German Court Rules that E-Liquids are Not Medicines
By Lindsay Fox Posted December 4, 2014
The question of how to regulate e-cigarettes has been reverberating around the world since the devices started rapidly gaining popularity. For the FDA, the chosen “solution” was a potentially industry-crippling proposal to regulate them as “tobacco products,” coming with bureaucratic burdens that will crush the small businesses making the most effective devices. Another strategy, which manages to suck even more than the FDA’s approach, is to treat e-cigarettes like medicines, as the MRHA is proposing in the UK. In Germany, after some consideration of the issue of whether e-liquids can be classed as medicines, the Federal Administrative Court has determined that e-liquids don’t meet the definition and can therefore be sold freely.
The Decision – Overturning Proposed Bans on E-Liquid Sales
The case in question involved a woman operating a vape store in the western city of Wuppertal. She was told by city authorities in 2012 that she was barred from selling e-liquids on the grounds that they were unlicensed pharmaceutical products and therefore couldn’t be marketed. She’d already questioned this decision, and a lower court agreed with her case. The case was then taken to a higher level court, but they also ruled against the city and in favor of the vape store owner. E-cigarettes can be sold freely in brick-and-mortar stores and online, according to the recent decision.
There are three related cases in Germany from the past few years. The decisions in the individual cases are all pretty much identical – it simply doesn’t seem appropriate to call e-liquids medicines. For something to be defined as a medicine, it has to be presented as a treatment for (or a preventative measure against) disease and be used with a view to correcting, restoring or modifying physiological function. For e-liquids, since they aren’t presented as a treatment for or a preventative measure against disease, the issue was a pretty simple one. When considering functional component of the definition, German courts also argue that e-liquids don’t have a lasting therapeutic effect, either.
In all of these cases, it was the sellers and manufacturers standing up for their rights that led to the decisions being overturned. It’s a shame that the expensive legal proceedings fall on independent businesses, but if the results are positive, they do a huge service to vapers in their respective countries in the process. Totally Wicked E-Liquid has recently won the right to question the EU e-cig rules, and we can only hope that science and common sense prevail in their case too.
Conclusion – How to Make Sensible Regulatory Decisions for E-Cigs
There is one big problem with stringent regulation of e-cigarettes: anything which reduces their availability will lead to fewer smokers making the switch and thereby reduce their massive harm reduction potential. E-cigarettes are undoubtedly safer than cigarettes, but they can only do the good work they’re capable of if manufacturers don’t have their hands tied by over-restrictive regulation. Pushing for consistency in manufacturing and establishing maximum concentrations of trace impurities makes sense, but needlessly crushing the industry and reducing availability of the best devices is effectively condemning smokers to an early death. FDA and MHRA, take note.