New study confirms no need for heavy-handed regulatory solution because of lack of problem with ecigs

(and interesting lack of funding bias in scientific research…)

By Tom Pruen

A study, recently accepted for publication in the journal Addiction, examined the levels of nicotine in ecig cartridges, and the delivery of nicotine in the vapour from them. It also touched on a recent literature search into the toxicity of nicotine, which is widely quoted as an LD50 of around 60mg, despite several documented cases of survival after ingested doses of up to 1500mg. There is increasing reason to believe that a more reasonable estimate needs to be derived.

The results, while quite possibly surprising to many outside of the e-cig industry, are much what we in ECITA would have predicted. One particular facet of the results came as quite a surprise to the researchers:

“The fact that the variation of nicotine content of the cartridges has little bearing on nicotine in vapour is the most striking finding of this study.”1

That the ability of a given device to deliver nicotine is dependent on its design, as well as the contents of the cartomiser, is not surprising; in fact it would be more surprising if the design did not affect the delivery. It does serve to show how little most of the researchers know about these products. Another example of this can be found in the suggestion that a specific regulation is required for child proof containers when, in fact, this is already explicitly required as part of the chemical labelling directives.

It may well be that they have been misled by the lack of obvious child proofing on disposable and cartomiser products they were examining. However, ECITA members are required to test both disposables and cartomisers for child resistance (by a recognised consumer product safety expert), and if the products themselves are not inherently child resistant, they need to be packaged in child resistant containers. It is not clear if others in the industry follow this example, but as child resistance is an existing legal requirement, we would anticipate this being the case. (The vast majority of modern cartomisers are inherently child-resistant.)

There is a general tendency in the vaping community (and indeed elsewhere) to assume that the source of funding for research predetermines the outcome of the research. While this can be clearly seen in some cases, it is fairly spectacularly refuted in this instance. Since this research was funded by the MHRA, it would be easy to assume that its predetermined outcome would be a recommendation for the MHRA to regulate ecigs as medicines – but this is far from the case.

The study did find that there was some variation in both the content and delivery from ecigarettes, but the conclusion they drew from it was:

“The medicinal products accuracy for nebulisers require 9 out

of 10 samples to lie between 75% and 125% of the average value (all must lie between 65% and 135%). The consistency of nicotine content in EC cartridges we tested is not perfect, but it is well within this range and seems overall acceptable”.

Because of the variation in the delivery from different devices, even with similar levels of nicotine in the cartridges, they also concluded:

“Our finding that the nicotine content of eliquid has little if any relationship to nicotine content in vapour (let alone nicotine intake by users) suggests that a pharmaceutical level of accuracy of labelling of the nicotine content in EC cartridges is also unlikely to be informative for the user”

and

“Consumers need to find models that suit their needs”

Despite a maximum variation of 31% within the same product, they concluded:

“Given the large variation in how nicotine is delivered to vapour and how EC are used, the consistency seems adequate.”

I am not entirely convinced of this – I think that the electronic cigarette industry can, and should, do better than this – but I do agree that this doesn’t require additional regulation (and particularly medicinal regulation), but rather reflects a need for vendors to insist on better quality control procedures from their suppliers. The ECITA standard requires a maximum deviation from stated level of 9% of the declared amount, rounded to the nearest 0.1% (i.e. a 2.4% liquid must fall between 2.2 and 2.6%) and we believe this is a level of accuracy that is both desirable and achievable. If one of our member’s products falls outside this margin, we require the product to be either relabelled or removed from sale , and that the member undertake corrective action within their supply chain.

 

The researchers’ conclusions that:

“The consumer protection regulations need to be implemented strictly to ensure that EC are safe, fit for purpose and ‘as described’”

and

“a regulation of EC over and above such consumer protection safeguards seems unnecessary”

are conclusions I can only agree with: what is needed is not a regulatory sledgehammer to solve a non-existent problem and create a perfect product; what is needed is better enforcement of the existing regulations to ensure that products are good enough. In parallel with this there is a real and urgent need for government agencies to stop describing these products as unregulated, and start insisting on the current regulatory regime being firmly enforced.

 

Posted in EU, MHRA, Uncategorized | 1 Comment

Cost of Medicines regulation based on the product ranges of some ECITA members

By Katherine Devlin and Tom Pruen

What does the MHRA proposal mean for real companies?

To us it looks more like “nuke the entire site from orbit, it’s the only way to be sure” than the MHRA’s claimed “light touch” or “right touch” regulation.

 

 

Using the cost data provided by the MHRA, as well information from discussions between the MHRA and ECITA, the cost of applying for medicines authorisation for the product ranges of four companies, demonstrating different business models typical of this industry sector, was calculated.

It is important to note that this excludes a number of areas where detailed cost information is not available:

  • Regulatory consultancy fees
  • Medical device approval costs
  • Cost of upgrading the supply chain
  • Cost of generating toxicological data for the inhalation of flavourings

Each of these would be expected to add costs of a minimum of several thousand pounds, and could potentially (particularly in the case of upgrading the supply chain to comply with the MHRA regulations) run into several million. The companies engaged in the process of gaining an MA have proven reluctant to give any indication of the costs involved in this, beyond the fact that it has proven difficult and expensive. The MHRA also have not provided any data on this.

Also not included are any costs resulting from the MHRA requirement for the nicotine doses to be consistent during the use of the product. This is not part of the design of the products, and achieving this is likely to involve significant redesign. This may be the reason that Mr Mean has been quoted as saying that none of the products currently on the market would meet MHRA standards.

There is also uncertainty as to whether or not different flavours will require a separate MA, as the MHRA has at various times suggested that this may or may not be the case. If flavours do not require an MA, they will still require a dossier and the non-clinical testing to ensure compliance with medical quality and efficacy requirements. (This has been confirmed to ECITA in a meeting with the MHRA). The MHRA have also stated that:

it would be necessary to demonstrate that the liquid is safe and effective in specified electronic cigarettes. Furthermore, such electronic cigarettes would need to be licensed.1

This would require testing each liquid with each atomising device it is intended for use with.

Owing to the huge range in the estimated annual costs for maintaining wholesale and import licences, a median value between the two extremes has been used. This includes educated assumptions of the number of batches produced each year, except where we have specific batch data to work with.

