UPDATE 31 July 2010

A Trading Standards Officer has written to a UK supplier to notify them that the outcome of the consultation will be a ban of all ecigs which don't have applications for certification as medical devices.

The letter can be found HERE

The UK Medicines and Healthcare Products Regulatory Agency have been conducting a public consultation (MLX 364) on The regulation of nicotine containing products. They want to introduce compulsory medical licensing for nicotine products with the exception of tobacco. As no ecig products have medical licenses this is simply a ban and would remove current commercial regulatory safeguards. A Banning Order is not being considered at the moment so unregulated supplies may be imported.

The consultation closed on 2nd June and the outcome is expected by September.

This is a report about the consultation from a UK government policy committee:

http://regulatorypolicycommittee.independent.gov.uk/rpc/wp-content/uploa...

Kate's response is attached, at the bottom of this page.

A great submission from e-cigs.co.uk

Ecigarettedirect.co.uk

Smartsmoker.co.uk have issued a response with some good legal arguments that may be relevant for all EU countries. It's attached to the bottom of this page.

ASH Scotland's submission
(They want recreational nicotine products except tobacco banned.)

No copy of ASH UK's response is available but they asked for compulsory licensing for non-tobacco nicotine products.

Royal Pharmaceutical Society

The Chartered Institute of Environmental Health

CASAA - Consumer Advocates for Smokefree Alternatives Association:

Theresa Whitt, M.D., Medical Director for The Consumer Advocates for Smoke-Free Alternatives Association (CASAA) says that ignoring the astounding 79% success rate of electronic cigarettes as replacements for tobacco cigarette smoking would be an abdication of the MHRA's mission to safeguard public health. CASAA wants the MHRA to exclude electronic cigarettes from its plan to step up regulation of nicotine-containing products.

Consumer Group Urges MHRA to Add E-Cigarettes to Harm Reduction Strategy

February 11, 2010: Mobile, Alabama

The Consumer Advocates for Smoke-Free Alternatives Association (CASAA) today called upon the Medicines and Healthcare products Regulatory Agency (MHRA) to exclude electronic cigarettes from its proposed regulatory framework, MLX 364, in view of the fact that 79% of regular users of an electronic cigarette have succeeded in using this product as a complete replacement for all their tobacco cigarettes. Electronic cigarettes are battery operated devices that vaporize a liquid that contains nicotine.

"As a result of eliminating their exposure to tobacco smoke, these consumers are experiencing significant improvement in their lung health and markers of cardiovascular health," stated Theresa Whitt, MD, CASAA Medical Director. "The 17% who have partially replaced their tobacco cigarettes are also reporting health improvements such as increased energy and improved sense of smell."

The statistics on the electronic cigarette success rate come from a survey conducted by the University of Alberta. There also have been recent news reports that, according to a poll conducted at Royal London Hospital, more than 50% of the people who stopped smoking during the past year preferred using the electronic cigarette. "If the MHRA doubts these statistics, it would take very little time and money for the agency to conduct their own survey to confirm or refute the findings," said Dr. Whitt. "But ignoring an astounding success rate like this, and taking action that might halt or reverse this positive outcome, would be an abdication of the MHRA's mission to safeguard public health."

"Recharacterizing the electronic cigarette as a medical product and regulating it as such stands to destroy its effectiveness as an alternative acceptable to smokers, Dr. Whitt continued. "One of the reasons that Nicotine Replacement Therapy, or NRT, products such as the nicotine patch, gum, lozenges, and inhalers have not worked for the majority of users is that the dose of nicotine is too low. The problem is then compounded when many revert to smoking as a result of discontinuing use of the NRT product."

The MHRA's Consultation Letter MLX 364 states "5% of smokers who quit using NRT remained quit after 8 years, and are assumed quit thereafter". Dr. Whitt believes that most, if not all, of the 79% who switched to electronic cigarettes will remain quit long-term, provided they can continue using their electronic cigarette.

"Many of those who have made the switch had no intention of quitting smoking," Dr. Whitt revealed. "But once they began using the electronic cigarette, they lost interest in lighting up a tobacco cigarette. In fact, many people report that when they attempt to smoke a regular cigarette again, they put it out after a puff or two because of the bad taste."

Dr. Whitt said that she believes the reason for the astonishing success rate of electronic cigarettes is that users can gear their nicotine intake to more closely match the nicotine level they used to obtain from smoking. Polls show that more than half of electronic cigarette users require a strength of 2.4% nicotine or higher, but less than 3% of users need a strength above 3.6% to stay off tobacco.

"Electronic cigarette consumers self-regulate their nicotine in the same way that tobacco smokers do, without much conscious thought," said Dr. Whitt. "They can increase or decrease the nicotine content in their cartridge, take more or fewer puffs, and adjust how they inhale. They determine their need for nicotine based on the same cues used by smokers: need for alertness, level of fatigue, mood, degree of stress, and state of muscular tension or relaxation."

