Tag: opinion

  • Abboud: Congress Intended for FDA to Use Discretion

    Abboud: Congress Intended for FDA to Use Discretion

    Credit: Sagittarius Pro

    By Tony Abboud

    Under the new law governing synthetic nicotine products signed on March 15, 2022, Congress imposed a short 60-day deadline for companies to file premarket tobacco product applications (PMTAs) and declared that if such applications were not approved within 120 days (the Act) they would be “in violation of” the Federal Food Drug & Cosmetic Act’s (FDCA) PMTA requirement.  

    Since no authorizations have been granted as of today, the question is will FDA use its enforcement discretion to continue reviewing PMTAs, or will it precipitously declare that all synthetic nicotine products must be removed from the market after July 13, 2022?

    There is no question that the FDA should use its enforcement discretion. In a series of direct engagements with FDA since the Act’s passage, the Vapor Technology Association (VTA) has provided a complete set of scientific and policy justifications for synthetic nicotine products, and specific recommendations on how FDA should use its enforcement discretion – just as it has in the past – to allow synthetic nicotine products to remain on the market during the PMTA review process.

    However, some have suggested that Congress mandated all products be removed from the market this week if they are not approved by FDA. But a close review of the Act reveals that the opposite is true: Congress did not require synthetic nicotine products with pending PMTAs to be removed from the market after July 13.

    In interpreting laws, a court will first look to the plain language of the Act and, only if there is an ambiguity, will it look to Congressional intent to resolve such a question. Here, both support the FDA’s continued use of enforcement discretion for pending PMTAs.

    The Plain Language Supports Enforcement Discretion

    There are four relevant sections of the Act. First, under Section (d)(2)(A), Congress expressly stated that “as a condition to market” all manufacturers wishing to continue selling their products must file a PMTA no later than May 14, 2022.

    Tony Abboud
    Tony Abboud

    Second, under Section (d)(2)(B), Congress expressly stated that companies which filed PMTAs “may continue to market” their products during what the Act calls a “transition period.” 

    Third, under Section (d)(2)(C), Congress expressly required that if a company did not file a PMTA for its synthetic products by May 14, 2022, that company is “not eligible for continued marketing.” In each of these sections, Congress expressly uses some variation of the term “market” to articulate its direction on what may (not) be marketed and when.

    However, in the operative Section (d)(3), which addresses what happens after July 13, 2022, Congress makes no statement regarding marketing at all. Instead, it states that products with pending PMTAs not yet approved would be “in violation of…section 910” of the FDCA (21 USC 387g).

    When presented with this question, a court likely would rule that because Congress did not expressly state that pending applicants are “not eligible for continued marketing” or that they “may not market” after July 13, as it clearly said in the immediately preceding sections, Congress did not require the removal of products with pending PMTAs.

    This places synthetic nicotine products with pending PMTAs in precisely the same position as all other products with pending PMTAs which, for years, FDA has made clear are “illegal” (i.e., in violation of section 910) but are allowed to remain on the market at FDA’s enforcement discretion.

    Congressional Intent Supports Enforcement Discretion

    Even if a court finds that Section (d)(3) is ambiguous, there is nothing in Congressional intent that would lead to the conclusion that Congress intended for products with pending PMTAs to be removed from the market.

    First, Congress could have banned synthetic nicotine products, if that is what it intended, but it did not do so. To the contrary, Congress expressly authorized manufacturers to bring new products to market after the Act’s passage. Thus, it would be folly to suggest that Congress intended all synthetic nicotine products be removed from the market without PMTA review.

    Second, Congressional intent is generally divined by on the record statements made in committee hearings and in floor debate (not from press releases or media statements). But there is little to nothing which a court could rely on [with] this question because the provision was quietly slipped into the Ukraine-omnibus spending bill with no relevant hearing or floor debate.

    Third, Congress was fully aware that FDA could not review PMTAs within 180 days (as required under the FDCA). In fact, the FDA told a court it will not be finished reviewing tobacco derived PMTAs until June of 2023.  Thus, no one could suggest that there ever was any reasonable expectation or intent that the FDA would rule on synthetic nicotine PMTAs in 60 days.

    Hence, the only reasonable conclusion that can be drawn from the plain language and Congressional intent is that Congress did not require removal of products with pending PMTAs but, rather, expected the FDA to continue to use its discretion in enforcing its PMTA regulation after July 13.

    Congress did, however, expressly state that products for which no PMTA was timely filed have no continuing ability to market, authorizing the FDA to take immediate action. VTA has repeatedly communicated to the FDA the need for it to aggressively remove all tobacco products from the market for which no PMTA has been filed and to publish a list of all products covered by a synthetic nicotine PMTA so that retailers know which products can be sold.

    A Careful and Complete Evaluation of Synthetic Nicotine PMTAs is Required

    We live in a world that remains captive to [combustible] cigarettes. Congress won’t ban them and Congress has prevented the FDA from doing so. While electronic nicotine-delivery system (ENDS) products offer a technological solution to delivering nicotine in a substantially less harmful way, synthetic nicotine now represents the first technological innovation in nicotine itself. 

    Synthetic nicotine uniquely offers consumers the cleanest and purest form of nicotine with numerous benefits, i.e., the absence of heavy metals, nitrosamines, and pesticides. Synthetic nicotine uniquely offers consumers the opportunity to break free from the last remaining vestige of the tobacco plant.

    Synthetic nicotine uniquely offers the FDA unprecedented product constituent clarity, replicability, and traceability down to the batch level. Not only does synthetic nicotine offer companies the opportunity to change the dynamics regarding total reliance on tobacco-derived nicotine for all tobacco and pharmaceutical nicotine products, but it also provides companies the ability to address their ESG [sustainability] goals and take a significant step to ameliorate the adverse environmental impacts of tobacco. 

    Our message to the FDA has been constructive and clear: it is critical to the adult smoker that FDA takes aggressive steps to create an orderly and regulated marketplace with a diversity of desirable nicotine alternatives.

    Given recent history with tobacco derived PMTAs, the best way for FDA to realize that objective now is to avoid the blanket denial mistakes of the past which have mired the agency in protracted litigation. Such litigation will only delay the time until we achieve an orderly and regulated marketplace. 

    Instead, we have asked the FDA to work companies which timely filed synthetic nicotine PMTAs – the good actors – through the PMTA scientific process and provide them the requisite time and guidance to fulfill FDA’s requirements.

    At the same time, we have asked the FDA to aggressively enforce against the non-compliant companies that have refused participate in the PMTA process – the bad actors – by interdicting such products at the border and removing such products from the market Congress has clearly required.

    In the end, it is incumbent on the new FDA leadership to use its power to create an orderly marketplace by embracing scientific innovations, stimulating additional financial investment, accelerating authorizations of pending tobacco-derived PMTAs, and ensuring that synthetic nicotine products which now contain the cleanest and purest form of nicotine that science has created are available to adult smokers.