The MHRA has provided cost estimates2 which we have used for the following calculations. In its document Licensing Procedure for Electronic Cigarettes and Other Nicotine Containing Products (NCPs) as Medicines, the MHRA states that: “An electronic cigarette would be expected to be a so-called complex application3, so it is not unreasonable to assume that the costs would be at the upper end of their estimates. The one-off and annual recurring costs for pharmacovigilance have been included as if there would be no difference between a company engaging in pharmacovigilance for a range of three products or for a range of many hundreds, since it is impossible to estimate how these could be applied to different licence holders when some may have a very small range of products, while others would have several hundred.

If the MHRA do not agree with these estimates, we would be fascinated to know what they do estimate for these companies. Our members would be hugely reassured to know that the MHRA’s regulatory proposal would not utterly destroy their businesses, as currently appears to be the case.

For clarity, these are the specific figures used:

 

Marketing Authorisation costs
One-off costs:

£

Preparing dossier

30,000

Pharmaceutical development studies for product quality

50,000

Batch manufacture (pilot scale) and stability studies

50,000

Quality/non-clinical studies (genotoxicity studies of impurities, analysis of vapour constituents, extractables and leachables

90,000

In-vivo pharmacokinetic studies and/or supporting efficacy studies

130,000

MHRA fee for abridged complex application

28,780

One-off cost of applying for a Marketing Authorisation:

378,780

Annual recurring costs:
Annual period fee

452

Annual GSL periodic fee

452

Annual recurring costs for maintaining a MA:

904

 

 

 

Manufacturer/Import Authorisation (MIA) costs
One-off costs:
Costs of preparing application

10,000

MHRA fee

3,027

Establishing testing facilities

10,000

One-off cost of Manufacturer/Import Authorisation

23,027

Recurring costs:
Re-testing products after import (per batch)

2,000

Inspection of manufacturer’s site (adjusted for annual4)

9,250

Inspection of UK site (adjusted for annual)

4,500

Qualified person

80,000

Non salary staff costs

24,000

Annual recurring costs of Manufacturer/Import Authorisation

119,750

Pharmacovigilance (PhV)
One-off costs:
Service provider to establish PhV systems

9,800

One-off costs of pharmacovigilance

9,800

Annual recurring costs:
Annual service provider costs

12,900

Inspection costs (adjusted for annual5)

3,333

Annual recurring costs of pharmacovigilance

16,233

Wholesale dealing
One-off costs:
Application for Wholesale Dealer’s Licence

3,926

Temperature monitoring equipment

3,000

One-off costs of Wholesale dealing

6,926

Annual recurring costs:
Subsequent inspections (adjusted for annual)

607

Compliance with Good Distribution Practice (adjusted for annual)

41,347

Annual recurring costs of Wholesale dealing

41,954

Any attempt to quantify the impact of the proposed regulatory framework on the companies operating within the electronic cigarette industry must acknowledge the diversity and range of the small to medium enterprises (SMEs) which currently make up the vast majority of this sector. Therefore, we have selected four companies to represent some of the different business models, and used the MHRA’s published figures to calculate the potential impact on each different business model.

The selected business models do not represent the entirety of the existing or possible variations within this sector, but we believe they can provide a useful guide for the purposes of this exercise.

 

Company One

Company one has a very limited product range consisting entirely of products resembling cigarettes. These are sold online as well as through a wide range of retail outlets. The products are available in three flavours, each of one strength, as well as a nicotine free product. Company One sources all its products from China.

Since Company One only has a single atomising device, the costs are relatively small.

 

One-off costs:

£

One-off cost of applying for 3 MAs

1,136,340

One-off costs of applying for MIA, PhV and wholesale licence

39,753

Total one-off costs:

1,176,093

Annual recurring costs:
Annual recurring cost of maintaining 3 MAs

2,712

Annual recurring cost of maintaining MIA, assuming 3 batches per flavour and strength per year, so 9 batches

18,000

9,250

4,500

80,000

24,000

Sub-total: 135,750

Annual recurring cost of maintaining PhV and wholesale licence

58,187

Total annual recurring costs:

196,649

 

Company Two

Company Two has a small product range, with six flavours in three strengths, six disposable products, and two designs of atomiser. All their liquids are in one excipient base. These are sold online as well as through a variety of retail outlets. Company Two sources all of its products from China.

Since Company 2 has disposable products, and two designs of atomiser, the costs are significantly higher. Company Two has a further twelve nicotine free products that would be unaffected by medicinal regulation.

Case one: flavour, strength and base excipient combinations require a separate MA

 

One-off costs:

£

One-off cost of applying for MAs

15,908,7606

One-off costs of applying for MIA, PhV and wholesale licence

39,753

Total one-off costs:

15,948,513

Annual recurring costs:
Annual recurring cost of maintaining MAs

37,968

Annual recurring cost of maintaining MIA, assuming 3 batches per flavour and strength per year, so 72 batches

144,000

9,250

4,500

80,000

24,000

Sub-total: 261,750

Annual recurring cost of maintaining PhV and wholesale licence

58,187

Total annual recurring costs:

319,937

 

Case two: only variations in strength and base excipient, but not flavour, require a separate MA. Flavourings would require only the dossier and non-clinical testing

 

One-off costs:

£

One-off cost of applying for MAs

4,545,3607

One-off costs of dossier and non-clinical testing for flavourings (so x6)

720,000

One-off costs of applying for MIA, PhV and wholesale licence

39,753

Total one-off costs:

5,305,113

Annual recurring costs:
Annual recurring cost of maintaining MAs

10,848

Annual recurring cost of maintaining MIA, assuming 3 batches per flavour and strength per year, so 72 batches

144,000

9,250

4,500

80,000

24,000

Sub-total: 261,750

Annual recurring cost of maintaining PhV and wholesale licence

58,187

Total annual recurring costs:

330,785

 

 

Company Three

Company Three supplies a wide range of liquids in a wide variety of flavours, from a wide range of suppliers, including the UK, US and China. The UK supplier was not counted in the costing, as it assumed that they will bear all the costs themselves, and this will only be reflected in the purchase price for products. Company Three has sixty five types of atomising device. These are sold online and through a number of specialist shops specifically for electronic cigarette products.

