On May 24, 2017, the US FDA published the executive summary and research summaries supporting Philip Morris International Inc.’s (PMI) (NYSE/Euronext Paris: PM) Modified Risk Tobacco Product (MRTP) application for the company’s EHTP. In doing so, the agency announced that it will publish a notice in the Federal Register establishing a formal docket for public comments on PMI’s application at a later date.
PMI submitted the application to the FDA on December 5, 2016.
Publication of PMI’s summaries initiates a substantive scientific review process by the FDA’s Center for Tobacco Products.
The FDA has made PMI’s application summaries publicly available here. The agency will publish additional modules of PMI’s MRTP application on a rolling basis. The FDA has established a one-year timetable for reviewing MRTP applications. However, that timing is non-binding.
“We welcome FDA and public review of the comprehensive scientific evidence package that we submitted to the agency through its MRTP application process,” said Dr. Moira Gilchrist, PMI Vice President Corporate Affairs of Reduced-Risk Products. “PMI’s application demonstrates our commitment to develop innovative, smoke-free technologies that can ultimately replace combustible cigarettes to the benefit of smokers, public health and society at large.”
Interested members of the scientific and public health communities can find more information on PMI’s EHTP at: PMIScienceUSA.com.
About Philip Morris International Inc. (“PMI”)
PMI is the world’s leading international tobacco company, with six of the world’s top 15 international brands and products sold in more than 180 markets. In addition to the manufacture and sale of cigarettes, including Marlboro, the number one global cigarette brand, and other tobacco products, PMI is engaged in the development and commercialization of reduced-risk products (“RRPs”). RRPs is the term PMI uses to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continued smoking. Through multidisciplinary capabilities in product development, state-of-the-art facilities, and industry-leading scientific substantiation, PMI aims to provide an RRP portfolio that meets a broad spectrum of adult smoker preferences and rigorous regulatory requirements. For more information, see www.pmi.com and www.pmiscience.com.