Joe Biden and Kamala Harris will assume the offices of president and vice president at a time of great societal division as the pandemic continues to ravage the United States.

It is unsurprising, therefore, that tobacco harms have been largely overlooked amid the unfolding political drama. Yet almost half a million Americans—more even than have so far died of COVID-19—lose their lives to smoking-related causes every single year.

The Biden-Harris administration will take office with a mission to promote public health based on scientific evidence. While tobacco harm reduction (THR) remains controversial in the US, the lower risks of nicotine products like e-cigarettes and snus compared with smoking are well demonstrated. Objections to THR seem, therefore, to be based on ideological opposition to harm reduction—an inclination which, troublingly, both Biden and Harris have sometimes shown in non-tobacco arenas.

US tobacco harm reduction advocates have endured numerous legislative defeats during the Trump presidency—from the January 2020 imposition of nationwide partial vape flavor ban to several state-level prohibitions and further recent restrictions on online vape sales. Will things get better, or worse?

To help us assess the outlook, Filter reached out to numerous experts with a variety of relevant specializations and perspectives. We asked them to elaborate on one simple question—what should Joe Biden realistically do to promote US tobacco harm reduction during his presidency?—or to comment on related issues of their choice. Here are their responses.

David Abrams is a professor of social and behavioral sciences at the New York University School of Global Public Health. He has previously directed institutions including the Centers for Behavioral and Preventive Medicine, Warren Alpert Medical School at Brown University, and the Office of Behavioral and Social Sciences Research at the National Institutes of Health.

“The most important thing the Biden administration can do to improve public health is to help the public understand the differences in risk between nicotine itself and nicotine delivered in smoke. We must support those who want or need nicotine to find a much less harmful non-combustible option.

Especially neglected are those smokers at disproportionate risk who smoke the most and have lower income and education, less access to or no affordable health care and have comorbidities, such as suffering from mental health and substance use problems and chronic diseases are that made much worse by smoking.”

Azim Chowdhury is a partner at Keller and Heckman LLP, where he helps lead the Washington, DC-based legal firm’s award-winning food and drug regulatory practice.

“The Biden-Harris administration has indicated that it will move quickly to reinstall science as a foundation for government policy; hopefully, that remains the case with respect to tobacco harm reduction. In addition to enforcing age and marketing restrictions to prevent illegal underage use, the new administration should emphasize the important goal of reducing, and hopefully eliminating, combustible cigarette use–which has dropped to historical lows (among all age groups), but seems to be on the rise again, in part due to misinformation and fear-mongering over ENDS [electronic nicotine delivery systems] and other reduced-harm nicotine products.

President Biden has also made clear that he is a ‘Presidency for all Americans.’  In this regard, in addition to following the science, the Administration should make [the] effort to listen to all of its constituents—including the nearly 10 million American adults who rely on ENDS to stay off of cigarettes. Not doing so will have serious consequences for the nation’s public health.”

Samrat Chowdhery is the president of INNCO (International Network of Nicotine Consumer Organizations), which works to support the rights of nicotine users worldwide. He lives in Mumbai, India.

“The direction the US takes has global impact—the ‘teen epidemic’ and EVALI scares in America were directly responsible for the rise in flavor ban legislation across Europe and outright ban of e-cigarettes in some countries, including India. The Biden administration should consider the weight of its actions, paying strong heed to science on tobacco harm reduction and its effectiveness in helping curb tobacco death and disease—and not fall prey to emotional hooks, which ultimately does a disservice to over a billion tobacco users.”

Alex Clark is the CEO of CASAA, a consumer advocacy group, affiliated with INNCO, which promotes the rights of US nicotine users. He lives in New York.

“While on the campaign trail, president-elect Biden committed to following the science, so the important thing is that the Biden/Harris administration knows which science to pay attention to.

There are currently tens of thousands of premarket applications for new nicotine products pending with [the] FDA which are supported by some of the best science in the world. Following such a dismal roll-out of the deeming regulation, it feels a bit off to suggest that deferring to the FDA is the best course of action, but it makes more sense than basing policy on fear and prejudice.”

Gregory Conley is a New Jersey-based attorney who is the founder and president of the American Vaping Association. He commented on Biden’s pick to head the Centers for Disease Control and Prevention.

“Dr. Rochelle Walensky is a respected professional with a background of work that suggests an understanding of the benefits of harm reduction strategies in public health. She has a tough task ahead of her; not just advising America through a pandemic, but rebuilding the CDC’s trust with the American people. Part of that process should include studying not just what went wrong with the CDC’s response to COVID-19, but also the CDC’s failures before the pandemic, when it blamed EVALI on nicotine vaping products.” 