Case one: flavours require a separate MA

 

One-off costs:

£

One-off cost of applying for MAs for liquids:
Liquid range one: 37 flavours, 7 strengths, 2 base liquids, so 518 MAs

196,208,040

Liquid range two: 57 flavours, 4 strengths, 2 base liquids, so 456 MAs

172,723,680

Liquid range three: 16 flavours in 3 strengths, 1 base liquid, so 48 MAs

18,181,440

Liquid range four: 4 flavours in 4 strengths, 1 base liquid, so 16 MAs

6,060,480

Liquid range five: 3 flavours in 3 strengths, 1 base liquid, so 9 MAs

3,409,020

Liquid range six: 4 flavours in 4 strengths, 1 base liquid, so 16 MAs

6,060,480

Liquid range seven: 4 flavours in 4 strengths, 1 base liquid, so 16 MAs

6,060,480

Liquid range eight: no flavour, 2 strengths, 2 base liquids, so 4 MAs

1,515,120

One-off costs of applying for MIA, PhV and wholesale licence

39,753

Total one-off costs:

410,258,493

Assuming that the testing and application for each atomiser design could be combined in the above liquid applications, there would be no additional one-off costs.
If separate testing were required, assuming that each atomiser requires a full MA with one liquid per supplier, and only a dossier and non-clinical testing for other liquids, it would cost:
Liquid range one x 65 atomisers with one liquid formulation

24,620,700

517 liquid formulations requiring dossiers and non-clinical testing

62,040,000

Liquid range two x 65 atomisers with one liquid formulation

24,620,700

455 liquid formulations requiring dossiers and non-clinical testing

54,600,000

 

Liquid range three x 65 atomisers with one liquid formulation

24,620,700

47 liquid formulations requiring dossiers and non-clinical testing

5,640,000

Liquid range four x 65 atomisers with one liquid formulation

24,620,700

15 liquid formulations requiring dossiers and non-clinical testing

1,800,000

Liquid range five x 65 atomisers with one liquid formulation

24,620,700

8 liquid formulations requiring dossiers and non-clinical testing

960,000

Liquid range six x 65 atomisers with one liquid formulation

24,620,700

15 liquid formulations requiring dossiers and non-clinical testing

1,800,000

Liquid range seven x 65 atomisers with one liquid formulation

24,620,700

15 liquid formulations requiring dossiers and non-clinical testing

1,800,000

Liquid range eight x 65 atomisers with one liquid formulation

24,620,700

3 liquid formulations requiring dossiers and non-clinical testing

360,000

Potential additional one-off costs:

325,965,600

Annual recurring costs:
Annual recurring cost of maintaining 1,083 MAs

979,032

Annual recurring cost of maintaining MIA, assuming 3 batches per each of the 8 liquid suppliers, per flavour, per base, per strength, per year, so 3,249 batches

6,498,000

9,250

4,500

80,000

24,000

Sub-total: 6,615,750

Annual recurring cost of maintaining PhV and wholesale licence

58,187

Total annual recurring costs:

7,652,969

Potential additional annual recurring cost (65 atomisers x 8 liquid ranges)

470,080

Potential total annual recurring costs:

8,123,049

 

The cost of testing each atomiser in full with all liquids would run to around £25 billion, and is clearly not worth considering further.

Company Three has an additional 201 non-nicotine products that would be unaffected by medicinal regulations.

 

Case two: only variations in strength and base liquid require a separate MA

 

One-off costs:

£

One-off cost of applying for MAs for liquids:
Liquid range one: 7 strengths, 2 base liquids, so 14 MAs

5,302,920

One-off costs of dossier and non-clinical testing for 37 flavourings

4,440,000

Liquid range two: 4 strengths, 2 base liquids, so 8 MAs

3,030,240

One-off costs of dossier and non-clinical testing for 57 flavourings

6,840,000

Liquid range three: 3 strengths, 1 base liquid, so 3 MAs

1,136,340

One-off costs of dossier and non-clinical testing for 16 flavourings

1,920,000

Liquid range four: 4 strengths, 1 base liquid, so 4 MAs

1,515,120

One-off costs of dossier and non-clinical testing for 4 flavourings

480,000

Liquid range five: 3 strengths, 1 base liquid, so 3 MAs

1,136,340

One-off costs of dossier and non-clinical testing for 3 flavourings

360,000

Liquid range six: 4 strengths, 1 base liquid, so 4 MAs

1,515,120

One-off costs of dossier and non-clinical testing for 4 flavourings

480,000

Liquid range seven: 4 strengths, 1 base liquid, so 4 MAs

1,515,120

One-off costs of dossier and non-clinical testing for 4 flavourings

480,000

Liquid range eight: no flavour, 2 strengths, 2 base liquids, so 4 MAs

1,515,120

One-off costs of applying for MIA, PhV and wholesale licence

39,753

Total one-off costs:

31,706,073

In the above list, there is a total of 44 MAs for the various liquids. However, this company supplies a total of 65 atomisers. Therefore, at an absolute minimum, another 21 MAs would be required, at a cost of £7,954,380. This presupposes that the remaining atomisers would only be tested with one eliquid.
If separate testing were required, assuming that each atomiser requires a full MA with one liquid per supplier, and only a dossier and non-clinical testing for other liquids, it would cost:
Liquid range one x 65 atomisers with one liquid formulation

24,620,700

517 liquid formulations requiring dossiers and non-clinical testing

62,040,000

Liquid range two x 65 atomisers with one liquid formulation

24,620,700

455 liquid formulations requiring dossiers and non-clinical testing

54,600,000

Liquid range three x 65 atomisers with one liquid formulation

24,620,700

47 liquid formulations requiring dossiers and non-clinical testing

5,640,000

Liquid range four x 65 atomisers with one liquid formulation

24,620,700

15 liquid formulations requiring dossiers and non-clinical testing

1,800,000

Liquid range five x 65 atomisers with one liquid formulation

24,620,700

8 liquid formulations requiring dossiers and non-clinical testing

960,000

Liquid range six x 65 atomisers with one liquid formulation

24,620,700

15 liquid formulations requiring dossiers and non-clinical testing

1,800,000

Liquid range seven x 65 atomisers with one liquid formulation

24,620,700

15 liquid formulations requiring dossiers and non-clinical testing

1,800,000

Liquid range eight x 65 atomisers with one liquid formulation

24,620,700

3 liquid formulations requiring dossiers and non-clinical testing

360,000

Potential additional one-off costs:

325,965,600

Annual recurring costs:
Annual recurring cost of maintaining 65 MAs8

58,760

Annual recurring cost of maintaining MIA, assuming 3 batches per each of the 8 liquid suppliers, per flavour, per base, per strength, per year, so 3,249 batches

6,498,000

9,250

4,500

80,000

24,000

Sub-total: 6,615,750

Annual recurring cost of maintaining PhV and wholesale licence

58,187

Total annual recurring costs:

6,732,697

Potential additional annual recurring cost (65 atomisers x 8 liquid ranges)

470,080

Potential total annual recurring costs:

7,202,777

 

 

Company Four

Company Four is a manufacturer of e-liquids within the UK. It supplies its products predominantly through wholesale to other businesses, but also supplies retail direct to consumers. Company Four does not sell any hardware, but has two hundred and thirteen flavours, in fourteen strengths, in twenty variations of base liquid. In the period Aug 2012 to Aug 2013, Company Four produced a total of 21,679 batches.

