December 7, 2017
My colleagues and I at UCSF, Stanford, and Georgia State have submitted this public comment to the FDA on PMI’s IQOS MRTP application. The tracking number is 1k1-9087-458e. A PDF of the comment is available here.
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
Bonnie Halpern-Felsher, PhD;1 Karma McKelvey, PhD, MPH;1 Minji Kim, PhD; Benjamin Chaffee, DDS, MPH, PhD; Maya Vijayaraghavan, MD, MAS; Lucy Popova, PhD; 2 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 7, 2017
December 7, 2017
As reported in Buzzfeed and elsewhere, Dr. Eunice Neeley has filed a lawsuit against me alleging sexual harassment and discriminatory behavior.
I have read the Buzzfeed article and deny every claim reported to be included in this lawsuit.
These allegations were made formally to the University of California in March 2017 and the University has been conducting an extensive investigation that has not yet been completed. I have been cooperating in every way with the investigation, including sitting for several interviews, each several hours long, as well as providing extensive written records. These records provide specific contemporaneous documentation that demonstrates that the related allegations, as reported by Buzfeed, are not supported by the documentary record.
I have also heard that another woman who has been collaborating with Dr. Neeley will be filing a lawsuit in the near future. She also filed a complaint with the University which is being investigated by the same and other offices. Based on the complaint filed last March I deny the claims made at that time.
December 5, 2017
The latest ad has been posted to Smokefree Movies. It’s running in The Hollywood Reporter on December 6 and in Variety on December 18. (We have used the graphic before; the text is new.)
Learn more:
• What the CDC says about smoking in movies
• Leading health organizations set June 2018 deadline for R-rating
• Investment managers join call for R-rating tobacco imagery
• How the R-rating will work
• WHO and its global tobacco control treaty back adult-rating and other countermeasures
See the full ad and access PDF version here.
November 30, 2017
My colleagues at the UCSF TCORS just submitted this public comment to the FDA and PMI's application to market IQOS as a modified (less) risk tobacco product. There is a PDF of the comment here and the tracking number is 1k1-903a-mnpl.
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
Lauren F. Chun, BA; Farzad Moazed, MD;
Michael A. Matthay, MD; Carolyn S. Calfee, MD MAS; Jeffrey E. Gotts MD PhD
Department of Medicine, Pulmonary Division
University of California San Francisco
UCSF Tobacco Center of Regulatory Science
Docket Number: FDA-2017-D-3001
November 30, 2017
November 30, 2017
My colleagues at the UCSF TCORS just submitted this public comment to the FDA and PMI's application to market IQOS as a modified (less) risk tobacco product. There is a PDF of the comment here and the tracking number is 1k1-9039-d91g.
PMI’s MRTP application for IQOS does not adequately evaluate potential for hepatotoxicity risk
Lauren F. Chun, BA; Farzad Moazed, MD; Michael A. Matthay, MD;
Carolyn S. Calfee, MD MAS; Jeffrey E. Gotts MD PhD
Department of Medicine, Pulmonary Division
University of California San Francisco
UCSF Tobacco Center of Regulatory Science
Docket Number: FDA-2017-D-3001
November 30, 2017