July 12, 2018
My colleagues and I have submitted this public comment to the FDA. The tracking number is 1k2-948f-o533 and a PDF of the comment is available here.
Tobacco Product Standard for Nicotine Level:
The FDA Should Set a Nicotine Level to be Achieved in a Single Step for All Combusted Tobacco Products
Docket No. FDA-2017-N-6189
July 12, 2018
My collegaues at UCSF and I just submitted this public comment to the FDA. The tracking number is 1k2-948f-bnar ; a PDF of the comment is available here.
Regulation of “Premium” Cigars
July 11, 2018
Dorie Apollonio and I recently published "Marketing with tobacco pack onserts: a qualitative analysis of tobacco industry documents" in Tobacco Control. This paper uses previously secret internal tobacco industry documents to understand how the industry uses onserts (little booklets attached to the outside of cigarette packs) to "educate" consumers about their products. Like many things, the industry has developed an excellent understanding about how to use onserts to communicate effectively with consumers. Equally important, they have learned how to coummincate ineffectively Not surprsingly, they use the ineffective approaches when pretending to communicate health information.
Regulatory agencies like the FDA and its counterparts outside the USA can learn a lot for this paper in terms of how they could require the tobacco companies to use onserts in a way to better and effectively inform consumers about the real risks of their products.
Two key points:
July 11, 2018
My UCSF colleagues recently submitted this public comment to the FDA on its proposed Nicotine Product Standard. A PDF version of the comment is here.
The FDA needs to look beyond nicotine alone in developing its standard for nicotine delivery in tobacco products
Docket No. FDA-2017-N-6189
Jesse Elias, MA, Yogi Hale Hendlin, PhD, Pamela M. Ling, MD, MPH
University of California, San Francisco
June 12, 2018
The FDA is considering its proposed nicotine product standard as part of its “comprehensive nicotine policy.” The FDA’s description of this proposal to date appears to focus narrowly on the pharmacological properties of nicotine. By reducing nicotine delivery in cigarettes, this standard would encourage smokers to switch to other nicotine delivery systems, including those made by tobacco companies, so as to reduce the harm caused by tobacco products. In the best case scenario, reduced-nicotine cigarettes will prompt smokers to quit smoking altogether, and cease use of all tobacco products. Second best, smokers will switch to non-combustible tobacco products yet maintain their nicotine addiction.
June 20, 2018
In November, 2017 I published “Philip Morris hides data in plain sight on dangers of new heat-not-burn product” in The Conversation that pointed out that the results from 24 clinical medical tests that PMI submitted to the FDA actually showed that IQOS was not detectably less dangerous than conventional cigarettes.
In reviewing all the information that PMI submitted to the FDA, the FDA’s Tobacco Products Scientific Advisory Committee voted unanimously (with one abstention) against approving PMI’s reduced risk claim.
I was surprised that PMI did not immediately have a come back.
Now, they (sort of, but not really) do. On June 15, 2018 PMI put out a press release, “Philip Morris (PM) Announces Positive Results from New Clinical Study on IQOS,” that says “all eight of the primary clinical risk endpoints moved in the same direction as observed for smoking cessation in the group who switched to IQOS, with statistically significant changes in five of the eight endpoints compared with on-going smoking.”