December 21, 2017

Stanton A. Glantz, PhD

Letter to FDA TPSAC urging them to delay action on IQOS until the record is closed and they can consider public comments

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. 
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.

Stanton A. Glantz, PhD
Professor of Medicine
Truth Initiative Distinguished Professor of Tobacco Control
Director, Center for Tobacco Control Research and Education

Public Comments Submitted on Philip Morris International’s MRTP applications for IQOS and Provided to TPSAC
1.  Letter Mitchell Zeller protesting the way that the public comment period has been managed dated December 12, 2017
2.  PMI’s Own Data on Biomarkers of Potential Harm in Americans Show that IQOS is Not Detectably Different from Conventional Cigarettes
3. The evidence PMI presents in its MRTP application for IQOS is misleading and does not support the conclusion that IQOS will not harm endothelial function; independent research done in a more relevant physiological model shows that IQOS harms endothelial function as much as conventional cigarettes
4. Philip Morris’s Population Health Impact Model Based on Questionable Assumptions and Insufficient Health Impact Measures Does Not Adequately Support its MRTP Application
5.  Because PMI application did not report the full range of HPHCs in IQOS aerosol, characterize HPHCs in sidestream emissions, include a non-targeted analysis of chemicals in emissions, or conduct clinical studies to describe exposure to toxicants during dual use with other tobacco products, FDA must deny PMI’s application
6. IQOS emissions create risks of immunosuppression and pulmonary toxicity, so FDA should not issue an order permitting IQOS to be labeled or marketed with reduced risk claims
7. PMI’s MRTP application for IQOS does not adequately evaluate potential for liver totoxicity risk
8. PMI’s MRTP Application for IQOS Does Not Consider IQOS’s Appeal to Youth or Adolescents, or the Likelihood that Youth and Adolescents will Initiate Tobacco Use with IQOS or Use IQOS with Other Tobacco Products
9. 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
10. Detailed analysis of the Executive Summary (Section 2.7) submitted by Philip Morris International in support of its MRTP application for IQOS
11. 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

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