On March 27, 2013 the EU-Parliament's Committee for Internal Market and Consumer Protection (IMCO) published a draft [1] of an amendment concerning the proposol for the Tobacco Directive (TPD2).
This proposal envisages to completely delete the already very low planned limit for the free trading of nicotine containing products. According to this these products are than to be sold only with an approval according to the directive for medicinal products 2001/83/EC.
Once again it is tried to enforce the answer to the question of the differentiation of medicinal products without following the existing regulations and court decisions [2] After all, the directive for medicinal products stipulates that a substance can only be a medicinal product after its healing characteristics have been proven. But still there is no proof that nicotine addiction can be cured with nicotine - as far as nicotine consumption without tobacco can even be called addiction.
Now it is planned to "guarantee" a deceptive safety of these products by classifying them under pharmaceutical law. The markings according to the hazardous materials regulations is established and we, the consumers, are familiar with it. But these markings are not needed on a medicinal product [3] as "patients" shall not be scared with skull symbols. On the other hand, exactly these markings ensure a cautious handling of the product.
On the contrary NRP are often offered in very attractive packaging. We can't over-estimate the danger of confusion with sweets or chewing gum from the supermarket. We would like to emphasize the customers' wishes and the vendors' efforts to place standardised packaging without significant promotional characteristics.
Just the fact that e-liquid (mixture according to CLP-regulation) can be dangerous when exceeding a certain concentration does not justify the classification as medicinal product.
Amendment 44 says it would be necessary to thoroughly examine all ingredients. It implies that these tests can only be ensured by a pharmaceutical procedure. Surveillance and regulations covering ingredients and manufacturing processes can be determined apart from pharmaceuticals and pharmacy - as existing regulations concerning food and cosmetics definitely show.
This draft is very similar to a statement of the DKFZ (Deutsches Krebsforschungszentrum - German Center for Cancer Research) and gives the impression that nicotine containing products shall be sacrificed due to the WHO objective of a smokefree world.
We once again point out our postulation that nicotine containing products must be regulated as a luxury consumable apart from the tobacco control measures of the WHO.
After this well-established and factual argumentation please allow us to sum up the consumers' opinion as follows:
Great possibilities arise from the e-cigarette. With a benevolent attendance through politics and institutes and and finally following a fair media coverage we could start to reduce the figure of about 600,000 annual European deaths resulting from tobacco smoke! We strongly assume that there is no other means granting similarly good results in the fight against lung cancer than the promotion of the e-cigarette in its current or a just gently regulated form.
"Vaping" is an enjoyment. It is successful because of the possibilities and the availability of many flavours allowing each consumer the individual configuration that suits him / her best. As soon as there will be only a few standard models with a few standard flavours, hardly anyone will use it. In this way - virtually in competition with nicotine patches - this product will not work. The e-cigarette is a product for enjoyment pleasure, for indulgence. The e-cigarette in the pharmacy respectively as a medicinal product will FAIL and the number of deaths from tobacco use will not change.
This open letter addressed to the IMCO committee members of the EU Parliament will also be published on our website.
Sincerely
Interessengemeinschaft E-Dampfen
[1] DRAFT OPINION of the Committee on the Internal Market and Consumer Protection
[2]
EuGH C-387/99 vom 29. April 2004
EuGH C-495/04 vom 30. März 2006
EuGH C-319/05 vom 15. November 2007
EuGH C-140/07 vom 15. Januar 2009
EuGH C-27/08 vom 30. April 2009,
[3] REGULATION (EC) No 1272/2008
Articel 1 (page 8)
5. This Regulation shall not apply to substances and mixtures
in the following forms, which are in the finished state, intended
for the final user:
(a) medicinal products as defined in Directive 2001/83/EC;
[5] E-CIGARETTE IN DANGER: REVISION OF THE EU DIRECTIVE ON TOBACCO IS TANTAMOUNT TO A BAN