ECigaretteDirect report on the MHRA consulation on whether to regulate nicotine cessation aids as medicines.
Jean and Mike from ECigaretteDirect travelled to London the day before the consultation and had a meeting with several other e-cigarette suppliers that evening. One of the main topics of discussion was the establishment of an industry body – this has been under discussion by email for some time.
A second meeting took place the next day at 11 am where it was agreed that cowboy suppliers who continue to illegally claim that the electronic cigarette can aid nicotine cessation are doing great harm to the prospects of the electronic cigarette being continued to be sold.
A third meeting – at 12pm ECD attended a third meeting of 12 vendors for further discussion of an industry body. Tony Price of the E-Cigarette-Forum turned up, took over the meeting, suggested himself as Chair and suggested that each company put in £3,000 pounds initially to fund a potential Judicial Review in the event of an unfavourable decision. Unfortunately, due to previous issues which ECigaretteDirect.co.uk, the NJOY distributor in the UK, has had with the E-Cigarette-Forum we feel we are unable to work with them or any association which involves them.
At 2.20 the MHRA meeting took place. According to Jean, the MHRA were very uninformed about the product (admitting this themselves). The MHRA showed images of numerous other smoking alternatives, and were taken aback to find that not one of the the 35 retailers supplied them. They were also surprised that not one of us claimed the e-cigarette was a smoking cessation aid.
The Vendors emphasised that the electronic cigarette was not a smoking cessation aid, and that it should be regulated by Trading Standards, and not by the MHRA, as it is at present designated as a General Sales Product by HMRC. Katherine Devlin explained that she had prepared an alternative regulatory framework, in consultation with various leading companies. She proposed that the industry should be voluntary regulated, with a Code of Practice to be agreed with Trading Standards and their governing body, Failure to comply would be alerted to trading standards as required by the industry as well as by TS normal checks.
We emphasised that the device is already regulated, by Trading Standards officers, and that calling it ‘unregulated’ – as the MHRA has being doing – is simply not true.
The physician present confirmed that blood absorption levels would have to be tested. There is a level above which nicotine affects a person’s metabolism. When it is above this level, it needs to need to be regulated in the UK. Our products may well be below this level, but unfortunately the attending physician did not know what level this is. It was suggested by those attending that we might have to increases the level of delivered nicotine to become legally described as a harm reduction aid.
Concern was expressed over the level of funding vendors would have to pay for licensing, which is estimated to be hundreds of thousands of pounds per electronic cigarette. It was recognised that this is totally unfeasible for a young entrepreneurial industry with a new and innovative device attractive to existing smokers.
In response to questions about time scale, it appears the e-cigarette industry has at the very least until September. All three options remain in place, including stopping sale of the e-cigarettes within 21 days of a decision being taken.
The MHRA has had over 1000 responses. Further responses are being accepted by the MHRA until June 9th.
We are continuing to propose that the MHRA do option 3 (do nothing) although the MHRA has itself stated that this is not an option.
We maintain that is the remit of Trading Standards, not the MHRA, and that Trading Standards can regulate the device perfectly adequately.