May 26 Seminars

The US market is now on the path to developing a regulated market as the FDA considers applications for approval to market millions of vape products, and starts to enforce against those not engaged in the process. There is so much talk about tighter enforcement, further flavour bans and a mountain of proposed legislation on a state and local level that it is difficult to identify what is likely to happen. But meanwhile, the US nicotine market is continuing to develop and change. In vape, flavour profiles are changing, consumers are moving towards smaller open and closed system pod devices, and disposables are very much still a big part of the market. Synthetic non-tobacco derived nicotine is starting to be offered. New reduced risk products are growing in popularity; nicotine pouches, which may be a disruptor to the chew tobacco market as vape was to combustible cigarettes, are becoming prevalent, and we believe heated tobacco will be rolled out nationally very shortly. This presentation will take a look at some of the latest consumer and market data from ECigIntelligence and TobaccoIntelligence for the US, and discuss some of the market issues which will be important not just for the development of the US, but will impact the market for tobacco harm reduction products globally.

Currently, the e-cigarette marketplace is only partially regulated.  But, FDA has received millions of applications from manufacturers who want to continue to market their e-cigarettes.  The U.S. Courts have required e-cigarette manufacturers to have a marketing authorization from FDA to continue marketing their products after September 9, 2021.  So, what is FDA doing to create a regulated e-cigarette marketplace by September?  How will FDA address youth initiation of e-cigarettes?  For example, how will FDA determine which flavors and e-cigarette types (e.g., open e-cigarettes) will receive marketing authorization?  In addition, to minimizing youth initiation of e-cigarettes, how is FDA going to help adult combusted cigarette smokers have access to e-cigarettes that allow them to switch away from smoking to vaping?

With the PMTA process for ENDS now fully underway, the United States is on the verge of a transformed ENDS marketplace – one in which the products lawfully on the market are there because FDA has reviewed the scientific evidence and found their availability to be appropriate for the protection of public health (APPH), and company marketing is subject to heightened oversight by FDA.  The combined efforts of FDA and PMTA applicants have created increased potential for such ENDS determined to be APPH to be embraced by the evidence-based public health community as preferable alternatives to combustion cigarettes – and help make smoking history.

How can we get a spectacular public health win at negligible cost? To paraphrase Lewis Carroll, "if you don't know where you are going, any road will get you there." To see where we could and should be heading, this presentation looks at five clarifying ideas that will set a pro-health direction for tobacco and nicotine policy. We need clarity about: overall goals; evolving technology; human behavior; youth and risk; the information environment; and policy and regulation.?

The COVID-19 pandemic has taken the lives of more than 550,000 people in the U.S. since March 2020. This number we are told could have been far larger without the public policy interventions to date, which involved a heavy intervention by public health professionals informed largely by an all-or-nothing tolerance for harm. Meanwhile, nearly half a million lives are lost every year in the United States from cigarette smoking, and the majority of policies we see states and federal lawmakers considering vis a vis tobacco control would actually move more people away from and not toward less harmful products like e-cigarettes. This session will explore the current state of harm reduction politics in the U.S., and examine the resurgence of cigarette use over the past twelve months as a result of these trends.

• As FDA issues marketing granted orders in response to e-cigarette PMTAs, how should FDA and CDC explain the meaning of such orders and their implications for smokers
• What will the change in U.S. administrations and leadership at the FDA and CDC mean to the future of ENDS
• If the PMTA does not conclude by the September deadline, what will happen next?
  

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Professor Levy will discuss the vaping and smoking regulatory regimes and smoking prevalence trends in Australia, England, Canada and the US.  Applying the SimSmoke tobacco control simulation model, he will present estimates of the effects of vaping on smoking prevalence for each of the countries, and discuss how these results depend on the regulations in effect.

On November 27, 2001, Dr Cheryl Healton, president and CEO of the American Legacy Foundation, addressed the National Conference on Tobacco or Health on the subject, “Tobacco as a Social Justice Issue.” Dr Healton described the excess burden that tobacco places on society’s poor and underserved populations and recommended ways to expand access to cessation services. She called upon the federal government to hold the tobacco industry accountable for decades of deceptive business practices. And she urged the states to fulfill their moral obligation to use Master Settlement Agreement funds to protect their citizens from future harm from tobacco. 20 years on, Dr Healton will consider what has been achieved and what has changed.

New Zealand has taken a progressive approach to tobacco harm reduction with the Government actively promoting the role of vaping as a harm reduction tool. In particular for populations experiencing health inequities. Currently, an estimated 5% of NZ adults vape regularly, increasing to 8% for the most deprived.

Legislation to control and regulate reduced harm tobacco products and e-cigarettes was passed in mid 2020.  The intent being to balance the benefits of vaping and smokeless tobacco products (as compared to smoking) with concerns about children’s and young people’s access to these products. The legislation favours a more flexible regulatory to vaping controls and will bring some clarity to what has been a totally unregulated e-cigarette market up until now.

However, proposed regulations risk undermining the governments objectives, and tip the balance back in favour of smoked tobacco. This presentation will summarise the major changes to the vaping market as a result of recent legislation, and explore whether it will enhance or hinder the goal to reduce tobacco harms and inequities.

