Presenting to the FDA real evidence about e cigarettes

US regulators and advocates showing the road to the Europeans

By Dr Farsalinos

It is now the appropriate time to reveal the reason for my visit to the US. On December 19, a very successful meeting with FDA s Center for Tobacco Products (CTP) officials took place at the FDA headquarters in Rockville Maryland. The meeting was organized by American E Liquid Manufacturing Standards Association (AEMSA), who invited me to present hard evidence, which means results from clinical studies, on the use of new generation devices and refillable atomizers in front of the US regulators.

After a very warm welcome and in front of an audience of more than 20 officials (most of them present into the room while some directly connected with the conference room through phone lines), the discussion was purely about evidence and the implications of our findings on both individual and population level. AEMSA had previously met twice with the FDA. Over the past few months we had some extensive discussions with AEMSA in order to be able to assess the concerns expressed by the FDA and ways to address them. During this process, I developed two protocols for clinical studies, evaluating the effects of e cigarette use on nicotine absorption, specifically assessing the effects of new generation devices and refillables compared with cigarette like devices and with tobacco cigarettes. The protocols were fully supported by AEMSA and were performed in the past 3 months.

It should be emphasized that when the FDA was first approached, their response was immediate (within 24 hours) and positive. The meeting was arranged after we were able to determine the time when we could have the results of the research available and analyzed. The behavior of the FDA officials during the meeting can be described with two words respect and a lot of attention to what we had to say. I was really surprised to see them not only taking notes during our presentation, but also engaging to the discussion by making key questions and allowing us to present our future plans for research, which will provide even more evidence in terms of the population and individual effects of e cigarette use. After the lengthy meeting, we were invited to come back whenever we have new evidence to present to them.

During the meeting, we presented data showing that new generation devices with refillable atomizers were up to 70% more effective in nicotine delivery compared with 1st generation (cigarette like) devices. Moreover, we presented comparative data showing that even new generation devices are much slower in nicotine delivery compared to tobacco cigarettes. In facts, vapers need to use such devices for approximately 30min in order to get plasma nicotine levels similar to those found after smoking 1 tobacco cigarette. In another study, smokers who were using the e cigarette for the first time showed significantly lower nicotine absorption compared to experienced users. Therefore, we provide sufficient data indicating that the addictive potential of e cigarettes (even the new generation devices) is much lower compared to smoking, while at the same time we proved that new generation devices are much more efficient and probably more effective for smokers. Moreover, we have shown that there is no chance of overdose or intoxication from e cigarette use in na ve users, even when a new generation device is used. Of note, an 18mg/ml e liquid was used in both studies. I doubt if a nicotine containing liquid with double concentration would deliver nicotine similar to a tobacco cigarette.

Besides information on nicotine absorption, we had the opportunity to present data on the impact of flavors in e cigarette experience andthe characteristics of the vapers population who is using new generation devices. AEMSA brought some new generation devices and more than 15 minutes were dedicated to showing them how they work and what are their advantages and disadvantages compared to cigarette like devices.

Will the FDA take into consideration our presentation? By seeing their reactions and facial expressions during the presentation and by interpreting their questions and interest to get as much information as possible, I believe they will certainly do so. Of course we know that they have already submitted their recommendations for e cigarette regulation, but there is a lengthy negotiation procedure ahead and a lot of things can change. More importantly, we should proceed with new studies which will provide more information to the regulators so that they will make proper decisions.

Two significant lessons are to be learned from this experience. Unlike the FDA, European regulators have completely ignored science (and are continuing to do so). It is impressive to see the immediate acceptance from the FDA of our proposal to meet, while at the same time Europeans do not even bother to reply to emails. Instead of the ridiculous 3 minutes period I was allowed to speak during a meeting in the EU headquarters in Brussels (March 2013), FDA allowed us to discuss for more than 90 minutes. European e cigarette advocates and the industry should also learn some lessons from AEMSA, from the way regulators were approached and by realizing that unless you provide them with hard evidence and scientific data none will take you seriously. There may be some hope in the US that FDA proposals will get better as the negotiation progresses. For Europe, I am afraid the e cigarette and the chance to revolutionize tobacco harm reduction have suffered a serious setback.

Europa – press releases – press release – one million smuggled cigarettes seized in customs operation

Indian smokes on line discount cigarettes

The cigarettes seized during the operation were found on freight trains carrying wood and iron. They represent losses of at least one quarter of a million euros in terms of evaded customs duties and taxes. The European Commission estimates that smuggling of tobacco products costs the EU and Member States approximately 10 billion euros in revenue losses every year.

This customs operation received support from the European Commission s Directorate General for Taxation and Customs Union (TAXUD), Europol, Frontex and the World Customs Organization. It is one of the activities of the Eastern Border Action Plan which Commissioner emeta launched last year to increase the Commission s efforts to reduce smuggling and customs fraud along the EU Eastern border (see MEMO/11/454).

Background

The customs authorities of EU Member States as well as some non EU countries, in cooperation with OLAF, carry out regular joint customs operations with specific checks at European level. These coordinated operations target actions of a limited duration to combat the smuggling of sensitive goods and fraud in certain high risk areas and/or on identified trade routes (e.g. EU Eastern border).

To make the exchange of information easier during the operation called “Operation Barrel”, an operational coordination centre with contact persons from the Member States, third countries and Europol was set up in OLAF’s premises in Brussels. OLAF s IT platform allowed for a secure exchange of information and intelligence in real time between all participants. Incoming operational information was analysed according to a set of predefined risk criteria in order to identify suspicious shipments. This information was then sent to the concerned border control point where the responsible customs authorities were able to conduct a physical control of the goods. The use of EU funded scanner equipment on the border between Poland and the Ukraine proved also to be a powerful instrument in the detection of smuggled goods.

For more information

MEMO/12/135

Photos of the operation available at

Video stock shots of the operation are available at

Video clip of the operation is available at

More information on joint customs perations

Homepage of Commissioner Algirdas emeta, EU Taxation and Customs Union, Audit and Anti fraud Commissioner

Contacts

Emer Traynor ( 32 2 292 15 48)

Natasja Bohez Rubiano ( 32 2 296 64 70)