The U.S. FDA authorizes Marketing PMI’s IQOS as a modified risk tobacco product

The U.S. Food and Drug Administration (FDA) authorized the marketing of IQOS, Philip Morris International’s (PMI) electrically heated tobacco system, as a modified risk tobacco product (MRTP) on Tuesday, July 7th 2020. In doing so, the agency found that an IQOS exposure modification order is appropriate to promote the public health.

The FDA decision was issued after reviewing scientific evidence that has been extensively carried out since last December 2016. With the orders now in place, IQOS is the first and only electronic nicotine product given marketing permission through the FDA MRTP process.

Mindaugas Trumpaitis, President Director PT HM Sampoerna Tbk. (Sampoerna) an affiliate of PMI, said: 

“The decision by the US FDA is a public health milestone illustrating that the IQOS system is fundamentally different compared to cigarettes and a better choice for adults who would otherwise continue smoking. This scientific evidence-based decision can be a reference of intensive discussions to form a regulatory framework for heated tobacco products. Specifically in Indonesia with close to 60 million adult smokers, we believe by having an appropriate regulatory framework will help adult smokers who would otherwise continue smoking to rapidly shift to scientifically substantiated smoke-free alternatives."

Scientific studies have shown that switching completely from cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.

The FDA decision was also based on an independent international scientific consensus that emerged that IQOS was a better choice than continuing to smoke, and following the orders in April 2019 which authorized the commercialization of IQOS in the United States.

“It provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health in particular to adults who otherwise continue smoking,” he concluded. 

Philip Morris International: Delivering a Smoke-Free Future

Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company and its shareholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, as well as smoke-free products and associated electronic devices and accessories, and other nicotine-containing products in markets outside the United States. In addition, PMI ships a version of its IQOS Platform 1 device and its consumables authorized by the U.S. Food and Drug Administration to Altria Group, Inc. for sale in the U.S. under license. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI's smoke-free IQOS product portfolio includes heat-not-burn and nicotine-containing vapor products. As of March 31, 2020, PMI estimates that approximately 10.6 million adult smokers around the world have already stopped smoking and switched to PMI's heat-not-burn product, available for sale in 53 markets in key cities or nationwide under the IQOS brand. 

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Media contact
Nazrya Octora
External Communications Manager
PT HM Sampoerna Tbk.