MHRA Consultation Report

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.

Industry Association

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.

MHRA Meeting

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.

Licensing

Metabolism

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.

Licensing fees

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.

MHRA Responses

The MHRA has had over 1000 responses. Further responses are being accepted by the MHRA until June 9th.

ECigaretteDirect Position

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.

12 thoughts on “MHRA Consultation Report”

  1. They even think that harm reduction is a medical term now, lol.

    If they’re admitting now that there is a level of dose needed for therapeutic use then they’re saying that they can’t override the Poisons Act which allows unlicensed nicotine under a certain concentration.

  2. “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 !!!!!!!!!!!!!!!???????? LOL.

    It’s good to know that Britain’s Medical Health Regulations Authority employ the Finest Physician’s GKS can buy.
    The guy next door to me smokes 60 B&H Kingsize a day. Try that as a starting point. That’s perfectly legal and must be safe otherwise they would’nt be on sale.

  3. The emphasis must surely be on smokers’ well-being. There are now two surveys saying that more than 60% of smokers will return to cigarettes if cigarettes are banned. With two weeks allowed for licensing, an estimated cost of £350,000 per electronic cigarette (a cost we think will grow) it is highly likely that if the MHRA does go for licensing the e-cigarette will become unavailable in this country.

  4. Deewal, we sent that report to all the scientists involved and one comment we got back was:

    “So, are they going to regulate Starbucks next?”

  5. jon h knapp boxhead

    so, this licensing fee? am i to understand this is for the mode?l or each and user pays? ah, i mem some stuff when i was in england 20 years ago about homopathic medcines getting a licensing and it was absorbed by pharmcsist and manufactures..( those little lactose mostly pills for aches and pain and stuff like that)
    but i dont think it was as high as this…maybe inflation?

    ala in all goood going guys, i hope this works out.

  6. You’d better hope you don’t have to pay it – at £350,000 per e-cigarette model it’s not cheap! And we think the real cost is going to be more than that.

  7. “Never give in, never give in, never; never; never; never – in nothing, great or small, large or petty – never give in except to convictions of honor and good sense.”

    Winston Churchill

  8. You should stay in contact with the American version of the e-cigarette forum. They have a tremendous battle with their FDA, which is seen as the equivelent of our MHRA.
    We fight a losing battle. The MHRA have already come to their conclusions. They are having further meetings with different parties, just to make sure they can answer any negatives, when they make their decisions known in October.

  9. When we suggested an association before the MHRA thing blew up – emailing every other supplier we knew at the time – not one single company replied. But actually, we worked together with several other companies in the lead up to the MHRA, sharing ideas and even, in some cases, proofreading each others work.

    I have gone off the idea of an association. In American it’s basically just turned out to be a couple of companies doing all the work and paying for everything. I think we will be diverted by politics and disagreement instead of actually putting our point of view forward.

  10. I have now read 4 different responses to the MHRA meeting, which was held on Friday the 4th of June. That’s exactly what they are 4 DIFFERENT VERSIONS.
    I read the sanitized MHRA minutes of the meeting first. Everyone seems to have looked at this problem with opinions to suit their own companies.
    It’s Clegg and Cameron in animation. If a Federation of e-cigarette suppliers is to be formed, try democracy and not little quangos.

  11. You’re fence-sitting, probably because you don’t know what to do or how to form a Federation. The American approach is far greater than you could imagine. You cannot dismiss their efforts against the FDA and various stupid state governers by referring to them as “a couple of companies” You should look to create a supporting International Federation. Tobacco cigarettes should disappear in about 20 years. This may not be because of e-cigarettes, but some other medical break-through. It’s all about power, politics, money and tobacco lobbyists at the moment. MHRA’s approach will eventually crumble if they try to go too far, just like the Gaza blockade.

  12. I am biting back a reply here because we are on the same side, but I do wonder how much you know about what is going on with with the American supplier’s approach in America. I agree with you about the causes of the opposition. And if, as you claim, you are the country’s leading importer of the electronic cigarette you are in a perfect position to take the lead in setting up a federation!

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