I agree. Admittedly I haven't dealt with the legal side in years and never outside my own country. But definitely talk to a specialist lawyer or other expert about it. Because of the oral application it might not even be the lowest level of medical device anymore. And with that comes a multitude of regulations. From durability to material to production environment.
I like the idea and as someone who had to use a dispenser in my youth, I appreciate the smaller profile of it.
With the difference that you are allowed to buy and consume beer and wine at the age of 16 (hard liquor with 18).
So the whole "protecting the youth"-spil is idiotic ...