Science FDA (and everyone else) needs to actively engage as they think about whether to authorize Juul and the other ecigs

When I read the FDA’s Technical Project Lead summary of its scientific justification for authorizing the sale of RJ Reynolds’ Vuse Solo e-cigarette, I was struck by the fact that it ignored the broad scientific literature on e-cigarettes and seemed to accept industry-framed arguments. For example: They ignored the evidence that as consumer products, e-cigarettesContinue reading “Science FDA (and everyone else) needs to actively engage as they think about whether to authorize Juul and the other ecigs”

E-cigarettes don’t help smokers stay off cigarettes

Last week the FDA authorized the sale of RJ Reynolds’ (BAT’s US subsidiary) Vuse e-cigarette despite heavy use by kids because “the manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure toContinue reading “E-cigarettes don’t help smokers stay off cigarettes”

No quitting benefit for e-cigs over FDA-approved therapies … and lots of dangerous dual use

The FDA Center for Tobacco Products concern about balancing potential benefits of e-cigs with demonstrated risks to youth presumes that adults using e-cigarettes will switch completely to e-cigs and that e-cigs are substantially less risky than cigarettes. Bekir Kaplan and colleagues’ new paper Effectiveness of ENDS, NRT and medication for smoking cessation among cigarette-only users:Continue reading “No quitting benefit for e-cigs over FDA-approved therapies … and lots of dangerous dual use”

An unbalanced consideration of the risks and benefits of e-cigarettes

Several people have asked me what I thought of the recent essay by Balfour et al and a group of former presidents of the Society for Nicotine and Tobacco Research, “Balancing consideration of the risks and benefits of e-cigarettes,” that argues that concerns over youth e-cigarette use needs to be “better balanced” against the valueContinue reading “An unbalanced consideration of the risks and benefits of e-cigarettes”

FDA’s recent press release raises 3 issues on how CTP is judging e-cigs

On August 26, 2021, FDA denied marketing orders for around 55,000 flavored e-cigarettes because the manufacturers had not made the case that authorizing the sale of these products was “appropriate for the protection of public health,” the standard in the 2009 Family Smoking Prevention and Tobacco Control Act that gave the FDA jurisdiction over tobaccoContinue reading “FDA’s recent press release raises 3 issues on how CTP is judging e-cigs”

Youth who use heated tobacco products have a much harder time quitting cigarettes

Philip Morris won FDA authorization for its heated tobacco product (HTP) IQOS without addressing the effects it would have on youth. FDA also allowed PM to promote IQOS’ “reduced exposure” claim based on the assumption that people would “switch completely” from combusted cigarettes to IQOS. An important new study from Hong Kong draws both assumptionsContinue reading “Youth who use heated tobacco products have a much harder time quitting cigarettes”

New WHO report highlights falling cigarette use and challenges that new tobacco products pose to public health and implementation of the FCTC

On July 27, 2021 the WHO released the WHO report on the global tobacco epidemic 2021: addressing new and emerging products, its eighth such report. The good news is that it documents solid progress in reducing tobacco use. After over a century of growth, “between 2007 and 2019, smoking rates decreased from a global averageContinue reading “New WHO report highlights falling cigarette use and challenges that new tobacco products pose to public health and implementation of the FCTC”

More details on how menthol helps Big Tobacco keep kids hooked

Keeping menthol in cigarettes (and other tobacco products) has been a priority for the tobacco companies ever since they got it exempted from the characterizing flavor ban in the 2009 Family Smoking Prevention and Tobacco Control Act that gave the FDA jurisdiction over tobacco products. The already-strong case for banning menthol just got stronger withContinue reading “More details on how menthol helps Big Tobacco keep kids hooked”

We know a lot about how e-cigarettes cause disease

The evidence on the health effects of e-cigarettes was the subject of two recently published reviews that focus on cardiovascular, pulmonary and immunologic effects of e-cigarettes. These reviews complement earlier reviews on the pulmonary effects of e-cigarettes, e-cigarettes and smoking cessation, and the gateway effect for smoking among youth and young adults. Taken together theseContinue reading “We know a lot about how e-cigarettes cause disease”

CDC’s new mask guidance and why FDA CTP should not assume e-cigs help smokers quit in the real world

On May 13, 2021 the CDC lifted most restrictions on the use of masks for people fully vaccinated against COVID-19 (two weeks after the second shot for Pfizer or Moderna and 1 week after J&J). While some people thought this was a political decision, CDC Director Walensky explained in detail that real world experience showedContinue reading “CDC’s new mask guidance and why FDA CTP should not assume e-cigs help smokers quit in the real world”