Several court cases challenging the U.S. Food and Drug Administration’s issuing of marketing denial orders (MDOs) in response to its review of premarket tobacco product applications are still pending. Last week, three high profile tobacco harm reduction advocates filed their fourth amicus brief in support of companies that are challenging the FDA.
Credit: Sang Hyun Cho
Clive Bates, director of Counterfactual Consulting, David Abrams, a professor of social and behavioral sciences at the NYU College of Global Public Health, and David Sweanor, adjunct professor of law at the University of Ottawa, filed the latest brief in support of Chicago-based Gripum LLC, which has had its MDO temporarily stayed by the court while the FDA’s actions are reviewed.
“The PMTA process and [appropriate for the protection of public health] APPH test do not apply to combustible cigarettes, which have a much less onerous path to market; accordingly, the most dangerous products are easily accessible throughout the United States, and their manufacturers do not face the threat of financial ruin from FDA’s regulatory burdens and determinations,” the brief states. “FDA’s regime for evaluating ENDS amounts to a major barrier to entry for less harmful products than cigarettes and unjustified regulatory protection of the incumbent combustible cigarette trade. The harms arising from adult and adolescent cigarette smoking far outweigh the harms arising from youth use of ENDS.”
The group also addressed the FDA’s having established an onerous new standard of evidence in PMTAs. The FDA has admitted to using a “fatal flaw” checklist to deny over one million PMTAs without further consideration because they do not provide randomized controlled trials, cohort studies, or other types of (unspecified) evidence that FDA had retrospectively deemed necessary. They also state that the APPH test doesn’t differentiate between adults and youth.
“The APPH test applies to the ‘population as a whole.’ There is no distinction drawn between adolescents and adults in the Act. In some circumstances, ENDS use can be beneficial to adolescents who would otherwise smoke,” the brief states. “As a matter of policy, FDA chooses to take no account of such benefits to youth, but that approach is incompatible with the APPH test in either the PMTA pre-market review process TCA §910(c)(4) or in rulemaking for setting product standards §907(a)(3).”
The group filed similar briefs in three other cases: Triton v FDA – Fifth Circuit (17 Nov 2021), My Vape Order v FDA – Ninth Circuit (24 Nov) and Bidi Vapor v FDA – Eleventh Circuit (24 Nov).
One hundred tobacco harm reduction (THR) experts have published a joint letter challenging the World Health Organization’s (WHO) approach to tobacco science and policy. The group is urging members of the Ninth Session of the Conference of the Parties (COP-9) of the Framework Convention on Tobacco Control (FCTC), a global intergovernmental treaty in which the WHO plays a major role, to encourage the WHO to support and promote the inclusion of tobacco harm reduction into its regulatory advisements.
Credit: Igor Golovnev.
“Smoke-free nicotine products offer a promising route to reducing the harms arising from smoking. There is compelling evidence that smoke-free products are much less harmful than cigarettes and that they can displace smoking for individuals and at the population level,” the letter states. “Regrettably, [the] WHO has been dismissive of the potential to transform the tobacco market from high-risk to low-risk products. [The] WHO is rejecting a public health strategy that could avoid millions of smoking-related deaths.”
The letter was published on Oct. 18 and will be sent to COP-9 delegates. In a joint statement, Ruth Bonita, former director of WHO Department of NCD Surveillance, and Robert Beaglehole, former director of the WHO Department of Chronic Disease Prevention and Health Promotion, stated that they were “extremely disappointed by WHO’s illogical and perverse approach” to reduced-harm nicotine delivery products, such as vaping.
“A key challenge in global tobacco control is to assist cigarette smokers to transition from burnt tobacco products to much less harmful options that provide the nicotine without the toxic smoke,” the statement reads. “[The] WHO’s continuing disregard of the wealth of evidence on the value of these products is condemning millions of smokers to preventable disease and premature death.”