Stefan Didak is a California-based THR advocate who was one of the founders of Not Blowing Smoke, an industry-backed vaping advocacy committee, and also founded the consulting agency Ignyter.  

“I think what the Biden administration should do is to avoid embracing prohibition-style policies while allowing the regulatory approval process to take its course, without making it worse than it is. The best way then to promote safer nicotine alternatives would be to ensure federal preemption applies so that states and local municipalities are not allowed to restrict adult access to these products.

This may not be the answer that’s expected but … realistic goals. Expecting anything like UK-style promotion along with radical simplification of the regulatory requirements would be unrealistic, and taking vapor products out of the tobacco regulation also would be unrealistic at this point. But if the administration stands behind approval of products that meet the incredibly high requirements then it’s only fair that banning legal and approved products, with appropriate sales restrictions, should be prohibited.”

Abigail S. Friedman is an assistant professor in health policy and management at the Yale School of Public Health. Her career has focused on the public implications of health regulations, including those pertaining to products like vapes. She commented on the US Food and Drug Administration’s regulatory process.

“Companies need clearer guidance on the type of data and analyses that need to be provided to meet FDA benchmarks, and the FDA needs more funding so that the (thousands of) applications they have already received can be reviewed in a reasonable amount of time. The current approach asks regulators to perform an almost Herculean task, whereas the submission fees needed to maintain it give large, well-established companies a clear advantage over smaller ones.”

Michael Landl is the director of the World Vapers’ Alliance, which advocates for the rights of vapers and nicotine users in the European Union and elsewhere. He’s based in Vienna, Austria.

“The new administration must be led by science and not by ideology on this issue. Instead of idealized goals, it needs to put practical solutions center stage. Harm reduction has proved to be effective and is accepted in many countries. To effectively reduce the burdens of smoking, harm reduction such as vaping needs to be actively endorsed. It is also essential that the affordability and variety of vaping products are ensured. The US needs to avoid higher taxes and burdensome regulation, like liquid flavor bans, on vaping products on every level.”

Michelle Minton is a senior fellow at the Competitive Enterprise Institute in Washington, DC. She is an advocate for THR, as well as in areas like cannabis legalization and gambling.  

“Biden has already endorsed reduced forms of harm reduction in some cases, for example supporting the use of treatments like methadone for opioid use disorders. The evidence is clear that low-risk nicotine products have a similar life-saving potential for smokers. If Biden is truly committed to science, his team will have to disregard media narratives, solicit input from a wide array of experts in the field—not just the politically-connected few—and make decisions based only on what will benefit public health most.”

Ethan Nadelmann founded the Lindesmith Center in 1994, which he merged with another organization to form the Drug Policy Alliance in 2000. He was DPA’s executive director until 2017, spearheading many drug policy reform successes. His advocacy has increasingly focused on THR in recent years. He lives in New York.

“Biden can learn from the mistakes he made in promoting the War on Drugs. He can insist that tobacco policy be grounded in science, compassion, health and human rights. He can seize the political advantage to be gained by treating with respect the 34 million Americans who still smoke, and encouraging those who can’t or won’t quit to try whatever works.”

“And, just maybe, he can persuade his old cigarette-addicted friend, Barack Obama, to publicly advocate for a harm reduction approach to tobacco.”

Yaël Ossowski is the deputy director of the Consumer Choice Center—a Washington-DC headquartered NGO that operates in Europe, Latin America and other regions as well as the US. He co-authored the center’s United States Vaping Index, which measures each state’s public-policy friendliness to vaping. 

“President-Elect Joe Biden has said he wants to better apply scientific knowledge to public policy, especially health policy, and that is to be applauded. But that will also mean listening to the science on the innovations in tobacco harm reduction, such as vaping and oral nicotine alternatives to smoking. These market alternatives have already proven successful in prolonging the lives of millions of Americans, and will continue to do so as long as the federal government promotes smart regulation and recognizes the studies that have proven they are less harmful.

Consumers deserve to have public officials who will not only make decisions on the science, but also respect and protect their wishes to improve their lives how they see fit.”

Riccardo Polosa is a professor of internal medicine at the University of Catania, Italy, and the founder of the university’s Center of Excellence for the Acceleration of Harm Reduction (CoEHAR). His research specializations include respiratory diseases, clinical immunology and THR. He was instrumental in persuading the Italian government to exempt vape stores from the country’s COVID-19 lockdown.

