Session 4:Tobacco harm reduction and industry regulation 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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