The ruling on the MPA position, on 5th March, confirms the prohibition of any sales of nicotine containing e-cigs, or nicotine containing refill fluids, without them being licensed as a medical product. Violations of this sales ban can carry a fine of $84,000 (€76,000) for each offence.
Although the regulation doesn’t apply to the private importation of products by individuals, other measures prevent importation of medical products without a prescription, thus leaving individuals who choose to source goods abroad open to possible repercussions, including confiscation and/or prosecution.
The ruling will be appealed but there is no guarantee that it will be heard in the Supreme Court of Administrative and Public Law. The MPA may suspend any action against vendors until the ruling from the superior court, but the impact and uncertainty for existing businesses, not to mention any expansion in the market, is likely to be very negative.
Overall the impact on vaping and vapers in Sweden is potentially devastating. This is likely to manifest itself more with women than with men. There are currently 260,000 ex-smokers in the male population who use snus, but only 90,000 women. The difference is attributed to the largely male use of snus. The negative ‘spin’ on snus, from public health in Sweden, despite the evidence of both its relative safety and effectiveness in switching from tobacco, coupled with aesthetic and cultural factors, deter female use of the product. The increasing availability of other alternatives, specifically e-cigs, can contribute to redressing this imbalance.
The response in the media to the MPA ruling was muted, with little coverage, beyond a few mentions on the inside pages of newspapers. This is deeply concerning, given that Sweden is the home of snus, a product that has encouraged vast numbers to switch from smoking and has seen the country enjoy the lowest rates of cancers and other diseases associated with smoking in Europe.
Despite the established and emerging evidence of their relative safety and effectiveness, public health in Sweden – as well as in many other countries – remains sceptical about snus and other new nicotine products. Any negative reports or statements are seized upon, and often distorted or embellished, to prevent their use in other jurisdictions. A classic example are the blanket-bans on all types of smokeless in many states in India.
The court ruling in Sweden is another setback for vapers, as well as to the industry that is growing to service them. Despite the arguments placed before the court that the products are recreational, that they make no claims to be beneficial to health, or are therapeutic in any way, and that states have the flexibility to decide within the parameters of the TPD and relevant country legislation whether products are medicines, the court chose to take the view that the MPA was correct in its decision.
In its conclusion the judgement stated:
‘…….. the court finds that the products have documented pharmacological properties in so much as that the nicotine content can be used to treat tobacco addiction, nicotine craving and withdrawal symptoms. These uses of the products would entail such positive effects on people's health [............] The fact that the products are not exclusively used for medical purposes, but also for other purposes, do not exclude them from being covered by the definition of medical products according to the medical products law. The Medical Products Agency were thus within their rights when under threat of a 76,000€ per offense fine ordering the company to cease and desist from further sales.’
Click here for the full text of the ruling, in Swedish.
It remains to be seen whether the higher court chooses to hear another appeal. Even if this happens, there is no certainty that it will reverse the last one and the future for Swedish vapers is indeed an uncertain one.