Dr. Whitt pointed out that applying "Option 3 - Do nothing" to electronic cigarettes would not equate to lack of regulation. There are already regulations in place in the U.K. to ensure the quality and safety of electronic cigarette products. U.K. companies that distribute electronic cigarette liquid have had registered laboratories conduct toxicological testing. The companies have posted the results on their public web sites. So far, no tests have determined that electronic cigarette liquid or vapor contains harmful substances in quantities that would present a danger to human health.

"Of all the testing that has been conducted world-wide," stated Dr. Whitt, "the least useful has been the test conducted by the U.S. Food and Drug Administration (FDA). The FDA, enmeshed in a law suit with the two companies whose products were tested, made alarming announcements about carcinogens and toxins being detected. However, FDA failed to point out two important facts that would have placed their findings in the proper perspective: (1) the quantities of carcinogens in the liquid match the quantities in FDA-approved NRT products, and (2) all of the potentially harmful substances detected are present in tobacco smoke in quantities that are thousands of times larger."

"The biggest danger to human health would be the disappearance of electronic cigarettes as a much safer alternative to tobacco smoking," said Dr. Whitt. Dr. Whitt commended the MHRA for its efforts to pursue a tobacco harm-reduction approach, but added that she hoped that smoke-free alternatives such as Swedish snus and electronic cigarettes would be considered as part of the harm reduction strategy.

CASAA is a non-profit organization that works to ensure the availability of reduced harm alternatives to smoking and to provide smokers and non-smokers alike with truthful information about such alternatives. The association is headquartered in Mobile, Alabama USA, and has members from the U.S., Canada, and the U.K.

For further information:
The Consumer Advocates for Smoke-Free Alternatives Association
182 St Francis Street STE 300
Mobile, AL 36602
Elaine D. Keller
(703) 244-8692
ekeller@casaa.org

Dr Nitzkin:

20100214UKCommentMLX364.doc

Regulation of nicotine containing products as proposed will do more harm than good from a public health perspective. E-cigarettes, snus and at least selected other low-risk tobacco and tobacco-related products should be made as readily available as cigarettes to enable smokers unable or unwilling to quit to transition to a much lower risk product that is more satisfying and most likely more effective than the prescription NRT products currently available.

I am a public health physician. I, and the organization I represent have no financial interest in any E-cigarette or any other tobacco-related enterprise. Over the past three years, in my capacity as the Chair of the Tobacco Control Task Force of the American Association of Public Health Physicians I have carefully studied and been deeply involved in the debate on and and implementation by FDA of the new federal FDA/Tobacco law.

FDA's proposed action and statements against E-cigarettes -- claiming they might be as hazardous or more hazardous than conventional cigarettes and claiming they might result in the recruitment of large number of teens to nicotine addiction were based on a total lack of information and were totally speculative in nature. FDA staff, on the urging by some ill-informed tobacco control activists complained that E-cigarette companies had not applied for FDA approval as drug-device combinations. The E-cigarette companies did not due so because they considered their products tobacco-related products not covered by the drug law or regulations.

In mid January I personally met with Dr. Joshua Sharfstein - Deputy Director of the Food and Drug Administration and a number of his key medical and legal staff. I verbally presented the case in favor of regulating E-cigarettes as a tobacco product rather than a "drug-device combination" and the public health importance of informing current and potential tobacco users of the huge differences in risk presented by the different classes of tobacco products. Conventional cigarettes are the most hazardous of all tobacco products. E-cigarettes promise to be the nicotine delivery product most acceptable to smokers who are otherwise unable or unwilling to quit their nicotine addiction. Conventional cigarettes kill about 1/3 of smokers and large numbers of non-smokers exposed to environmental cigarette smoke. The risk posed by E-cigarettes, as best we can tell is about 0.1% (one tenth of one percent) of the risk posed by conventional cigarettes. They emit no environmental tobacco smoke.

On the basis of my presentation at FDA, I was invited to formally submit a citizens petition to FDA to formally present, in writing, the case in favor of both regulating E-cigarettes as a tobacco product, and the potential public health benefit of this action by FDA. This last week I put two such petitions in the mail to FDA, with 303 pages of attachments. The first petition asks FDA to do this reclassification. The second asks for a press conference to follow-up their July 22, 2009 press conference that left so many (including some in the State of Utah) to erroneously believe that E-cigarettes are more risky than conventional cigarettes. All these materials are readily available for review and download on the Tobacco Issues page of our http://www.aaphp.org web site.

Please feel free to contact me if you have any questions about this communication or the attached document.

Joel L. Nitzkin, MD