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Yesterday the European Parliament finally acted on the Tobacco Products Directive in a landmark
move that will have reverberations worldwide. Electronic cigarettes are not to
be treated as medicinal products. Although today’s decision is not the end of
the matter, as there are still legislative hoops to jump through, it makes it
probable that the action will be finalized by the end of the year. The decision also bans
sale of e-cigs to persons less than 18 years of age, and places tight
restrictions on advertising, but the question of where they may be used is left
up to the individual countries that make up the European Union. The directive
also bans menthol cigarettes and other flavors, a ban that is to take effect in
8 years. Lobbying was intense,
both by users of e-cigs, and by large tobacco firms like Philip Morris. Many
have feared that pharmaceutical regulation would make it more difficult to obtain
e-cigs, placing onerous certification procedures on the market, which would
make it difficult for smaller suppliers to survive. Since many users see them
as life-saving devices which have enabled them to quit smoking where other
smoking cessation products have been ineffective, tight regulations are seen as
a death sentence of sorts, blocking their path to a healthier lifestyle. Of
course there are ironies here, as this is tantamount to saying that e-cigs are
indeed are a health product, but must not be so defined by
regulatory authorities, in order to keep them widely available. It brings into
play the whole question of the definition of a medicine. Some things that make
you healthier are not considered medicines: orange juice, for instance, gives
you lots of vitamin C, but doesn’t have to be regulated by pharmaceutical
authorities. E-cigarettes are in an even more peculiar category, as they do not
directly make you healthier, but keep you from doing something that is just
terrible for your health, smoking combustible cigarettes with tobacco in them. The EU legislation,
although cheered in Strasbourg by vapers from
around Europe, still has hurdles to pass. It
must be taken up by the European Council (comprising representatives of member
nations) and the European Commission (the EU’s executive branch, based in Brussels),
both of which
have been tending toward advocating medicalisation. But the decision not to
medicalise seems safe at this point, and should be finalized by the end of the
year. Then of course the individual countries will take up the matter, deciding
how to implement the decision. Fourteen member nations, including the UK,
consider
the product a medicine, and may continue to do so.
Of
course there is
much interest in the forthcoming rulings of the American Food and Drug
Administration, which has promised to announce its decision this month. This
will come after a long delay, since a US
court in 2010 denied the FDA’s
move to regulate e-cigarettes as pharmaceuticals. Attorneys General from 41 states,
along with 14 health organizations, recently petitioned the agency to come
forward with this decision, and particularly with the ban on sale to minors,
although the FDA had already promised to issue regulations this month. The ban
on sale to minors has been opposed at the state level by some health
organizations, although it has been vigorously supported by e-cigarette
suppliers and advocacy groups. FDA “deeming regulations” are expected by the
end of the month.
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