    Tony Abboud serves as president for Strategic Government Solutions, Inc., and executive director of the Vapor Technology Association (VTA).

  • Bentley: Juul Exit Threatens Progress in Harm Reduction

    Bentley: Juul Exit Threatens Progress in Harm Reduction

    Photo: steheap

    The Food and Drug Administration’s order to remove Juul products from the U.S. market threatens progress in tobacco harm reduction, according to Guy Bentley, director of consumer freedom at the Reason Foundation.

    Guy Bentley

    Writing on the foundation’s website, Bentley reminds his audience that e-cigarettes are not only less harmful than their combustible counterparts, but they are also more effective in helping smokers quit than FDA-approved therapies such as nicotine gum and patches

    The FDA, he writes, acknowledged as much when it authorized Vuse e-cigarettes in 2021 and claims it recognizes the role these safer nicotine alternatives can play in reducing smoking.

    If the Juul order is implemented, says Bentley, many Juul users will likely return to smoking, while a portion of smokers who would have transitioned to Juul will continue to light up.

    Bentley says the FDA Juul denial makes a mockery of the claim that it’s evaluating science in the best interests of public health. A study published in the New England Journal of Medicine found e-cigarettes to be twice as effective as traditional nicotine replacement therapies.

    According to Bentley, the decision also punctures a hole in the logic of the FDA’s recently announced policy to reduce nicotine levels in cigarettes to minimally or non-addictive levels. Without an acceptable legal alternative, smokers may simply smoke more cigarettes to get their nicotine fix.

    “By banning the most popular e-cigarette among adults, the agency’s commitment to transitioning smokers to safer alternatives rings hollow,” writes Bentley.

  • What’s Next for Vapor?

    What’s Next for Vapor?

    The long roller coaster ride for the vapor industry will likely continue for the foreseeable future.

    By Chris Howard and Rich Hill

    It’s been a long and arduous journey since the finalization of the Deeming Rule in 2016. As most of you will recall, this was the moment when we transitioned from operating in an unregulated market to plowing forward under a complicated and onerous regulatory scheme in the blink of an eye. Shortly thereafter, the U.S. Food and Drug Administration announced a renewed prioritization of harm reduction and proclaimed that vapor could play a leading role in that effort.

    Chris Howard
    Chris Howard
    Rich Hill

    Then, as quickly as a bright future for harm reduction blossomed, the lights dimmed, and vapor became the villain in the harm reduction story overnight. In addition to paralyzing propaganda and misplaced demonization by activist groups throughout the U.S., the industry also faced an onslaught of crippling requirements associated with a 10-month window to submit premarket tobacco product applications (PMTAs). Costing millions of dollars, 99 percent of the PMTAs ultimately submitted to the FDA’s Center for Tobacco Products (CTP) were summarily rejected based upon a standard, akin to a clinical cessation trial, that none in the industry expected.

    As of the date of this writing, some of the largest players in the e-liquid space have closed their doors or have moved into yet another risky proposition—synthetic nicotine. Despite the setbacks over the past several years, many still believe reports of vapor’s death as a harm reduction tool are greatly exaggerated. Notwithstanding this cautious optimism, it is clear that 2022 is going to be yet another difficult year for the vapor category.

    Current state as we enter 2022

    As we enter 2022, much of the flavored e-liquid market is gone and may never return. While we have seen marketing orders for first-generation e-cigarettes and tobacco disks that are no longer marketed, we have not seen marketing orders for any modern electronic nicotine-delivery system (ENDS) or oral nicotine products. We have seen a marketing order for a combustible low-nicotine cigarette, along with a reduced exposure order for the same. While litigation continues around the rejected PMTAs, the FDA still lacks a commissioner, and we have no knowledge of who will replace retiring CTP Director Mitch Zeller. Most importantly, other than removing flavors from the market, we have no clear understanding of the FDA’s harm reduction strategy.

    Predicting the future in 2022

    PMTAs. Few question the fact that the CTP was given a Herculean task by the Maryland federal court. Processing, let alone reviewing, 6.5 million PMTAs in a year was unquestionably an impossible requirement. Candidly, the fact that the CTP was able to get the majority through acceptance and filing was a significant achievement. Of course, for most reading this, the outcome was obviously disappointing as nearly all requests for marketing orders for flavored ENDS products were rejected in late 2021. As the various challenges to the marketing denial orders play out over the next year, many hold out hope that the CTP will be found to have violated the Administrative Procedures Act and/or acted arbitrarily or capriciously in its decision-making process.

    Credit: JHVEPhoto

    With respect to those applications that remain pending with the CTP (primarily tobacco and menthol flavors, pod systems and disposable devices), we believe the FDA will issue marketing orders for several tobacco-flavored pods and disposable e-cigarettes in 2022. Assuming the remaining applications otherwise meet the statutory standards, there is little reason for the CTP to deny applications for tobacco-flavored pods, e-liquids and disposables given the evidence that such products are not particularly attractive to youth. That said, we question whether any action will occur before the new FDA commissioner and CTP director are in place and have an opportunity to address policy concerns.

    As for menthol offerings, we anticipate that the FDA will not act until the proposed product standard banning menthol is released. It was interesting to note that a menthol-flavored combustible cigarette with lower nicotine levels was granted an exposure modification order. The CTP’s action may indicate a desire to provide “off-ramps” for combustible menthol cigarette smokers in a world where menthol cigarettes are potentially banned. Ideally, the CTP will grant marketing orders for menthol-flavored ENDS to provide an alternative product for current menthol cigarette smokers. This would provide a potential cessation or maintenance product to the millions of menthol smokers in the U.S.—thus reducing the risk of the formation of black and gray market activities.

    Credit: SYCprod

    Finally, marketing orders for flavored ENDS products seem unlikely in 2022. If the clinical cessation trial/longitudinal cohort study requirement proves to be administratively appropriate, it would seem difficult, if not impossible, that any flavored product will even make it to the review phase with such data for six months to 12 months at a minimum. Even then, it is an open question as to how much and what kind of data will be deemed to be sufficient by the CTP. We see a world where flavored ENDS are once again marketed, but it seems unlikely to occur in the near future.

    Product standards. We have all heard that the CTP intends to issue draft product standards banning both menthol in cigarettes and flavored cigars by April of this year. These purported product standards, along with the recent marketing orders granted for lower nicotine combustible cigarettes, are telling with where the focus of the FDA’s policy stands. The standards appear to demonstrate an agency bent on removing any flavors from combustible tobacco products unless those products cannot create or sustain addiction. We can be assured that the product standards will face a blizzard of regulatory and legal challenges and will likely take many years to implement.

