Every May 31st, the W.H.O. endorses a "World No Tobacco Day." This is in keeping with their utopian, fundamentalist worldview in which not only smoking, but also tobacco and nicotine can, at last, be eradicated from our midst, the "endgame for tobacco." This approach, which brooks no compromise with nicotine use from any source (except of course those FDA-approved patches, gums and inhalers), has left us in the current situation, with "public health" officials everywhere lying to smokers and the public about illusory "potential" harms of e-cigarettes/vapor products. The prohibitionist “quit or die” demand that smokers trying to quit (as three-quarters of them wish to do) use only the patches, gum and drugs approved by the FDA consigns all-too-many of them to lingering illness and death, as these methods fail to help nine times out of ten.
Experts predict one billion tobacco-related premature deaths this century — almost all of which will be as a result of cigarette smoking. None will be from vaping, the act of inhaling e-cigarette vapor with its few chemicals, nicotine, and water. Yet, enslaved to their "no nicotine" ideology, our health gurus, academics, journals and nonprofits exaggerate (or simply make up) studies of ostensible vapor-related harms while ignoring the obvious experimental and empirical facts before their eyes: millions of smokers switching to e-vapor products. (Five hundred thousand British ex-smokers recently surveyed attributed their successful cessation to vaping).
The head of the FDA’s Center for Tobacco Products is an ex-salesman for GlaxoSmithKline products named Mitch Zeller. He has frequently alluded to his belief in the “continuum of risk” of nicotine and tobacco products, and that regulation of these products should be commensurate with their actual risk.
But his actions as CTP chief belie this evidence-based approach.
His FDA tobacco center makes a pretense of seeking solid scientific data to assess the risks and benefits of vapor products. But what, in fact, are they actually doing? They are seeking proposals solely for the purpose of detecting harmful effects, funding no study — not one — whose aim is to discern beneficial effects, as compared (of course) to smoking. This week the agency is hosting a "workshop" on e-cigarettes, replete with presentations from die-hard harm reduction antagonists, well-known data-manipulators and charlatans whose experimental outcomes were a foregone conclusion well before the experimentation was done. Meanwhile, respected clinical researchers with rigorous data supporting the beneficial impact of e-cigs were not tendered invitations to present their work. Again: not one (some were granted a 3-minute slot to present the science-based facts to the invited panelists: a task akin to Tantalus pushing that rock uphill).
Worst of all, last year his agency crafted a regulatory schema to include e-cigs and vapor products known as the “deeming” regulations. This regulatory proposal went to the Office of Information and Regulatory Assessment (OIRA), standard procedure for important rules before they can become published and implemented. Instead of exercising wise flexibility as per his stated beliefs, the proposed regulations hewed closely to the letter of the Tobacco Control Act (2009) which bestowed regulatory authority over tobacco to the FDA — much too closely for sound public health oversight. The stringent pre-market and “substantial equivalence” requirements for e-cigs and vapor products would essentially ban them from the market; in the best case scenario, those few devices acceptable would be snapped up by Big Tobacco companies — the opposite of the law’s ostensible intentions.
Why was someone from the clearly conflict-of-interest-laden pharmaceutical sales force chosen to head the FDA’s tobacco center? Could Zeller’s prior work with Big Pharma have possibly influenced his decision to construct regulations that would essentially ban reduced-harm products, which in turn would support sales of cigarettes and Big Pharma’s nicotine-replacement therapies? In the absence of any valid rationale for subjecting low-risk products to regulations as stringent as those applied to lethal, addictive cigarettes, that anti-science, anti-health agenda might be inferred.
In our country alone, among 43 million smokers, almost half a million die each year from cigarettes. Surely the option of vaping the watery mist of e-vapor products should be encouraged, not falsely maligned. I find it amazing, tragically, that here we have in our hands a likely solution to the worst public health problem in our nation — the disastrous, preventable toll of smoking — and we who are truly devoted to public health have to fight against those who wield the power of life and death. And watch them choose death, in their crusade against nicotine and ecigs.
Why? Well, the forces arrayed against reduced-harm products include Big Pharma, Big Tobacco, and Big Government. Money is certainly a factor: many among the more extreme harm reduction antagonists (academic centers and nonprofits) are beholden to substantial donations from the pharmaceutical industry devoted to maintaining lucrative markets for their ineffective (and often toxic) drugs, patches and gum. Budget-conscious politicians crave cigarette tax revenues as much as smokers crave nicotine, and don’t seem to care much (if at all) from propping up cigarette sales on the bodies of sick smokers. Others — veterans of the “tobacco wars” of the past — abandon their responsibilities and ethics for ideology: antipathy to nicotine, and to those who use it.
But the crucial impediment to wider uptake of lifesaving harm reduction products is Big Tobacco Control. The role the cigarette companies played in the 20th century has been usurped in this century by those who promulgate false alarms about e-cigs: led by the CDC and its director Tom Frieden, our premier public health agency has taken charge of spreading duplicitous propaganda in the guise of public health concerns, in the service of an agenda entirely antithetical to its stated mission.
