February 6, 2020
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 regulations.gov 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
February 5, 2020
February 5, 2020
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 regulations.gov 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
February 3, 2020
Rebecca Evans-Polce and colleagues just published “Trends in E-Cigarette, Cigarette, Cigar, and Smokeless Tobacco Use Among US Adolescent Cohorts, 2014-2018” in American Journal of Public Health. They used data from the National Youth Tobacco Survey from 2014-2018, the years in which e-cigarette use really took off, to assess the age at which kids started using e-cigarettes, cigarettes, smokeless tobacco, and cigars. They found that the age of initiation for cigarettes, smokeless, and cigars did not change over these 5 years, but that the age initiation for e-cigarettes dropped.
In 2014, 8.8% of lifetime e-cigarette users had started by age 14; in 2018 this fraction had increased to 28.6%.
This result adds to the overwhelming case that e-cigarette use is an epidemic with kids and highlights the need to continue to press for bans on the sale of all flavored tobacco products, including e-cigarettes, and also stopping the sale of all e-cigarettes that have not been approved as “appropriate for the protection of public health” by the FDA.
This is also more evidence that the FDA’s “enforcement policy” that exempts popular new disposable and refillable e-cigarettes is likely to fail to have much impact on youth use. It needs to be comprehensive.
Here is the abstract: