PMPSA’s Population Health Impact Model for IQOS underestimates the health impact of IQOS, does not adequately address new published research and information on population health impacts, and does not demonstrate benefits to individual or population health, 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 kta-koyn-mf7k. A PDF is available here. PMPSA’s Population Health Impact Model for IQOS underestimates the health impact of IQOS, does not adequately address new published research and information on population health impacts, and does notContinue reading “PMPSA’s Population Health Impact Model for IQOS underestimates the health impact of IQOS, does not adequately address new published research and information on population health impacts, and does not demonstrate benefits to individual or population health, so FDA should not issue an exposure modification MRTP order for IQOS 3”

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”

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”

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”

Good news: Youth e-cig use dropped in 2020

The CDC recently reported big drops in e-cigarette use between 2019 and 2020 (high school dropped from 27.5% to 19.6% and middle school dropped from 10.5% to 4.7%). As the figure above (courtesy of CDC.) shows, however, e-cig use is still very high, way above where cigarette smoking and e-cigarette use were nine years earlierContinue reading “Good news: Youth e-cig use dropped in 2020”

FDA authorized sales of Philip Morris’ IQOS 3 in an opaque process that gave short shrift to protecting the public health

On December 7,2020, FDA issued a marketing order authorizing Philip Morris Products to sell its IQOS 3 heated tobacco product, an updated version of the IQOS 2.4 system FDA had previously authorized for sale in April 2019.  Based on FDA’s streamlined review of Philip Morris’ “supplementary application” comparing IQOS 3 to IQOS 2.4, FDA determinedContinue reading “FDA authorized sales of Philip Morris’ IQOS 3 in an opaque process that gave short shrift to protecting the public health”