June 27, 2014
My colleagues Gideon St.Helen, Peyton Jacob III, and Neal L Benowitz just submitted this comment to the FDA:
June 27, 2014
Hookah smoking is an alternative form of tobacco use traditionally associated with eastern societies, whose recent rapid spread globally and in the U.S. is a cause of public health concern 1. The spread and surge in popularity in the U.S. may be driven by the introduction of flavored tobacco preparations, reduced-harm perception, social café culture, exotic appeal, and marketing of hookah bars 2,3. Given the widespread use and accumulating scientific evidence showing significant intake of nicotine and carcinogens and some epidemiologic data showing harm, we support the FDA’s proposed deeming rule to regulate hookah tobacco and devices. However, to fully protect the public health, FDA needs to include hookah charcoal as a component of hookah devices for FDA regulation; mandate health warning labels on hookah tobacco and all components/parts; and, ban flavoring additives to hookah tobacco and flavorings on hookah charcoal and water.
June 27, 2014
The California Poision Control System based at San Francisco General Hospital just submitted this public comment to the FDA (PDF).
Child resistant packaging of electronic cigarette devices and refill liquid containers containing nicotine to prevent childhood poisoning
Docket No. FDA-2014-N-0189
California Poison Control System
Department of Clinical Pharmacy
University of California San Francisco.
June 25, 2014
Several months ago, California Senator Ellen Corbett introduced SB 648, a good piece of legislaion that would have said that ecigarettes cannot be smoked anywhere that cigarettes cannot be smoked. She managed to get it out of the Senate, but the pro-tobacco Assembly Speaker John Perez sent to the Governmental Organizations committee, where good tobacco legislation goes to die.
Late last week the bill was gutted to remove all the good language and simply prohibit ecigartte vendining machine sales in vending machines within 15 feet of the door of adult establishments. (This is exactly how the tobacco companies turned vending machine restrictions into a joke back when the issue was cigarette vending machines.)
The bill would only be useless if that had been all they did. But tobacco and ecigartte lobbyists also got the same problemmatic language listing e-cigarettes separately as neither a “cigarette” nor a “tobacco product” that put them in a special category, opening the door for allowing them special treatment and opening the potential for loopholes in a range of other legislation.
This is a strategy that the tobacco industry has been using all over the country to complicate regulation of e-cigarettes and also to create problems for the FDA, should Obama ever actually let the FDA do anything about ecigs.
June 24, 2014
The FDA posted marked-up copies of the deeming rule that it submitted to President Obama's Office of Managment and Budget showing the changes that OMB made.
Toni Clary and Sharon Begley from Reuters did an excellent job of highlighting the key changes; their story is here.
Key changes they describe include:
June 24, 2014
I submitted this comment to FDA.
June 21, 2014
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA–2014–N–0189
RE: More evidence against “continuum of risk” related to heart disease
The paper, “Discontinuation of Smokeless Tobacco and Mortality Risk After Myocardial Infarction,” by Gabriel Arefalk, MD; Kristina Hambraeus, MD; Lars Lind, MD, PhD; Karl Michaëlsson, MD, PhD; Bertil Lindahl, MD, PhD; Johan Sundström, MD, PhD, published on On June 24, 2014, by Circulation (DOI: 10.1161/CIRCULATIONAHA.113.007252) speaks directly to the assumed “continuum of risk” that the FDA is assuming exists.
This paper examined the drop in mortality following acute myocardial infarction among people in Sweden who quit smoking or quit using snus (a form of smokeless tobacco that is widely promoted as less dangerous than smoking cigarettes) compared to people who continued their tobacco use. They found that both quitting smoking and quitting snus had essentially the same effect on reducing mortality risk following an acute myocardial infarction (and adjusted hazard ratio of 0.54, 95% CI 0.32-1.02 for stopping smoking and 0.51; 95% CI .29-.91 for stopping snus) despite the fact that the snus users do not inhale combustion products.