PMPSA’s supplemental modified risk tobacco product application for IQOS 3 does not support the conclusion that IQOS will not harm vascular endothelial function and does not address new published research, so FDA should not issue an exposure modification MRTP order for IQOS 3 support the conclusion that IQOS will not harm vascular endothelial function and does not address new published research, so FDA should not issue an exposure modification MRTP order for IQOS 3

My colleagues and I at the UCSF TCORS just submitted this public comment to the FDA. The tracking number on Regulations.gov is kta-aq6w-3tph. A PDF is available here. PMPSA’s supplemental modified risk tobacco product application for IQOS 3 does not support the conclusion that IQOS will not harm vascular endothelial function and does not addressContinue reading “PMPSA’s supplemental modified risk tobacco product application for IQOS 3 does not support the conclusion that IQOS will not harm vascular endothelial function and does not address new published research, so FDA should not issue an exposure modification MRTP order for IQOS 3 support the conclusion that IQOS will not harm vascular endothelial function and does not address new published research, so FDA should not issue an exposure modification MRTP order for IQOS 3”

FDA can and should prioritize youth over Juul and other e-cigs sales while it ponders the long term

After years of delays and deadline extensions that allowed thousands of e-cigarettes to remain on the market without any FDA premarket review and millions of kids to become nicotine addicts, health groups successfully sued FDA to force action. As a result, on July 11, 2019 Judge Paul Grimm ordered FDA to require premarket tobacco product applications (PMTAs) forContinue reading “FDA can and should prioritize youth over Juul and other e-cigs sales while it ponders the long term”

Understanding how unhealthy food companies influence advertising restrictions

Advertising is a key vector used to promote unhealthy products, and there is a long history of efforts to ban or restrict advertising as a key element of tobacco control. Advertising restrictions are also starting to be implemented to protect the public from promotions for other unhealthy products, including junk food. In particular, in 2019Continue reading “Understanding how unhealthy food companies influence advertising restrictions”

IQOS emissions create risks of immunosuppression and pulmonary toxicity and the supplemental modified risk tobacco product application for IQOS 3 does not address new published research on these risks, so FDA should not issue an exposure modification MRTP order for IQOS 3

My colleagues and I at the UCSF TCORS submitted this public comment to the FDA. The Regulations.gov tracking number is kt4-u9mw-wc65. A PDF version is available here. IQOS emissions create risks of immunosuppression and pulmonary toxicity and the supplemental modified risk tobacco product application for IQOS 3 does not address new published research on theseContinue reading “IQOS emissions create risks of immunosuppression and pulmonary toxicity and the supplemental modified risk tobacco product application for IQOS 3 does not address new published research on these risks, so FDA should not issue an exposure modification MRTP order for IQOS 3”

President Biden willing to eliminate vaping

At a campaign stop on January 6, 2020, then-candidate Joe Biden said he would prioritize health over business and eliminate vaping if the evidence showed damage to lungs and other bad effects. E-cigs do damage lungs and much more. So the FDA doesn’t have to worry about the President blocking them as Obama and TrumpContinue reading “President Biden willing to eliminate vaping”

e-cigs are a gateway to cannabis too: evidence from Germany

In addition to the sizable literature showing that e-cigarettes are attracting many kids at low risk of initiating nicotine use with cigarettes to nicotine, many of whom go on to smoke cigarettes, there is strong consistent evidence that e-cigarettes are a gateway to the cannabis use in the USA. Now Ann-Kathrin Seidel and her colleaguesContinue reading “e-cigs are a gateway to cannabis too: evidence from Germany”

Tobacco documents: The end of the beginning

When I got the first box of around 4000 pages of secret tobacco industry documents on May 12, 1994, I thought they would have an impact, but didn’t have a clue as to how big that impact would be. Being able to look inside the tobacco companies to appreciate — in their own words —Continue reading “Tobacco documents: The end of the beginning”

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”