma nicotine levels or PK profile) of the NCP with an appropriate currently marketed form of NRT
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Specific efficacy data is very unlikely to be required provided the pharmacokinetic parameters are consistent with the appropriate currently marketed form of NRT
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Comparison with data on the pharmacokinetic profile of nicotine from smoking a conventional cigarette may be useful when considering efficacy as well as safety.
In order to facilitate any company wishing to apply for a MA, the MHRA are prepared to meet with them on a one-to-one basis to discuss the requirements specific to their product .
Determination of dependence/addiction
Addiction is defined as a disease within the standard medical reference, Diagnostic and Statistical Manual of Mental Disorders. Substance dependence/addiction is defined as having three or more of the following elements
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Tolerance
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Withdrawal
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Large amounts used over a long period
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Unsuccessful efforts to cut down
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Time spent in obtaining the substance replaces social, occupational or recreational activities
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Continued use despite adverse consequences
By these criteria, nicotine (and as a consequence tobacco products) would be defined as being addictive/causing dependence as it meets 5 out of the 6 elements. Only time spent in obtaining the substance replaces social, occupational or recreational activities may not be applicable. It is well established that licensed NRT can reduce the cravings and withdrawal symptoms that occur when stopping smoking, and, can increase the likelihood of a successful outcome in those motivated to abruptly quit and assist smokers to cut down whilst increasing the likelihood of a subsequent quit attempt. The data is summarised is the UK Public Assessment Report, which can be accessed via the following link (http://www.mhra.gov.uk/Publications/Cons...ON065617).
The PK profile of a drug (as well as personal traits) contributes to the development of dependence (and/or abuse). Elements of a drug’s profile that predict greater risk include – rapid onset and high blood concentrations. Rapid onset is associated with drug-seeking for subjective effects. Although there is possibility that those addicted to nicotine from tobacco could become addicted to nicotine from NRT, this is not particularly likely as NRT does not mimic the characteristics of a cigarette (onset slower: only moderate blood nicotine levels reached) so, in respect of addictive potential, is a poor substitute. However, even if dependence did occur, data indicate that is easier to break than smoking dependence and would be considerably less harmful than continuing to smoke.
Safety of NCPs
We know from work done by the Food and Drug Administration (FDA) in the United States that laboratory analyses of e-cigarette samples were found to contain carcinogens and toxic chemicals, against which general product safety legislation could not protect. Bringing all current unlicensed NCPs into regulation would eliminate these risks.
Recreational use of nicotine
As stated in my letter of 23 March 2010, recent legal advice is that nicotine containing products which appreciably affect metabolism in normal usage falls within medicines legislation by virtue of the second limb (b). The MHRA would not support recreational use of a medicine.
MHRA promotion of public health
Smoking kills around 80,000 people a year and so effective medicines that help to reduce this death toll are a public health priority. We want to ensure that all NCPs on the market, both NRT and currently unlicensed products such as electronic cigarettes, have all been required to meet the same standards of safety, quality and efficacy so that smokers have access to products that are acceptably safe and that support them in reducing the number of cigarettes they smoke or to quit.
Yours sincerely
21/04/2010
Quote:Hi Ms B***
Thanks very much for your replies to my questions, I appreciate your patience. Here are some initial thoughts from me, my formal response to your consultation will be more considered.
I'm pretty sure there are a lot of substances meet your medical criteria but are not regulated as medicines so I'm sure you'll want to deal with those in order to be consistent in your approach and not single out vulnerable people or small businesses for special harassment.
Since you told me before that there is no threshold for acceptable levels of nicotine then there is no ambiguity that foodstuffs containing nicotine are, by your own definition, medicines. They will therefore have to prove efficacy, quality and safety before being allowed to be sold by licensed vendors under restricted conditions of sale.
Treating nicotine addiction (the apparent 'disease') with nicotine products is an interesting concept and I anticipate will provide a good laugh in court. NRTs are commonly known to be mostly ineffective and unsatisfying as smoke alternatives, in fact recent research suggests that 'cold turkey' is twice as effective for cessation. The NHS, bureaucrats et al do not seem to want to know this and it leads many people to suspect collusion and conspiracy to promote the interests of pharmaceutical companies at tax payers expense.
I believe that medical standards are being eroded to accommodate claims from vested interests that nicotine can cure disease. Effectiveness, quality and safety of medicines is paramount and should not be compromised, especially in light of the fact that there are so many medically induced illnesses and deaths. Talking of deaths, I was reading poisons statistics for the US (2004) and noticed that the only fatality from nicotine was from medially approved nicotine (out of the categories - pesticides, plants, tobacco and medical). In fact, it appears that as far as poisonings go, medical products beat all other categories put together. I have no confidence that being at your mercy will improve my health and safety. As an autonomous being rather than a government department, I believe that I know what I want and am best suited to weigh up the risks of whether that's good for me or not. Education and support for the public is a lot better than prohibition, nothing beats individual informed choice.
Regarding safety, the carcinogens and toxins allowed in NRT products are higher than the levels found in PV liquid and they don't appear to carry in vapour http://www.ecassoc.org/downloads/Respons...ummary.pdf http://truthaboutecigs.com/science/5.php
The single valid concern from the FDA report is the finding of 'approximately 1%' diethylene glycol in one of eighteen samples. I don't believe the General Product Safety Regulations exclude testing for that sort of contamination or that removing the product from the market is the answer to such a minor problem. If you ban recreational non-tobacco nicotine then users will return to much more dangerous practices via imported, unregulated supplies or nicotine delivery via smoke. As I said before, it's commonly believed that NRT is unsatisfying and the people who use vapour tend to be people who do not want to quit the habit of smoking and/or have tried and failed with NRT. Smokers who enjoy smoking and do not enjoy being forced to comply to the will of over-influential, self appointed guardians of misery. Infantalising us and removing our personal freedoms will not make us safer, just more dependent, costly and stupid. Long unhappy lives are overrated anyway, if that is your intent.
This isn't very scientific but should give you an idea of what might motivate some people to swap from smoking to ecigs:
![[Image: EcigUserPoll.jpg]](http://i365.photobucket.com/albums/oo92/narkybeast/Vapers%20Network/EcigUserPoll.jpg)
Electronic cigarettes have zero record of serious harm in over six years of availability, hardly an example of a pressing public health concern. Hypothetical risks and speculation do not guarantee you can do any better, in fact, the record shows your endorsement often does more harm than good. The EU has received one notification under the RAPEX rapid alert system and that was from the UK about incorrect packaging: http://www.europarl.europa.eu/sides/getA...anguage=EN
As far as banning a recreational drug, I'm pretty sure that's not the remit of the MHRA, lifestyle choices are usually dictated from parliament.
Thanks again for your help, my considered response to your consultation will be with you before June. Luckily I have contacts who have told me that you changed the deadline or I wouldn't have known - you have chosen not to inform more than 20% of the population who use nicotine and who stand to lose another of the most effective smoke alternatives all in the name of 'safety'. Rather than promote public health I suggest you consider carefully whether you are in fact creating a greater public health risk with your interference.
Kate B
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