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Philip Morris Intl. CEO: Vaping needs sensible regulation—and tobacco companies should be part of the conversation

January 16, 2020, 6:00 PM UTC

For the first time in history, smoke-free alternatives to cigarettes are available that can make a profound difference for people who smoke.

Of course, the best choice for these individuals is to quit tobacco and nicotine altogether. And for those who have never smoked, especially youth, the best option is never to start using any tobacco or nicotine product.

However, thanks to rapid advances in science and technology, better alternatives now exist for those adults who would otherwise continue to smoke: Smoke-free products, including e-cigarettes and heated tobacco products, can be a much better choice than cigarettes. The burning of tobacco produces the vast majority of harmful chemicals in cigarette smoke, and by eliminating the burning process—as is the case with smoke-free products—the levels of harmful chemicals generated can be significantly reduced compared with cigarette smoke. Whether a product reduces emissions of harmful chemicals compared to cigarette smoke has to be scientifically assessed for each product.

But this opportunity for trajectory-shifting progress in public health is in jeopardy. In the U.S., the recent incidents of lung illness—which the Centers for Disease Control and Prevention, among others, has linked largely to THC-containing vaping products—were conflated with the use of unadulterated, legal e-cigarettes. At the same time, media widely reported on the very valid concerns around the use of e-cigarettes by youth in the U.S. This combined coverage has left many men and women who smoke confused about smoke-free alternatives.

Further compounding the issue, a handful of tobacco control NGOs in several countries are seizing the opportunity to call for legislation that either prohibits some or all smoke-free alternatives, or severely restricts smokers’ access to and ability to learn about these products and how they differ from cigarettes. If regulators respond to these calls by choosing a prohibitionist route over a science-based approach, the opportunity for progress in public health may be lost.

To be clear, smoke-free alternatives are not risk-free and should never be used by youth or non-smokers. But these products can be a much better choice than continuing to smoke, provided that they are scientifically substantiated, manufactured using the appropriate safety and quality controls, and marketed responsibly.

It’s our belief at Philip Morris International (PMI) that all tobacco and nicotine products should be regulated. The question is not whether but how, and governments have a crucial role in defining the way forward. They can influence the pace and scale at which adult smokers switch to better alternatives by adopting risk-proportionate regulations that keep pace with scientific and technological progress.

The parties to the World Health Organization (WHO) Framework Convention on Tobacco Control will convene in the Netherlands this fall. Delegates to the biannual conference will, among other matters, decide on the future of smoke-free alternative products in private. Such deliberations have historically been fairly one-sided, leaving little to no room for different viewpoints to be taken into consideration.

For decades, tobacco control policy has focused on measures to encourage cessation and prevent initiation; smoke-free alternatives did not exist at the scale needed for widespread consumer adoption, so regulating them was not top of mind. Now we’re at a crossroads: We can continue to let these decisions be made without broad public debate and risk impeding progress, or we can call for an open and informed debate around how best to regulate these innovations.

An inclusive and transparent process—with governments, scientists, civil society, and the tobacco industry represented—would allow a thorough review of the scientific progress made so far. It would also facilitate a meaningful conversation about how best to enable adults who would otherwise continue smoking to switch from cigarettes—the most harmful way of consuming nicotine—to smoke-free alternatives, so that we maximize public health benefits.

Unfortunately, as of now, some tobacco control organizations—intentionally or unintentionally—allow emotion, politics, or ideology to lead, refusing to consider the innovations coming from the tobacco industry as viable alternatives that governments can use to supplement existing smoking cessation and prevention measures. I recognize the tarnished history of our industry, but I am nonetheless dismayed by the logic that discredits progress without an objective assessment of the public health opportunity.

Experts and national health authorities—the U.S. Food and Drug Administration (FDA) as well as Public Health England, among others—are rigorously reviewing the science behind smoke-free products, acknowledging harm reduction as a viable and much-needed approach to tobacco control.  

As part of this process, we think it is important that the industry openly shares its research programs and results. At PMI more than a decade ago, we committed to an R&D program inspired by the methods used in the pharmaceutical industry and we aligned with FDA guidance. To date, we have conducted 18 non-clinical and 10 clinical studies and have made substantial efforts to widely share our scientific findings, including in peer-reviewed publications, at scientific events, and on dedicated online platforms. You can view the results of our studies on the PMI Science website.