The letter goes on to make seven points about the current vaping regulatory environment, such as the value of vaping in THR and the unintended consequences of poor regulatory policies. The authors then go on to make six suggestions for the WHO to consider:
Make tobacco harm reduction a component of the global strategy to meet the Sustainable Development Goals for health, notably SDG 3.4 on non-communicable diseases.
Insist that any WHO policy analysis makes a proper assessment of benefits to smokers or would-be smokers, including adolescents, as well as risks to users and non-users of these products.
Require any policy proposals, particularly prohibitions, to reflect the risks of unintended consequences, including potential increases in smoking and other adverse responses.
Properly apply Article 5.3 of the FCTC to address genuine tobacco industry malpractice, but not to create a counterproductive barrier to reduced-risk products that have public health benefits or to prevent critical assessment of industry data strictly on its scientific merits.
Make the FCTC negotiations more open to stakeholders with harm-reduction perspectives, including consumers, public health experts, and some businesses with significant specialised knowledge not held within the traditional tobacco control community.
Initiate an independent review of WHO and the FCTC approach to tobacco policy in the context of the SDGs. Such a review could address the interpretation and use of science, the quality of policy advice, stakeholder engagement, and accountability and governance. The Independent Panel for Pandemic Preparedness and Response (IPPPR), initiated to evaluate the response to the COVID-19 pandemic, offers such a model.
Another signatory, David Sweanor, adjunct professor of law, chair of the Advisory Board of the Centre for Health Law, Policy and Ethics University of Ottawa, Canada, in a separate statement, said that effective public health efforts need to be based on science, reason and humanism. Instead, the WHO is aligning itself against all three when dealing with nicotine.
“The result is that one of the greatest opportunities to improve global health, separating nicotine use from smoke inhalation, is being squandered. Global trust in health authorities, and the WHO in particular, has never been so important,” the statement reads. “Yet the WHO is abandoning science, rationality and humanism on nicotine and instead apparently pursuing the moralistic abstinence-only agenda of external funders. This is a public health tragedy that extends well beyond the unnecessary sickening of the billion-plus people who smoke cigarettes.”
Policy experts weigh in on the vaping industry’s future under the Biden administration.
By Maria Verven
Within days of assuming office, U.S. President Joe Biden issued executive orders to respond to Covid-19, by far the biggest global health threat in over 100 years. It may be months or even years before anyone knows how the new administration and the U.S. Centers for Disease Control and Prevention (CDC) and its new director, Rochelle Walensky, will respond to another major health threat: the 480,000 annual deaths caused by combustible cigarettes.
Vapor Voice interviewed vapor industry leaders and legislative experts for their opinions on how the vapor industry might fare under the new administration. The panel includes:
Mark Anton, executive director, Smoke-Free Alternatives Trade Association (SFATA)
“Let’s get the junk science funded by big pharma and the tobacco Master Settlement Agreement out of the narrative of harm reduction. The federal government must be guided by the best science to ensure responsible decision-making.”
Gregory Conley, president, American Vaping Association (AVA)
“Legal nicotine vaping products are far less hazardous than smoking and serve a vital public health role in helping adult smokers quit.”
Michael Siegel, professor, Department of Community Health Sciences, Boston University School of Public Health
“Vaping is, for many smokers, a life-saving health decision. It is much safer than smoking and is literally saving the lives of smokers who would likely die if they weren’t able to stop smoking.”
David T. Sweanor, adjunct professor, advisory board chair, Centre for Health Law, Policy & Ethics, University of Ottawa
“It’s the smoke, stupid.”
Vapor Voice: What policy changes might the Biden administration make regarding vaping products?
Anton: During the Biden administration, SFATA is taking the lead in youth prevention with the creation of the Responsible Industry Network, which we presented to HHS and the FDA. This would allow adults to access flavors while protecting small businesses through the FDA’s PMTA (premarket tobacco product application) process.