    Synthetic nicotine. A few months ago, synthetic nicotine seemed like the last bastion of flavored ENDS products in the marketplace. While these products currently do not have a regulatory home, we fully expect that the existing legislative efforts will ultimately provide the CTP the authority to regulate synthetic nicotine. Once granted, all regulatory requirements for deemed tobacco products will apply, such as PMTAs. In the unlikely event Congress does not successfully provide such authority, we expect state legislatures to address the issue with prohibitive laws banning synthetic nicotine.

    FDA administration. One wildcard in the mix is the turnover in key personnel at the FDA. In his largely collegial confirmation hearing, the commissioner nominee, Robert Califf, stated that his top two priorities upon confirmation were not tobacco related. Rather, he intends to focus on (a) emergency preparedness and response and (b) patient and consumer protection through “systematic evidence generation” related to medical and food products. While he faced few questions on tobacco-related issues, many skeptics believe his views toward tobacco products are similar to the current administration. Whether he will take a proactive stance toward prioritizing harm reduction is unknown.

    Credit: Neil Lockhart

    Unfortunately, Zeller’s retirement removes a harm reduction proponent. What can we expect in a replacement? In short, the most likely replacement will be a candidate who has solid tobacco control chops and is aligned with the current policy flow against flavored products. We don’t expect to see any novel tobacco control or harm reduction policies (akin to former FDA commissioner Scott Gottlieb’s approach in 2018).

    The roller coaster ride continues

    Unfortunately, it appears that the long roller coaster ride for the vapor industry will continue for the foreseeable future. The good news, if you can call it that, is that the Biden administration has a variety of nontobacco-related issues to address—particularly up to the mid-term elections—which could lessen the likelihood of additional draconian polices imposed on the industry. At this point, it appears that 2022 will be about waiting—waiting for court decisions, waiting for policymakers and waiting for policy decisions.

    We won’t be so naive as to say that things can’t get worse in 2022. That said, if you have made it this far, now certainly doesn’t seem like the time to give up.

    Chris Howard is vice president, general counsel and chief compliance officer, and Rich Hill is compliance director and associate general counsel of E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands.

  • The Watchful Eye

    The Watchful Eye

    Credit: Sergey Nivens

    Tobacco companies should be allowed to transition to harm reduction products, but under history’s watchful eye.

    By George Gay

    I don’t go along with the oft-repeated idea that, if we don’t remember the past, we are condemned to repeat it. This is not to say that particular versions of the past, whether real or invented, are not repeated, just that mostly it is impossible to know whether an event is an original or a repeat. For one thing, memories of the past are mostly not the result of direct experiences and so are not fixed and generally agreed. History, into which the past is roughly sieved, is never objective. It is most often weighted, open to interpretation and subject to disagreements.

    I would be happy to consign all versions of history to oblivion, but then, as somebody famously said, there would be no point. In saying that we consign something to oblivion, we suggest that it is simultaneously forgotten and preserved. We are incapable, it seems, of letting go of favorite versions of the past, which get stuck to our shoes like carelessly discarded chewing gum.

    Specifically, it concerns me that history, or versions of it, are being allowed to act as a drag on advances that could be being made in reducing the health consequences of cigarette smoking. I recently attended a nicotine conference and, as part of one generally good presentation, a still of a video was shown in which CEOs from U.S. tobacco companies told a Congressional oversight committee sitting a quarter of a century ago that they did not believe nicotine was addictive. I have seen this still, or similar ones, on more occasions than I care to remember, often presented as shorthand for how heinous the tobacco industry was or even is.

    But one problem in my view is that what is presented here is a version of history directed by the enemies of the tobacco industry who feel they won the moral war. In other words, a history presented by the victors. It implies that those CEOs were willing to lie about something that everyone knew to be true—that nicotine was and is addictive. There is no time for nuance in a single still. There is no room for other interpretations.

    Credit: Sky Next

    For instance, were all the CEOs referencing the same, agreed version of addiction? And if, as generally supposed, they were all referencing the same definition of addiction, were they acting in bad faith, or were they, or at least some of them, not informed or badly informed by the scientists working in their companies who did believe that nicotine was addictive? Is it possible the CEOs were right and everybody else was wrong? Was one or more of them delusional and in need of help?

    I ask above whether all of the CEOs were referencing the same definition of addiction and, frankly, I have no idea what the answer to that question is. I tend to the view, however, that they were, because I find it difficult to believe their legal teams would have allowed them to give the answers they did without knowing exactly what they were signing up for.

    But I have one troublesome doubt in this regard. As far as I am aware, five of the seven CEOs who testified in 1994 said they believed that nicotine was not addictive; one said he believed that neither nicotine nor his company’s products were addictive while another said he believed cigarettes and nicotine clearly did not meet the classic definition of addiction because there was no intoxication.

    The reference to “the classical definition” surely suggests that it was admitted there was more than one definition, which possibly means the answers need to be interpreted individually. Additionally, it cannot be ruled out that even if a CEO knew that his company’s scientists believed nicotine to be addictive, his personal view might have been different. We all become fed up with experts at one time or another.

    The oversight committee’s hearings later revealed that all sorts of skulduggery had gone on; for instance, at least some of the people within these companies knew or believed that nicotine was addictive and that some had manipulated their products to try to make them more addictive, whatever that means in the context of whatever definition you are using.

    But where did this information come from? It came in part from documents voluntarily handed over to the committee at the behest of the CEOs. This seems to suggest that the CEOs were either not aware of what was in those documents or that they were not aware of all that was in them.

    But let’s say for the sake of argument that the CEOs, or at least some of them, told the committee they believed nicotine was not addictive, knowing that all this skulduggery had been going on—would they not have been acting in exactly the way they would have been expected to act—perfectly in line with business and societal norms? After all, they were CEOs charged with maximizing company profits at a time when greed was good, so there was some collateral damage. But then, starting only with the “A’s,” look at the alcohol, arms and automobile industries.

    I don’t want to defend what the CEOs said during that committee hearing or what the tobacco industry got up to because I don’t know enough about this stuff. But it seems a little odd to me that, at a time when the U.S. was deep in the grip of neoliberal dogma, these men (they were all men) were condemned for following the logic of the market and maximizing profits.

    But the committee seemed to want to set itself above all of this tacky business stuff, somewhere on the moral high ground. This is, in part, what the chairman on April 14, 1994, said in opening the hearing: “For decades, the tobacco companies have been exempt from the standards of responsibility and accountability that apply to all other American corporations. … This hearing marks the beginning of a new relationship between Congress and the tobacco companies. The old rules are out; the standards that apply to every other company are in.”

    I would imagine that what a lot of people took away from this, whether it was meant or not, is that there goes the wicked tobacco industry again, avoiding its responsibilities for decades. But, if the finger is to be pointed anywhere, it should surely be pointed at Congress, which, as is more or less admitted by the chairman, allowed this situation to exist and to continue. It cannot be expected that businesses will, in the normal course of things, lobby Congress to saddle themselves with additional regulations.