 

Case one: flavours require a separate MA

 

One-off costs:
One-off costs of applying for MAs for liquids:

£

213 flavours, 14 strengths, 20 base liquid formulations, so 59,640 MAs

22,590,439,200

One-off costs of applying for MIA, PhV and wholesale licence

39,753

Total one-off costs:

22,590,478,953

Annual recurring costs:
Annual recurring cost of maintaining MAs

53,914,560

Annual recurring cost of maintaining MIA, based on the 21,679 batches produced between August 2012 and August 2013

43,358,000

9,250

4,500

80,000

24,000

Sub-total: 43,475,750

Annual recurring cost of maintaining PhV and wholesale licence

58,187

Total annual recurring costs:

97,448,497

 

This is clearly beyond the realms of plausibility.

 

Case two: only variations in strength and base liquid require a separate MA

 

One-off costs:
One-off costs of applying for MAs for liquids:

£

14 strengths, 20 base liquid formulations, so 280 MAs

106,058,400

One-off costs of dossier and non-clinical testing for 213 flavourings

25,560,000

One-off costs of applying for MIA, PhV and wholesale licence

39,753

Total one-off costs:

131,658,153

 

Annual recurring costs:
Annual recurring cost of maintaining MAs

253,120

Annual recurring cost of maintaining MIA, based on the 21,679 batches produced between August 2012 and August 2013

43,358,000

9,250

4,500

80,000

24,000

Sub-total: 43,475,750

Annual recurring cost of maintaining PhV and wholesale licence

58,187

Total annual recurring costs:

43,787,057

 

Furthermore, this does not address the problem that this excludes the cost of testing the liquids with the atomising devices used by the various companies that Company Four supplies. Since there are in excess of sixty five atomising devices on the market, the costs associated with gaining approval for the liquids for use with all of them is likely to prohibitive, significantly limiting the ability of Company Four to continue its wholesale business.

However, in reality, these costs are unlikely to apply. We would anticipate that Company Four, taking a common sense approach, would produce its two hundred and thirteen flavours in twenty base combinations as zero nicotine products, and licence unflavoured high strength nicotine in two bases on a single atomiser.

This would allow the consumer to produce their own ‘off label’ e-liquid, and the company to almost totally avoid the MHRA regulations.

This significant loophole would also apply to most companies, particularly where the devices and nicotine are supplied separately, since any product that is not supplied with nicotine would be unaffected by the MHRA regulatory proposal. This would place an unfair burden on those companies who only supply pre-filled products.

This would also significantly complicate the enforcement of the regulation of these products by the front line enforcements agents – trading standards officers. Since the MHRA proposal would set a completely different regulatory framework in place purely on the basis of the presence or absence of nicotine, products would need to be tested for the presence or absence of nicotine before the appropriate regulatory framework could be identified.

ECITA has always sought proportionate and robust regulation of electronic cigarettes, and the MHRA proposal seems to impose excessive costs on some businesses, while providing significant loopholes, in part because of the poor ‘fit’ of the products into the medicines regulations – a framework demonstrably designed for an entirely different product sector. The fact that it would make enforcement more difficult and expensive for the on-the-ground regulators also seems counter-productive.

 

2 http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con286852.pdf Please note that the Annex containing the pertinent figures is reproduced hereafter.

4 5 days at £2,500 per day = £12,500, plus £6,000 travel/accommodation = £18,500. MHRA assumes two-yearly inspection, so £18,500 divided by 2 for annual recurring cost of £9,250.

5 MHRA fees of £5,000 plus Inspection hosting costs of £5,000. MHRA assumes 3-yearly inspection, so £10,000 divided by 3 for annual recurring cost of £3,333.

6 42 MAs required for 6 flavours x 3 strengths x 2 atomisers, plus 6 disposable products.

7 12 MAs required for 3 strengths x 2 atomisers, plus 6 disposable products.

8 The total number of MAs required for the liquids is 44, but there must be at least 65 in total, because of the number of atomisers.

 

Posted in Uncategorized | 9 Comments

Analysis of the MHRA guidance: “Licensing Procedure for Electronic Cigarettes and Other Nicotine Containing Products (NCPs) as Medicines”

By Katherine Devlin and Tom Pruen

 

This is appearing rather belatedly, but is our analysis of the guidance provided for those who wish to seek an MA for electronic cigarette products. It was produced on the 1st of August, immediately following the publication of the guidance by the MHRA.

 

Introduction

The MHRA’s guidance1 is aimed at assisting vendors of NCPs in successfully applying for a Marketing Authorisation for their product(s). Assessing the applicability of this advice to NCPs other than electronic cigarettes is outside our remit, and no comment is made on this.

The MHRA begins its guidance by declaring uncertainty as to the final form the EU regulation will take. Since there is still debate at the European level as to whether electronic cigarettes should be reclassified as medicinal products, there is the possibility that the MHRA’s attempt to pre-empt the regulation may yet have an embarrassing lack of support at EU level. Certainly, France has expressed reservations about this course of action, in part because, in France, this would limit the sale of electronic cigarettes to being through pharmacies only. The same is true of 20 of the 28 EU Member States.

Presumably to avoid this, the MHRA is suggesting that applicants should apply for Marketing Authorisations (MAs) on the basis of presentation (i.e. should make a medicinal claim which will require testing for efficacy). This evades the current debate in Europe, as well as the questionable legality of determining electronic cigarettes as medicines by function. Regulation as a medicine by presentation is universally accepted as a legally viable option; it is the regulation of the products in the absence of medical claims that is legally questionable (according to the Opinion of Sir Francis Jacobs QC2).

The potential future importance of the difference between classification as a medicine by function, or by presentation, is not mentioned in MHRA’s guidance. This is likely to mislead applicants who may not understand that they would be effectively ‘trapped’ by having made medicinal claims for otherwise non-medicinal products.

The vast majority of the advice consists of links to existing documents on the method of applying for an MA, and does not discuss how these relate to electronic cigarettes (or indeed other NCPs). The Q&A section does, however, attempt to clarify the position as regards electronic cigarettes.

