PMI files modified-risk application

Philip Morris International (PMI) has filed its highly anticipated Modified Risk Tobacco Product (MRTP) Application with the U.S. Food and Drug Administration (FDA). The company is seeking the right to make a health claim on its iQOS heat-not-burn vaporizer.

Filing the MRTP application keeps PMI  on track with its goal to file by year end. If approved, the firm would be able to market iQOS in the U.S. as a modified exposure or a modified risk product.

The FDA has 60 days (“at minimum”) to accept the application for substantive review and then up to one year to make a final decision (early 2018). The application is rumored to be more than 2 million pages in length.

To commercialize iQOS in the U.S., PMI will need an approved Pre-market Tobacco Application (PMTA), which PMI is planning to file in the first quarter of 2017 with a decision expected as early as July 2017. A PMTA would allow iQOS to be marketed in the U.S. without a health claim, similar to how iQOS is currently being marketed in many countries, including Japan, with great success.

“While this designation could be very powerful from a global public health standpoint, PMI will need to file a Premarket Tobacco Product Application (PMTA) to actually commercialize the product in the U.S. via an exclusive licensing agreement with Altria,” said Wells Fargo analyst Bonnie Herzog. “We are encouraged by the timeliness of PMI’s first FDA application submission.”