Mark Anton / Credit: SFATA
Adults need access to products that help them transition away from combustible cigarettes, so unfavorable e-cig policies and flavor bans should not be on their agenda. Vaping is truly a good tool for tobacco harm reduction. The industry is made up of former smokers who strive to develop the best manufacturing practices without the FDA’s help. To protect against youth use, SFATA supports the enforcement of T21 [Tobacco 21], passed by Congress and signed by the president. Covid[-19] policies have prevented true enforcement.
Finally, the CDC should always give true assessments and release reports to the media and medical and public health journals. Last year, the CDC failed to give a full accounting of EVALI (vaping-related lung illnesses), when they should have made a declarative statement that vaping nicotine e-cigs was not the cause.
Conley: Sadly, there is no use answering this question as there’s no indication whatsoever that the Biden Administration will make favorable decisions with regard to vaping products. I would be thrilled to be wrong, but after a decade of fantasizing about smart policy and regulations and only getting the opposite, it’s time to stop dreaming and work within the broken system we have.
Siegel: Introduce legislation to ban the sale of tobacco products, including vaping products, with the exception of stores only open to [consumers] 21-plus that only sell these products. And direct health insurance companies to cover electronic cigarettes just as they cover other forms of nicotine-replacement therapy.
Encourage physicians to promote vaping for smokers who are unable to quit using other means. And direct the CDC, FDA and other national health agencies to endorse the use of vaping products for smoking cessation, especially when traditional medications do not work. Finally, discontinue the requirement for PMTAs for vaping products and, instead, directly regulate these products by forcing the FDA to promulgate safety regulations.
Sweanor: Follow the science on relative risk and communicate truthfully with the public. And empower those who use nicotine to have control over their health though ready access to a wide range of low-risk alternatives to cigarettes and risk proportionate regulation of the spectrum of products. Access to alternatives to cigarettes should be no less urgent a public health goal than access to Covid[-19] treatments and vaccines. Government policy should reflect this urgency.
What were the most egregious policies implemented during the Trump administration?
Anton: Clearly, CDC misinformation about EVALI, falsely accusing e-cigarettes and seeking to ban flavors without sufficient scientific evidence is high on the list of misguided policies. And despite all the research to the contrary, they created hysteria by calling e-cigarette use by minors an ‘epidemic’ when it was not. The true epidemic is 480,000 smokers dying every year from smoking combustible cigarettes.
Conley: [Former]President Trump created a wave of issues when he declared that flavored vaping products should be banned because they were killing people. He was undoubtedly being fed bad information from his advisors, but it was ridiculous coming from the supposed pro-business, anti-regulation POTUS. Even Trump’s biggest fans realized that one of his flaws was his inability to hire competent people who shared his worldview. Putting Alex Azar in as Secretary of Health and Human Services assured there would be no positive movement to reform vaping regulations at any of the agencies HHS oversees.
Greg Conley / Credit: AVA
Siegel: The ban on flavored e-cigarettes in pod systems and the requirement that companies must submit PMTAs to stay on the market both need to be reversed. There does need to be regulation of nicotine strengths, especially for nicotine salts, but getting rid of flavors isn’t going to solve the problem of youth vaping, and it is hurting many adult ex-smokers.
Sweanor: I think the biggest failure was the failure to remove the mounting barriers confronting less hazardous products such as e-cigarettes. After a steep decline in cigarette sales by substituting safer products, particularly vaping, cigarettes started making a comeback as the CDC and other agencies engaged in a massively misleading campaign against vaping.
Meanwhile, the FDA put vaping at a marketplace disadvantage compared to cigarettes. Research showed those most at risk were misinformed about the relative risks.
At the end of Biden’s term, what state do you think the vaping industry will be in?
Anton: The outlook is not very bright for the small vaping industry based on Biden’s cabinet selections; many have anti-vaping outlooks and ignore the multitude of studies in support of the harm reduction potential of vaping products. The focus has been on youth use even though it’s decreasing at record levels. Much of the vapor industry success or demise will hinge on the Biden administration’s willingness to look honestly at the science. Additionally, Congress has pushed to ban flavors despite the fact that flavors are an important tool for the average smoker to quit smoking.
