A troubling look inside FDA CTP staff highlighting interference with scientific assessment of PMTAs

Yesterday (November 7, 2022), after Lauren Lempert finished working on our letter to the Regan-Udall Foundation raising issues about the FDA’s scientific standards for assessing premarket tobacco product applications, she browsed the Foundation page listing all the comments that had been submitted to the Expert Panel. The picture that emerges from looking at just aContinue reading “A troubling look inside FDA CTP staff highlighting interference with scientific assessment of PMTAs”

Calif voters overwhelmingly confirm ban on flavored tobacco products

After the California legislature and the governor signed a state law ending the sale of almost all flavored tobacco products including menthol, in 2020, the tobacco companies spent $22 million to force a voter referendum. That suspended the law for two years until the voters could weigh in. Now they have, crushing Big Tobacco withContinue reading “Calif voters overwhelmingly confirm ban on flavored tobacco products”

Recommendations to improve FDA premarket tobacco product application review to follow statutory mandates and improve scientific rigor

On October 21, 2022, Lauren Lempert presented at one of the Regan-Udall Foundation Expert Panels listening sessions on how to improve FDA operations of FDA’s Center for Tobacco Products operations. She and I followed up with a written comment letter detailing many of the problems with the tobacco product application processes, including both the premarketContinue reading “Recommendations to improve FDA premarket tobacco product application review to follow statutory mandates and improve scientific rigor”

Kids more addicted to e-cigs since Juul introduced protonated nicotine

One of the big innovations Juul pioneered was adding acid to the liquid in e-cigarettes to make the nicotine aerosol less alkaline and easier to inhale. This so-called protonated nicotine allows the e-cigarettes to deliver higher doses of the addictive drug nicotine. Therefore, we would expect to see increasing measures of addiction among e-cigarette usingContinue reading “Kids more addicted to e-cigs since Juul introduced protonated nicotine”

Regan-Udall Foundation review of FDA tobacco regulation “listening sessions” dominated by pro-industry speakers

Regan-Udall Foundation review of FDA tobacco regulation “listening sessions” dominated by pro-industry speakers The FDA has asked the Regan-Udall Foundation for recommendations on how to improve tobacco product regulation.  The Foundation’s Tobacco Independent Expert Panel has had three “listening sessions” that have been dominated by industry players and “harm reduction” advocates.  I have previously expressedContinue reading Regan-Udall Foundation review of FDA tobacco regulation “listening sessions” dominated by pro-industry speakers

Compromised blood vessel function caused by cigarettes and e-cigarettes is mediated by lung irritation

Cigarettes and e-cigarettes deliver the addictive drug nicotine to the lungs where it is absorbed and rapidly delivered to the brain. The holy grail of the idea that e-cigarettes are a form of harm reduction is that the e-cigarette aerosol has fewer specific bad chemicals than cigarette smoke.  New research from Pooneh Nabavizadeh and colleaguesContinue reading “Compromised blood vessel function caused by cigarettes and e-cigarettes is mediated by lung irritation”

One reason why dual use of ecigs and cigs is worse than using either product alone

Once upon a time, people – including me – thought eicgs were just cigarettes without the combustion, so they had to be less toxic.  By this logic, dual users (people who used e-cigs and cigs at the same time) were probably no worse off than smokers. Now we know that is wrong.  While they doContinue reading “One reason why dual use of ecigs and cigs is worse than using either product alone”

FDA pulls some menthol e-cigs off the market: What about the rest?

Last week FDA took the important step of denying permission for Logic Technology to market is menthol e-cigarettes.  In its press release, FDA specifically recognized the attraction of menthol e-cigarettes to youth: For non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, existing evidence demonstrates a known and substantial risk with regard to youth appeal, uptake and use. RecentContinue reading “FDA pulls some menthol e-cigs off the market: What about the rest?”

Opioid industry document library continues to grow, this time with documents from big pharmacies

Last week Today the University of California, San Francisco and Johns Hopkins University announced the addition of over 2,200 documents to the Opioid Industry Documents Archive (OIDA) that detail the role of retail pharmacies in the opioid epidemic. The release of these documents coincides with a report by STAT that explores individual and systemic failuresContinue reading “Opioid industry document library continues to grow, this time with documents from big pharmacies”

New report explains menthol marketing from the beginning and why we need to end it

Robert Jackler and his colleagues at the Stanford Research Into the Impact of Tobacco Advertising recently released “ADVERTISING CREATED & CONTINUES TO DRIVE THE MENTHOL TOBACCO MARKET: Methods Used by The Industry to Target Youth, Women, & Black Americans,” an encyclopedic history of menthol marketing in the United States. Jackler and his colleagues complement aContinue reading “New report explains menthol marketing from the beginning and why we need to end it”