Philip Morris International (PMI) has filed a Modified Risk Tobacco Product Application to the FDA for its iQOS system. The Tobacco Control Act requires FDA authorization before any manufacturer can make statements that claim that its product is less harmful or presents a lower risk of disease than other tobacco products. The Act also requires that the FDA make the application materials available and accept comments on them. To view PMI’s application, visit the FDA’s website. The Tobacco Products Scientific Advisory Committee (TPSAC) evaluated the application at the committee’s meeting on January 24-25, 2018. The docket for this application is closed but members of the public health community can still send information to the FDA.
Link for docket: https://www.regulations.gov/docket?D=FDA-2017-D-3001