    I thought the opening remarks strange in another way also. The chairman at one point says: “Nearly a half million Americans die every year as a result of tobacco. This is an astounding, almost incomprehensible statistic. Imagine our nation’s outrage if two fully loaded jumbo jets crashed each day, killing all aboard. Yet that is the same number of Americans that cigarettes kill every 24 hours.”

    As I see it, the chairman is making a comparison as part of what I suppose was meant to be a moral argument, but that comparison does not stand up to even basic scrutiny. As human beings, we take risks every day, balancing those risks, either consciously or unconsciously, against perceived benefits. Smoking and drinking alcohol are two obvious everyday examples of this. And so, too, for a lot of people (though perhaps not recently) is getting on an airplane. As things stand, people get on airplanes because they are overwhelmingly safe to use, so the benefit-to-risk ratio is hugely positive.

    But it is inconceivable that if two jumbo jets crashed each day in the U.S. alone, people would still board them. The chairman was ignoring the fact that people make risk assessments so as to conjure up a situation that would never occur. People understand that smoking might cause them to die in 40 years to 50 years, and they understand that falling from 30,000 feet brings on death a lot quicker.

    The idea of risk can be manipulated, and often is, as in the story about the therapist with a patient who is still nervous of flying even after being told that the chances of a bomb being on board a plane is a billion to one; the therapist advises her to take her own bomb on board next time she flies because the chances of there being two bombs on board are a trillion to one.

    I need to emphasize that I am not trying to defend the past behavior of the tobacco industry or the CEOs in question. What concerns me here is that a single picture is being regularly presented as telling a story that is far simpler than it really is. What has passed into history—what I would imagine most people would “remember” from the picture of the subcommittee hearing—was that all of the CEOs lied in saying that nicotine was not addictive. I doubt that many people would realize that what they said was they believed nicotine was not addictive, let alone the back story to this event.

    This is the problem with the versions of history we drag around with us. In the end, what did the hearings bring about? Reputational damage to tobacco companies for sure. But they are still operating in one form or another, and part of their business is largely unchanged. It is said that the number of smokers fell after the hearings, but who knows whether the hearings were a causal factor in this.

    It is more interesting to examine what continued: taxes. Local, state and federal agencies continued to benefit from people smoking through the taxes they paid, and later was added the proceeds of the Master Settlement Agreement, very little of which is ever spent on ameliorating the toll of tobacco smoking; so who gets to stand on the moral high ground?

    Credit: Gawriloff

    Well, the answer to that question might seem strange. I say above that it is not usual for businesses to lobby Congress to try to saddle themselves with additional regulations. But, in fact, odd as it might seem, this is exactly what many nicotine and tobacco companies have been doing in recent times.

    I’m not saying they are perfect and that part of this new way of thinking hasn’t to do with competition, but in part it is a genuine attempt to ensure that the new generation products that are being developed and offered to help people transition to safer forms of nicotine consumption are not causing, and can be seen not to be causing, unintended consequences.

    And for those people who tend still to be wedded to the idea portrayed by the still of the tobacco CEOs, it is worth noting that, importantly, in the recent past the major tobacco companies have found a way of offering reduced-risk products while roughly maintaining the sorts of business models that were so successful for them in the past. Does this put them on the moral high ground? Of course not, but it has mapped out a route to that ground.

    Times are changing, and we desperately need to stop slowing the transition into a new world of nicotine consumption by constantly dragging behind us a little-examined history of what went on 20 years to 30 years ago—a time that few working in the nicotine and tobacco industries could probably remember.

    There was a furor just after I started to write this piece about a proposed takeover by Philip Morris International of the pharmaceutical company Vectura, which in news reports was said to be developing inhaled treatments for respiratory diseases. Why the furor? Well, it’s all about history, of course. PMI has in the past sold traditional cigarettes and still does; so, the detractors claimed, we cannot let it near a pharmaceutical company.

    There seems to be no way such people can accept that, in order to move ahead with the transition from smoking to other forms of nicotine consumption, we have to look at innovative, even daring ways of doing things.

    I have no insights into what PMI is up to beyond what has been reported in the general press, but it doesn’t take a genius to figure out that it might be looking, in part, to benefit from some cross fertilization of ideas in respect of inhalation technologies—ideas that just might allow it to make a breakthrough in respect of reduced-risk, next-generation nicotine products.

    At least we should allow companies to try such things—while keeping an eye on them, of course. We should not let history stand in the way.

  • Greenhut: Utah Nicotine Limits Bad for Harm Reduction

    Greenhut: Utah Nicotine Limits Bad for Harm Reduction

    When it comes to government regulation, it’s sometimes hard to get the details right, according to Steven Greenhut in an opinion hew wrote for InsideSources. He says that the Utah Department of Public Health’s proposed new rules that would reduce the amount of nicotine that sellers and manufacturers can include in their “closed-system” electronic cigarettes derail harm reduction efforts.

    Two years ago, the agency adopted a compromise that capped the amount of nicotine in closed vaping products at 5 percent. That 2019 rule attempted to protect consumers from the over-consumption of nicotine. But the 5 percent cap still enabled vape users to consume a sufficient amount of nicotine to satisfy their cravings. However, the newly proposed regulation would reduce the nicotine cap to 3 percent.

    Greenhut states that the proposed rules could make consumers vape more than they do now, switch to open systems that allow the use of higher-nicotine liquids or even mix their own e-liquid recipes, raising a host of troubling health concerns. Some might even return to cigarette smoking.

    “Regulators, at the behest of anti-smoking activists, are missing the forest for the trees—or at least overlooking the 7,000 carcinogenic chemicals that make traditional cigarette smoking so detrimental while focusing on one highly addictive but not particularly dangerous substance,” he states. “Many public-health advocates take a zero-tolerance approach toward anything tobacco or nicotine-related. They seek to ban—or overly regulate—e-cigarettes as a means to reduce availability. Their goal is abstinence, although they often support the use of Food and Drug Administration (FDA)-approved smoking-cessation products, such as patches and gum, that contain some nicotine.”

    In their zeal to quash the use of vape and other lower-risk nicotine products, health advocates are endangering public health, explains Greenhut. “One needn’t be a health expert to realize that if nicotine-addicted people can’t get enough nicotine to fulfill their needs, they will try alternatives,” he states. “Utah already adopted a defensible approach to nicotine regulation. Maybe now, the best approach is to leave well enough alone.”

    Steven Greenhut is Western Region director for the R Street Institute.

  • Gay: Politicians Think Nicotine Users Are Broken

    Gay: Politicians Think Nicotine Users Are Broken

    By George Gay

    If you are struggling to work out whether you and your fellow human beings will be able to save the only planet on which we can live from being made uninhabitable by climate change, it is possibly because you are looking in the wrong direction for the answer—you are looking at the data, which, because it comprises complex inputs from many interacting sciences, is impossible for a layperson to interpret.

