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Case Proposal for the Management of Electronic Cigarettes Within MHRA Regulation

As the MLX364 fiasco continues Totally Wicked and TECC (The Electronic Cigarette Company) continue to lobby the MHRA for a relevant and workable solution. Here is the Case proposal put forwards to the MHRA that covers all bases, and enables the UK regulators to place an Electronic Nicotine Imitation Cigarette in its rightful place as a NCP (R) Recreational.

If you feel this is a correct definition, please contact the MHRA asking for this policy to be dually considered.

Executive Summary

Whilst outside of the scope of MHRA Document MLX 364, there has been an oversight regarding the use of electronic cigarettes as a viable recreational alternative to conventional cigarettes.

Due to the fact that the nicotine added to the liquid used in electronic cigarettes is derived from tobacco, this means that these products are within the scope of Article 1, item 1, of the EU Directive on tobacco containing products (2) and it is also possible that they could be regarded as such.

By formally categorising electronic cigarettes as either a Recreational Nicotine Containing Product (NCP-R) or Therapeutic Nicotine Containing Product (NCP-T), where the latter will require a MHRA-issued Medicinal Product Licence, ambiguity as to the intended use of these products can be removed and controlled via a two-tier regulatory framework. How the products are categorised will simply be a matter of how the products are marketed and sold.  Furthermore, in order to be provided with a medicinal product licence exemption certificate for all NCP-Rs, most electronic cigarette manufacturers, suppliers, and vendors (within, or supplying the UK), that chose to take this route would willingly be subject to an annual (or biannual) inspection by either the MHRA or Trading Standards in order to maintain their exemption status. Those companies that refuse to comply with these measures, or breach the exemption conditions proposed in this document, could then be easily dealt with appropriately by local enforcement agencies.

Rationale for the proposal

The following proposal is being put forward for consideration by the Department of Health and the MHRA; with a view to assisting in safeguarding their best interests and those of:

The Pharmaceutical companies selling products for the treatment of Nicotine Dependence Syndrome

Electronic cigarette manufacturers, suppliers, and vendors, who advertise their products for the sole purpose of them being used recreationally, as a direct-replacement alternative to cigarettes

And, most importantly, the general public and those that use nicotine recreationally but no longer wish to smoke conventional cigarettes

Benefits of the Electronic Cigarette when compared with the Conventional (Combustible) Cigarette

Whilst the concerns regarding electronic cigarettes for use as a medicinal NRT product have already been cited in MHRA Document MLX 364, the advantages of electronic cigarettes when compared directly with conventional (combustible) cigarettes are the following:
·         Electronic cigarettes do not produce by-products of combustion and they do not produce offensive acrid smells or second-hand smoke

·         Electronic cigarettes have been categorically proven by the Food and Drugs Administration to contain, in magnitudes of order, far fewer carcinogens and toxins (in both quantity and type) than conventional cigarettes (3)

·         Electronic cigarettes are not devices that require combustion in order to deliver nicotine, so these products can reduce some of the fire risks that have been attributed to / associated with the careless use of conventional cigarettes

·         Start-up costs of using electronic cigarettes are expensive, when compared with conventional cigarettes, and could potentially deter younger people from experimenting with them

·         Electronic Cigarettes are a positive step forward with regards to EC Directive EC/2001/37, Article 11

The majority of Electronic Cigarette manufacturers and distributors in the UK are law-abiding businesses that have acted upon, without formal governmental assistance, on the measures available to them to safeguard both their customer’s and the general public’s health and safety. A few examples of the steps that have already been undertaken are as follows:
1.      Nicotine-containing electronic cigarette liquid is treated as “toxic” and the packing it is supplied in (by the majority of vendors) is compliant with the CHIP4 regulations and the emerging CLP regulations. In addition to childproof caps, CoSHH hazard warning signs are present on the labelling to alert individuals to the possible dangers present, and safety warning triangles are also affixed to alert the blind, and the partially-sighted, as to the inherent dangers of the contents of these bottles and cartridges

2.      Explicit warnings are advertised on the majority of legitimately run websites advising potential customers that electronic cigarettes are not smoking cessation devices, that they are not suitable for use by (or available to) anyone under the age of 18, those that are pregnant, or any individual predisposed to any problem associated with the use of nicotine

IE the Current warning displayed on all Totally Wicked and TECC (The Electronic Cigarette Companies) Websites.

WARNING: the electronic cigarette will not cure a smoker’s addiction to nicotine, the electronic cigarette serves the same purpose as a tobacco cigarette- it delivers its user nicotine. If you do suffer from the disease of Tobacco/Nicotine Dependence Syndrome and want to take steps to give up smoking or cut down the quantity of cigarettes you currently smoke. We recommend you visit your health care provider to discuss NRT (Nicotine Replacement Therapy) or a nicotine harm reduction programme.

Please Note: We are not a pharmaceutical company and we do not produce medical products.

