New report highlights marketing of synthetic and “non-tobacco” nicotine products

Just as Congress is moving toward giving FDA explicit authority over non-tobacco nicotine products, Rob Jackler’s group at Stanford released a new report, “Marketing of ‘Tobacco-Free’ and ‘Synthetic Nicotine’ Products,” that details how these products are being promoted. In 2009 Congress gave the FDA jurisdiction over consumer products “made or derived from tobacco,” which includesContinue reading “New report highlights marketing of synthetic and “non-tobacco” nicotine products”

Proposed FDA menthol rules sent to Biden OMB for approval before release for public comment

One February 24, 2022, the FDA submitted two proposed rules on menthol to the White House Office of Management and Budget for review before public release: “Tobacco Product Standard for Menthol in Cigarettes” and “Tobacco Product Standard for Characterizing Flavors in Cigars.” The OMB can approve the proposed rules as submitted, deny them, or approveContinue reading “Proposed FDA menthol rules sent to Biden OMB for approval before release for public comment”

Court inaction continues to block Congressionally-mandated graphic warning labels on cigs

The 2009 Family Smoking Prevention and Tobacco Control Act directed FDA to issue a rule requiring state-of-the-art graphic warning labels on cigarette packages. FDA issued such a rule, but the tobacco companies sued and blocked the original warnings in court in 2013. It took years, but in March 2020 FDA issued a new carefully designedContinue reading “Court inaction continues to block Congressionally-mandated graphic warning labels on cigs”

More real world evidence that e-cigs make it harder to quit cigarettes

The evidence that e-cigarettes do not work for smoking cessation just keeps piling up. The latest high quality real world study, “Effectiveness of e-cigarettes as aids for smoking cessation: evidence from the PATH Cohort Study, 2017-19,” published by Ruifeng Chen and colleagues at UCSD in Tobacco Control reports on the association between e-cigarette use andContinue reading “More real world evidence that e-cigs make it harder to quit cigarettes”

The fact that daily ecig users quit more is not relevant to FDA CTP’s assessment of whether to authorize the sale of e-cigs

The new paper “Association of e-cigarette use with discontinuation of cigarette smokers among adult cigarette smokers who were initially planning to quit” in JAMA Open Network by Karin Karza and colleagues confirms that smokers who use e-cigarettes daily are more likely to quit cigarettes than those who don’t use e-cigarettes. Also consistent with earlier studies,Continue reading “The fact that daily ecig users quit more is not relevant to FDA CTP’s assessment of whether to authorize the sale of e-cigs”

Researchers write Acting Commissioner Janet Woodcock asking FDA to withdraw marketing authorization for RJR Vuse Solo ecig

Colleagues at UCSF and Stanford and I wrote FDA Acting Commissioner Janet Woodcock raising concerns that FDA’s October 12, 2021 Marketing Granted Orders for Vuse Solo failed to substantiate its determination that authorizing the marketing of Vuse Solo will provide a net improvement to public health. In particular, FDA failed to quantify the benefits vs.Continue reading “Researchers write Acting Commissioner Janet Woodcock asking FDA to withdraw marketing authorization for RJR Vuse Solo ecig”

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”