Sweden E-Cig Laws and Regulatory Environment

March 14, 2016

Update: Sweden E-Cig Laws Take a 180 Degree Turn

As of May 2016, the Swedish Supreme Administrative Court has passed down a ruling that e-cigarettes are no longer to be classified as a medical product, so long as they are not marketed as a smoking cessation tool. This ruling overturned the precedent put in place by the country’s Medical Product Agency, which created a blanket ban on e-cigs and e-liquids that contained nicotine.

EU case law was applied to the case, stating that in order to be a medicinal product, the product must be capable of correcting, restoring, or modifying physiological functions when used as intended. Since nicotine, the active substance in most e-liquids simply affects the body’s functions, the courts ruled against the MPA and decided that e-cigarettes and e-liquids containing nicotine should not be classified as a medicinal product. The current Sweden e-cig laws follow the EU’s Tobacco Products Directive.

No More Nicotine for Swedish E-cigs?

In many ways, Sweden e-cig laws are at the heart of the global debate surrounding tobacco alternatives. As the chief exporter of one of the world’s most popular smokeless alternatives, Snus, Sweden enjoys special privileges within the E.U. allowing them and only them to legally produce and sell the unique product. Snus has been highly effective at combating the tobacco smoking epidemic in Sweden as it has been associated with lower smoking rates in males and consequently lower rates of oral and lung cancers and diseases. However, when it comes to e-cigarettes, Sweden e-cig laws are based on the two tier approach that many countries currently have: Products without nicotine are sold freely, but those with nicotine are prohibited.

Recent rulings in Swedish courts have officially classified e-cig products containing nicotine as medical devices, which means distributors must obtain a license from the government before selling their goods. E-cig sales remained unregulated while an e-cig distributor in Malmo appealed the initial 2014 decision, but the challenge failed in early 2015, effectively banning the import, distribution or sell of e-cigs with nicotine and nicotine refills.

The body responsible for issuing approval for medical devices in Sweden is the Medical Products Agency, or MPA. Other existing laws require that individuals have a prescription to purchase medical products, so consumers can now also be prosecuted for possession of nicotine-containing e-cig products. E-cigs and liquids that do not contain nicotine are unaffected by the ruling.

There’s a chance that the ban will be temporarily lifted again if Sweden’s supreme court is asked to address the issue; however, legal uncertainty and negative publicity already threaten the existing e-cig market and will certainly prevent newcomers. This ruling does not take into account the E.U. Tobacco Products Directive, which member states are expected start enforcing in 2016. The TPD is wrapped in its own legal battles as E.U. courts have found that the directive unfairly penalizes e-cig producers. Nonetheless, the current language of the TPD is more permissive than Swedish law as it stands.

Banning e-cigs is always done under the guise of protecting public health, but taking these devices away from consumers has deadly repercussions. While Snus has helped over 200,000 Swedish men quit smoking, women smokers haven’t been as quick to make the switch. E-cigs would provide female tobacco users with another potentially safer alternative to their addiction. The court acknowledged in their decision that e-cigs “have documented pharmacological properties in so much as that the nicotine content can be used to treat tobacco addiction, nicotine craving and withdrawal symptoms.” However, instead of opening more doors for these reduced risk devices, the decision actually outlaws all of them.

Sweden is also making news in other parts of the world. Swedish Match, the international producer of authentic Swedish Snus, has requested “modified risk” status from the U.S. Food and Drug Administration, which would allow the company to display labels with the text, “WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” It would also eliminate the phrases “This product can cause mouth cancer” and “This product can cause gum disease and tooth loss” in the existing warnings. No such status has been granted to tobacco alternatives in the U.S., so the FDA’s decision on Snus will set a precedent.

Given all the evidence that Snus and other tobacco alternatives can be beneficial to public health, why are things suddenly going south in Sweden for e-cig vapers? Tobacco tax revenues give governments an incentive to keep smokers addicted, and the tobacco and pharmaceutical companies that market ineffective smoking cessation products work in lockstep by lobbying lawmakers to keep e-cigs and other alternatives from cutting into their slice of the consumer pie.

It’s worth noting that at least seven courts in other E.U. countries have overturned attempts by government agencies to ban e-cigs. The legal challenge in Sweden unfortunately suffered from a relative lack of funding and expert support, which emphasizes how important these elements are when going against large government and corporate entities. Hopefully, more organized efforts to stop government overreach will result in better rulings down the road.