US Food and Drug Administration (FDA) Begins Scientific Review of Philip Morris International’s Modified Risk Tobacco Product Application for its Electronically Heated Tobacco Product (EHTP)
LAUSANNE, Switzerland--(BUSINESS WIRE)--May 25, 2017--
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.
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