The Medical Health Regulatory Authority (MHRA) which is responsible for regulating all medical products in the UK, have held their first meeting to discuss document MLX364. This proposes implementing licensing restrictions on the sale of Electronic Nicotine Devices, which are commonly referred to as Electronic Cigarettes.
On the 4th of June 2010, the 10 employees of the MHRA met with 25 industry professionals, including Katherine Welch, a director of The Electronic Cigarette Company, a leading online retailer of Electronic Cigarettes in the UK. The purpose of the meeting was to discuss the options proposed by the MHRA with industry representatives.
The Industry informed the MHRA that;
We are already regulated by Trading Standards/LACORS, and have conformed with all regulations. The Industry has self regulated with nicotine fluid testing to ensure quality and safety. The MHRA seemed unaware of this.
The Electronic Cigarette did not fall within the remit of the MHRA, as Electronic cigarettes are not medical devices, and none of the traders present sold them as such.
The industry representatives repeatedly stated that e-cigs do not fall under the remit of the MHRA, there are no known negatives to using electronic cigarettes, no record of harm from their use and no research to suggest they are harmful.
The MHRA admitted their lack of knowledge regarding the e-cig industry, and appeared on face value to be open to information, knowledge and opinion given by the industry.
Worryingly the MHRA did not have, nor appeared to know of required clinical information regarding levels of nicotine necessary for a product to be classed as NRT, thus leaving the industry none the wiser as to some of the statements in MLX 364 that claim justification for further regulation.
Further meetings are to be held with the MHRA and health professionals to discuss further proposed regulation of the industry. It was expressed that these meetings should not be biased, and that people present should be aware that the electronic cigarette industry is already regulated by LACORS.
The most promising result of the day was that e-cigarette representatives agreed to form a UK trade body to continue to improve on self-regulation. It was agreed that they should work together to fund lobbying, legal advice, and self-imposed sane and sustainable controls such as a unified strategy for correct practice in packaging, marketing and materials testing.
This in itself is something of a victory since it has compelled the trade to work together in the face of an outside threat.
It was also pointed out to the MHRA that over regulation would force this industry underground, where little or no control of quality or safety would be possible, thereby endangering the public, and achieving the complete opposite of MHRA’s remit which is to safeguard the publics health.