Australia was an early and vigorous adopter of what is now conventional international tobacco control policy. Cigarette taxes were increased 9 times in the last 10 years and Australian cigarette prices are now the highest in the world. Harm minimisation, defined as comprising supply, demand and harm reduction, has been the official national drug policy since 1985. Harm reduction is explicitly supported in the National Tobacco Strategy and the 2003 Framework Convention on Tobacco Control (which Australia has signed). Yet of all High Income Countries (HIC), Australia has been the most hostile in response to tobacco harm reduction, including vaping. It is the only HIC to require a doctor’s prescription for nicotine liquid for vaping. Almost all major Australian health organisations strongly support this approach. Further restrictions, not yet announced in detail, will be introduced on 1 October. Twenty eight government backbenchers, representing 25% of all government members of parliament, publicly criticised proposed new restrictions in June 2020 and December 2020, forcing the Health Minister to retreat. Australian smoking rates have missed official targets twice in recent years and have been almost flat since 2013. New drug harm reduction interventions such as methadone treatment, needle syringe programs and drug consumption rooms were also bitterly resisted for many years before being accepted and acknowledged as effective, safe and cost effective. Like tobacco harm reduction products, they were also strongly supported by compelling and increasing evidence. The significant decline in share price of major tobacco companies in recent years with the impressive growth in companies committed only to tobacco harm reduction products suggests that economic factors will also powerfully influence government policy in Australia and other countries. There is good reason to anticipate a political correction although this will probably take some time and involve many incremental steps.

At the beginning of April 2021, the UK Government set out its plans for the transformation of public health after the abolition of Public Health England. The vision is ambitious stating that “Health will no longer only be the business of the DHSC, but a core priority for the whole of government. “The vision will be delivered by rolling the national functions of Public Health England back into the Ministry of Health within an Office of Health Promotion (OHP), due to be up and running by October 2021.   The OHP will have a broad remit to drive “action across government on prevention and the wider determinants of health”. The reorganisation is taking place as a new Tobacco Control Plan is under development. Public Health England has played a leading role in establishing the UK’s considered and evidence-based policy position on e-cigarettes. This presentation examines what the impact of its abolition and the reorganisation of public health are likely to be on the UK’s e-cigarette policy going forward.

• Is smoking a social justice issue – are we supporting those that need it the most
• Does tobacco harm reduction compromise core tobacco control principles?
  

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The American Lung Association lists as one of their legislative priorities to “raise the tax on e-cigarettes to parity with cigarettes.” In late 2019, the US House of Representatives passed such a tax, and in the current Congressional session legislators have introduced similar bills in both the House and the Senate. Meanwhile, 28 states have enacted e-cigarette taxes of varying magnitudes, with some actually exceeding the cigarette tax equivalency. In this presentation, I summarize the quasi-experimental research on e-cigarette taxes to date. These studies generally find across a variety of populations and data sets, that e-cigarette taxes sharply reduce e-cigarette use and sharply increase more dangerous cigarette use, suggesting that these taxes may overall harm public health. I suggest an alternative legislative priority instead of increasing taxes on alternative combustible tobacco products like cigars, whose taxes are in many cases overdue for raising.

Cigarette smoking is commonly viewed as a chronic, relapsing problem requiring long-term, repeated attention and multiple quit attempts. Yet the question of whether e-cigarettes may assist with cessation is often examined with a binary, single event, “all or nothing” lens. There may be advantages of using e-cigarettes within a relapse prevention/recovery of smoking abstinence framework when more adaptively used in targeted, individually tailored situations. This presentation will discuss potential approaches of how e-cigarettes can be used in sequential quit attempts to promote abstinence following smoking lapses; the potential role of transitions in self-identity away from being a “smoker”; and research designs to maximize more targeted and tailored approaches to help identify a role for e-cigarettes.

Successful public health campaigns rely on establishing and maintaining the public’s trust in the recommendations that are given.  This presentation highlights concerns that I have about the erosion of trust in tobacco control that appears to be happening because previously trusted public health officials are staking out policy positions that distort the truth about lower risk alternative nicotine products.

Human rights have been invoked strategically as motivation to oppose tobacco industry activities. Analysis of human rights can also be applied to tobacco harm reduction with, arguably, more support. This involves close examination and identification of the limits of public health paternalism, respect for human autonomy and agency, and advocacy for those who are marginalized in society. I will review current public health political dynamics that have placed THR in a subordinate role, and suggest some strategies to level the playing field.

The ways in which those who oppose tobacco harm reduction mimic the tactics of those who opposed reform of illicit drug policies is profoundly disturbing.  Politicians and public health officials ignore the voices and concerns of consumers and others who would most benefit from harm reduction policies.  Government and philanthropic funders focus almost entirely on potential harms and little if at all on benefits, or the role of pleasure, or personal agency, choice and human rights.  Powerful activist groups adapt the rhetoric and lies used by now discredited anti-marijuana groups.  Bans on harm reduction devices are justified in terms of protecting children notwithstanding evidence that they actually fail to protect young people while endangering adults.  Scant attention is given to the potential downsides and unintended consequences of overly restrictive regulations and prohibitions.  Medical associations and professionals accept and propagate claims that have no basis in scientific evidence.  None of this is consistent with responsible public health, good public policy or ethical standards of communication, public advocacy and serious political leadership.  Those who mimic the rhetoric, tactics and abuses of now discredited drug war proponents need to be called out and discredited.

• Have the socio-economic disparities in smoking been sacrificed for preventing youth uptake
• Has tobacco control become an anti-vaping movement?
• From flavor bans to increasing taxation – what are the intended and unintended consequences
  

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