December 21, 2017
The attached letter (reproduced below) has been submitted to the docket; the tracking number is 1k1-90fp-cqy1. A PDF of the letter is available here.
December 18, 2017
Mr. Mitchell Zeller
Director, Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Re: 82 FR 60206, Docket no. FDA-2017-N-4678, Modified Risk Tobacco Product Applications: Applications for Six Camel Snus Smokeless Tobacco Products Submitted by R.J. Reynolds Tobacco Company; Availability
Dear Mr. Zeller:
Today, December 18, 2017, FDA filed for substantive scientific review six modified risk tobacco product applications (MRTPA) from R.J. Reynolds for six styles of Camel Snus smokeless tobacco products referenced above. We are writing to complain about the public comment process for review of the above-referenced docket.
December 21, 2017
We are in the process of migrating the Tobacco Center website to a new website and it is very difficult to capture and transfer comments. As a result no comments made between now and when the new site is up (around a week or two) will be considered for posting.
Replies will be considered for posting when the new site is up.
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