December 21, 2017
Eric Leas, John Pierce and their colleagues at UC San Diego just published “Effectiveness of Pharmaceutical Smoking Cessation Aids in a Nationally Representative Cohort of American Smokers” in the Journal of the National Cancer Institute, which adds to the case that NRT used over-the-counter without being part of an organized smoking cessation effort that includes counselling does not work.
This is, of course, something that the tobacco industry has known for a long time, ever since shortly after NRT was introduced. As Dorie Apollonio and I pointed out in our paper “Tobacco Industry Research on Nicotine Replacement Therapy: ‘If Anyone Is Going to Take Away Our Business It Should Be Us,’” that is why the tobacco companies don’t fight spending money giving away NRT and and why they are now selling their own recreational NRT.
It also points to the folly of the FDA adopting the tobacco industry’s “harm reduction” approach of simply seeking alternative delivery systems for nicotine other than conventional cigarettes.
December 21, 2017
It is almost an article of faith in tobacco control that about 90 of adult smokers smoke their first cigarette before age 18 and that virtually no one starts smoking after age 26. That is likely why all the studies on the gateway effect of e-cigarettes leading to smoking have been done with youth, where the evidence is strong and consistent.
Now a troubling new study shows that e-cigarettes have changed that.
Brian Primack and colleagues recently published “Initiation of Traditional Cigarette Smoking after Electronic Cigarette Use among Tobacco-Naïve U.S. Young Adults” that shows that the odds of never-smoking young adults (age 18-30) who use e-cigarettes having started to smoke cigarettes 18 months later at 6.8 times higher than young adults who don’t use e-cigarettes even after adjusting for a wide range of other factors that predict smoking.
This is a stunning result. They found that 47.7% of never-smoking young adults who used e-cigarettes at baseline were smoking cigarettes a year later compared to just 10.2% of non-users.
December 21, 2017
Lauren Lempert submitted this comment to FDA on December 20, 2017. The comment Tracking Number is 1k1-90gh-rnjp.
Reuters published a special report on December 20, 2017 identifying several irregularities in Philip Morris' IQOS research. The kind of industry behavior documented in this report is questionable but not new, and FDA should consider this when making a determination on PMI's IQOS applications. See attached Reuters report and PMI's 10-Year Corporate Affairs Objectives & Strategies report discussed in Reuters report.
Uploaded File(s):
December 21, 2017
Reuters Special Report: How Philip Morris is selling regulators on its hot new smoking device http://reut.rs/2Dm4euV
Philip Morris executives are traversing the globe to lobby health authorities on the benefits of iQOS, the little machine the tobacco giant says is key to the company's future. The novel argument: While iQOS uses tobacco, it shouldn't be categorized as a cigarette because it doesn't burn the leaf, a Reuters investigation published today shows.
For earlier stories in the series, please visit https://www.reuters.com/investigates/section/pmi/
December 21, 2017
The attached letter (reproduced below) has been submitted to the docket; the tracking number is 1k1-90fp-cqy1. A PDF of the letter is available here.
December 18, 2017
Mr. Mitchell Zeller
Director, Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Re: 82 FR 60206, Docket no. FDA-2017-N-4678, Modified Risk Tobacco Product Applications: Applications for Six Camel Snus Smokeless Tobacco Products Submitted by R.J. Reynolds Tobacco Company; Availability
Dear Mr. Zeller:
Today, December 18, 2017, FDA filed for substantive scientific review six modified risk tobacco product applications (MRTPA) from R.J. Reynolds for six styles of Camel Snus smokeless tobacco products referenced above. We are writing to complain about the public comment process for review of the above-referenced docket.