Philip Morris International (PMI) announced that the US Food and Drug Administration (FDA) has authorised the marketing of the IQOS, PMI`s electrically heated tobacco device, as a modified risk tobacco product (MRTP).
During a virtual conference on Monday, PMI noted that the device is the first and only electronic nicotine product to be granted marketing orders through the FDA’s MRTP process
As a result of the FDA decision, the company presented its next steps as part of its bold ambition to encourage those smokers who would otherwise continue smoking cigarettes to switch to alternatives deemed better, based on scientific research, like the IQOS,.
“In my view, we are witnessing a historic moment, not only for PMI but for public health, because to understand the context today, for many years, tobacco control policies have focused on restrictive marketing and fiscal measures, to convince people to quit or prevent them from starting cigarette smoking,” said André Calantzopoulos, CEO of PMI, “And to a very large degree, these are appropriate measures but they have, in many countries worldwide, reached a limitation, and unfortunately we still have 1 billion people who smoke.”
Calantzopoulos added, “Restricted measures on cigarettes must continue, but it’s pretty clear that as technology has advanced and there are products that has no tobacco combustion, so these products are better alternatives to cigarettes and produce less harmful substances.”
He also said that governments around the world should adopt a two-pronged policy of creating different regulations for smart smoking alternatives that are scientifically reviewed, and the continuation of restrictive measures on cigarette smoking.
“I do hope we’ll put at least an end to the debate on whether all tobacco products are the same, as the answer is no,” Calantzopoulos said, ”It’s not nicotine or tobacco that are the issue, but we all now know that it is the type of combustion that is the issue.”
He noted that the FDA decision makes it possible to inform adults that switching completely to IQOS is a better choice than continuing to smoke. In addition, scientific studies have shown that switching completely from conventional cigarettes to the IQOS system reduces the body’s exposure to harmful or potentially harmful chemicals.
“Through the MRTP, the FDA aims to ensure that information directed at consumers about reduced risk or reduced exposure from using a tobacco product is supported by scientific evidence and understandable,” he concluded.
He said that to date, IQOS has been launched in 53 market, and had almost 15 million users in Q1 of 2019. At the same time, estimated IQOS users who have stopped smoking cigarettes and switched to the device reached 73% in Q1 of 2019.
Moira Gilchrist, Vice President of Strategic and Scientific communication at PMI, said that the FDA policy considers that nicotine and tobacco products exist on a risk continuum and should be regulated according to two relevant pathways.
The first of this would mean that new tobacco products are authorised for commercialisation, determined by whether the product is appropriate for the protection of public health.
“The second pathway is the MRTP in which the tobacco product is authorised as a modified risk tobacco product with reduced risk or reduced exposure information,” Gilchrist said, “PMI went through the two processes, so that customers know it is appropriate for health of the public.”
Gilchrist noted that PMI had submitted multidisciplinary scientific research to the FDA, alongside consumer perception and behaviour assessments, to present a full package of information for the agency to scrutinise.
The FDA reviewed all available science and confirmed that the IQOS device is distinctly different from cigarettes. This is due to their heating tobacco rather than burning it, significantly reducing the production of harmful and potentially harmful chemicals. PMI noted that now is the time to rapidly encourage adult smokers away from cigarettes, as scientifically substantiated alternatives that are better, such as the IQOS, represent a public health opportunity.