10.2. SR 09-08-2015 - Laserfiche WebLink

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17 products or to allow medicine licensing. After the proposal of the Commission and Council to regulate e-cigarettes as medicines was thrown out by the European Parliament on 8 October 2013, a new directive was hastily contrived entirely behind closed doors, without any consultation and with minimal supporting analysis or scrutiny. The resulting directive (2012/40/EC – Article 20)57 has numerous flaws of arbitrary and unscientific policy and poor policy-making process, and is likely to be found in breach of key treaty principles. • A ban on almost all advertising sponsorship and promotion. The anti-competitive ban protects the incumbents from a disruptive challenger and is unjustified in a directive with a single market legal base, and disproportionate relative to tobacco. Most tobacco advertising is banned in the EU, but tobacco kills 700,000 per year. In contrast, vaping is likely to reduce premature deaths. • Limiting the strength of nicotine liquids to 20mg/ml. Approximately 25-30% of consumers use liquids stronger than this. They may be more important for more heavily dependent smokers and those just switching. The threshold is arbitrary and pointless. • Limiting liquid container sizes. We manage hazardous liquids (like bleach) by having packaging and labelling standards not by limiting the containers to tiny and inconvenient sizes. • Requiring large warnings. The directive requires cigarette-like warnings that contain misleading and off-putting information covering 30% of the pack. The warnings are not proportionate. • Numerous technical measures that would fail a reasonable risk-benefit assessment. • A continuing ban on snus – despite it being the reason, beyond doubt, for the best tobacco- related health outcomes in Europe in Sweden, snus will remain banned throughout the rest of the EU. It is unscientific, unethical and probably unlawful to ban this product. Legal challenge. A UK-based vendor, Totally Wicked, has challenged article 20 of the directive via the English Courts and a case will likely be heard in Court of Justice of the EU in 2016 58. The directive has entered into force and its provisions apply in stages from 2016/17. 4.3.3 United States approach Following a legal challenge to its designation of e-cigarettes as medicines in 2010 59, the currently favoured approach of US Food and Drug Administration is to treat e-cigarettes as tobacco products on the basis that the pure nicotine used is originally extracted from tobacco. In April 2014, the FDA announced its intention to apply tobacco legislation to e-cigarettes 60 (the so-called ‘deeming regulation’). This means the provisions of the Family Smoking Prevention and Tobacco Control Act will apply. This legislation was designed with the primary purpose of slowing innovation and creating burdens for the cigarette manufacturers, and it is wholly excessive and inappropriate to use this to regulate a disruptive low risk entrant to the cigarette market. It will mean almost all products are removed from the market and only the mass commodity products market by the largest companies will meet approval 61. 57 Directive 2014/40/EU ‘Tobacco Products Directive’ [link] 58 See more details at: Totally Wicked legal challenge to the Tobacco Products Directive e-cigarette measures, Counterfactual, November 2014 [link] 59 U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 2010 [link] 60 United States Food and Drug Administration. FDA proposes to extend its tobacco authority to additional tobacco products, including e-cigarettes (press release with links) 24 April 2014 [link]. Also see SFATA (industry) [link] and CASSA (consumer) [link] resources 61 See CASAA assessment in: Fourth Call to Action for FDA Proposed Regulations Streamlined Version, 26 July 2014 [link]