Politics have clouded the potential of this industry’s ability to reduce harm in the U.S. regarding smoking combustible cigarettes. If the Biden administration follows this path, we will be worse off. But if they choose science and real life, it will be better. Much hinges on the role the FDA will play in issuing marketing authorizations.
Conley: Right now, most adult vapers can easily access tens of thousands of different vaping products in every flavor you can think of. While there will always be a gray market and internet sales, the legal market will never be as free as it is today.
Four years from now, there will still be a legal market for tobacco-derived nicotine vaping products authorized by the FDA. It may not be a great market, but it will exist. Companies with authorized products will do everything in their power to disrupt the gray market such as stand-alone devices, nicotine-free or tobacco-free nicotine e-liquids that many vapers rely on.
Siegel: It will probably be worse off. If the administration enforces the PMTA rules, many vaping products will be taken off the market. Big tobacco companies and a few large independent companies will dominate the market. The growth of the e-cigarette sector will wane. Many ex-smokers will return to smoking, and e-cigarettes will no longer serve as an off-ramp for as many smokers.
Dr. Michael Siegel
Sweanor: Ultimately, disruptive technology, science, rationality and human rights will win, and cigarettes will go the way of previous categories of unreasonably hazardous goods and services. The question of whether that happens within four years depends on the way politics unfolds and the emergence of leaders who see the opportunity and relentlessly pursue it.
Is limiting the level of nicotine a viable solution for users of conventional tobacco?
Conley: Bloomberg-funded prohibitionists and legislators who can’t differentiate between classes of vaping products are not going to be swayed by nicotine limits. Their goal is prohibition. When you give in to the prohibitionists, all you’re doing is guaranteeing they’ll be back next year to argue that we need flavor bans because nicotine limits didn’t work.
Siegel: Yes. Limiting nicotine in e-cigarettes will help reduce youth addiction to these products. There is also evidence that very low nicotine cigarettes can result in much lower levels of addiction in cigarette smokers.
Sweanor: No. It’s a replication of the disastrous Volstead Act that ushered in Prohibition, which forced beer and wine to have no more than a minimum level of alcohol.
David Sweanor
The total U.S. nicotine market is over $80 billion, and the cigarette market alone is over $60 billion, with tens of millions of consumers. The products are far more dependence-producing than alcoholic beverages. A prohibitionist policy is very unlikely to garner political acceptance and could rapidly lead to the sort of entrepreneurship and criminality long associated with other abstinence-only campaigns.
Many who are pushing for such a policy also oppose the wide availability of consumer-acceptable low-risk alternatives to cigarettes, demonstrating that this is a flawed moralistic strategy rather than a pragmatic public health one.
What chance do any of these proposed changes/solutions have at being implemented?
Anton: The previous FDA leadership has called the millions of smokers who have transitioned from combustible cigarettes to flavored vapor products ‘anecdotal evidence’ without investing any funds into research. The Biden administration and the new FDA leadership now has the opportunity to affect public health on a massive scale by investigating this hypothesis.
The U.K.’s National Health policy recommends that smokers who want to quit switch to vaping. They recognize vaping is safer than cigarettes. This is from the country that put warning labels on cigarette packs four years before the U.S. The Responsible Industry Network is a framework that will help prevent youth access, limit marketing to age-restricted stores and develop a pathway to prevent the loss of tens of thousands of small businesses. It brings together all the elements of the Tobacco Control Act (TCA)—protecting youth from smoking and tobacco use while assisting millions of adults who are trying to stop smoking.
While these are foundational items of the TCA and the FDA, politicians are missing the opportunity to help millions of current smokers because vaping is so politicized and youth use and access to vapor products has been blown out of proportion.
Siegel: The likelihood [that] these policies will be implemented is very low. I just don’t think the mainstream tobacco control and health organizations support the idea of harm reduction in tobacco control.
