Another way FDA is cutting ecig companies slack: shelf life

E-cigarettes have finite shelf lives because they become more toxic over time while they sit on the shelf.  E-cigarettes are often contaminated with bacteria and fungus that grow while the e-cigarettes sit on the shelf. In addition, the chemicals in the e-liquid continue reacting with each other after they are mixed, growing more toxic overContinue reading “Another way FDA is cutting ecig companies slack: shelf life”

Juul knows why FDA denied its request to legally sell its ecigs. Why won’t FDA tell the rest of us?

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?”

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”

Another organ e-cigs adversely affect: blood

Yao Wang and colleagues compared the results of the Complete Blood Count (CBC), a routine blood tests used in clinical practice to diagnose a range of conditions, among participants in the US National Health and Nutrition Examination Survey (NHANES). In contrast to most national health survey, NHANES includes in person clinical tests on participants. TheirContinue reading “Another organ e-cigs adversely affect: blood”

Where are the Juul documents?

Perhaps the most important provision in the settlement between the State of North Carolina and Juul involved the release of previously secret internal Juul documents. These documents are particularly timely given the fact that Juul and the FDA are now fighting over FDA’s decision not to authorize the same of Juul e-cigarettes as well asContinue reading “Where are the Juul documents?”

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”

Direct evidence that Juul increases nicotine addiction, especially among kids

John Pierce and his colleagues at UCSD just published “Daily E-cigarette Use and the Surge in JUUL Sales: 2017-2019” that shows shows that after Juul came on the market there was a 3.6-fold higher rate of progression to daily e-cigarette use — a marker of addiction — among 14-17 year olds compared to 3 yearsContinue reading “Direct evidence that Juul increases nicotine addiction, especially among kids”

FDA prejudged e-cigs as good before it evaluated a single application

An August 31, 2020 memo detailing FDA’s plan for dealing with the expected flood of Premarket Tobacco Applications (PMTAs), clearly prejudges e-cigarettes as a good thing before looking at a single application. In particular, the FDA describes its “public heath goals” as including Ensure a variety of ENDS [electronic nicotine delivery systems] have an opportunityContinue reading “FDA prejudged e-cigs as good before it evaluated a single application”

FDA does JT/Logic’s work for it to justify authorizing 3 of its ENDS

On March 24, 2022 FDA authorized the sale of three electronic nicotine delivery systems distributed by Japan Tobacco’s US company Logic Technology Development, – two conventional e-cigarettes and one heated tobacco product.  FDA withheld the Technical Project Lead (TPL) report that provides the scientific justifications for its decision. Thanks to my colleague Lauren Lempert filingContinue reading “FDA does JT/Logic’s work for it to justify authorizing 3 of its ENDS”

FDA proposed updating its HPHC list in 2019; it needs to finish the job

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 assessing the risks of tobacco products. It hasContinue reading “FDA proposed updating its HPHC list in 2019; it needs to finish the job”