Fenit Nirappil’s comprehensive Washington Post story How Black activists became defenders of Big Tobacco (June 21, 2024) includes the 2018 smoking gun document linking Al Sharpton the African American leader who played a key role in convincing Biden to pull FDA regulations ending menthol cigarettes and flavored cigars, as well as other African American andContinue reading “Smoking gun document ties Al Sharpton to Juul, efforts to protect menthol cigs”
Category Archives: FDA
FDA should consider the significant public health issues, especially for youth, created by PMI co-marketing of its Swedish Match General Snus and ZYN oral nicotine products and not reauthorize modified risk claims for General Snus
My colleagues at UCSF and I submitted this comment to the FDA Tobacco Products Scientific Advisory Committee opposing extension of PMI’s current authorization to make modified risk claims because its co-marketing with its ZYN nicotine pouch is fundamentally misleading. TPSAC is holding a meeting to discuss the modified risk request on June 26, 2024. AContinue reading “FDA should consider the significant public health issues, especially for youth, created by PMI co-marketing of its Swedish Match General Snus and ZYN oral nicotine products and not reauthorize modified risk claims for General Snus”
Implications of new RCT showing similar effects on quitting for nicotine e-cigs vs varenicline
Almost all the randomized controlled trials of e-cigarettes as clinical interventions for smoking cessation have compared e-cigarettes to nicotine replacement therapy. Varenicline, which is a prescription medication that works by blocking nicotine receptors rather than replacing the nicotine that cigarettes provide, is more effective than NRT. Anna Tsiku and colleagues new paper “Electronic Cigarettes vsContinue reading “Implications of new RCT showing similar effects on quitting for nicotine e-cigs vs varenicline”
FDA did the right thing when it withdrew its 2022 Juul marketing denial order; it should finish the job quickly by prohibiting Juul on solid grounds
On June 6, 2024, two years after the FDA issued, then suspended its Marketing Denial Order for Juul e-cigarettes based on narrow toxicology issues, FDA formally withdrew the MDO. This does not mean that the FDA has authorized Juul for sale in the US, it just lets FDA start over in its assessment of whetherContinue reading “FDA did the right thing when it withdrew its 2022 Juul marketing denial order; it should finish the job quickly by prohibiting Juul on solid grounds”
Tobacco companies use subliminal menthol to achieve the same goals as menthol as a characterizing flavor. Regulators should prohibit all menthol, not just as a characterizing flavor.
While most countries, including the US FDA, regulate menthol as a “characterizing flavor” — at levels that impart a discernible taste — previously secret tobacco industry documents show that tobacco companies have long used menthol at subliminal levels — below levels that impart a discernible taste — to reduce smoke harshness, reduce dryness, increase smokeContinue reading “Tobacco companies use subliminal menthol to achieve the same goals as menthol as a characterizing flavor. Regulators should prohibit all menthol, not just as a characterizing flavor.”
Altria uses dubious claims of preventing youth use to justify dangerous two-way bluetooth communication between NJOY ecigs and Altria
Altria submitted a Premarket Tobacco Product Application to FDA requesting permission to market its NJOY 2.0 device, which features bluetooth technology theoretically designed to prevent underage usage by authenticating the user before unlocking the device. (Additional news coverage) This is the same argument Juul made for its Juul 2 device when it submitted a PTMAContinue reading “Altria uses dubious claims of preventing youth use to justify dangerous two-way bluetooth communication between NJOY ecigs and Altria”
Why is the FDA still pushing e-cigs as lower risk based on ancient evidence?
Today (April 16, 2024) the FDA released a new web page on The Relative Risks of Tobacco Products that irresponsibly promotes e-cigarettes as a lower risk alternative to cigarettes. This recommendation is based on the 2018 National Academy of Sciences, Engineering and Medicine report on e-cigarettes that concluded that e-cigarettes reduce exposure to some toxicContinue reading “Why is the FDA still pushing e-cigs as lower risk based on ancient evidence?”
FDA needs to reconsider its promotion of the “continuum of risk” for e-cigarettes
As of February 22, 2024, the FDA was continuing to embrace the idea that there is a “continuum of risk” with combusted tobacco as the riskiest and e-cigarettes being substantially less risky. As a result, FDA promotes e-cigarettes as a way for smokers to reduce risk. This view is based on the fact that e-cigarettesContinue reading “FDA needs to reconsider its promotion of the “continuum of risk” for e-cigarettes”
E-cigs have similar risks to cigs for some diseases and nearly as high for others. Dual use riskier than smoking alone
It is an article of faith among e-cigarette advocates that they are substantially less risky than cigarettes. Rather than being based on the actual associations between e-cigarette use and disease, this belief is based on the fact that e-cigarettes do not burn tobacco, so avoid the toxic combustion products that cigarettes produce. In recent years,Continue reading “E-cigs have similar risks to cigs for some diseases and nearly as high for others. Dual use riskier than smoking alone”
Banning menthol leads a quarter of menthol smokers to quit
The two justifications for the FDA’s proposed product standard prohibiting menthol cigarettes and cigars are (1) it will reduce youth initiation, and (2) it will help menthol smokers to quit. Now Sarah Mills and colleagues have published a review and meta-analysis of the effects of menthol bans around the world, The Impact of Menthol CigaretteContinue reading “Banning menthol leads a quarter of menthol smokers to quit”
Stanton Glantz blog 