3.      The majority of vendors only permit transactions to be undertaken with a credit card or Paypal®, to ensure that the eligible customer is above the age of 18 before they can make a purchase

4.      In order to minimise product quality risks to consumers, a number of manufacturers in Europe now only use pharmaceutical-grade BP/USP/EP monographed raw materials in the manufacture of recreational nicotine-containing products

Differentiating between Electronic Cigarettes for Therapeutic Use and Electronic Cigarettes for Recreational Use

It is not disputed that manufacturers and distributors of electronic cigarettes who choose to make positive health or smoking cessation claims should not be subject to MHRA regulation and their products licensed. However, for those companies that wish to sell electronic cigarettes for recreational purposes only, the participants (representing the electronic cigarette industry) named in this document propose the following:
1.      Any customer making a first-time access to any website promoting these devices will be taken through a Nicotine Dependency Syndrome questionnaire devised by the Department of Health (Note 1). These series of questions will seek to ascertain if the intended customer is seeking treatment for Nicotine Dependency Syndrome, or if they intend to use the advertised products as an aid to stop smoking permanently.

2.      Using a “weighting system”, agreed by both the Department of Health and all participating electronic cigarette manufacturers and/or suppliers, if an individual is considered to be seeking help for the aforementioned condition the following steps will be taken:
a.      The customer will be refused sales service and will then be automatically directed to either the NHS Quit-Line, and / or, any other government approved smoking cessation initiative.
b.      The customer will be advised of the alternatives that can be used to stop smoking and be directed to the websites that sell MHRA-licensed smoking cessation products, such as J&J’s Inhalator, etc.
Manufacturers, suppliers, and vendors, will agree to an annual (or biannual inspection) that grants them a product licence exemption certificate once they have satisfied the regulators (or Trading Standards) that:
1.      Procedures are in place to direct customer traffic to the appropriate help-lines and licensed medicinal products if they are seeking treatment for Nicotine Dependence Syndrome

2.      The electronic cigarette products being advertised are not making any positive health claims, either blatantly or covertly, that could in any way mislead, entice, or suggest, to the potential customer that these devices will assist them to stop smoking

3.      Procedures are in place to prevent access to such devices and products by anyone under the age of 18, and that the websites (and/or any advertising) is not targeted toward minors or those that do not already routinely use cigarettes
Note 1. If a customer contacts a sales office by telephone for the first time, the exact same procedure (to determine if the sale is for the treatment of Nicotine Dependency Syndrome, or not) will apply.

Benefits of the Alternative Proposal

Implementation of such an option, as outlined in this document, will assist in providing the following benefits:
1.      For those individuals seeking treatment for Nicotine Dependence Syndrome, they will be directed to the appropriate healthcare channels to be dealt with by those qualified to do so in such matters. Furthermore, these individuals can then be advised of the therapeutic products available which will best suit their needs, were they not already aware. This form of “free advertising” will also assist in the unbiased promotion of all medicinally licensed products and help prevent electronic cigarettes diverting sales away from legitimate smoking cessation aids; thus ensuring that the pharmaceutical companies maintain control of their stake in NRT products

2.      The illusion that electronic cigarettes are a Nicotine Replacement Therapy, or a legitimate aid to prevent, treat, or cure, nicotine addiction, will be removed unless it has a product licence for such treatment

3.      The electronic cigarette industry will become legitimised by a regulatory framework, which is at present non-existent, and this can then be managed through a series of requirements that are punishable by confiscations, fines, or imprisonment, for any breaches

4.      In order to be provided with a product licence exemption certificate, electronic cigarette suppliers, vendors and manufacturers will have to comply with routine announced (or unannounced, where it is deemed necessary) inspections by either the MHRA or Trading Standards, in order to maintain their product licence exemption certification.

Conclusion

The following proposal is a fair and balanced alternative to an outright ban, or restrictive product licence requirement, where the current MLX 364 document does not take into account those individuals who simply do not wish to be treated for Nicotine Dependence Syndrome but do, however, want an alternative to conventional cigarettes; whether this choice is due to simple user-preference, or for personal hygiene reasons.
An outright ban (or the insistence on a time-constrained product licence submission) at this juncture is only likely to drive the market underground (as did prohibition of alcohol in the United States during the 1930s) and encourage the purchase of these products from countries where the MHRA has no jurisdiction or control. Another factor to be taken into consideration will be the difficulties that are likely to be encountered in enforcing and policing a ban. Considering the number of people now using these products, it is highly unlikely that Revenue and Customs will be able to seize all shipments of electronic cigarettes and nicotine containing liquid imported into the UK should an “effective” ban be put in place. Furthermore, with regard to product safety, whilst participants in the European markets are taking pro-active positive steps to improve product quality standards by employing the use of pharmaceutical grade raw materials in their products, these expectations cannot be guaranteed by the markets outside of Europe.
By creating two distinct categories of electronic cigarettes, those that wish to make health claims will have to go through the appropriate MHRA channels; and those that wish to sell them as a recreational product will have to satisfy the regulators or trading standards that they are exempt and be issued with a fee-payable product license exemption certificate. By employing a two-tier approach, both routes can be subject to a degree of regulation and appropriately controlled without destroying the electronic cigarette business entirely within the UK.

References

(1)  Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001, Article 11
(2) Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001, Article 1

The Electronic Cigarette Company

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