Unlike the FDA, the CDC doesn’t even bother to make a pretense of adhering to science or ethics in its anti-harm-reduction crusade. Its minions think nothing of distorting their own data to confuse the public regarding e-cigarettes: a recent survey of teen tobacco use clearly showed a historic decline in youth smoking, accompanied by a significant increase in teen e-cig use. The CDC’s press releases ignored the decline in smoking among youth, possibly the most important health datum of the past few decades, to focus on the increase in vaping. This was easily accomplished: they simply added smokers and vapers together, concluding thereby that the “tobacco use” rate was nearly unchanged. (Let’s remember that there is neither tobacco nor smoke involved in e-vapor products). This shameful deception was eagerly parroted by the sensation-seeking press, who also ignored the fact that almost all of the young vapers were former smokers using e-cigs for the same reason their parents do: to quit cigarettes.
Big Tobacco Control cares not for facts: they will use any scare story or innuendo to push their propaganda. Nicotine ("e-liquid") poisoning our toddlers? Sure! (The facts: there has been exactly one child who may have been harmed by such exposure). Flavors and e-cig “industry” advertising targeting youth? Sure! But surveys clearly show that adults prefer flavors overwhelmingly: what recent quitter wants to be forced to vape tobacco flavor only? Toxic "second-hand vapor"? Sure, let's include e-cigs in our clean indoor air acts! But several good studies have documented either the absence of toxins in vapor, or their presence in such minute quantities as to pose no threat to anyone's health, vaper or bystander. This should come as no surprise, given the few chemicals in the devices themselves — but you’d never know that from the fear-mongering, flawed or plain phony “studies” purporting to detect various toxins in e-cig vapor, headlined in medical journal press releases and the media.
Here's the key: e-cigarettes and vapor products may not be completely "safe" over the long-term (nothing is, actually). But all they need to be is significantly less harmful than smoking combusted tobacco, which the harm reduction opponents know but never acknowledge when they lie and distort to scare desperate addicted smokers away from vaping. And it’s working: more and more smokers now believe that e-cigarettes are no safer than smoking combusted tobacco. Congratulations, CDC, FDA, et al.: Big Tobacco Control.
Why will so-called scientists not allow truthful communication to reach the smokers who desperately need this information? How can the control freaks and liars live with themselves?
The current panoply of innovative e-vapor products are only being used by a relatively small number of the vast smoking population. With appropriate, light-hand regulation as consumer products — neither drug delivery systems nor tobacco — these devices will continue to evolve (think of cell-phones and computers between 1990 and today) to become ever more effective and safer (assuming they are not “safe” now), helping more smokers escape cigarettes’ toxic grip. If so, reliable experts have predicted that within 10 years or so, e-cigs will eclipse cigarettes in sales, with a parallel benefit for public health, worldwide.
If agenda-driven over-regulation abolishes or severely restricts these developments, the opportunity for major reductions in “tobacco-related” disease and death will be impaired, perhaps severely and permanently. As renowned nicotine expert Jean-Francois Etter put it: “Regulators must consider the unintended consequences of excessive regulation, and should be held accountable for any such consequences. Given that e-cigarettes and vaporizers are already much safer than combustible cigarettes, any benefit of regulations will be small, whereas the unintended consequences can have a large negative impact. Unfortunately, current proposals for regulation are often worse than the status quo. It is sad that this is happening with the help of some public health professionals, scientists and elected representatives of the people.”
What, realistically, can be done to avoid this destructive outcome? Several opportunities seem possible, even if unlikely:
1-The FDA’s final rule may diverge from the original proposal in a manner sufficient to allow for continued marketing and innovative improvements in e-vapor products without expensive, time-consuming submissions. I believe this is unlikely at best, given the CTP’s prior statements.
2-OIRA in Washington DC might mandate such changes in the name of public health and economic benefits as well. Those of us devoted to public health should try to make our science-based positions manifest to these oversight regulators: they are accessible to such discussions.
3-a bill proposed in Congress by Rep. Tom Cole would delay the “substantial equivalence” date for allowing products to remain on the market from February 2007 to whenever the new regulation is enacted. The FDA DEEMING AUTHORITY CLARIFICATION ACT OF 2015 would merely delay the implementation of the full “deeming” regulations, so it is a half-measure at best.
In summary, the best interests of public health clearly lie in carving out a specific and separate regulatory framework for these products which contain no tobacco. Deeming them equivalent to tobacco cigarettes would constitute a public health debacle of the worst order. It would hinder the development of safer and more effective products, force many ex-smokers to relapse to cigarette smoking, create a vast, global black market, and propel once-thriving e-vapor companies into the eager arms of Big Tobacco. Is this what will be — or what may be, as Ebenezer Scrooge asked one Christmas day? If public health can loosen the shackles of Big Tobacco Control, as it did with Big Tobacco a decade ago, this sad prediction may be averted and millions of lives saved.