Combustion, not nicotine, is the problem – PMI

    “Combustion is the issue, not nicotine,” said Philip Morris International Chief Executive Officer André Calantzopoulos while referring to the recent US Food and Drug Administration’s (FDA) authorization to market IQOS as a Modified Risk Tobacco Product (MRTP) with reduced exposure claims.

    During a virtual press briefing held recently, Calantzopoulos said the US FDA “recognizes that better alternatives do exist, because they are all non-combustibles. It articulates very clearly, combustion is the issue.”

    On July 7, 2020, the US FDA released the MRTP marketing order for IQOS, the first innovative electronic product to receive “exposure modification” orders, authorizing IQOS to be marketed with the following claims:

• The IQOS system heats tobacco but does not burn it.
• This significantly reduces the production of harmful and potentially harmful chemicals.
• Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

    With the FDA’s authorization, Calantzopoulus is optimistic that it will end the debate on better alternatives to cigarettes.

    “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,” Calantzopoulos said.

    For her part, Dr. Moira Gilchrist, PMI’s vice president for strategic and scientific communications said the science-based FDA regulation recognizes the difference between cigarettes and smoke-free nicotine products.

    “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.

    “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,” she said.

    “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 said the US FDA regulation clearly recognizes that nicotine and tobacco products exist on a continuum of risk.

    She added that this is an “important information that consumers—adult smokers—need to get to know in order to help guide their choices. 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,” Gilchrist said.

    Gilchrist noted that 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.”

    Aside from the US FDA, other regulatory bodies around the world have also examined the evidence in relation to IQOS with similar conclusions.
    “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.

    She said “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.


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