January 21, 2014
As the largest trade association dedicated to promoting education and information of personal electronic vapour (PEV) products such as electronic cigarettes, we at the Smoke-Free Alternatives Trade Association (SFATA) write to you today to express our concerns over Tobacco Products Directive and ask that you consider the facts and information we provide before rendering your decision.
SFATA represents seventy members, comprising a wide cross section of the “smoke-free” industry including distributors, manufacturers and retailers who will be hurt in different but equally damaging ways in the absence of appropriate and proportional regulation which meets the objectives of governments and public health regulators.
SFATA respectfully submits that changes made in trilogue to Article 18 render it an entirely new directive, deserving a fresh start and full review and point to the following issues in the current version of grave concern to our members:
A. Ban extension on refillable products
Depriving countless adult users of these products across the E.U. in the event that a block of any three member states eventually elects to ban them individually, would unfairly and disproportionally disenfranchise the voices, needs and contributions of businesses and consumers across the E.U. who deserve and support continued access to these technologies.
B. Consistent Dosing Requirement
Requiring that these products all deliver identical puffs would stifle the ongoing innovation that continues to drive superior and diverse products in the industry, which are designed to accommodate the customization and individuality desired by of adult consumers.
C. Limits on Nicotine Levels
Addiction to nicotine is both physical and behavioural; the proposed mandate requiring minimal amounts of nicotine ignores documented evidence that more than 20mg/ml of nicotine content is required for current smokers to successfully maintain the switch to vapour products like electronic cigarettes and is therefore inappropriate. See, Farsalinos KE, Romagna G, Tsiapras D, Kyrzopoulos S, Voudris V. “Evaluation of Electronic Cigarette Use (Vaping) Topography and Estimation of Liquid Consumption: Implications for Research Protocol Standards Definition and for Public Health Authorities’ Regulation.” International Journal of Environmental Research and Public Health. 2013; 10(6):2500-2514. http://www.mdpi.com/1660-4601/10/6/2500
D. Bans on Advertising The proposed ban on advertising censors communications so as to prevent the industry from raising awareness about vaporizers and truthfully communicating with consumers about how vaporizers such as ecigs may serve as an alternative to tobacco products. We believe such censorship would create a severe disservice to adult consumers looking for accurate, truthful and helpful information about ecigs and how they may serve as an alternative to tobacco products.
E. Cross Border Sales Ban
Vaporizer technology products are neither medicinal nor pharmaceutical products and should not be treated as such. As you know, the EU Parliament recently voted against Amendment 71 of the TPD which would have seen ecigs legislated as medical products under restricted sale. The current proposed languages attempts to similarly and inappropriately misclassify vapour products like e-cigs as medicinal products and such language should not be adopted.
SFATA remains committed to ongoing communications and constructive engagement with the European Commission and Parliament so that appropriate regulations can be created which more acutely address the unique benefits, issues and concerns raised by vaporizing technologies.
SFATA believes that the concerns and issues raised can be directly addressed by the creation and implementation of Good Manufacturing Practices and Standards which are drafted in joint effort and collaboration between members of the industry and government.
|Kind regards, Cynthia CabreraExecutive Director, SFATA|