In the past, when FDA announced that it was authorizing the sale of new products through the Premarket Tobacco Authorization process (PMTA), they released a detailed scientific summary of the rationale behind their decision known as the Technical Project Lead (TPL) report. These documents were released on the FDA web page announcing the positive decisions.Continue reading “Why is FDA withholding details of its approval for 8 Logic e-cigs and HTP?”
Category Archives: FDA
FDA sends another signal that it will authorize menthol ecigs despite high youth use
The FDA continues to telegraph that it is going to authorize the sale of menthol e-cigarettes. The first strong indication was not acting on the Vuse Solo menthol PMTA, which has allowed RJ Reynolds to continue selling menthol Vuse side-by-side (screen capture below) with the authorized tobacco flavor. Now, the FDA press release announcing itsContinue reading “FDA sends another signal that it will authorize menthol ecigs despite high youth use”
E-cigarettes more likely to lead to ongoing nicotine addiction than NRT
E-cigarette advocates and, more important, the FDA, takes it as given that e-cigarettes were developed as a harm reduction tool to help smokers quit cigarettes by “switching completely.” This assumption is, however, inconsistent with the tobacco companies’ actual reasons for developing e-cigarettes and other non-combustible products, including tobacco company products approved as NRT: To deterContinue reading “E-cigarettes more likely to lead to ongoing nicotine addiction than NRT”
Higher nicotine content and flavors increase e-cig abuse liability
As debates over nicotine and flavors in e-cigarettes continues to heat up, Mari Gades, Aleksandra Alcheva, Amy Riegelman, and Dorothy Hatsukami just published “The role of nicotine and flavor in the abuse potential and appeal of electronic cigarettes for adult current and former cigarette and electronic cigarette users: A systematic review” in Nicotine and TobaccoContinue reading “Higher nicotine content and flavors increase e-cig abuse liability”
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”
Stanton Glantz blog 