One area of broad agreement between industry and public health at FDA’s recent “listening session” on the Center for Tobacco Product’s pending strategic plan was that FDA should be more transparent about the standards it uses for judging new tobacco products. My UCS colleagues and I submitted this public comment listing several specific ways thatContinue reading “Simple ways FDA could improve review of new tobacco product applications”
Category Archives: FDA
CTP should finally set a maximum nicotine level for tobacco products
In 2018 FDA announced that it was working on a rule setting a maximum level of nicotine in cigarettes. As part of our public comments to FDA on its pending strategic plan my UCSF colleagues and I urged FDA to finalize such a rule and expand its scope beyond just cigarettes. (A PDF is here.Continue reading “CTP should finally set a maximum nicotine level for tobacco products”
CTP should finalize the rules prohibiting menthol in cigarettes and prohibiting characterizing flavors in cigars, including menthol analogs
The fact that menthol is the most important additive in tobacco products is clear from the fact that the tobacco companies made exempting menthol from the ban on characterizing flavors in the original 2009 Family Smoking Prevention and Tobacco Control Act as well as the companies ongoing (unsuccessful) efforts to fight local and state prohibitionsContinue reading “CTP should finalize the rules prohibiting menthol in cigarettes and prohibiting characterizing flavors in cigars, including menthol analogs”
FDA should finalize its updated list of Harmful and Potentially Harmful Constituents by December 2023
In April 2022, I pointed out that one of the nerdy, but very important, parts of the FDA tobacco product regulatory process is the list of “Hazardous and Potentially Hazardous Compounds” (HPHC) list that FDA released in 2012. This list contains 93 bad chemicals — mostly carcinogens — that FDA identified as important when assessingContinue reading “FDA should finalize its updated list of Harmful and Potentially Harmful Constituents by December 2023”
FDA (and others) should integrate the relationship between cannabis and tobacco use
My UCSF colleagues and I submitted a public comment to the FDA Center for Tobacco Products regarding its upcoming strategic plan urging FDA to more strongly integrate the crossover between tobacco and cannabis use into its planning. While FDA does not (yet) have jurisdiction over cannabis, there is no question that growing cannabis use hasContinue reading “FDA (and others) should integrate the relationship between cannabis and tobacco use”
FDA should prioritize direct measures of health and behavioral effects over indirect measures or assumptions in making regulatory decisions
Last week I posted by oral testimony to the FDA listening session for developing its strategic plan, “FDA CTP should prioritize direct epidemiological population measures of health and behavior over indirect measures or assumptions.” My UCSF colleagues and I also subsequently submitted a written public comment amplifying the points in the oral testimony, including citations forContinue reading “FDA should prioritize direct measures of health and behavioral effects over indirect measures or assumptions in making regulatory decisions”
FDA CTP should prioritize direct epidemiological population measures of health and behavior over indirect measures or assumptions.
On August 22, 2023 the FDA Center for Tobacco Products held a listening session to gather public input to help it prepare it’s strategic plan. Here is what I said: My name is Stanton Glantz. I am a retired UCSF Professor of Medicine and served as principal investigator of the UCSF TCORS until I retired. Continue reading “FDA CTP should prioritize direct epidemiological population measures of health and behavior over indirect measures or assumptions.”
Juul 2: Facebook merges with a drug cartel
E-cigarette company Juul has applied to the FDA for permission to market its Juul 2 e-cigarette, which allows two-way communication with the device, nominally to prevent youth use. Juul reports that the Juul 2 pairs with a phone app to verify a user’s age: “The user must upload their photo ID and take a real-timeContinue reading “Juul 2: Facebook merges with a drug cartel”
UC publishes oral history of Stanton Glantz: Putting Cardiovascular, Epidemiological, Economic, Political, and Policy Research into Action at UC San Francisco and Beyond
Today the Oral History Center at the University of California Bancroft Library published an oral history of my career, which is freely available to all. Beginning in elementary school in Cleveland, Ohio, the history follows me through college and gradual school. It discusses my work to develop the emergency protocols for the Apollo 5 missionContinue reading “UC publishes oral history of Stanton Glantz: Putting Cardiovascular, Epidemiological, Economic, Political, and Policy Research into Action at UC San Francisco and Beyond”
FDA denies myblu menthol e-cig
FDA has denied a marketing order for Fontem’s myblu menthol e-cigarette. This is FDA’s second denial of a marketing order for a menthol e-cigarette, following its denial of RJR’s Vuse Solo menthol and other menthol e-cigarettes. With this decision, FDA continues to move away from its previous permissive policy toward menthol e-cigarettes, which appears toContinue reading “FDA denies myblu menthol e-cig”
Stanton Glantz blog 