In the spring of 2018 the UK Parliament engaged in a discussion with government departments and the vape industry on a variety of hot topics. So what did they talk about and what did we learn from the proceedings? Here, we cover the key learnings from the meetings in two parts. This is Part 1.
4 Key Learnings from the UK Parliament Meetings
Part 1 includes:
- MHRA to test marketed products for TPD compliance: What does it mean for the industry?
- Medicinal e-cigs: NJOY announce application for medicinal e-cig
You should read this if you:
- Run a vape store (physical or online)
- Are a manufacturer, importer or wholesale/distributor of e-liquids and e-cigs
- Sell TPD e-cigs and e-liquids or short fills ‘shake n vape’ e-liquids in the UK
About the meetings
Interested parties – including members of the public and industry – were invited to provide a written submission – or ‘evidence’ – to the Science and Technology Committee. The Committee reviewed the responses and subsequently asked a select few to participate in a face to face meeting with MPs. It was an opportunity for vape industry and MPs to openly discuss the hot vape-related topics.
What topics did they discuss?
Issues for discussion included:
- Impact of electronic cigarettes on health and smoking cessation
- Suitability of the TRPR regulations
- Financial implications of a growing market on the vape industry and the NHS.
Copies of the submitted evidence and transcripts of the meetings can be found here.
1. MHRA to test marketed products for TPD compliance
The MHRA said they were supporting Trading Standards in the testing of e-liquids for compliance with the TRPR. In front of MPs at the Science Committee meeting, Dr Hudson, the Chief Executive from the MHRA explained that testing was necessary “…to confirm that they comply with the regulations and notifications—and also to ensure that there are no banned substances…”
MHRA to start testing e-liquids for compliance with TPD
Banned substances are not the only thing in scope of the test. According to the MHRA, there are cases where e-liquids with nicotine strength over the 20mg limit have been sold. In light of this, testing of e-liquids would also be carried out to confirm that products on the market nicotine strength complied with the limit. Dr Hudson explained that they would take action – through Trading Standards – to “ensure that the companies are brought into compliance”.
Short fills in scope of testing
The MHRA have implied that the testing is not limited to TPD products. It seems that shake and vape would be in scope of the testing scheme as part of an investigation into the potential health risks. We can expect further statements from the MHRA on the regulation of short fills once the test results are in.
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Trading Standards Compliance Checks
While the MHRA testing is ongoing, the local Trading Standards offices (TS) have already done research into the extent to which vape stores – both physical and online – are complying with the TRPR. In the study, they looked at:
- Age verification systems
- Non-compliant products (e.g. leaflet/labelling)
- Consumer rights violations relating to cancellation period
- Cross border supply to EU markets
- Tank extenders (read more about this TPD loophole here)
- Short fills safety issues relating to the mixing with nic shot by the consumer i.e. incorrectly mixing and handling.
The TS have said the results will be available this month (May) so we can expect a statement from them in the coming months.
Update: A compliance report has been published by Trading Standards. Click here to download (we cannot confirm that this is the report of the compliance check).
What do these compliance checks this mean for the vape industry?
Up until now, the industry has enjoyed quite a lax regulatory environment. The MHRA and Trading Standards have taken a ‘light touch’ to implementation and enforcement: the notifications seem to have been only lightly been scrutinized and, to our knowledge, few products have undergone analytical testing to confirm TPD compliance. But things are starting to change.
Over the next 12 months, as the results from the testing and research by MHRA and Trading Standards become available, we may start to see more letters from Trading Standards alerting vape stores and manufacturers to compliance issues.
Compliance issues that vape stores could face include:
- Selling of unnotified products or products with banned ingredients
- Non-compliant packaging – incorrect health warning label or leaflet text, for example.
- Breaches of the vape advertising rules
If you receive a letter from Trading Standards
Don’t panic. Help is at hand. We will help you understand your regulatory obligations and address any vape compliance issues in a timely manner without undue expense.
2. Medicinal E-cigs
Medicinal e-cigs were a topic of conversation at the meetings and were also mentioned in a handful of written submissions. Notable submissions included:
NJOY announce application for medicinal e-cig
NJOY Innovations Ltd has submitted an application for a Marketing Authorisation (MA) to the MHRA. According to the written evidence sent by NJOY the application was made in December last year. If approved it would be only the second electronic cigarette that had achieved medical licence status – the first being e-voke by Nicovations (never marketed).
A medicinal e-cig could be available in 2019
It is too soon to say if NJOY’s licence application e-cig will be successful. The dossier is currently under review by the MHRA. We expect that, as is the case for MA applications, the assessors reviewing the dossier will have questions and comments to which NJOY must address before the licence is issued. If all goes smoothly we can expect approval by early 2019 and launch by end of the year (should they decide to market).
What would a medicinal e-cig look like?
Given the strict regulations for medicines, it is likely any medicinal e-cig, including NJOY’s offering, would be a non-configurable device. It would likely take the form of a ciga-like type device with disposable cartridges – you would not be able to add your own e-liquid or change the power setting. It may come in a small range of flavourings and strengths but because each variant requires a separate licence there is a cost associated with each so the range would be limited to 2 strengths and 1 or 2 flavours.
What would the medicinal e-cig taste like?
Given the restrictions on levels of impurities in medicinal products, it is unlikely that the e-liquid in any given medicinal e-cig, including NJOY’s, will be a complex flavouring. So we can rule out a vanilla custard and other pudding-related flavours as well as tobacco e-liquid. It is more likely to be rather plain or, at best, a simple fruit flavour.
IBVTA: Concern for a medicinal e-cig market
Among the written evidence, the IBVTA – a vape trade association – expressed a concern for the UK’s plan to seemingly make it a little easier for companies to register a medicinal e-cigarette. It stems from an announcement by the UK government made in a Tobacco Control Plan.
In the plan, it says the MHRA “will ensure that the route to medicinal regulation for e-cigarette products is fit for purpose so that a range of safe and effective products can potentially be made available for NHS prescription.”
The IBVTA referenced their own experience with quit smoking techniques as justification for their position and recommended that, instead of a medicinal e-cig, the “experts in the stop smoking services partner with independent vaping stores and businesses”.
They did accept that, in specific circumstances where the start-up costs of vaping presented a barrier to entry, then a medicinal e-cig “would be sensible”.
Our experience in medical licensing
Given our experience in obtaining medical licences for a number of products, we have a valuable insight into the regulations, timings and costs. Please contact us if you have any questions.
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