Increasing Stakeholder Engagement

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Accelerating actions to clear the smoke: finding common ground in a polarized world

By Scott D. Ballin

During September and October 2024, there were a number of tobacco-related and nicotine-related conferences, including the Global Tobacco and Nicotine Forum in Athens; the Nicotine and Tobacco Science Conference in Charleston, South Carolina, USA; the Tobacco Science Research Conference in Atlanta; CORESTA in Edinburg; and the Food and Drug Law Institute annual tobacco and nicotine conference in Washington, D.C. The E-Cigarette Summit will convene in London in December.

All of these conferences have a number of things in common, including looking at how to move forward in advancing public health and harm reduction and advocating for more stakeholder engagement. While these objectives are to be applauded and enjoy support, the tobacco and nicotine space remains more divided, polarized and tribal than ever.

This division and the animosity that often goes with it mirrors what we see happening in societies around the world. This is tragic in terms of public health when more time is being spent fighting perceived enemies than looking for common-ground solutions to save lives.

The divide is not merely between Big Tobacco and mainstream public health organizations but now also seems to include anyone associated with tobacco and nicotine. It is troubling to me that significant divisions continue to occur within the public health community to the extent that some take the position that anyone engaging with the tobacco and nicotine sector needs to be “called out,” blacklisted and even banned from attending some meetings or conferences.

For some years now, I have taken the position that “safe-haven” dialogues between stakeholders are essential to advancing our public health objectives of reducing disease and death from the use of tobacco and especially the combustible cigarette, which is by far the riskiest tool for nicotine consumption. Today’s rapidly changing tobacco and nicotine environment is very different from the days of the “tobacco wars” of the late 20th century.

We should be constantly reminding ourselves that globally, there are approximately 1 billion smokers who are subject to dying prematurely from cigarette smoking. In the U.S. alone, the number of smokers remains close to 30 million, making cigarette smoking the single most preventable cause of death.

Many battles must be fought, but new approaches, ideas and opportunities need to be discussed and considered as well.

A Role for CTP

The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has an important role to play in providing stakeholders a safe haven where civil dialogue can take place. For me, obtaining FDA regulatory oversight of the tobacco industry and its products was a major priority and a gamechanger in reigning in the bad behavior of the tobacco industry. All three CTP directors—Lawrence Deyton, Mitchell Zeller and Brian King—recognized and acknowledged the critical need for stakeholder engagement. Stakeholder input and engagement has and will continue to assist the agency in its efforts to not only prevent future generations from using tobacco and nicotine products but also to provide significantly lower risk, science-based regulated products to the millions of addicted adult smokers worldwide. It can ensure that bad actors distributing, marketing and selling illegal, unauthorized products are punished and expeditiously removed from the marketplace.

Many will recall that in July of 2017, the FDA announced a visionary, comprehensive tobacco and nicotine plan. In its press release, then FDA Commissioner Scott Gottlieb and the Center for Tobacco Products Director Zeller wrote: “Envisioning a world where cigarettes would no longer create or sustain addiction and where adults who need or want nicotine could get it from less harmful alternative sources need to be the cornerstone of our efforts, and we believe it is vital that we pursue common ground …. To succeed, participants from all sectors [emphasis added] need to take a step back and work together to reach greater common ground.”

This visionary plan was generally well received by a broad spectrum of stakeholders as a way to discuss and address important issues in a rapidly changing environment. Unfortunately, and for many reasons, the CTP has put much of the plan on the back burner.

The time has come for the FDA/CTP to move the comprehensive plan back to the “front burner” and to begin a series of important discussions on how many of these ideas, challenges and opportunities can be addressed and implemented.

The Morven Dialogue

In July, the University of Virgnia’s Institute for Engagement and Negotiation (IEN) released its latest report, titled Accelerating Action to Clear the Smoke: Finding Common Ground in a Polarized World. Referred to as the Morven VII dialogue, the report builds on past dialogues and reports and lays out a set of 10 interrelated and overlapping core principles designed to “provide stakeholders guidance and encouragement to commit to engage and work together in a more transparent and cooperative way.”

The report addresses topics such as updating definitions and terminologies; recognizing the differences between the risks and relative risks of a spectrum of products along the continuum of risk; the need to “modernize” and develop a more flexible and consumer-friendly regulatory framework; ensuring that scientific research is of the highest integrity; encouraging innovation and technology; ensuring comprehensive regulatory oversight while providing flexibility for “fast-tracking” of approved lower risk products for use by adults; ensuring that adolescents do not have access to any tobacco and nicotine products; providing consumers, the general public, medical professionals and other stakeholders with truthful, accurate and consistent information about the risks and relative risks of all tobacco and nicotine products; and encouraging all stakeholders in both the public and private sectors to engage civilly and honestly.

The Morven VII dialogue report serves as a means for having a more in-depth civil discussion on issues confronting the tobacco and nicotine space. As the IEN director has stated: “It is owned by no one but can be used by everyone.” There are no copywrite restrictions on the report, and all entities are encouraged not only to use it but also to make it available to others, including policymakers, medical professionals, nongovernmental organizations and the media.

The Morven VII report can be accessed at http://www.tobaccoreform.org.