Key points

 

  • Emissions testing would require that nicotine liquids are only sold for use on specific devices – this is not the way the market currently operates;
  • Flavours without available literature on inhalation would be impossible to license, even if there is also no evidence of harm;
  • The cost of a single SME electronic cigarette company applying for MAs for its products (£315m, minimum) exceeds the total value of over-the-counter NRT market (£100m);
  • Ability of users to combine different products (an important aspect of the current market) is extremely problematic within the medicines framework in many areas
  • This user combination of products will make pharmacovigilance effectively impossible;
  • Medicines regulation completely ignores electronic cigarettes that do not contain nicotine – even where the devices are the same;
  • The creation of two completely different regulatory frameworks will increase the cost and difficulty of regulation;
  • There is an absence of evidence that such expensive and complicated regulation is actually required.

Detailed analysis

The first question is “What is involved in the marketing authorisation application – what do I need to submit?

This provides guidance on literature searches and pharmacokinetic studies that would be expected. However, it also states:

 “The safety of the product can be supported by literature only, assuming that the vapour produced by the device does not contain any components that may raise concerns and that the literature data supports the safety of all components of the formulation via the inhaled route.”

 This is directly contradicted by comments made in a face to face meeting between ECITA and the MHRA on the same day that the guidance was published. Amongst the MHRA representatives at this meeting was Dr Ryan Tomlinson, Unit Manager of the Product Lifecycle Assessment Team, who, we were told, would be assessing any applications from electronic cigarette companies. Dr Tomlinson said that not only does the MHRA have concerns about the potential for acrolein and formaldehyde in the vapour due to publications in the literature, but it has not had any data submitted to it on this point; in his words: “we don’t know” if the products of vapourisation are acceptably safe. (We would suggest the published literature, particularly a recent meta-study perform by Dr Igor Burstyn3 indicate that there is good evidence to suggest that the products of vapourisation are acceptably safe). When ECITA pointed out that the emissions from an electronic cigarette would depend on both the liquid used and the device used to vapourise it, Dr Tomlinson suggested that data would have to be generated for each liquid and every device it was intended for use in. Given that there are upwards of 20 atomising device designs currently in widespread use, this would require either that the applicant conduct 20 sets of testing for each nicotine solution that they placed on the market, or that the applicant restrict such liquids only for use in a single specified device. This is not the way the market currently functions, and would not fit with the expectations, needs, or use-patterns of consumers.

There is also very limited information in the literature about the safety profile of inhaled flavourings, making such a search much more problematic than the MHRA implies.

Since food flavourings (in order to be considered safe for use in food at the levels found) must have a plausible method of metabolism or excretion in order to be safe in food, there is limited prospect of them being dangerous if inhaled. It is also important to note that the quantities of flavoured nicotine solution consumed in a day are quite small, with almost every user consuming between 2 and 5 millilitres per day (approximately 2 to 5 grams) of ‘eliquid’, containing at most 20% flavourings. This would result in users consuming no more than 0.4 to 1 millilitre (approximately 0.4 to 1 gram) of the flavourings over the course of 24 hours. (The amount of flavouring added is usually closer to 10%, so this represents the most extreme example.) The MHRA position, therefore, is a prohibition on flavours that cannot be proven to be safe based on existing data, rather than a more sensible prohibition on flavours that have been proven dangerous, or those that are proven so in the future.

 

This point is also addressed in questions 3 and 12 “What do I need for the non-clinical (safety) part of the marketing authorisation application?” which also discusses the potential problem of leaching from the atomising device into the liquid/vapour, and “Do I need a marketing authorisation if my product is an e-liquid or nicotine liquid only?

 

The MHRA guidance states:

 “A comprehensive evaluation of the potential extractables and leachables originating from all components of the electronic cigarette should also be provided, with associated toxicological review.”

 and

 “It would thus be possible to apply for a MA for the nicotine liquid only. However, it would be necessary to demonstrate that the liquid is safe and effective in specified electronic cigarettes. Furthermore, such electronic cigarettes would need to be licensed.”

 How this might be achieved, when – in the current market – a large proportion of users buy the liquid and hardware separately (and not infrequently from different vendors), is not addressed. We can only assume that this would again require the liquid to be sold for use only in one or more specified licensed devices. As Dr Tomlinson said during the meeting between MHRA and ECITA, “It would become very complicated.”

 

Question 4 addresses efficacy: “What do I need for the clinical (efficacy and safety) part of the marketing authorisation application?Oddly, this does not appear to make any reference back to the claim made when presenting the product (while the MHRA is taking voluntary applications on the basis of presentation), but assumes that nicotine delivery is the key measure, which is to treat the product as a medicine by function. The guidance does, however, then state that the product must “demonstrate safe and efficacious levels of nicotine for each claimed indication”, which seems to contradict this. Furthermore, it does not provide any useful information on the MHRA’s stated intent to regulate the products by function (i.e with no claims made). The bulk of the evidence required for this, according to the guidance, is comparison of bioequivalence of the product with an existing medicinal NRT product, in a small scale clinical trial. The form of these trials was discussed at the meeting between MHRA and ECITA, specifically concerning the effect this might have on the pace of innovation within the market, particularly with regard to the introduction of new electronic cigarettes. During this discussion, Dr Tomlinson informed us that these studies (as well as lab testing) would need to be done to determine if a design change to a product would make it sufficiently different to ‘trigger’ a new Marketing Authorisation. This would have to be done prior to placing a new product on the market, and the clinical trial alone, according to the MHRA estimates, would cost between 50 and 100 thousand pounds.

This would clearly have a negative effect on innovation within the market.

 

Question 5 addresses the regulation of the electronic cigarette hardware as medical devices:

 “The MHRA considers the part of the electronic cigarette containing the battery together with any associated charging accessories to be a Class IIa medical device as an active therapeutic medical device.”

 However, a significant proportion of electronic cigarette products are sold with nicotine supplied separately from hardware (i.e. the liquid is sold separately from the hardware it is to be used with). Where this is the case, the MHRA has stated (in question 10 of their guidance) that if an electronic cigarette contains no nicotine, and makes no medical claims, then they do not intend to regulate it.

This would create a situation where the same hardware would be on the market, but regulated in completely different ways, solely on the basis of the inclusion of nicotine. This places a disproportionate burden on those companies who supply prefilled products, and since in most cases the same hardware would be available with much lighter regulatory costs, prevent such companies remaining competitive.

This combination of heavy-handed and expensive regulation, while simultaneously allowing the current state of regulation to continue will also increase the problems of enforcement, since in order to determine how a product should be regulated, it will first require a determination as to whether or not it contains nicotine. This will make the role of the enforcement agents (Trading Standards Officers) much harder, and increase the costs of enforcement, since samples will have to be analysed for the presence of nicotine prior to even being sure which regulatory framework applies.

