UNIVERSITY OF CALIFORNIA SAN FRANCISCO BERKELEY • DAVIS • IRVINE • LOS ANGELES • MERCED • RIVERSIDE • SAN DIEGO • SAN FRANCISCO SANTA BARBARA • SANTA CRUZ STANTON A. GLANTZ, PhD 530 Parnassus Suite 366 Professor of Medicine (Cardiology) San Francisco, CA 94143-1390 Truth Initiative Distinguished Professor of Tobacco Control Phone: (415) 476-3893 Director, Center for Tobacco Control Research and Education Fax: (415) 514-9345
[email protected] December 20, 2017 Tobacco Products Scientific Advisory Committee c/o Caryn Cohen Office of Science Center for Tobacco Products Food and Drug Administration Document Control Center Bldg. 71, Rm. G335 10903 New Hampshire Ave. Silver Spring, MD 20993–0002
[email protected] Re: 82 FR 27487, Docket no. FDA-2017-D-3001-3002 for Modified Risk Tobacco Product Applications: Applications for IQOS System With Marlboro Heatsticks, IQOS System With Marlboro Smooth Menthol Heatsticks, and IQOS System With Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris Products S.A.; Availability Dear Committee Members: We are submitting the 10 public comments that we have submitted to the above-referenced docket on Philip Morris’s modified risk tobacco product applications (MRTPA) for IQOS. It is barely a month before the meeting and the docket on IQOS has not even closed. As someone who has served and does serve on committees similar to TPSAC, I do not see how the schedule that the FDA has established for TPSAC’s consideration of this application can permit a responsible assessment of the applications and associated public comments. I sincerely hope that you will not be pressed to make any recommendations on the IQOS applications until the applications have been finalized, the public has had a reasonable time to assess the applications, and TPSAC has had a reasonable time to digest both the completed applications and the public comments before making any recommendation to the FDA.