    But never mind; I have cut through all this data for you and come to a conclusion that I believe is rock solid. No, we won’t save the world.

    And to become a fellow believer, you need look no further for evidence than the existence of the powered leaf blower. That people, with the possible exception of the disabled, buy these things rather than brooms during a climate emergency engendered largely by the overuse of unrenewable energy provides indisputable evidence that humans refuse to engage their brains and, therefore, won’t—and probably shouldn’t—survive.

    There is a man of my acquaintance who uses a powered blower to corral the leaves in his garden, which is the size only of one of those large, starched napkins beloved, for good reason, of spaghetti eaters, and at the front of his house, including the pavement, which forms a larger area.

    It is fascinating to watch him because, like a dog rounding up sheep, he has to keep going back for stragglers, which are often stragglers only because they have been hit by a puff of wind, possibly caused, in part, by climate change, which, in turn, is being exacerbated by the use of the leaf blower …

    But his offense is worse than this because, after corralling his leaves, he gets into his car, which is not much smaller than a bus capable of carrying half a dozen people and all their worldly goods, and drives off, alone, to the gym, contributing as he goes to the already high and probably illegal levels of pollution we happily maintain in these parts.

    Credit: Good Ideas

    He could have obtained a good level of exercise by wielding a broom at those leaves, but no, he prefers to burn fossil fuels driving down to the gym where he mounts an exercise machine manufactured using huge amounts of energy and materials dug out of the ground or manufactured so as to be, like Tithonus, cursed with an immortality not mitigated by eternal youth.

    At least you would think that the machine he mounts would be connected to the gym’s power supply so that the work he does has some purpose. But no, this is a lesson in entropy, so the work he does is converted into heat that causes the gym’s air-conditioning system to kick in, burning more energy …

    And as my acquaintance works on his machine, happily watching his pain and discomfort reflected back at him by giant mirrors, keenly monitoring on his wrist-mounted electronic device the state of organs whose position in his body he couldn’t identify, and listening distractedly to music delivered through sweat-encrusted headphones, his wife is vacuuming the house—getting rid of the dust that, in no small part, comprises small leaf particles created and driven into the air by the actions of her husband and his leaf blower.

    Is this sensible? Of course, I admit that, even though there are a lot of people like my acquaintance and his wife, to a certain extent, what individuals can do to help ameliorate the climate emergency is a drop in the ocean compared with what could be done by businesses, industries and governments, but I think the situation would be helped if individuals showed a greater awareness of the problems we face and the sorts of actions that are plain stupid if the aim is to save the planet.

    In that way, perhaps, they would be in a better position and more likely to put pressure on businesses, industries and governments to take action. After all, it would be awful to go out with a whimper.

    There is no point in expecting politicians to act logically without their being pressured to do so because, as somebody nearly once said, people are governed by parliaments, not by logic. Unfortunately, we in the tobacco and nicotine industries are similarly governed—not by logic, but by governments largely swayed by half-baked ideas delivered by lobbyists, broken economic systems and pollsters, not to mention great dollops of hypocrisy.

    So my eye was caught recently by the heading of a May 7 story by Sarantis Michalopoulos for EURACTIV.com based on an interview with Michele Rivasi, who was described as a French EU lawmaker from the group of the Greens/European Free Alliance (Europe Ecologie) of the European Parliament, MEP: E-cigarettes have a place in the EU Cancer Plan, but we must remain vigilant. Given this was a report based on an interview with a Green politician, I was keen to read it because I am interested in the environmental credentials of e-cigarettes, a subject that doesn’t seem to attract enough debate.

    However, I was disappointed. This was another of those fence-sitting exercises in which the risk-reduction characteristics of e-cigarettes are acknowledged but in which it is said that nothing should be done to encourage their use, which seems to miss the point that if their use isn’t encouraged, then their risk-reduction potential remains hanging in limbo.

    Credit: Balint Radu

    “E-cigarettes ‘undoubtedly’ reduce risks compared to traditional cigarettes and have a place in the EU’s plan to fight cancer,” Michalopoulos quotes Rivasi as saying. “However, these products should not enjoy ‘lighter’ regulation, and Europe should treat them with the same vigilance as tobacco products. I see no reason why the electronic cigarette and its products should benefit from tax reductions or exemptions.”

    What is being said here? Well, as I read it, nothing helpful or rational. Rivasi seems to be saying that traditional cigarettes and e-cigarettes are, at one and the same time, different but the same. These products are so different that e-cigarettes can be seen as part of the weaponry with which to fight cancer, whereas traditional cigarettes comprise part of cancer’s own armory. But, at the same time, they are so similar that they should be treated the same when it comes to regulations and taxes.

    You have to wonder what Rivasi believes smokers will make of such a stance, if indeed it can be regarded as a stance. Most smokers, I imagine, make some kind of compromise in moving from traditional cigarettes to e-cigarettes, perhaps in respect of satisfaction, taste, convenience … Even so, in the early days of e-cigarettes, it was probably relatively easy to get smokers to convert because many of them were willing to make compromises simply on the basis that they were moving to a less risky product.

    Now, in those countries where a significant level of conversion has taken place, it becomes necessary to try to reduce the compromises that must be made and, in this way, encourage more-committed smokers to convert. Tobacco and nicotine businesses tend to do this simply because they are in competition; they want their products to be more satisfying, tasty and convenient than those of their competitors.

    But an important way of reducing the compromises that have to be made is through price—i.e., tax—differentials or through regulation, such as that allowing the use of e-cigarettes in at least some public places where traditional cigarettes may not be smoked. Lumping together traditional cigarettes and e-cigarettes in respect of taxation and regulation is simply ridiculous if the aim is to get smokers to transition to vaping. It sends out a signal that e-cigarettes do not offer a real health benefit.

    Rivasi has more to say on products that to her way of thinking are similar. “For us, the Greens, if the use of electronic cigarettes is claimed to be an alternative to tobacco [use], as a substitute product or as a way of reducing the ravages associated with conventional cigarettes … we need to consider electronic cigarettes as a medical device in the same way as gum or patches are pharmaceutical products,” Michalopoulos reports Rivasi as saying.

    I’m not sure whether a distinction is being made here between a medical device and a pharmaceutical product, but I assume not. So what seems to be being said is that if e-cigarettes are claimed to be a substitute for or alternative to traditional cigarettes, they should be treated as if they are nicotine-replacement products (NRTs), an idea that seems to ignore the fact that NRTs are not consumer products and therefore cannot be seen as substitutes for or alternatives to traditional cigarettes.

