E-cigarettes deliver nicotine to users by aerosolizing “e-liquid” that is a solution containing nicotine and flavoring agents. The solvent used to dissolve these elements usually consists of propylene glycol and glycerin (PG/VG), which is recognized by the FDA as “generally recognized as safe” (GRAS) for ingestion (eating), so people generally don’t worry about it. InContinue reading “e-cig PG/VG and nicotine promote tumor growth and metastasis”
Category Archives: FDA
Genetic evidence that e-cigarettes increase cancer (and other disease) risk among young adults
E-cigarette advocates — as well as regulators like the FDA — are fond of pointing out that nicotine is not a carcinogen (chemical that causes cancer) and noting that because they do not involve combustion, e-cigarettes do not deliver many carcinogenic chemicals produced by burning cigarettes. A new paper by Stella Tommasi , Ahmad BesaratiniaContinue reading “Genetic evidence that e-cigarettes increase cancer (and other disease) risk among young adults”
FDA should deny renewal of PMI’s modified risk claim for Swedish Match Snus because of joint marketing with ZYN nicotine pouches
My UCSF colleagues and I submitted this public comment to FDA. It is an updated version of the one we submitted to TPSAC on June 20, 2024. A PDF is here. The Regulations.gov tracking number is lz3-50m7-es1x. FDA should consider the significant public health issues, especially for youth, created by Philip Morris International’s co-marketing ofContinue reading “FDA should deny renewal of PMI’s modified risk claim for Swedish Match Snus because of joint marketing with ZYN nicotine pouches”
New meta-analysis of e-cigs and cardiovascular disease shows increased risks
Chen Chen and colleagues recently published Assessing the association between e-cigarette use and cardiovascular disease: A meta-analysis of exclusive and dual use with combustible cigarettes that found significantly elevated cardiovascular disease risk in dual users (people who use both e-cigarettes and cigarettes) and former smokers who had switched to e-cigarettes compared to people who hadContinue reading “New meta-analysis of e-cigs and cardiovascular disease shows increased risks”
Smoking gun document ties Al Sharpton to Juul, efforts to protect menthol cigs
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”
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”
Stanton Glantz blog 