“We will be missing an enormous public health opportunity if scientifically proven better alternatives to tobacco will not be made available to adult smokers.”
This was the pronouncement made by Philip Morris International (PMI) Chief Executive Officer André Calantzopoulos during the company’s recently held global virtual media briefing following the US Food and Drug Administration’s (FDA) authorization of marketing IQOS as a Modified Risk Tobacco Product (MRTP) with reduced exposure claims.
“The reality is, if the products that are scientifically reviewed are not made available to the smokers of today, and if we do not have appropriate post-commercialization policies and surveillance so that we maximize adoption of these products by adult smokers and minimize any unintended use from non-smokers, especially youth, I think we will be missing an enormous public health opportunity,” Calantzopoulos said.
The US FDA authorization “is a very important and historic moment, not only for PMI but for public health,” Calantzopoulos said. “It is pretty clear that technology has advanced, and we have novel products, all of which have one foundational characteristic—they do not burn. There is no combustion. These products, because there is no combustion of tobacco, produce less harmful substances.”
“Undeniably, these products are better alternatives to cigarettes. The whole analysis and the decision of the FDA, I do hope, will put at least an end to the debate on whether all tobacco products are the same. The answer is they are not,” he said.
Calantzopoulos said because IQOS system heats tobacco but does not burn it, it significantly reduces the production of harmful and potentially harmful chemicals. Scientific studies have also shown that switching completely from conventional cigarettes to the IQOS system significantly reduces body’s exposure to harmful or potentially harmful chemicals.
He said the FDA’s order is a very clearly articulated policy. “It recognizes that better alternatives do exist, because they are all non-combustibles. It articulates very clearly, combustion is the issue,” he said.
IQOS is the first innovative electronic product to receive “exposure modification” orders, which permits the marketing of a product as containing a reduced level of or presenting a reduced exposure to a substance or as being free of a substance when the issuance of the order is expected to benefit the health of the population.
Calantzopoulos welcomed the authorization by FDA for PMI to communicate the reduced exposure claim of IQOS, compared to cigarettes.
“I think the FDA and the US have a very clear overall policy. They want continuous restrictions of cigarettes, but at the same time create a climate under which alternative smoke-free products can be offered to smokers so they have a choice, they are informed about them, and we have appropriate regulatory regimes for these products that are different from cigarettes,” he said.
Dr. Moira Gilchrist, PMI’s vice president for strategic and scientific communications who has been an integral part of the work to engage with the FDA, said the FDA authorization is an important moment for 1 billion smokers around the world.
“I think this is really an important moment for us, but more importantly a really important moment for men and women in the United States who would otherwise continue to smoke and we also hope that this information gets propagated across the world so that other governments start to look at their own policies as well,” she said.
Gilchrist said the comprehensive FDA regulation recognizes the difference between cigarettes and smoke-free nicotine products. “I think ultimately, this shows us that IQOS is fundamentally different from cigarette. Not only that, this is important information that consumers—adult smokers—need to get to know in order to help guide their choices.”
Gilchrist stressed that, “Underpinning all of these decisions is a science-based approach. And that is certainly something we would like to see happening in many countries around the world.”
“Overall, we believe this historic moment is going to really help propel us forward into our smoke-free future by really rapidly switching smokers away from cigarettes. And we hope that this is embraced as a public health opportunity that it really is,” she said.
“That means at one end, you have the most harmful form of nicotine consumption which is through combustible cigarettes, but on the other end you have a series of products that don’t combust tobacco. The policy recommendation recognizes that they are likely to have a different risk profile than cigarettes themselves. And this is really important from the scientific perspective, and we set out really to demonstrate through high-quality science that our product IQOS, our heated tobacco product, is a completely different product than cigarette first and foremost,” she said.
PMI submitted its application for MRTP in December 2016. “We submitted science that went across many different disciplines to FDA, from chemistry to toxicology, clinical studies and also consumer perception and behavior assessments as well. So a full range of package of science was available for FDA to scrutinize,” she said.
Gilchrist said that during the application process, demonstrating that IQOS does not burn is important. “It is the burning of tobacco that causes the production of the vast majority of the harmful chemicals that go on to cause smoking-related diseases. To be clear, IQOS is not risk-free and it is addictive because it contains nicotine. Nevertheless, the FDA recognized that heating rather than burning is an important piece of information that adult smokers should have access to,” she said.
Gilchrist noted that aside from the US FDA, other regulatory bodies around the world have also examined the evidence in relation to IQOS.
“The FDA’s conclusion is essentially in line with earlier conclusions from authorities, for example in the UK, in the Netherlands and in Germany who also came to the conclusion that the IQOS system significantly reduces harmful and potentially harmful chemicals compared with cigarettes and that exposure reduction is there as well,” she said.
“So we start to see a consensus building which is really important because I think other countries can take some comfort from the fact that there are many regulatory bodies that are looking at the science, coming to similar conclusions. I think now is the time we move towards making that information available to consumers, to adult smokers just as the FDA has authorized in the United States. We believe that it is really important that adult smokers have information like this in order to guide their choices because we know that although the best thing they could do is to quit altogether, we also know that most of them don’t,” she said.