    Again, the lack of logic drives you to impossible places. If, as above, it is claimed that NRTs are the same as e-cigarettes, which are the same as tobacco products, you have to assume that all three should be taxed at the same level and subject to the same regulations. So, for instance, people shouldn’t be allowed to wear nicotine patches in enclosed public places.

    Quite clearly, this would be ludicrous for a number of reasons, and the problem stems from trying to pretend that different things are the same. Traditional cigarettes and e-cigarettes are two similar but different consumer products, whereas NRTs are medical devices, even though, in the U.K., for instance, they have been licensed for harm reduction rather than just cessation.

    During the interview, we get much else that seems to discourage the use of e-cigarettes. We get the EVALI (e-cigarette or vaping use-associated lung injury) distraction and a totally unconvincing passage about what Rivasi sees as the gateway vaping provides to smoking.

    Credit: Aleksej

    Later, she is quoted as saying the shortcomings of legislation concerning heated tobacco and electronic cigarettes are known. “We need better regulation of sales and advertising, a thorough analysis of additives and their cocktail effect, a ban on flavorings and mandatory health warnings to alert nonsmokers to the risks, as is the case for traditional cigarettes,” she is reported as saying.

    These are just throwaway lines. What does it mean to talk of “better regulation”? Better regulation to somebody steeped in tobacco harm reduction is going to look a lot different to better regulation as seen by those supporting a quit-or-die agenda while goodness knows what better regulation looks like to somebody perched on the fence.

    And what is the point, apart from providing cover for science departments to carry out pointless “research,” in calling for a thorough analysis of additives while at the same time calling for a ban on flavors, which make up a huge proportion of those additives?

    Towards the end of the reported interview, Rivasi moves to a favorite of politicians: the attribution to a group of a claim that the group has not made and then the condemnation of that claim. “The electronic cigarette is undoubtedly a product that can reduce risks, but it is not the panacea its followers—and the companies behind them—would have us believe,” she is quoted as saying.

    I have never heard people who promote e-cigarette use over traditional cigarette use claiming such a move is a panacea. The panacea quip is another throwaway line and one that needs to be thrown away. Indeed, Rivasi knows as much. Earlier in the interview, she is quoted as saying, “The industry itself acknowledges its ignorance and wants to know more about the real impact of its products.” That doesn’t sound to me to be an industry claiming to have already developed a panacea.

    There is something odd here. As I mentioned above, there is no mention in the interview of the area of the e-cigarette debate to which Rivasi could, I assume, make a valuable contribution. How do you compare the environmental impacts of traditional cigarettes, e-cigarettes, other new generation products and NRTs?

    The major problem is that politicians often believe they need to fuss around tidying up the lives of smokers and nicotine users without considering the wider picture. They are like my acquaintance and his use of the leaf blower. In fact, I would much sooner hear Rivasi talking about leaf blowers and patio heaters … There is no point in extending by a few years the lives of some smokers if we’re all going to die prematurely of pollution and the effects of climate change.

  • Stroud: Hypocrisy of the American Healthcare System

    Stroud: Hypocrisy of the American Healthcare System

    You don’t have to be a doctor, or even play one on TV, to see the conflict: American healthcare policy that promotes taxpayer-funded needle exchanges for drug addicts, but opposes vaping as an alternative for smokers.

    The Biden administration recently announced a robust plan to address the nation’s crippling opioid epidemic, which was responsible for 500,000 American deaths between 1999 and 2019. That harm reduction includes needle exchanges, long a controversial policy. In 1988, Congress barred the use of federal funding for needle exchange programs. In 2015, amid the growing opioid crisis, then-President Barack Obama signed the Consolidated Appropriations Act, “which modified the restriction on use of federal funds for distributing sterile needles or syringes,” and allowed for funding to be used for other services, but not syringes.

    The Biden administration plan mentions “harm reduction” a total of 12 times and hopes to “enhance” and “support” emerging harm reduction efforts. Although attempting to tackle the opioid epidemic is an admirable goal, the administration is doing an about-face in terms of adult access to all harm reduction products, and they’re not the only ones.

    Rhode Island lawmakers recently held hearings on a series of bills that would ban flavored tobacco substitutes like vaping products. But those same Ocean State legislators held a floor session for the final vote on a bill that would establish “harm reduction centers.” A spirited debate took place for nearly an hour. Ultimately the measure passed by a vote of 62-9.

    Harm reduction centers for opioid users are a worthwhile goal, but it is overwhelmingly hypocritical for lawmakers to support government funding those, while simultaneously blocking adult access to tobacco harm reduction products including e-cigarettes, heat-not-burn, and smokeless tobacco.

    It is the smoke in combustible cigarettes that is responsible for the damage wrought by tobacco. Tobacco harm reduction products eliminate that smoke while allowing adult users to access nicotine, which in itself is not the harmful component of cigarettes. The U.S. Food and Drug Administration (FDA) has noted that it is the “mix of chemicals – not nicotine – that causes serious disease and death in tobacco users.”

    The FDA currently regulates vapor products. But the agency, which fought so hard to regulate these products, has yet to approve a single premarket tobacco product application for any e-cigarette product. During a U.S. House oversight subcommittee meeting last month, lawmakers urged the agency to not approve any flavored e-cigarette product to “protect youth.”

    In the Rhode Island House hearing, a spokesman for Campaign for Tobacco-Free Kids (CTFK) urged lawmakers to ban flavored tobacco and vapor products while supporting lawmakers’ efforts in increasing access to clean syringes and opioid antagonist medications, including methadone.

    This makes no sense.

    Is anyone arguing that more Americans should smoke? Or that health policy should promote smoking? Of course not, just as needle exchange advocates aren’t hoping more people will get hooked on heroin. It’s simply an acknowledgment of human nature, and an effort to reduce harm.

    The infamous anti-tobacco and vaping crusader Michael Bloomberg similarly supports opioid harm reduction, but not tobacco harm reduction. A recent New York Times article interviewed the director of drug use initiatives at Vital Strategies, a Bloomberg-backed “philanthropic group.” The director noted that harm reduction programs help persons “stay safe and healthy and alive first and foremost.” Since 2016, Vital Strategies has worked in tandem with the World Health Organization to ban adult access to tobacco harm reduction products. In 2019, the organization highlighted India’s ban on e-cigarettes as a victory. Bloomberg himself has donated $160 million over a three-year period to “fight flavored e-cigarettes.”

    In Rhode Island, the CTFK spokesperson noted that opioid harm reduction programs don’t create new users. That may be true, but e-cigarettes create former smokers by helping adults quit smoking. Moreover, they don’t cost taxpayers a dime, and as a harm reduction product, they help to reduce health care and other smoking-related costs.

    The FDA has the ability to save millions of lives by approving tobacco harm reduction products. They shouldn’t let misinformed entities and people like CTFK and Michael Bloomberg stand in the way of science and common sense.

