Tobacco Center Faculty Blog

February 7, 2020

Stanton A. Glantz, PhD

Today we submitted this public comment to FDA and its Tobacco Products Scientific Advisory Committee.  The tracking number is 1k4-9evp-yi5f. A PDF is available here.

22nd Century’s VLN cigarettes marketing with modified exposure claims has not been tested and will likely be appealing to youth and young adults


Lucy Popova, PhD*; Bonnie Halpern-Felsher, PhD; Benjamin Chaffee, DDS, MPH, PhD; Lauren K. Lempert, JD, MPH; Stanton A. Glantz, PhD


February 6, 2020

Stanton A. Glantz, PhD

Today we submitted this public comment to the FDA explaining why they should not approve modified risk or exposure claims for very low nicotine cigarettes.  It also points out that FDA erred in approving this product for sale because the company changed the name for the cigarette from VLN to Moonlight after FDA finished assessing the PMTA application.  This means that the assessment was not based on the actual name of the product, which is important for marketing and the public health effect.  The tracking number is 1k4-9eva-3mp5.  A PDF of the comment is here.  We also submitted a similar comment to the FDA Tobacco Product Scientific Advisory Committee, which will be considering this application soon.


22nd Century’s MRTP application for its VLN cigarettes should be denied because it does not adequately address how its product would be actually used and because the modified exposure claim misleads consumers to believe this product is less harmful than conventional cigarettes


February 5, 2020

Stanton A. Glantz, PhD

My colleague Michael Matthay, a Professor of Medicine, Associate Director of the UCSF Intensive Care Unit, and an expert in mouse studies submitted this public comment to FDA. The tracking number is 1k4-9et5-a588  and a PDF of the comment is available here.


PMIs’ mouse study demonstrates increased morbidity and mortality in mice exposed to IQOS aerosol, and PMI’s December 20, 2019 response to FDA’s Request for Information fails to show otherwise


Michael A. Matthay, MD

University of California San Francisco TCORS


Docket Number: FDA-2017-D-3001


February 3, 2020