Health groups raise important substantive and procedural issues with PM’s application to make reduced exposure claims for IQOS 3

The American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative have submitted a well-conceived public comment to FDA opposing Philip Morris’ request to make “modified exposure” claims about the new IQOS 3. In addition to providing important information about new studiesContinue reading “Health groups raise important substantive and procedural issues with PM’s application to make reduced exposure claims for IQOS 3”

Industry easily adapts to FDA’s limited action on e-cig flavors

In response to skyrocketing youth e-cigarette use, driven largely by Juul removable pod flavored e-cigs, in January 2020, FDA said they would “prioritize enforcement” against most flavored pod e-cigs. Not surprisingly, youth and young adults have shifted to menthol and disposable flavored e-cigs that FDA is not prioritizing. Now Shivani Gaiha and her colleagues atContinue reading “Industry easily adapts to FDA’s limited action on e-cig flavors”

Philip Morris’ modified risk tobacco product application for IQOS 3 does not adequately consider new research on IQOS’s appeal to adolescents or young adults, consumer perceptions, or the likelihood that the consumers will misunderstand labeling and marketing; FDA should not issue a reduced exposure MRTP order

Philip Morris has applied for permission from FDA to make reduced exposure claims for its new IQOS 3 heated tobacco product. My colleagues and I at the UCSF TCORS have submitted a public comment opposing this request. The main thrust of the comment is a discussion of 57 papers published since 2018 that consider IQOS’sContinue reading “Philip Morris’ modified risk tobacco product application for IQOS 3 does not adequately consider new research on IQOS’s appeal to adolescents or young adults, consumer perceptions, or the likelihood that the consumers will misunderstand labeling and marketing; FDA should not issue a reduced exposure MRTP order”

Health groups back in court pressing FDA to act on menthol and e-cig PMTA applications

Menthol Over the last year health groups have started suing the FDA in efforts to force action, particularly in the areas of menthol and evaluating e-cigarettes and other new tobacco products. As part of a political compromise, the 2009 Family Smoking Prevention and Tobacco Control Act banned characterizing flavors (but not the flavors themselves) exceptContinue reading “Health groups back in court pressing FDA to act on menthol and e-cig PMTA applications”

New meta-analysis confirms that e-cigs do not help smokers quit in the real world

Linnea Hedman and colleagues in Sweden just published a new meta-analysis of the relationship between e-cigarette use and smoking cessation, Electronic cigarette use and smoking cessation in cohort studies and randomized trials: A systematic review and meta-analysis. Like our earlier meta-analysis, did separate analyses of population-based observational studies and randomized trials of e-cigarettes provided asContinue reading “New meta-analysis confirms that e-cigs do not help smokers quit in the real world”

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”

PM’s modified risk tobacco product application for IQOS 3 ignores new published research on toxic emissions in IQOS aerosol and does not demonstrate benefits to individual or population health; FDA should deny its application to make reduced exposure claims

My UCSF TCORS colleagues and I submitted this public comment to the FDA opposing Philip Morris’ application for authorization for them to make modified risk claims for its new IQOS 3 heated tobacco product. A PDF of the comment is here. The Regulations.gov tracking number is kur-iypq-uf1v. Here is the comment: The supplemental modified riskContinue reading “PM’s modified risk tobacco product application for IQOS 3 ignores new published research on toxic emissions in IQOS aerosol and does not demonstrate benefits to individual or population health; FDA should deny its application to make reduced exposure claims”

“Big Vape” is well worth reading

As I said in my review of Lauren Etter’s history of Juul, The Devil’s Playbook, my definition of a good book on tobacco is that I learn things I didn’t already know from reading it. Even after reading Etter’s book, Jamie Ducharme’s Big Vape is a good book. While all the key major events appearContinue reading ““Big Vape” is well worth reading”

Menthol: Two wrongs won’t make a right

After refusing to authorize the sale of over a million e-cigarette flavors, the FDA still has not dealt with menthol (or tobacco flavored) e-cigarettes. As detailed in an earlier blog post, I remain concerned that FDA will authorize the sale of menthol e-cigarettes using the incorrect logic that menthol e-cigarettes need to remain available asContinue reading “Menthol: Two wrongs won’t make a right”

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”