Question 6 addresses the costs of an MA, with a link to the MHRA table of periodic fees. This however provides rather less information than the costs estimated in the MHRA’s “Impact assessment to support the UK’s position in EU negotiations on the regulation of Nicotine Containing Products, which are currently being considered along with changes to the Tobacco Products Directive4, which estimates the combined cost of an MA application at between £215,000 and £350,000 per application. Since the MHRA states that “An electronic cigarette would be expected to be a so-called complex application”, it is not unreasonable to assume that the costs would be at the upper end of this estimate.

This led to a situation where an ECITA member company contacted the MHRA directly, and was told that they would require 900 MAs to cover their product range. Based on the MHRA cost estimates, this would cost £315,000,000 purely for MAs. This does not include the associated costs of GMP compliance, nor importing, wholesale, or pharmacovigilance fees, which would also add significant costs. It also takes no account of future costs, such as R&D into new products, which would also require significant expenditure.

This is the cost for a mid-sized company with a turnover of around £5 million. Clearly, it is not possible for this type of company – which is very typical of the SMEs which make up the electronic cigarette industry – to invest such an excessive amount of money.

In its document “Proportionate regulation5 the MHRA states that the value of the over-the-counter market in licensed NRT products is £100 million – less than the cost of a single electronic cigarette company applying for MAs for its product range, and with no guarantee that it will receive them.

It is also not clear why electronic cigarette companies should engage in pharmacovigilance for their products, when tobacco cigarettes – the most direct competition as a nicotine delivery method – do not, despite the very clearly demonstrated harms caused by smoking. It is also not clear how the MHRA intends to apply pharmacovigilance in an industry where a consumer can buy the three components of an electronic cigarette (battery, atomiser and nicotine solution) from three completely unrelated suppliers (except that, as noted, the current market would be destroyed by the MHRA’s regulatory proposal). It is difficult to reconcile this with the MHRA statement that “The cost of regulation need not affect price or competition…”.

This is precisely why the vast majority in the industry, and also the consumers of these products, view medicines regulation of these products as a de facto ban.

This does not appear to be proportionate regulation by any measure, particularly since the MHRA has not made a compelling argument that electronic cigarettes need to be shoe-horned into medicines regulation – despite the demonstrable lack of ‘fit’. The fact that the electronic cigarette industry covers such a vast range of products, supplied with and without nicotine, makes it particularly inappropriate to apply the medicinal regulatory framework, since this would leave all non-nicotine containing electronic cigarettes under an entirely different regulatory regime. If the MHRA considers the current regulations so unfit for purpose as to require the sledgehammer of medical regulations, why are they so willing to leave products on the market under the current regulatory framework?

Perhaps this is because, despite the concern they express over the current regulations, they have stated in their published documents:

 

However, as yet there is an absence of scientific evidence that shows long term harm to health is occurring in reality because of product safety6

While contaminants in ENDS have been identified, and the long term health effects of inhaling ENDS vapour are unknown, so far there is an absence of evidence that shows that these problems create significant harm to health.7

Safety concerns have been reported. Given the extent of use, however, and despite the lack of a formal reporting mechanism (such as the yellow card scheme), these do not of themselves suggest a major public health concern.8

Given the low toxicity of nicotine at the doses observed and the fact that long before any dangerous levels of nicotine concentration could be reached, an over-enthusiastic user would be warned by nausea, there is little concern that e-cigarettes can harm their users by delivering toxic nicotine levels.9

 

 

 

 

 

 

 

 

5 http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con286850.pdf (Note also, on this document, that ‘Light Touch Regulation’ has been recast as ‘Right Touch Regulation’.)

Posted in Uncategorized | 3 Comments

The Daily Fail strikes again

By Tom Pruen

The Daily Mail has a considerable history of reporting on e-cigs that is not so much poor as pathetic (for the past history of the Mail’s ineptitude on this subject, Try our blog here, and here, and Clive Bates complaint to the Press Complaints Commission (PCC) here, which was resolved in his favour).

It seems that the Mail are not only so lacking in journalists that can do research that they are happy to publish other peoples press releases as verbatim truth, but also that these journalists feel the need to add in their own interpretation of the press release. Sadly, it is immediately evident that these reporters lack the basic knowledge which would make these interpretations anything other than scaremongering nonsense.

The Mail’s headline is “E-cigarettes are as harmful as cigarettes and could cause cancer, claims study”. Unfortunately, however, this is not what the study claims, nor is it what they found. Of the varied models and brands that were studied, some had levels of a single potential carcinogen that rivalled those in traditional tobacco cigarettes. They did not find many of the thousands of other carcinogens in tobacco smoke. It is therefore incorrect to claim the E-cigarettes are as harmful as tobacco ones, based on the evidence in this study. It does not take an expert in toxicology or risk assessment to discern this; it is well within the grasp of any educated individual.

It is true to say that e-cigs do appear to have some slight risk associated with them, something which we would agree with. The study also calls for further research, which we would also agree with, since if the risks can be reduced even further, it can only be a good thing. There is nothing in this study to suggest that our long held position is incorrect, however. E-cigs offer massively reduced harm compared with tobacco cigarettes, and offer a huge potential for smokers to be able to choose, for themselves, a safer alternative.

Given that this headline is similar to the last one, “E-cigarette ‘can cause more harm than smoking’, experts say” and the evidence to support it is just as lacking now as it was then, we expect the verdict of the PCC to be very similar. What this means that in contrast to the big headlines the Mail are currently misleading people with, in a couple of months, they will publish a small paragraph (probably virtually identical to this one) retracting it. But by then, of course, the damage is already done, and people will have been dissuaded from switching to e-cigs, or even worse scared into swapping back from e-cigarettes to the deadly tobacco ones.

This is journalism that is shoddy to the point of potentially causing actual harm to consumers.

So there we have it, the Daily Fail – where having a scary headline about electronic cigarettes is more important than anything resembling the truth – seem to be a clear example of why there must be controls on a free press.

We can only hope the PCC insists on a more robust retraction this time.

*Update*

The Mail have since modified the news story to make it a little more accurate, but it still does a very poor job of providing accurate information.

Posted in Uncategorized | 1 Comment

The full text of Sir Francis Jacobs QC’s Opinion on the legality of medicines regulation of electronic cigarettes in the revisions to the TPD (and elsewhere)

Please be patient while the embedded document loads.

Posted in EU, MHRA | 7 Comments

Sorry… WHO??