“Although ideology and politics will continue to maximize the risk (and minimize the benefit) associated with vaping, in a perfect world Biden should listen to unbiased science on how vaping can reduce the harmful effects of tobacco. Biden needs to listen to all the voices (and particularly to consumers) and just pull away from those who continue to spread fear, confusion and doubts.

The new administration should first of all appoint a strong leader for the Food and Drug Administration, not just another bureaucrat. Then the new leader should revisit the pre-market requirements for all lower-risk tobacco and nicotine products. In their current form, these regulations act as a barrier to entry for all companies except the established tobacco corporations who have the money to go through the approval process.

Then the Health and Human Services branch should form a committee to address the use of tobacco products and tobacco harm reduction should be considered as a strategy.” 

Helen Redmond is Filter’s senior editor. She’s a journalist, documentarian and social worker, and an adjunct professor at the New York University Silver School of Social Work.  

“I’m tempted to say President-elect Biden just needs to get out of the way of the vaping revolution in America that is saving millions of lives, but I can’t. That’s because the groups that oppose tobacco harm reduction have created a war on nicotine and some of the most obnoxious drug warriors are Democrats like Chuck Schumer and billionaire Michael Bloomberg. They have whipped up a classic drug panic and succeeded in passing a variety of bans on vaping products, making it increasingly difficult for adult smokers to switch.

The reality for 2021 is the Biden administration, as well as state and local governments, will need to be publicly and relentlessly pressured by pro-vaping organizations and the vaping industry to repeal all anti-vaping legislation.”

Lindsey Stroud is a board member of the Smoke-Free Alternatives Trade Association, a consultant to vaping companies and the manager of THR101.org. She lives in Chicago.

“President-elect Joe Biden has positioned himself as a man of science and has consistently reiterated to the American public to listen to science. I truly hope that as president, he himself will listen to the science and embrace tobacco harm reduction products, especially electronic cigarettes and vapor devices which are effective tools in helping smokers quit—despite the fact that the FDA is still lagging in promoting the efficacy of their role in cessation.

Undoubtedly, the Biden administration will be plagued by the anti-vaping zealots that have pursued on through virtual hearings in every possible locality to restrict access to these products, even though youth vaping has decreased from 2019 and 2020. If the Biden administration truly wants to listen to the science, he will take time to speak with the industry, including the small vapor product manufacturers whose products are not overwhelmingly associated with youth use, to develop a robust policy that will address youth use of age-restricted products while maintaining adult access.”

Michael Siegel is a professor of community health sciences at the Boston University School of Public Health. His THR-related work has been published in many academic and non-academic sources, and he has testified to Congress on vaping legislation.

“President-elect Biden should prioritize three actions to promote tobacco harm reduction: First, the Biden administration should immediately rescind the FDA regulatory requirement that all e-cigarette companies submit premarket tobacco applications (PMTAs). The PMTA requirement would decimate the vaping market, eliminating close to 99 percent of the products on the market, greatly limiting choice for adults, and invariably leading to many ex-smokers switching back to smoking.

Second, in lieu of the burdensome PMTA requirement, the Biden administration should force the FDA to issue safety regulations regarding e-cigarettes and vaping products. These regulations should address concerns such as battery safety, temperature regulation, additives, nicotine formulations, and maximum nicotine levels. The proper way to regulate e-cigarettes is to regulate them, not to effectively ban them.

Third, the Biden administration should direct the CDC and other health agencies to endorse e-cigarettes and vaping as a legitimate and effective method of smoking cessation for adult smokers. Under the past two administrations, e-cigarettes have been demonized by the CDC and other agencies within HHS (and by HHS itself), invariably resulting in deterring many smokers from quitting and causing some ex-smokers to return to smoking. Such an action would also provide a much-needed stimulus for physicians to actively recommend vaping as a smoking cessation alternative for patients who are unable to quit using other methods (which represent about 90 percent of patients).”

David Sweanor is an adjunct professor of law at the University of Ottawa, Canada, and serves as the advisory committee chair for the university’s Centre for Health Law, Policy and Ethics.

“The key message should be to reinforce the importance of empowering people who would otherwise smoke cigarettes to move to low-risk alternatives. This means turning the FDA from a barrier to a facilitator in that transition, ensuring the public is told the truth about relative risks and using policy levers to make better choices for health easier choices to make.

There are literally millions of lives on the line, lives of people Biden cares about. Science and technology now allow us to send cigarettes to history’s ashtray, and that is a goal worth pursuing.”

Originally published here.