    This opinion originally appeared at Inside Sources.

  • Taxing the Solution

    Taxing the Solution

    Credit: Farizun Amrod

    Vaping products don’t create costs; they make some of the costs of tobacco use disappear.

    By George Gay

    According to a Vapor Voice news story quoting a CStoreDecisions piece by Isabelle Gustafson, lawmakers have introduced into the U.S. Senate a bill that would establish a federal tax on vaping products and increase the traditional tobacco tax rate for the first time in a decade.

    I quote below three of the five-paragraph news story in full because I believe that some of the points made by those supporting the bill need to be challenged, though I acknowledge that such challenge will not affect the final outcome:

    The Tobacco Tax Equity Act of 2021 aims to “close tax code loopholes for tobacco products by increasing the federal tax rate on cigarettes, pegging it to inflation to ensure it remains an effective public health tool and setting the federal tax rate for all other tobacco products at this same level.”

    “Tobacco-related disease accounts for one out of every five deaths in America, and I know that story firsthand,” Senate Majority Whip Dick Durbin was quoted as saying. “Data shows that the most effective strategy to prevent children from starting this deadly habit is to price it out of their range. This bill would help reduce tobacco and e-cigarette use by ending loopholes that the industry has exploited to target our children. If America can kick its nicotine addiction, it would go a long way to improving our public health for generations to come.”

    “Loopholes in our tax code continue to favor big tobacco while the American public, especially our youth, pays the price,” said Representative Raja Krishnamoorthi. “The Tobacco Tax Equity Act increases taxes on cigarettes and finally imposes taxes on the e-cigarettes hooking our children on nicotine, which would generate billions of dollars in federal revenue. As a father of a high schooler and middle schooler, I’m determined to make sure we end the youth nicotine and vaping epidemic.”

    I would like firstly to question the term “loopholes,” which is used three times, once in the introduction and once each by the two politicians quoted. The word loophole is used normally to convey the idea that some scam is in operation that allows a disreputable individual, corporation or organization to gain an advantage over others by obeying the letter of a law or rule but not the spirit of that law or rule. And that implied criticism is aimed at one of the usual suspects—big tobacco.

    But is this what has been going on here? Has big tobacco been using loopholes in the tax system to target young people? Not from the evidence presented. The politicians quoted seem to be complaining that big tobacco hasn’t been falling in line with tax rules not yet in place, which seems a tad unfair. In other words, the complaints, if any, should be aimed at the politicians for not having brought in these new rules earlier, given that they seem to believe they are so important.

    But it is not the way of politicians to blame themselves or even to admit that they have been neglectful of their duties, so the politicians try to clamber onto the word loopholes as if it somehow represents the moral high ground.

    And on that somewhat unstable ground, they teeter. Durbin is quoted as implying that one or more people from within his circle of family and/or friends died from a tobacco-related disease. I’m sure that most people would sympathize with Durbin at this point, but the problem here is that he is trying to convince people of the correctness of his position by arguing from the particular to the general.

    And the concern must be that despite the fragility of such arguments, other politicians will be won over. It makes you wonder what would happen if a politician called for extra taxes on automobiles because somebody from within her circle had been killed in an automobile wreck.

    What I don’t like, also, about Durbin’s position is that it smacks of collective punishment. Tobacco consumption led to the death of somebody from within his circle, so all tobacco users should be punished through the taxation system, even though what they are doing is legal and even though they had no interaction or involvement with the dead person. Such actions are banned even in war.

    Then, from the dizzying moral heights of language loopholes and particularities, the announcement moves on to the favorite ploy of all: emotional blackmail. We are told that the new taxes will protect “our children”—or, rather, children (three mentions), youth (two mentions) and schoolers (two mentions).

    I wonder how? Perhaps, in the light of not enough attention being paid by politicians to some of the other needs of children, the additional money raised through the new taxes could be used to feed the 18 million children who are projected to face hunger in the U.S. this year. But don’t hold your breath.

    Credit: Auremar

    Krishnamoorthi is quoted as saying that the Tobacco Tax Equity Act “increases taxes on cigarettes and finally imposes taxes on the e-cigarettes hooking our children on nicotine.” Note the use of “finally” here, which I guess is meant to imply that it has taken a long time to bring the bill forward because of the heroic efforts that politicians have had to put in to overcome the huge barriers standing in the way of tax reform, when, presumably, the reason is that they have not been bothered up to this point.

    I would also like to take issue with the idea that Krishnamoorthi trots out about “e-cigarettes hooking our children on nicotine.” Does he know this to be the case, I wonder? Has he proof? It is true that if you look on the website of the National Institute of Drug Abuse, you will see a piece that says, “Consuming nicotine—through regular cigarettes or vaping—leads to the release of the chemical dopamine in the human brain. As with many drugs, dopamine prompts or ‘teaches’ the brain to repeat the same behavior (such as using tobacco) over and over.”

    But according to a review by Rivka Galchen (London Review of Books, April 22) of The idea of the Brain, the author, Matthew Cobb, casts doubt on such an idea. “The connection of dopamine to addictive behavior—Cobb cites a Facebook founder saying the site was meant to be addictive, to ‘give you a little dopamine hit’—is ‘nonsense’ and ‘neurobollocks,’” Galchen quotes Cobb as saying. I am not saying that Cobb is correct. I am not in a position to be able to judge such things, but what he has to say must surely give people, even politicians, pause for thought, for he is not alone in thinking this way.

    One problem in assessing the rights and wrongs of taxing vaping products in the U.S. arises from the fact that politicians have fallen for the Food and Drug Administration’s descent from science to alchemy in “deeming” these products to be tobacco products. Imagine a U.S. in which bread has not been invented and a significant proportion of the population lives on cake as a staple, with the consequence that these people are wobbly fat.

    In trying to improve the situation, the authorities have turned to imposing high taxes on cake, but the sugar content proves to be too appealing, and the people keep buying cake, whether tax-paid or illicit. The authorities then declare war on the cake manufacturers who, after a while, admit that too many wobblies are dying, and come up with bread, with which they claim they can wean at least some of the people off cake.

    What do the authorities do? Do they welcome this development? Not if we are talking about the FDA. They say that bread, like cake, contains flour, and, since there are still small amounts of sugar in bread to make it palatable, bread must be deemed to be cake. At which point, the politicians, desperate for funds, realize that bread can be taxed. Alice has gone headfirst through the looking glass.

    Credit: Highway Starz

    A couple of other points come out of the announcement of the bill. It is clear that part of the aim of the bill is to force the U.S. “to kick its nicotine habit.” But nicotine and tobacco use are both legal in the U.S., so people have the right to consume tobacco and nicotine products. There is a danger here that politicians are going to muddle up issues of ethics with those of rights.

