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”

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”

Philip Morris ordered to suspend IQOS sales in the US

After losing a patent dispute with British American Tobacco over its IQOS heated tobacco product, Philip Morris has been forced to suspend sales of the device in the US. Specifically, BAT says that the heating element in IQOS violates a BAT patent. Philip Morris had met with the FDA and urged it to intervene withContinue reading “Philip Morris ordered to suspend IQOS sales in the US”

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”

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”

Why FDA’s reduced exposure marketing order for IQOS is not a reliable global model

There are two separate decisions that the FDA makes about new products: (1) whether to authorize the sale of the product, and, if they allow sale of a product, (2) whether to allow a company to make reduced exposure or reduced risk claims about the product. To further confuse the situation, the separate decisions aboutContinue reading “Why FDA’s reduced exposure marketing order for IQOS is not a reliable global model”

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”

FDA should not grant exemptions to its proposed standard banning menthol in cigarettes that would continue to allow menthol heated tobacco products or low nicotine cigarettes

FDA’s proposed standard banning menthol in cigarettes is very well-done except for its provision that would allow FDA to exempt heated tobacco products like Philip Morris’ IQOS, BAT’s glo or JTI’s Ploom — which are considered “cigarettes” under the law — or low nicotine cigarettes. (FDA has only authorized sale IQOS so far.) This isContinue reading “FDA should not grant exemptions to its proposed standard banning menthol in cigarettes that would continue to allow menthol heated tobacco products or low nicotine cigarettes”