Sweanor: I have little ability to discern the likelihood of rational policies, in part because the current politics around nicotine seem to favor a War on Drugs mentality where the pursuit of total abstinence takes precedence over a public health orientation. Much will depend on Americans who use nicotine, a demographic Biden appears to care very much about.
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a P.R. and marketing firm specializing in the vapor industry.
A pragmatic health advocate, David Sweanor, is recognized for philanthropy.
By George Gay
There seems to be an unwritten rule that says you should never talk to an adversary until circumstances dictate that you have to talk to him, no matter how much harm is caused in the meantime. To start with, you simply lob rocks at him in the certain knowledge that your rocks are bigger and sharper than are his, and that soon he will admit to this difference in firepower and capitulate. But, after a while, your arm becomes tired and your head sore, and you become conscious of the idea that there could be another way of settling your differences that would result in less harm being inflicted on both sides. With any luck, some of the rocks that fell short of their target will have mingled in no man’s land, forming a little common—if bumpy—ground. At this point, talks can start. They’re a bit formal to start with—stiff even—but they loosen up once you realize that the other guy isn’t all bad and, in fact, occasionally makes some fair points.
Such a scenario has been mapped out during many government campaigns against freedom fighters/terrorists, and it reflects the course of the tobacco industry’s dealings with public health campaigners/anti-tobacco activists. The tobacco wars weren’t fought with rocks, of course, but they did involve statistics and arguments so weighted that they should have been banned under some international convention. If anybody is under the impression that truth first took flight during last year’s votes in the U.K.’s EU referendum and the U.S. presidential election, they should look back at the history of the tobacco wars.
But at least we have reached the point where, barring some skirmishes, the wars are largely over. Both sides have made significant concessions. The major tobacco companies have stated publicly that cigarettes are addictive and can cause a wide range of diseases that are often fatal. And some thought leaders in the tobacco control community have conceded that, even given this danger, it is not an easy matter for people simply to stop consuming tobacco and nicotine in any form, a view that has led them to focus on tobacco’s most dangerous and most commonly used product, the cigarette.
Stifling the conversation
The common ground, of course, is the concept of harm reduction in the form of e-cigarettes, heat-not-burn devices, some smokeless tobacco products and no doubt other devices that researchers and entrepreneurs are developing. But it is also made up of the need for the industry—now the tobacco and nicotine industry—and tobacco control to work together to ensure that the process doesn’t take any wrong turns on its new journey toward massively less hazardous alternatives for consumers.
Given the importance of the above, it seems odd that some would want to stop the nascent conversation between the industry and tobacco control. But that is clearly the case. The seventh meeting of the Conference of the Parties to the World Health Organization’s Framework Convention on Tobacco Control, which was held in India in November, barred from attending—even as an observer—anybody associated with tobacco or nicotine, whether they were industry players or government employees, along with a lot of other groups, including the media, and individuals.
And before Vapor Voice’s sister publication Tobacco Reporter staged the Global Tobacco & Nicotine Forum (GTNF) in Belgium in October, at least some tobacco control advocates and researchers who were scheduled to attend received a letter from the Campaign for Tobacco-Free Kids and the European Network for Smoking and Tobacco Prevention, informing them that these organizations hoped that the “misunderstanding” that had led to the prospective participants signing up to attend would soon be “rectified.”
Even leaving aside the fact that the letter seemed to insult the intelligence of those to whom it was addressed by suggesting that they didn’t have the wit to realize that a tobacco and nicotine forum staged by a tobacco and nicotine industry magazine would attract tobacco players, this was an extraordinary missive. It seemed to be aimed at raining down “friendly fire” on tobacco control’s advanced units as they used the GTNF to gauge whether the industry was serious about tobacco harm reduction and whether significant numbers of people could be encouraged to quit smoking by switching to the new generation of products being offered by the industry, the use of which might not be 100 percent safe—what is?—but that are by most people’s reckoning hugely safer than is smoking.