    Just because you object to something on ethical grounds doesn’t bestow on you the right to make it unobtainable for those who don’t go along with your ethical views. In the U.K., we seem to get stuck in the same morass when discussing the issue of assisted dying, and all too few politicians are willing to make the stand that though they might be ethically opposed to assisted dying, they recognize the rights of others to avail themselves of it. As I believe Michel de Montaigne pointed out in the 16th century, “Life is slavery if freedom to die is wanting.”

    At the same time, it seems to me that we enter the tobacco and nicotine tax debate too far along the line. We enter it on the assumption that tobacco and nicotine products should be taxed. But why is this so? Well, one idea has it that products should be taxed according to the harm that they cause. This point was made by a couple of speakers who addressed the Western Economic Association International (WEAI) virtual conference during March.

    According to a news report, one of them, Woo-Hyung Hong, professor in the Hansung University Department of Economics (South Korea), said that tobacco taxes should be based on a product’s external economic costs. Such a system should consider medical costs, loss-of-labor capital costs, costs from cigarette-related fires and avoidance costs, among others.

    There is a certain logic associated with this idea, but if you accept that logic, then surely you have to apply it to everything. Automobiles, for instance. Look at the medical costs that arise from people driving automobiles. There are, of course, the deaths and injuries caused by car wrecks, the deaths and injuries caused by the pollution most automobiles contribute to, pollution that has now been acknowledged to be a bigger killer worldwide than tobacco consumption. And then there is the issue of people becoming wobbly fat because they use their cars rather than walk.

    This, in part, is what the U.S. Centers for Disease Control and Prevention has to say on this subject: “Obesity is serious because it is associated with poorer mental health outcomes and reduced quality of life. Obesity is also associated with the leading causes of death in the United States and worldwide, including diabetes, heart disease, stroke and some types of cancer.”

    And what about the loss-of-labor costs? Well, for a start, all of the medical problems outlined above are likely to lead to such loss of labor, and just imagine the loss caused by people snarled up in highly polluting traffic jams.

    And while most automobiles still run on fossil fuels, there is the billion-dollar cost of subsidizing the oil companies for pumping these fuels out of the ground—fuels, the use of which is causing eye-watering costs associated with climate change and environmental breakdown, costs from which we might never recover.

    None of this is to say that tobacco should not be taxed. We are too far down the road to go back now. But all of the revenue from such taxes should be used to relieve some of the causes that encourage people to take up smoking; one of which is clearly poverty since poverty is a good predictor of the likelihood of a person being a smoker. I believe in the idea of redistributive taxes, but the way that tobacco taxation works at the moment is that it is redistributive “upward,” which is obscene.

    And finally, there is no reason to tax vaping devices. They don’t create costs; they make some of the costs of tobacco use disappear. They are a solution, not a problem.

  • Tobacco Control Veteran: Time to End War on Vaping

    Tobacco Control Veteran: Time to End War on Vaping

    Photo: pavelkant

    It is time to the end of the internecine warfare over vaping, according to Clifford Douglas, former vice president of Tobacco Control at the American Cancer Society and founder of the Center for Tobacco Control.

    In a recently published commentary, Douglas writes that the U.S. tobacco control community is “letting down tens of millions of adult smokers, their families and friends, healthcare providers and government decisionmakers.”

    “I refer to my community’s approach to dealing with electronic cigarettes,” Douglas writes. “We are now neck-deep in intractable internecine warfare between the mainstream tobacco control community, whose primary focus is on protecting youth from the dangers of vaping, and the tobacco harm reduction (THR) community, some of whose scientists are also committed participants in mainstream tobacco control efforts. The THR community emphasizes the potential benefits of vaping for adult smokers who cannot or will not quit smoking otherwise. It seems that ne’er the twain shall meet.”

    There are ways to prevent youth use that won’t inflict harm on adult smokers.

    Vapor advocates welcomed Douglas’ comments.

    “The Canadian Vaping Association commends Douglas for trying to bridge the gap between tobacco control and vape advocates,” the CVA wrote in a press note. “In the end, we all have the same goal of a tobacco free society. The past practices of tobacco companies have caused distrust of the vape industry with regulators and the public. It is important to remember that this industry was created by smokers, for smokers. We don’t want youth vaping and have proposed many reasonable solutions. There are ways to prevent youth use that won’t inflict harm on adult smokers,” said Darryl Tempest, executive director of the CVA.

    Douglas has also formerly served as a special counsel on tobacco issues in the U.S. House of Representatives, as a tobacco control policy advisor for the U.S. Assistant Secretary for Health and the U.S. Surgeon General, and as a lawyer representing injured smokers and state attorneys general in litigation against the tobacco industry.

  • Irvine: Health Canada’s Nicotine Cap is Deadly Decision

    Irvine: Health Canada’s Nicotine Cap is Deadly Decision

    If Health Canada has its way, this year vaping will be dealt three knockout blows that will see, not just the end of the business as we know it, but an increase in smoking-related deaths nation-wide, says Ian Irvine, a professor of economics at Concordia University.

    Ottawa is recalibrating the delicate equilibrium between harm reduction and youth use of nicotine. It plans to introduce a mandatory limit on nicotine concentration in e-cigarettes and to ban most flavours. Maximum permissible content is currently at 66 milligrams per millilitre; the new limit will be 20. Eventually, we will see strike three: excise taxes.

    Ian Irvine, courtesy Concordia University

    Harm reduction tries to induce smokers to switch to nicotine products with greatly reduced toxins, particularly if they are habituated or even addicted to nicotine. Public Health England has repeatedly stated that the toxins in e-cigs are at most five per cent of those in regular cigarettes. The toxins that cause cancer come from the burning of tobacco at 700 degrees Celsius. But vaping devices heat rather than burn. Nicotine is not the health demon. It does cause habituation. But it’s the burning that shortens lives.

    In an article for the Regina Leader-Post, Irvin explains that e-cigarettes are not harmless. The health problem vaping poses is that between five and 10 per cent of teens are regular vapers and nicotine is bad for the developing brain. But while a pack-a-day smoker will on average lose 10 years of life, an equally indulgent vaper might lose just one. Most adults who drink moderately, gamble, like sugar too much, or exercise insufficiently might think one year off a normal lifespan a reasonable price to pay to indulge a passion or need.

    As for adult smokers, people considering a transition from smoking to vaping require a product yielding enough nicotine to satisfy their craving. Many potential switchers will not make the transition — and will end up dying prematurely — if they cannot get a strong enough nicotine substitute for their cigarettes. Canada has about 40,000 smoking-related deaths per year, so if even a small percentage of smokers don’t transition because of insufficient nicotine, that will mean thousands more deaths annually.

    If Health Canada succeeds in introducing both a nicotine cap and a flavour ban on vaping, smoking rates will continue to be higher than necessary and many thousands of unnecessary deaths will folllow.

    The entire opinion can be read here.