Déjà vu: Sweden’s repeal of an e-cig ban sounds eerily familiar

In a legislative ruling by the Supreme Administrative Court last year, Sweden officially overturned its somewhat controversial ban on the sale of e-cigs and vaping devices nationwide.  In an earlier court ruling, the judge upheld a claim by the National Drug Agency (NDA) – Sweden’s version of the U.S. Food and Drug Administration (FDA) – that the agency was given the authority to regulate the entire industry however it saw fit.

However, unlike the FDA which is choosing to regulate the American vaping industry into a slow, excruciating death-by-bankruptcy via the FDA deeming regulations of May 2016, Sweden’s NDA simply decided to ban the sale of all products instantaneously.  The NDA’s reasoning behind the initial e-cig ban was that the electronic devices are deemed to be medical devices.

Sweden and the USA: History repeating

As such, companies wanting to sell vaping products were required to gain a stamp of approval by the country’s Medical Products Agency.  Meanwhile, most retailers could not afford the application fees and could not successfully prove their products to be “medical technology” anyway.

But thanks to the overruling decision by Sweden’s highest court in the land, the e-cig ban is now kaput.  The court’s official ruling states the following.

“To be a medical product, it must have the ability prevent or treat a disease and, therefore, provide a beneficial effect on human health.”

If this chain of events sounds a bit familiar, a very similar series of events took place in the United States several years ago. The U.S. lawsuit involved a fledgling e-cig manufacturer named NJOY which sued the FDA for trying to regulate e-cigs as medical technology – just like a local Malmo supplier did in the Swedish case.

And just like the Swedish case, both lawsuits made their way through the court system, although the NJOY lawsuit did not go all the way to the U.S. Supreme Court.  But in both the U.S. and Swedish battles, small business triumphed over federal authoritarianism.

The historical NJOY case was Sottera Inc. NJOY v. U.S. Food and Drug Administration, and the final ruling by the Federal Court of Appeals occurred in 2010. 

Another striking similarity between the two cases in the proposed regulation by both federal drug administrative agencies to require e-cig and vaping retailers to acquire an “approval” of some sort.  In Sweden, vape shops were supposed to acquire a stamp of approval by the Medical Products Agency.  In America, the FDA is demanding all retailers submit a Pre-Market Tobacco Application (PMTA) whose cost is unclear but will likely soar to the million-dollar range.

America is still fighting the PMTA battle, but Sweden seems to have beat us to the punch.  Whereas the U.S. vaping industry is still trying to encourage Congress to repeal the FDA deeming regulations that mandate the need for a PMTA in the first place, Sweden seems to have resolved the totality of their regulations issues in a single, victorious lawsuit - at least, for the time being.


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