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“The Cube” is PMI’s R&D centre in Lauzanne (Switzerland)

A press release by Philip Morris International (PMI) indicates that the Big Tobacco company submitted on December 5, 2016, a Modified Risk Tobacco Product (MRTP) application with the US Food and Drug Administration’s (FDA) Center for Tobacco Products for its electronically Heat Not Burn cigarette, iQOS. This confirms the company’s intention to propose the iQOS in the USA after a successful launch in Japan and a presence in numerous important cities.

The announcement was made by the end of October that “Altria continues to partner with Philip Morris International Inc. (PMI) on its FDA applications for iQOS“, and “plans to submit a modified risk tobacco product application to the FDA by the end of 2016, and a pre-market tobacco product application in the first quarter of 2017“.

According to PMI, an administrative review should be conducted within 60 days.

“PMI anticipates the FDA taking a minimum of 60 days to complete an administrative review to determine whether to accept the application for substantive review.”Philip Morris International

The FDA has said it rules on such cases within 180 days…. but…

The race between PMI and independent manufacturers of vaping products has started. Any FDA approval would be interpreted as a positive sign from the US Agency but it could also mean that PMI would be susceptible to market iQOS as a safer alternative to smoking earlier than any other vaping products.

A 12-month delay after submitting the MRTP would oblige PMI to wait until the fourth quarter of 2017 to inform consumers of iQOS’ relative safety profile. Marketing the product could happen six months after the pre-market tobacco product application (PMTA) is submitted, likely at the beginning of 2017, to coincide with MRTP.

The MRTP application for iQOS is likely a file containing 2 to 3 million pages which represents a paper stack of 1 500 meters high for a weight of about 15 tons. For a single employee, reviewing PMI’s application would take something like 30 years of work…


More readings about HNB cigarettes and the iQOS:

What you need to know about Heat-not-Burn (HNB) cigarettes