Tobacco Center Faculty Blog

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
 

Reuters has reported that “The U.S. Food and Drug Administration said on Wednesday it is considering measures to speed development of products that help people quit smoking, including easing requirements for approval of over-the-counter nicotine replacement therapies... The new measures could enable e-cigarette companies to get the devices approved as medical products, which could offer consumers greater reassurance that they perform as advertised and also open the possibility of being covered under health insurance.”
 
While developing better ways to help smokers quit is always a good thing, there is a good chance that this FDA initiative will end up helping the tobacco companies keep people smoking.
 
As Dorie Apollonio and I reported last October in our paper “Tobacco Industry Research on Nicotine Replacement Therapy: ‘If Anyone Is Going to Take Away Our Business It Should Be Us,’" the tobacco companies figured out back in the 1990s that, while NRT is very effective when used with proper medical management, few physicians ensure that their patients will use it correctly and OTC NTR was associated with less not more quitting.