Marketing order sought

Philip Morris International said on Friday that it had submitted a Premarket Tobacco Product Application (PMTA) for its iQOS Electronically Heated Tobacco Product (EHTP) to the US Food and Drug Administration’s (FDA) Center for Tobacco Products.

A PMTA marketing order is a prerequisite to commercializing on the US market a new tobacco product such as PMI’s EHTP. A favorable decision on the PMTA would allow the marketing of the EHTP, without modified risk claims, independent of a decision on the Modified Risk Tobacco Product (MRTP) application that PMI submitted to the FDA on December 5

In a note posted on its website, PMI said the filing of the PMTA application was consistent with its stated goal of submitting it during the first quarter of 2017.

‘PMI’s PMTA seeks authorization to commercialize the EHTP in the United States,’ the note said. ‘Should FDA grant the requested marketing order, Altria Group Inc. would be responsible for commercializing and marketing the product in the United States under the terms of a licensing agreement with PMI.’

Meanwhile, in a note posted on its website, Altria confirmed that, should the PMTA be granted, it would commercialize the product in the US.