By Vicky Grant

Yet another ‘damning’ article, written by the World Harm Organisation, was published today and yet again they have singularly failed to demonstrate any understanding – or even ability to read! Why is it that, with all the research out there in the ether, the WHO is incapable of finding it, even when sent this information directly? So I shall endeavour, World ‘Health’ Organisation, to fill in some blanks for you. (Don’t worry – I’ll use small words, and try to communicate plainly.)

Vapers, correct me if I am wrong, but I have never heard of, nor experienced a cartridge filled with 100mg/ml strength of nicotine!? In fact this would be not only stupid, but very cost ineffective, from the point of the manufacturer and/or supplier. Maybe, rather than making this stuff up, the WHO could spend a little time purchasing a few of these items so that they could see for themselves, or better still actually DO some unbiased research on the products they ‘believe’ to be, and publicly decry as, so terrible. But maybe I am missing the point, and I digress.

Now this makes my blood boil…. ‘The safety of ENDS has not been scientifically demonstrated’ Have these people been living under rocks all this time?? Are you seriously telling me that NO scientific research has been done on the safety of these products? Was I imagining listening to Professor  Jean-François Etter, make an unbiased presentation of his research on electronic cigarettes at the ENVI workshop? (Link to Professor Etter’s thoughts.) Clearly I must have, since his research does not actually exist! The fact that Dr Roberto Bertollini, Chief Scientist and World Harm Organisation representative, was sitting on the same panel, indicates he had either fallen asleep, had his fingers in his ears, or just simply didn’t understand that he should have been paying attention. If you wish to know more please cast your eyes over this.  The fact that this research would have probably landed on all their desks, prior to the event for them to have a read through, means that the research probably contained information that the World Harm Organisation doesn’t want to hear.  Now, you see, if this was the only research done, I could probably find it in my heart to forgive them for missing it…. But it’s not! There are many other pieces of research and reports out there for all to see:

Dr Tobias Schripp performed a study, ‘Does e-cigarette consumption cause passive vaping?’ which researched the effect of vapour on indoor-air and second-hand vapour.

Dr Maciej L. Goniewicz has done another research paper: Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Again, this examines the safety of e-cigarettes.

Oh look!  There are 2 research papers I have managed to find and there are more out there, so why is it, I ask myself, apparently completely impossible for the World ‘Health’ Organisation to find this information for themselves?? In my honest opinion, it isn’t that they haven’t read this – and more.  It is that, for some reason, it does not say what they want to hear.

So why is the WHO still bleating on about not knowing anything about e-cigs and vapour? Is it because of the money that stands to be lost by the big ‘I am’s’; the health of the world’s citizens; or (more likely) due the fact that they have considerable quantities of ‘egg on their faces’, since it is the smokers themselves – yes, those very pariahs so resoundingly reviled and viewed as a scourge by the WHO – who have sounded the death knell for deadly tobacco smoking? All by themselves? Without any help from the Public Health Industry, the Tobacco Control Industry, or the WHO?

Well good on you, WHO. You should feel embarrassed; you have done nothing; you continue to do nothing to help. The best thing to do would be to slither off, back to your rock, and let the people decide if electronic cigarettes are right for them to use, because – let’s face it – we have found something miraculous all by ourselves. And all you can do is scaremonger and watch your coffers empty away. You have seriously lost sight of your role in public health. According to your website, you are “responsible for providing leadership on global health matters, shaping the health research agenda…”.

Isn’t it closer to the truth that you are responsible for making bucket-loads of cash for your pharma buddies from the suffering of others??

I will leave that to you to answer, but know this: others will make up their own minds and judge you on your actions.

Posted in EU, FDA, MHRA, Uncategorized, WHO | 8 Comments

Counsel Opinion Confirms No Justification for Changes to E-Cig Regulation

Sir Francis Jacobs QC, President of the European Law Institute and former Advocate-General to the European Court of Justice describes the proposed ban on e-cigs as “an unreasonable measure which is liable to be annulled as being contrary to the principle of proportionality and/or the principle of non-discrimination.

At the request of ECITA (EU) Ltd, Sir Francis Jacobs has provided his expert Opinion on the Commission’s proposals for a revised Tobacco Products Directive, as they pertain to electronic cigarettes. There are one or two surprises, but it comes as no surprise whatsoever to the growing community of vapers, who have already made the switch to electronic cigarettes, often entirely replacing their smoking habit, that Sir Francis is of the opinion that the proposed change to the regulation of these revolutionary products:

represents a very extreme and intrusive form of regulation.

In summary, Sir Francis concludes:

As far as we are aware, those (few) national courts that have addressed this issue to date have held that, on the facts of the cases before them, electronic cigarettes are not medicinal devices.”

Elsewhere in his Opinion, Sir Francis specifically mentions the MHRA in the UK:

In the UK, the MHRA has recently announced that it intends to subject electronic cigarettes to this [medicinal] kind of regulation by 2016. [...] we would expect future [court] decisions to follow the clear trend of the existing case law, which excludes them from the definition of medicinal products by function on the basis that they are effectively a substitute, not a cure, for conventional smoking.” [Our emphasis.]

Sir Francis finishes by stating:

…we are of the opinion that by effectively excluding a significant proportion of electronic cigarettes from the EU market Article 18(1) is manifestly inappropriate to the objective of removing barriers to intra-state trade and thus contrary to the principle of proportionality, and is also unjustifiably discriminatory towards manufacturers of electronic cigarettes by comparison with manufacturers of tobacco cigarettes. This provision of the revised TPD would therefore be likely to be invalidated by the Court of Justice on a reference under Article 267 TFEU.” [Our emphasis.]

Time for an honourable climb-down from the proponents of this proposal, methinks.

Posted in EU, MHRA, WHO | 15 Comments

Propaganda by press release

By Tom Pruen

A press release has been issued by Corporate Europe Observatory (CEO). CEO describe themselves as “a research and campaign group working to expose and challenge the privileged access and influence enjoyed by corporations and their lobby groups in EU policy making”

To the outrage of everyone here at ECITA, they appear to have assumed (on the basis of no evidence) that the electronic cigarette industry and the tobacco lobby are at least allied, and possibly one and the same.

The truth is that there are very few tobacco companies currently investing in the EU electronic cigarette market – and none of the ones who are is a member of ECITA. In point of fact, the only major e-cig company owned by a tobacco company is also the only one currently seeking approval for its products as a medicine. The tobacco lobby and the e-cig industry are not fighting the same corner here.

To put it simply, the current EU proposal to regulate e-cigs as medicines is APPROVED BY BIG TOBACCO – and OPPOSED BY THE E-CIG INDUSTRY.