Our science encompasses an analysis of the chemical emissions in our smoke-free products’ aerosol, laboratory tests to assess the aerosol’s toxicity compared with that of cigarette smoke, and clinical studies investigating—under real use conditions—whether the exposure to harmful chemicals is reduced for smokers who switch completely to these new products and whether switching has a beneficial effect on their health trajectory. We also conduct premarket testing to understand how our smoke-free products will be perceived and used by adult smokers, as well as long-term assessment once the products are placed on the market to evaluate their contribution to harm reduction.

The available evidence—ours and others’—shows that switching completely to scientifically substantiated smoke-free alternatives, although not risk-free, can be a better choice than continuing to smoke cigarettes. We consistently invite the scientific community and regulators to study our science, verify our results, and conduct their own independent research—and it is encouraging that over the last few years, numerous independent studies have confirmed key elements of our research.

Last year, following rigorous scientific review, the FDA authorized IQOS—PMI’s heated tobacco product—for sale in the U.S. In its decision, the agency determined that marketing this product in the U.S. market “is appropriate for the protection of the public health.” This made PMI the only company with an electronically heated tobacco product authorized through the FDA’s premarket application pathway.

The FDA is continuing its substantive scientific review of our modified risk tobacco product applications, which will determine whether we’ll be able to market the product in the U.S. with risk-related messages. As such, and while this process is ongoing, we are refraining from making any statements directed to consumers in the U.S. about the product’s risk profile.

But based on our encouraging research results—and the positive reception of adult smokers around the world to our smoke-free products—PMI has chosen a smoke-free future. We look at smoke-free products not just as an addition to our portfolio, but as innovations that will lead the company into a future without cigarettes.

Others in the industry, along with many startups, are also developing and commercializing alternatives to cigarettes. In the U.S., these companies will soon be expected to submit their products to the FDA for review and authorization—a step that we believe is important in offering adult smokers a range of scientifically substantiated alternatives.

According to the WHO, there are 1.1 billion smokers in the world today; the organization estimates that that number will be roughly the same in 2025. Those who would otherwise continue smoking deserve to know about better alternatives so that they can make more informed choices. Our ambition is that by 2025, at least 40 million people who otherwise would have continued to smoke will have switched to our smoke-free products. For context, in the five years since we launched IQOS, approximately 8.8 million adult smokers have switched completely to the product and abandoned cigarettes (as of the end of September 2019).

To be clear, the commercialization of smoke-free alternatives cannot come at the expense of youth or people who don’t smoke. Sensible regulation is key to striking the right balance. This means adopting regulation that recognizes the role of smoke-free alternatives in helping those adults who would otherwise continue to smoke to move away from cigarettes, while protecting youth and non-smokers. Responsible marketing also plays a vital role: Tobacco and e-cigarette manufacturers should market their products only to adults who smoke or use smoke-free products. At PMI we have in place a set of Good Conversion Practices that we apply wherever we commercialize our smoke-free products. For example, we refuse to offer these products to people who have never smoked or those who have quit smoking.

Coming from the CEO of one of the world’s largest tobacco companies, I understand that our vision of a smoke-free future may be met with some skepticism. While I can’t speak for the industry as a whole, I can tell you that for PMI, this is much larger than any one product or idea. We are in the process of a full-scale business transformation. In fewer than five years, we have shifted our global commercial expenditure from 8% on smoke-free products to 60%. As a business—and we do not deny that there’s a business opportunity—our commitment to go smoke-free is clearly demonstrated by the numbers. Our smoke-free products represented already nearly 14% of our total net revenues in 2018 up from 0.2% in 2015, and we have the ambition to achieve 38-42% by 2025.

Beyond my position within the company, I feel as an individual that the choice to bring to market these better options for smokers has always been clear. Can you imagine the criticism we as a company would face if we kept these products behind closed doors?

We’re at a critical juncture in the tobacco industry. I’m hopeful that we can find mutual ground on which to move toward a smoke-free future built on innovation and facts.

André Calantzopoulos is the CEO of Philip Morris International.

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