January 4, 2020
My colleagues Poonam Rao, Jiangtao Liu, and Matt Springer just published “JUUL and Combusted Cigarettes Comparably Impair Endothelial Function” in Tobacco Regulatory Science. They compared to Juul, a third generation tank system e-cigarette (the kind FDA is giving a pass in its enforcement against some e-cig flavors), and a Marlboro Red cigarette against clean air affect arteries’ ability to dilate (get larger) in the face of increased demands for blood flow. Impairment of this so-called flow mediated dilation (FMD) makes impaired functioning of the cardiovascular system and predicts future heart attack risk.
The graph below (taken from Figure 3 of the paper) shows the similarities in how these three tobacco products reduce FMD:
January 2, 2020
The FDA has released its detailed “guidance” document that outlines what enforcement action it plans to take against flavored e-cigarettes. It is important to understand that this is not a law or even a regulation, but rather a non-binding statement of how FDA plans to enforce the law.
This plan is based on the fact, stated several times (pages 3, 11, and 12) that all e-cigarettes currently on the market are there illegally. The FDA is simply going to stop giving all of them passes and is going to start enforcing the law against some e-cigarettes. As FDA says on page 3, “This guidance does not in any way alter the fact that it is illegal to market any new tobacco product without premarket authorization.”
What the FDA says it is going to do is "prioritize enforcement" to stop the sale of:
January 1, 2020
The recent paper “Life-threatening bronchiolitis related to electronic cigarette use in a Canadian youth” provides a very well documented case report of a 17 year old youth who developed serious lung disease, likely from vaping.
Unlike the cases of EVALI that have been attracting a lot of attention in the US, the authors make a good case that this young man developed bronchiolitis obliterans, a rare form of serious lung disease also known as “popcorn lung” because it was first identified among workers in a factory making microwave popcorn.
What’s the connection? Microwave popcorn is often flavored using diacetyl to give it a buttery flavor. While fine to eat, it seriously damages lungs. Diacetyl is a widely used flavoring agent in e-cigarettes.
Diacetyl causes different problems that vitamin E acetate, which has been identified as one likely casue of EVALI.
December 31, 2019
Updated January 1, 2020 to reflect more information. "Baby step" is being too kind; this is a complete capitulation to industry that portends a lax regulatory environment for e-cigs as companies submit their premarket applications.
Press reports on New Year’s eve indicated that the White House will allow the FDA to stop allowing the sales of flavored e-cigarettes except menthol for closed systems (like Juul pods), but continue to all sales of flavored tank (open) systems.
This is a big win for the big tobacco companies (including Juul) because menthol is the most important flavor. Juul, like the rest of the big tobacco companies, has been lobbying to keep menthol (and tobacco) flavors.
Why? When Juul stopped selling other flavors, sales of mint skyrocketed and made up the difference. (Menthol is derived from mint.)
As CNN reported when covering the announcement:
December 30, 2019
Last October, RJ Reynolds submitted its Premarket Tobacco Product Application (PMTA) to FDA seeking approval to market its Vuse e-cigarette. Because, unlike claims of modified risk, FDA is not required to make PMTA applications available for public comment, we have no idea what is in the RJR application or whether they meet the standard in the law that allowing marketing of Vuse would be “appropriate for the protection of public health.”
As the first known application for an e-cigarette, the Vuse decision will set important precedents for approval of all e-cigarettes. For this reason alone, FDA should submit the PMTA to its Tobacco Products Scientific Advisory Committee (TPSAC) for external assessment. Doing so will also make the PMTA available for outside public comment, through comments submitted to TPSAC.