July 22, 2014
July 23, 2014
Docket No. FDA-2014-N-0189
On July 15, 2014, the New York Times published the attached article, "E-Cigarette Makers Are in an Arms Race for Exotic Vapor Flavors," that documents the importance of flavored e-cigarettes, particularly in attracting youth to the use of nicotine.
The FDA should seriously consider this information, particularly the change in NJOY's assessment of the effects of flavors on youth between when it was not using flavors to when it decided to start using flavors to maintain its market share, and prohibit the use of flavors in e-cigarettes as part of the current rulemaking (and not delay action to a subsequent rule making).
The e-cigarette companies state that flavors are important for attracting not only youth but also adults to their products. The FDA needs to resist the urge to focus entirely on youth and consider these effects on adults, because the Family Smoking Prevention and Tobacco Control Act requires the FDA to apply a population public health standard to the entire population not just to youth.
Stanton A. Glantz, PhD
Professor and Director
July 22, 2014
We just submitted this comment to FDA on the deeming rule.
FDA Should Not Exclude Accessories from the Scope of the Deeming Rule
Docket No. FDA-2014-N-0189
July 22, 2014
Matthew Farrelly and collaegaues at RTI and the CDC Office on smoking an health recently published a nice paper, "Are tobacco control policies effective in reducing young adult smoking?" in Journal of Adolescent Health that shows that spending on state tobacco control programs and clean indoor air laws are associated with less young adult smoking.
Here is the abstract:
PURPOSE:
We examined the influence of tobacco control program funding, smoke-free air laws, and cigarette prices on young adult smoking outcomes.
METHODS:
July 21, 2014
Judge Richard Leon, who has consistently ruled against the FDA on everything related to tobacco, is at it again, ruling that the FDA Tobacco Products Scientific Advisory Committee is flawed. (Why does every tobacco case on the FDA end up in front of the same hostile judge?)
The opinion basically concludes that because the challenged members acted as consultants to companies selling cessation products (or in the case of Henningfield an ownership interest in a cessation product), they would have a conflict because banning Menthol might generate consulting fees. The judge also concludes that the challenged members would have a conflict because they would want to protect their past expert testimony on tobacco (and in one case menthol) issues and would want plaintiff lawyers to hire them in the future.
This is truly amazing to disqualify scientists for something they might do in the future. Perhaps Judge Leon has a time machine to observe the future.
You can read Judge Leon's ruling at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2011cv0440-82
TFK put out the following statement, which I completely agree with:
July 18, 2014
My colleagues at UCSF just submitted this comment to the FDA on the deeming rule:
The Regulatory Impact Analysis Must Consider the Benefits of the Likelihood that the Regulated Companies will Pass the Costs of Compliance on to Smokers, which Will Raise the Cost of the Regulated Products, thereby Reducing Consumption and Improving Health
Docket No. FDA-2014-N-0189
Hai-Yen Sung, PhD
Professor of Health Economics
Wendy Max, PhD
Professor of Health Economics
James Lightwood, PhD
Professor of Health Economics
University of California San Francisco
July 15, 2014
The U.S. tobacco companies have a long history of passing increased costs through to consumers, as recently evidenced by the large price increase following the Master Settlement Agreement (Alamar, Mahmoud, and Glantz, 2003). The companies also often increase wholesale prices concurrently with excise tax increases by more than the amount of the tax increase to maintain revenue streams in the face of price-induced declines in consumption (Sung, Hu and Keeler, 1994; Keeler and Hu et al., 1996; Chaloupka and Cummings et al., 2002; Hanson and Sullivan, 2009; Sullivan and Dutkowsky, 2012).