But if that weren’t insult enough, in reporting on the GTNF, The Times newspaper, while generally supporting the case for tobacco harm reduction using new-generation nicotine products, turned its fire on the industry, which was to have been expected, but also on five of the nonindustry tobacco control advocates and nicotine researchers and experts who attended. In fact, its aim when it came to the nonindustry people was so far off target that it retracted the stories and had to issue an apology, saying that, despite what it had previously written, the five were “internationally respected for their long-standing global work to reduce smoking, and their work on the issue of nicotine harm reduction,” and that their work “has not been tainted by the influence of tobacco industry funding.”
Vapor Voice asked one of those who had been named in the Times report, David Sweanor, a long-standing public health expert and adjunct professor of law with the Centre for Health Law, Policy & Ethics at the University of Ottawa, what his reaction had been to the newspaper’s piece, and he simply replied, “Here we go again.”
“I have studied the history of public health and know that virtually any rational advance engenders vicious attacks from those committed to the status quo,” he said in an email exchange. “Their challenges are not based on facts but on very personal attacks. It is disturbing but it is very common, and I feel I am walking in the footsteps of many of the historical public health innovators I have long admired.”
Sweanor made the point that it was not just “working with” the industry that was condemned as on a par with “working for” the industry, but any contact at all, even if you were simply trying to understand the dynamics within and between the various players within the tobacco/nicotine universe by, sensibly, talking to the various players. “This really hits home when senior anti-tobacco people claim that there is no difference between, say, [Philip Morris International] and an independent vape shop—that they are all, equally, ‘industry’ and thus the enemy!” he said.
Quiet philanthropist
Sweanor wasn’t chosen randomly to answer the question about how he had reacted to the suggestion that he had been working on tobacco harm reduction for the money. On Nov. 17, not long after attending the GTNF and the publication of the Times piece, he was named by the Ottawa chapter of the Association of Fundraising Professionals as the city’s Outstanding Individual Philanthropist for 2016, an award for which he had been nominated by HealthBridge. It turns out that, far from accepting tobacco money, he has been working on tobacco harm reduction for free, while donating millions of dollars to charity.
Sixteen years ago, Sweanor created a family fund with the Community Foundation of Ottawa, but he has only recently chosen to go public about his philanthropy. And it is interesting to note that his reasons for giving anonymously at first, for lately going public and for his support for tobacco harm reduction are all grounded in his rationality and pragmatism.
As Don Butler wrote in a piece for the Ottawa Citizen, Sweanor gave anonymously when he set up his family fund with the foundation in 2001 because he wanted to protect his young children from the glare of publicity; because he saw anonymity as representing the highest level of gift giving, one where you expected absolutely nothing in return; and because it shielded him from being bombarded by requests from charities he wasn’t supporting. But when the circumstances surrounding his giving started to change, Sweanor decided to discard his cloak of anonymity. With his children grown into young adults, it was time to go public in the hope of encouraging other people to look at setting up funds within the foundation.
Rationality and practicality were there from the start. In a video interview posted on the Ottawa Citizen website (goo.gl/zdBx5f), Sweanor describes how he spent his legal career doing public policy work to reduce smoking. He said he had found there were many things that could be done that were incredibly cost-effective. There were things that could be done that saved a tremendous number of lives for very little in terms of time, effort and money. And there were so many issues like that in the world, so many things where people could cost-effectively make a difference, and that was why he had worked with HealthBridge, which he described as a really cost-effective international development body working on a wide range of projects in a number of countries.
And rationality and practicality are still there. Having spent much of his working life in the front lines of the fight against smoking, he now thinks that e-cigarettes could be one of the biggest breakthroughs ever in public health. And watching him speaking on the Ottawa Citizen video, it is hard to avoid the conclusion that he is not going to be shaken from this view by a few sticks and stones. If you want to change his opinion, you’re going to have to venture onto the common ground—armed with some impressive arguments.
