@DaveP I think the issue with the "structure/function prong" is that it means that even if you don't consider smoking a disease, if a product (any product) is marketed as being an alternative to smoking, it is making a medical claim: after all, there's nothing quite like smoking in terms of disease burden on the body, even if the behavior of smoking itself isn't a disease.
Under this reading, if I say "beer enables you to stop drinking whisky", I'm making a medical claim for beer because there will be differences in the metabolic effects of both whisky and beer. It's a hyper-legalistic interpretation of the medicines law.
My principal concern with this rule is that, in my mind,
vape stores have a unique role and opportunity in helping people migrate from smoking to
vaping. As I see it, anyone who's opened a
vape store with this in mind is going to have to be extremely careful in how they run their business. I think this is a huge public-health own goal.
Consider: in the UK now we have our National Smoking Cessation Services queueing up to partner with e-cig companies to help educate smokers properly on e-cigs and how to use them. I think this is probably unique in the world. What a damned shame this won't happen in the USA, where there are 4 times as many smokers in need of such advise.
Also, it's absolutely canonical that replacing nicotine helps people to stop smoking. This has been known for a long time. Why on earth this can't just be accepted with e-cigs is, I must say, beyond me.