On June 23, 2022, FDA denied Juul’s application for authorization to sell its e-cigarettes in the USA. While FDA quickly backed down and allowed Juul to remain on the market while the FDA considered “scientific issues unique to the JUUL application that warrant additional review,” there is a lot of interest in FDA’s reasoning forContinue reading “Juul knows why FDA denied its request to legally sell its ecigs. Why won’t FDA tell the rest of us?”
Category Archives: FDA
FDA was correct in not quantifying consumer surplus in its analysis of the proposed standard for menthol in cigarettes
My colleagues at UCSF and other universities and I have submitted this comment to the FDA in response to its proposal to prohibit the use of menthol in cigarettes. A PDF of the comment is here. The Regulations.gov tracking number is l6b-h3rv-v16n. FDA was correct in not quantifying consumer surplus in its analysis of theContinue reading “FDA was correct in not quantifying consumer surplus in its analysis of the proposed standard for menthol in cigarettes”
FDA’s economic model underestimates the benefits of the proposed product standard prohibiting menthol in cigarettes, so the benefits would be even greater
My colleagues at UCSF and other universities and I have submitted this comment to the FDA in response to its proposal to prohibit the use of menthol in cigarettes. A PDF of the comment is here. The Regulations.gov tracking number is l6b-gxso-b6yq. FDA’s economic model underestimates the benefits of the proposed product standard prohibiting mentholContinue reading “FDA’s economic model underestimates the benefits of the proposed product standard prohibiting menthol in cigarettes, so the benefits would be even greater”
FDA should extend the scope of its proposed cigar flavor standard to prohibit flavors in all tobacco products, including e-cigarettes and smokeless tobacco, to make them less appealing to adolescents and young adults
My colleagues at the UCSF TCORS and I submitted this public comment to the FDA on its proposal to remove flavors from cigars. A PDF of the comment is here. The Regulations.gov tracking number is l6c-lwj1-vcu7. FDA should extend the scope of the proposed flavor standard to prohibit flavors in all tobacco products, including e-cigarettesContinue reading “FDA should extend the scope of its proposed cigar flavor standard to prohibit flavors in all tobacco products, including e-cigarettes and smokeless tobacco, to make them less appealing to adolescents and young adults”
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”
FDA should prohibit all menthol flavor additives, compounds, constituents, and ingredients in cigarettes, and should not limit the proposed standard to prohibiting menthol as a “characterizing flavor”
My colleagues at UCSF and other universities and I have submitted this comment to the FDA in response to its proposal to prohibit the use of menthol in cigarettes. A PDF of the comment is here. The Regulations.gov tracking number is l6b-ew3y-c1ye. FDA should prohibit all menthol flavor additives, compounds, constituents, and ingredients in cigarettes,Continue reading “FDA should prohibit all menthol flavor additives, compounds, constituents, and ingredients in cigarettes, and should not limit the proposed standard to prohibiting menthol as a “characterizing flavor””
FDA science leader Matt Holman leaves FDA for PMI
Matt Holman, who has served as head of the FDA Center for Tobacco Products since 2017, is leaving the FDA to take a job with Philip Morris International. According to a story in The Hill, a spokesperson for Philip Morris said Holman “is committed to helping existing adult smokers access scientifically substantiated smoke-free alternatives whileContinue reading “FDA science leader Matt Holman leaves FDA for PMI”
Outside review of FDA CTP operations brings opportunities and risks
FDA Commissioner Rob Califf announced (Politico, Associated Press, New York Times) that he was asking the Regan-Udall Foundation to conduct a process review of the FDA’s tobacco and food centers. As someone who has been critical of the poor and incomplete scientific assessments FDA has completed of so-called “harm reduction” products — particularly e-cigarettes andContinue reading “Outside review of FDA CTP operations brings opportunities and risks”
Since FDA has made a mess of Juul, the health community & Congress should force FDA to ban menthol e-cigs now
The day after FDA denied Juul’s application to continue selling its e-cigarettes on June 23, 2022, Juul sued and obtained an emergency Stay from the US Court of Appeals. On July 5, the FDA announced that it was issuing its own Administrative Stay and allowed Juul to remain on the market while the FDA considersContinue reading “Since FDA has made a mess of Juul, the health community & Congress should force FDA to ban menthol e-cigs now”
As a matter of health equity and social justice, FDA should immediately finalize and implement the proposed standard for menthol in cigarettes to reduce smoking-attributable deaths and health disparities among African Americans
Several colleagues at UCSF and elsewhere and I submitted this comment to the FDA on its proposed rule to end menthol in cigarettes. A PDF is here; the regulations.gov tracking number is l4s-xj6c-9kba. As a matter of health equity and social justice, FDA should immediately finalize and implement the proposed standard for menthol in cigarettesContinue reading “As a matter of health equity and social justice, FDA should immediately finalize and implement the proposed standard for menthol in cigarettes to reduce smoking-attributable deaths and health disparities among African Americans”
Stanton Glantz blog 