NEW YORK – The U.S. Food and Drug Administration (FDA) has started its formal review process of Philip Morris International’s “heat-not-burn” technology, according to the company.
The FDA made Philip Morris International’s (PMI's) application summaries public online May 24 and will publish additional modules of PMI’s Modified Risk Tobacco Product (MRTP) application on a rolling basis. The publication begins a “substantive scientific review process” by the FDA’s Center for Tobacco Products, PMI officials said in a statement.
“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, vice president of corporate affairs of reduced-risk products for PMI. “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.”
The FDA also 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 original application to the FDA on Dec. 5, 2016.
Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.