Millions of Euros are quoted for the funding of big tobacco lobbying, but other than by implication, no mention is made of how much the e-cig industry is spending. Now, I cannot speak for those companies outside of ECITA, but for those within it:  Our spend on ‘lobbying’ (much of which is spent on travel to and from Brussels for meetings) is in the low tens of thousands. We are not some sort of troll-like corporate giant, bludgeoning people with sacks of money – we are the little guy in this fight.

As for the talk of ‘Astroturfing’ – all of us here at ECITA find this extremely offensive! The community of e-cig users (vapers) PREDATES the forming of our association. All of us were members of that community before forming the trade association to help OUR suppliers. All of us still emotionally belong to that community – not the other way round!

And on that note, I dread to think how completely outraged the community is going to be by this.

This is the thing that the pencil pushers of all ilks seem unaware of – the community of vapers is active, and extremely passionate. I cannot think of any other product that has such huge support from its users, not because the industry has brain-washed them, but because these are people who feel that these products have really changed their lives – and maybe even saved them. These are people who have read the scientific research, done the homework – and REALLY, REALLY care about this issue.

This press release is an insult to not only the electronic cigarette industry (we can take it) but it is a deathly insult to the millions of everyday vapers who have attempted to engage with the political process – exactly as they are supposed to!

CEO has clearly failed to do any research at all – and their prejudice is insulting to me, my colleagues, and ESPECIALLY to the ordinary vapers.

This press release is a travesty.

Posted in EU | 2 Comments

The World Health Organisation: To idiocy and beyond.

By Tom Pruen

On Philippine television (video available on YouTube) the following statement was made:

“The most dangerous thing about this product is that the nicotine goes directly to the lungs while regular cigarettes have a filter. With this delivery device the nicotine goes directly to the lungs.”

Now if this was the statement of some well-intentioned but clueless member of the public, it would be wrong, but understandable. However, this was the pronouncement of a doctor (of what, I am not entirely sure, given the complete lack of knowledge expressed in this brief statement, possibly a PhD in media studies?); even worse, a doctor who works for the World Health Organisation as a ‘technical officer’ advising, it would seem, on tobacco products.

On the face of it, this is a person who could (and should) be expected to be able to tell the difference between nicotine and smoke. But in a statement of complete ignorance and stupidity, he apparently does not know the difference – or indeed know what the filter on a cigarette is for.

The filter on a cigarette is intended to reduce the amount of tar (essentially combustion by-products including a wide range of polyaromatic hydrocarbons, and other products of pyrolysis, several of which are known to be strongly carcinogenic) delivered to the users’ lungs.

It is worth noting that despite the filter, a significant amount of tar is still delivered to the user, which is why smoking is one of the leading causes of preventable death.

Electronic cigarettes do not have (and do not need) a filter for one, very simple, reason:

They do not generate any smoke, and hence contain no tar. None at all. There is nothing to filter out.

Why is a technical officer, who is also allegedly a doctor advising on tobacco on behalf of the WHO, so utterly clueless that he is unable to differentiate between smoke, with all the dangerous combustion by-products it contains, and nicotine?

Clearly this is a man who has spent too long reading his own (and his organisation’s) propaganda.

To add even more insanity to this pronouncement, I suspect that Dr Trinidad’s recommended treatment for tobacco addiction is NRT, despite the fact it contains the same nicotine he assumes to be so dangerous.

He even goes so far as to imply that tobacco cigarettes are safer than electronic ones – completely ignoring all the evidence to the contrary.

The World Harm Organisation strikes again.

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Good News from the MHRA (yes, really!)

While the MHRA decision to reclassify and regulate (via the EU, provided, of course, that the EU is willing to go along with the idea) electronic cigarettes as medicines is far from good news, the documents they provided as part of their study provide a wealth of good news. Good news from a fairly unimpeachable source, the UK’s medicines regulator.

For example, remember the DKFZ allegation that glycerol causes Lipoid Pneumonia? I rubbished it, Prof. Seigel rubbished it. The MHRA rubbish it too:

“As the major constituents of electronic cigarette vapour, propylene glycol and glycerine, are water soluble the potential for these compounds to be involved [in] lipoid pneumonia is not clear at present. The MHRA is not aware of any other cases of lipoid pneumonia associated with propylene glycol or glycerine products.”

 

Similarly, the WHO suggested a terrible risk of poor, uninformed users accidently killing themselves by overusing their e-cig.

Nic content and toxicity slide 4

Anyone with even the vaguest hint of knowledge about e-cigs recognised that as rubbish, but so did the MHRA:

“Given the low toxicity of nicotine at the doses observed and the fact that long before any dangerous nicotine concentrations could be reached, an over-enthusiastic user would be warned by nausea, there is little concern that e-cigarettes can harm their users by delivering toxic nicotine levels.”

 

They also have a rather less strident and panicky view than many about the potential of electronic cigarettes to be a gateway into smoking:

“There is little evidence of non-smokers taking up electronic cigarettes.”

“The available evidence from the UK, Europe and the USA suggest that only very low proportions of adults who have never reported smoking have tried electronic cigarettes.”

and

“What little use that was reported was confined almost entirely to children who currently smoke or used to smoke.”

 

The MHRA is clearly not overwhelmed by the argument that electronic cigarettes renormalize smoking, either:

“The denormalisation of smoking behaviour, if electronic cigarettes become commonly used indoors, is as likely to occur whether electronic cigarettes remain regulated under the current legislation or under medicines regulation.”

 

What the MHRA documents DON’T do is make a case for interfering in the electronic cigarette market at all.

As I quoted in a previous blog:

“However, as yet there is an absence of scientific evidence that shows long term harm to health is occurring in reality because of product safety.”

“While contaminants in ENDS have been identified, and the long term health effects of inhaling ENDS vapour are unknown, so far there is an absence of evidence that shows that these problems create significant harm to health.”

“Safety concerns have been reported. Given the extent of use, however, and despite the lack of a formal reporting mechanism (such as the yellow card scheme), these do not of themselves suggest a major public health concern.”

So the final bit of good news is that the MHRA has demonstrated that there is no need for further regulation, identifying as they have that there is a total “absence of scientific evidence that shows long-term harm to health”. Clearly, it would be completely disproportionate, therefore, to increase the regulatory burden on our thriving young industry. Evidence, it would seem, that even a regulator with an extreme preconceived bias, cannot justify reclassification as a medicine.

 

It appears that the MHRA can’t ‘level the playing field’ for the tobacco industry after all….

Posted in Uncategorized | 4 Comments