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Science of Electronic Cigarettes

Denmark: E-Cig Regulatory Environment

The State of E-Cig Regulations in Denmark

Something is hazy in the state of Denmark: Laws regarding e-cigarette regulations continue to confuse consumers and producers as the government’s proposal for implementing the European Union’s Tobacco Products Directive, or TPD, faces legal challenges in international courts.

For many years, Denmark has had a two-tier system, which means e-cigs without nicotine are treated differently than nicotine-containing products. E-cig hardware and refills without nicotine are sold with little regulation, but e-cigs with nicotine are considered medicinal products and therefore require a special permit for sale. The restrictions and administrative obstacles imposed by the Danish Health and Medicines Authority are too steep for most companies to sell their products legally; nonetheless, as is the case in most countries with two tier systems, finding e-cigs with nicotine in Denmark online or in small smoke shops isn’t very difficult.

However, stronger laws and enforcement are impending. Health Minister Nick Haekkerup has called e-cigs a “training tool” for smoking tobacco, and the E.U. has already sued Denmark’s government for failure to adequately stop the sell of snus, an oral tobacco substitute, in the country. Denmark and all other E.U. countries are expected to pass laws that codify the regulations set out in the Tobacco Products Directive by the end of 2016.

The E.U. makes decisions regarding the trade of consumer goods based on votes by representatives from member countries. Directives provide members guidelines and time tables for developing their own laws to meet the regulations agreed upon by the E.U. Parliament. Progress on implementing article 20 of the TPD, which addresses e-cigs, has stalled in all E.U. countries because of a lawsuit from e-cig distributor Totally Wicked, which claims tobacco industry lobbyists unfairly influenced lawmakers to regulate e-cigs more harshly than traditional tobacco products.

The new Danish laws proposed to comply with the TPD would bring positive and negative consequences, but, at time of writing, they seem to have stalled. Currently, there are no age restrictions on the purchase of e-cigs in Denmark, but the new proposed regulations will restrict sales to customers over 18, which is a measure most people can get behind. However, other pieces of the pending legislation embrace the slippery slope of treating e-cigs exactly like tobacco products in every way, which includes banning their use in all places where tobacco smoking is prohibited. Tobacco alternatives would also be subject to the same advertising restrictions and health labeling requirements as actual tobacco. Considering that only about 150,000 Danes say they smoke e-cigs on a regular basis, the measures seem a little extreme to say the least.

Regulations don’t stop there. The way the Danish proposal is written, all e-cigs on the market will be effectively outlawed regardless of nicotine content. In addition to capping e-liquid refill containers at 10 ml and pre-filled containers at 2ml, the law requires that producers must register with the Danish government before selling or face heavy fines. After government approval, a waiting period of six months is mandatory before selling is permitted (no “Grandfather date, such as in the USA), and since this process does not open up until the law takes effect, this means all e-cigs will be illegal for at least six months. Companies outside of Denmark that sell to Danish customers must meet the same requirements lest they break international trade law and face legal action from the E.U.

Each product “variant” sold will require it’s own approval process and the $450 price tag that comes along with it. This includes each separately sold sub-part, each e-liquid variant and each individual aroma, so the cost of getting products to market in Denmark can quickly become astronomical. With such high hurdles to clear, few if any producers will make it through the process, and innovation will be stifled.

Given that the Danish government classifies e-cigs with nicotine as medicinal products, someone in the medical community must recognize the therapeutic benefits that these devices can have for current tobacco smokers. Unfortunately, the growing red tape surrounding the industry is depriving people from obtaining e-cigs, meaning more smokers will continue to stick with tobacco cigarettes, which everyone knows are more deadly than alternatives like e-cigs. Instead of trying to criminalize e-cigs, the Danish government should put more energy into helping smokers get them so we can address the real public health issue of tobacco use.