The US Food and Drug Administration (FDA) authorised, on Sunday, the marketing of the IQOS, Philip Morris International’s (PMI) electrically heated tobacco device, as a modified risk tobacco product (MRTP).
In doing so, the agency noted that an IQOS exposure modification order is appropriate in promoting public health.
The decision demonstrates that IQOS is a different product to standard tobacco, and a better choice for adults who would otherwise continue smoking. The device is the first and only electronic nicotine product to be granted marketing orders through the FDA’s MRTP process
The FDA authorised marketing of IQOS devices as a unit that heats tobacco but does not burn it. With this heating system in place, the production of harmful and potentially harmful chemicals are significantly reduced.
Scientific studies have shown that switching completely from conventional cigarettes to an IQOS device reduces the human body’s exposure to harmful or potentially harmful chemicals.
The agency concluded that the available scientific evidence demonstrates that IQOS devices are expected to provide reduced health impairments in comparison to standard cigarettes. This takes into account both users of tobacco products and those who do not currently use them.
The FDA’s decision further builds on the emerging independent international scientific consensus that IQOS devices are a better choice than continuing to smoke standard cigarettes. It also follows the agency’s April 2019 decision authorising for IQOS devices to be sold in the US.
Additionally, the FDA’s decision is an important example of how governments and public health organisations can regulate smoke-free alternatives to differentiate them from cigarettes to ensure greater health protections.
The decision follows a review of the extensive scientific evidence package PMI submitted to the FDA in December 2016 to support its MRTP applications.
“The decision makes it possible to inform adults that switching completely to IQOS is a better choice than continuing to smoke,” PMI CEO André Calantzopoulos said, “The FDA determined that scientific studies show that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals.”
Calantzopoulos added that IQOS is a different product to combustible cigarettes and must be regulated differently, as the FDA has recognised. The decision reflects the urgent need for a different, cooperative approach to achieve a smoke-free future.
“We are excited that this important decision will help guide the choices of adult smokers in the US, and that the best health choice is to never start smoking or to quit altogether,” Calantzopoulos said, “For those who don’t quit, the best thing they can do is switch to a scientifically substantiated smoke-free product.”
He added that PMI estimates that, as of 31 March, statistics show approximately 10.6 million adult smokers worldwide have already stopped smoking and switched to IQOS.
“We believe that this decision can help to further accelerate the transition of US adults away from cigarettes” Calantzopoulos said, “We, along with our licensee Altria, are committed to guarding against unintended use and fully support FDA’s focus on protecting youth.”
“Moreover, the decision is a result of our ongoing commitment to put science at the forefront as we continue on our quest to replace cigarettes with smoke-free alternatives as quickly as possible,” he added.
Vassilis Gkatzelis, Managing Director of Philip Morris Egypt & Levant said, “This is a historic milestone. The FDA reviewed all available science and confirmed that IQOS is distinctly different from cigarettes, because it has been demonstrated to reduce exposure to harmful chemicals. Now is the time to rapidly shift adult smokers away from cigarettes. Scientifically substantiated better alternatives like IQOS represent a public health opportunity.”
Philip Morris International (PMI) is leading a transformation in the tobacco industry, to ultimately replace cigarettes with smoke-free products and create a smoke-free future. It looks to create products that benefit adults who would otherwise continue to smoke.
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