December 21, 2017
We submitted this letter to the FDA Tobacco Products Scientific Committee on the PMI MRTP application. A PDF of the letter, including all the UCSF public comments to date on the IQOS is available here.
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.
December 12, 2017
Lauren Lempert and I submitted this letter to Mitch Zeller at the FDA by email and submission to the PMI IQOS dockett (tracking number 1k1-90bh-d1uh ). A PDF of the letter is here.
December 12, 2017
Mr. Mitchell Zeller
Director, Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
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 Mr. Zeller:
We are writing to complain about the public comment process for the above-referenced docket on Philip Morris’s modified risk tobacco product applications (MRTPA) for IQOS.
December 11, 2017
Lauren Lempert, our colleagues at UCSF, Georgia State University and Stanford, and I have submitted this comment on PMI's IQOS application to the FDA. The tracking number is 1k1-90at-5wj2 and a PDF of the comment is available here.
Because PMI has not demonstrated that IQOS is associated with lower risks, FDA should not permit modified exposure claims, because such claims are likely to be misunderstood as modified risk claims
Lauren K. Lempert, JD, MPH; Lucy Popova, PhD; 1 Bonnie Halpern-Felsher, PhD;2
Karma McKelvey, PhD, MPH;2 Minji Kim, PhD; Benjamin Chaffee, DDS, MPH, PhD;
Pamela Ling, MD, MPH; Stanton A. Glantz, PhD
University of California San Francisco TCORS
1 Georgia State University
2 Stanford University
Docket Number: FDA-2017-D-3001
December 11, 2017
December 9, 2017
Lauren Lempert and I submitted this public comment to the FDA on PMI's IQOS MRTP application. The tracking number is and the PDF is available here.
Detailed analysis of the Executive Summary (Section 2.7) submitted by Philip Morris International in support of its MRTP application for IQOS
Stanton A. Glantz, Ph.D. and Lauren K. Lempert, JD, MPH
UCSF Tobacco Center of Regulatory Science
Docket Number: FDA-2017-D-3001
December 9, 2017
This comment is a detailed analysis of the Executive Summary of Philip Morris International’s application, including commentary on specific statements in the Executive Summary. For detailed discussion of these issues, including relevant references, see the public comments that the UCSF TCORS has submitted.[1]
While there are many issues raised in the Executive Summary Philip Morris International (PMI) submitted, there are four overarching problems that represent fatal flaws in the application:
December 8, 2017
My colleagues at UCSF, Stanford, and Georgia State University have submitted this public comment to the FDA. The tracking number is 1k1-908n-holz and a PDF of the comment is available here.
The evidence cited in PMI’s MRTP Application indicates that the proposed labeling and warnings for IQOS will mislead consumers, particularly youth, about the product
Bonnie Halpern-Felsher, PhD;1 Karma McKelvey, PhD, MPH;1 Lucy Popova, PhD; 2 Minji Kim, PhD; Benjamin Chaffee, DDS, MPH, PhD; Maya Vijayaraghavan, MD, MAS; Pamela Ling, MD, MPH; Lauren K. Lempert, JD, MPH; Stanton A. Glantz, PhD
University of California San Francisco TCORS
1 Stanford University
2 Georgia State University
Docket Number: FDA-2017-D-3001
December 8, 2017