When the European Parliament (EP) flouted the European Commission's (EC) proposed Tobacco Products Directive (TPD) by vetoing medicine regulation for electronic cigarettes (e-cigs) last October, American public health experts (myself included) heaved a sigh of semi-relief. Such regulation would have, in effect, banned e-cigs, made all the effective devices illegal in the EU and turned millions of 'vapers' into relapsed smokers or criminals. The beneficiaries? Big Tobacco and Big Pharma.

But no! The EP drew the line at such a destructive regulatory overreach, limiting regulations to mostly commonsense dictums, by a substantial margin at that. Now, me and my American colleagues thought, we can go back to worrying about what our own ill-advised, conflicted Food and Drug Administration (FDA) would promulgate in its ongoing mission to sabotage the low-risk devices. Our e-cig regulations, due that same month, has been delayed a bit by that whole "government shutdown" thing, so we yanks remain on tenterhooks, waiting for the reveal to come from the oversight agency, OIRA.

Wouldn't you know it? While our backs were turned, sulking members of the EC (who represent whom, exactly?) decided not to let their perceived slap by the EP go unanswered, and decided to try a clever bypass of the democratically-elected legislature by resuming their assault on e-cigs.

Perhaps knowing the kerfuffle this would engender, they wisely attempted to undertake this measure in secret…but not so wisely allowed it to be leaked to the press before it gained much momentum in the smoke-filled back rooms, as the commissioners had hoped.

For those who don't care a whit about tobacco issues, e-cigs come in various guises, but they have this in common: they replicate the hand-to-mouth and exhaled 'smoky' rituals of cigarette smoking, and the large majority of them deliver a potent hit of the addicted smokers drug of choice, nicotine. Some 'cigalikes' – are widely available in convenience stores and pharmacies, and often resemble tobacco cigarettes. Some have red glowing tips courtesy of an LED signal, some have a blue glow; some are white like regular smokes, some are black. They emit propylene glycol (PG) and flavorings with their water-vaporized nicotine in various concentrations.

All of the known components are generally recognized as safe in the U.S., although none have been studied via inhalation over a long period of use (well, PG has been used in some medical inhalers without any health signals noted). Another key fact: millions of people, most from Europe and the USA, have purchased e-cigs: their market has doubled each year since 2010, and now number almost 3 millions 'vapers' (as they are called, not smokers, jamais!) in America and an even larger number in Europe. (Exact figures are hard to come by, as governments seem to be trying to ignore this phenomenon whilst companies regard such figures as proprietary and are fine with exaggerating or downplaying, as their interests dictate).

Why are they so popular? And why do so many governments and regulators want to stamp them out, render them impotent or tax them out of reach? First, we must confront a fact that those who hate and fear e-cigs never address: cigarette smoking is the most prevalent, lethal and preventable public health issue in the world. WHO predicts that, if current trends continue unabated, one billion will die of smoking-related diseases worldwide this century. The annual toll in the EU is almost 800,000 now, and in the US about 450,000 out of our 45 million smokers cigarette addiction has been shown to eventually kill over one-half of their users. And although most smokers want to quit, and over half try to each year, the "success" rate remains in the 5% range cold turkey without help. Unfortunately, the government approved methods to help smokes quit only improve that rate by two- to three-fold, meaning they succeed only slightly more often than one out of 10 attempted quitters: smoking is a devilishly hard addiction to break, at least on a par with cocaine or heroin.

Why is the EC now attempting to force medicine regulation on e-cigs through the "back door," as it were? Given the public health disaster of smoking and the EU has the highest percentage of smokers of any similar geographical region and the likelihood of major benefits (if not miracles) from widespread uptake of e-cigs, what's not to like? For reasons that can only be guessed at, hobgoblins and hypothetical concerns have been rescued from the trash heap they had been consigned to after the EP vote. What will happen to vapers in 5, 10, 20 years? What about the children: will they not become nicotine addicts if they experiment with e-cigs, as kids are wont to do? And those flavors! And those sexy TV ads! Remember Big Tobacco! It's all a devious plot by BAT-PMI-RJR to get back in the game, entice youngsters into newly-cool vapes, and next thing you know, a dedicated smoker! And those carcinogens the FDA managed to detect in 2009? And what about "second-hand vapor"?

If these 'concerns' sound trumped-up (not to say phony), they are. None of these hypothetical 'risks' of e-cigs have been shown to be a realistic concern, and even arguendo they might have some merit, balancing such against the well-known addictive power and lethal health effects of the repetitive inhalation of tobacco smoke should make the argument a brief one. Yet, here we are: rushing willy-nilly towards a stringent regulatory environment effectively killing off this promising technology, along with hundreds (thousands?) of small businesses and substituting the agenda, or even more insidious interests, of unelected, unaccountable bureaucrats for that of millions of desperate former smokers and the elected representatives in the EP. What's the rush, anyway?

Yet another component of this sordid tale: the presidency of the EU is a Lithuanian who is a fervent opponent of e-cigs; his term expires at the end of the year, and the next EP election is in May. The forces trying to keep e-cigs off the market, to deny access to this simple, effective and relatively inexpensive cigarette substitute, don't want to wait to see who the new president will be, when this one is so sympathetic.

We don't know, but strongly suspect, that e-cigs are an effective cessation aid, despite the lack of proof that usually comes from controlled clinical trials. We infer efficacy based upon these undeniable facts: more and more smokers have switched to vaping, while sales of real cigarettes have plummeted in a historically unprecedented manner.

What now? The EP, EC, and European Council (ministers representing the national governments) are even now engaging in a "trialogue" to meld their disparate positions into a new Directive that can be agreed upon by all parties. While this would ordinarily be a desirable goal, I tremble at the possible outcomes that might leave vapers out in the cold. They made their desires manifest clearly with demonstrations in and around the various EU offices over the past spring and summer, hoping to influence the EP vote and it worked! Now they, as those of us in science-based public health, feel betrayed, although not (yet) abandoned: solid parliamentarians are holding the line against the EC advocates of tight regulation, and hopefully will succeed. But compromises akin to that made in 1994 when Sweden joined the EU at the price of keeping low-risk snus off the market in the EU a nonsensical, counterintuitive position then and now must be avoided: the baby should not again be disposed of with the bathwater.

Sound, reasonable, science-based regulation of e-cigs is a must, all of good faith agree. The EP's recently-passed Amendment 170 contained those: good manufacturing standards, age restrictions for sales and marketing/advertising, accurate ingredient labeling, child-proof containers for 'juice' (nicotine liquid for those who disdain cigalikes), and no health claims allowed. These are similar requirements to those in the US for "nutritional supplements," and there's no reason in the world why they would not be applicable to safe, effective, maybe miraculous e-cigarettes too. Else, those who sow the wind should prepare to reap the whirlwind: a vast angry black market will spring up to meet the voracious demand sure to follow if the EC's ill-advised, corrupt measures are adopted.

Gilbert Ross M.D.

Medical and Executive Director,

The American Council on Science and Health

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