In September 2012 we wrote to the MHRA calling for an explanation on their stance on electronic cigarettes. They has been threatening to bring down the ban hammer at 21 days notice, meaning that we were unable to carry adequate stock for our customers or wholesalers, and living with day to day uncertainty about the future of the industry. The leaked letter from which the information on the ban was discovered can be found here.
I am writing to you to make you aware of the grave concerns we have over the conduct of the MHRA since the ill-informed inception of the interminable consultation process MLX364. We are one of the many small to medium enterprises in the UK Electronic Cigarette Industry. The MHRA’s consultation process was launched on 1st February this year, and threatened our business with the arbitrary removal of our products from sale within 21 days of their decision under their ‘preferred option’. We have submitted a response to the consultation process, together with many hundreds of our colleagues, and many hundreds of electronic cigarette users.
“The RPC strongly criticised the consultation process, with particular emphasis on the lack of robust evidence, entirely insufficient Impact Assessment, and the method in which it has been carried out.”
The original consultation letter gave a closing date of May 4th. This date was put back to the 9th June, and was then put back again (following a meeting between stakeholders from our industry and the MHRA) to September this year – with no specific date being offered. We have now received an offer from the MHRA to have a further meeting with us on the 28th September, and they are now saying that they are unable to give us a date when their decision will be forthcoming.
This is totally unacceptable, particularly in light of the fact that any and all complaints we have submitted to the Department of Health, the Better Regulatory Executive, and assorted MPs, receive a standardised response stating that no action will be considered until the consultation process has concluded. In light of the fact that we have no indication whatsoever as to when this might be, I am sure you will appreciate that this is a completely inadequate response.
On 9th June this year, the Regulatory Policy Committee published their Opinion on the MHRA’s consultation MLX364. The RPC strongly criticised the consultation process, with particular emphasis on the lack of robust evidence, entirely insufficient Impact Assessment, and the method in which it has been carried out. The RPC also pointed out the lack of evidence of any demonstrable risk posed by these products, which have not caused a single incidence of harm anywhere in the world in 7 years of global market availability.
“The MHRA have refused to answer my requests for information as to their response to the RPC Opinion.”
The MHRA have refused to answer my requests for information as to their response to the RPC Opinion. I am anxious to know if the RPC is to be ignored, if the consultation process is to be reviewed and whether or not we will have an opportunity to examine and contest any attempt to ‘redraft’ the Impact Assessment.
The UK economy desperately needs to encourage and support its small businesses if we are to successfully attain the ‘sunny uplands’ of economic recovery. This simply will not happen if an entire industry can be summarily destroyed by an over-zealous, under-informed, and massively conflicted regulatory agency, which appears to be able to totally ignore the independent checks and balances of its regulators, the RPC.
“…the MHRA could decide at any moment that all our products must be removed from sale within 21 days?”
We are a small business being hampered by burdensome and excessive regulatory threats at a time when the domestic (and global) economy is in dire straits, despite assurances from the coalition government that they are committed to removing layers of unnecessary regulatory restriction. We need to be able to make our business plans, forward-plan our marketing strategy, order product with allowances for 4 week lead times, etc. etc. How can we do this when the MHRA could decide at any moment that all our products must be removed from sale within 21 days?
We have a member of staff (with a young family) who is attempting to secure a mortgage. What can we say to him about his job prospects? We have several wholesale customers. Are we going to have to let them down at short notice? How can they make their business plans? We should be booking the winter trade shows, but we can ill afford to pay out the significant deposits for these shows, to secure our places, if the MHRA is going to destroy our business before we can attend. However, if we are unable to attend these shows, we will lose significant business growth in the event that the MHRA designs to give us a stay of execution. It is an impossible and untenable situation, and we need your assistance to stop the rot.
The key point is that we must have a definite date for the MHRA’s decision, in order to allow our business to either continue in the UK or to relocate to a more sympathetic European Member State with a more sensible regulatory approach to our industry. It is quite simply too late to stop the sale of these products; too many people know about them and want them. The stark reality is that the MHRA’s decision will be largely irrelevant, in real terms: either companies will relocate off-shore or on the continent, and continue to trade legally, or there will emerge an entirely unregulated black market. We would prefer to remain in the UK, supporting our domestic economy with our corporate taxes, VAT, etc., and being regulated by Trading Standards under the General Product Safety Regulations, with CHIP compliance, etc. This, we believe, is an entirely suitable and appropriate regulatory framework, and it would be an enormous shame – and a significant risk – to lose this safety net due to the MHRA’s misguided attempts to reclassify nicotine containing products as medicines (despite simultaneously attempting to leave tobacco products alone).
Thank you for taking the time to read this, and I trust we can count on your support to put an end to this ridiculous situation. If you would like any further information, please feel free to contact me.