Regulatory authorities insist on medicinal regulation – What are the implications?
It is impressive to realize how much effort has been put by the regulatory authorities to implement the medicinal regulation on e-cigarettes. They have ignored several court rulings (USA, Estonia, The Netherlands, Germany and Greece), they have even ignored the Legal Affairs Committee of the European Commission which specifically mentioned that such a ruling would be illegal and against public health interest.
I would prefer not to examine the motives of such a decision, it is not my job. However, I need to make clear that such a regulation will have significant negative implications in e-cigarette’ success as a smoking substitute.
E-cigarettes are not, and they should be treated as, a medicinal nicotine inhaler. Any medicinal product has a specific way of administration and use and needs to be consistent in the delivery and absorption of the active ingredient. Should e-cigarettes comply with such principles? They cannot and they should not. E-cigarettes are popular because they provide pleasure and satisfaction to the user. This means that every user finds what he likes in terms of devices and flavors, and uses the e-cigarette because he likes it. This is never the case in a medicine. Applying a medicinal regulation would, by definition, limit the availability, variability and access of e-cigarettes to users. This is problematic both for current users and for potential users (smokers). We know that more than 80% of smokers do not quit with currently available approved methods. We should not blame the smokers for that, we should blame the ineffective medications. However, the medicinal regulation is in fact a punishment for the e-cigarette; and the only reason for implementing it is because we want to have a fair competitive market with other nicotine-delivery products. Should we deny the nature of e-cigarette use and their popularity among smokers just because another class of products will virtually disappear from the market? Is this the way public health authorities should treat smokers?
Is there any kind of regulation on e-cigarettes necessary? Of course it is. The industry denies publishing the results of any tests they have done on their products (let alone that most of them have done absolutely no testing). They deny providing a list of ingredients. They deny providing any documentation about the purity of the nicotine, propylene glycol and glycerol used. It is common to see vendors advertize the quality of their products, but they provide no evidence for that; just words. This should stop. It is not only wrong; it is a sign of disrespect towards the vapers. And vapers should take the matters into their own hands. They should push vendors into displaying proof of the quality of their products. Obviously, there are some exceptions to the above, but they are just confirming the rule which is that anyone can sell whatever he wants without having to provide proof of the quality of his products.
Regulation is necessary, but medicinal regulation should definitely be avoided. It is against the nature of the product, it is contrary to the reasons smokers use e-cigarettes and it will destroy the efficacy of e-cigarettes as smoking substitutes. It is imperative that the regulatory authorities realize this before making any decisions; otherwise we will lose a historic opportunity to reduce smoking-related disease.