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.
June 21, 2014
Sujatha Sankaran, Heikki Hiilamo, and I just published "Implementation of graphic health warning labels on tobacco products in India: the interplay between the cigarette and the bidi industries" in Tobacco Control.
Here is the abstract:
Objectives To understand the competition between and among tobacco companies and health groups that led to graphical health warning labels (GHWL) on all tobacco products in India.
Methods Analysis of internal tobacco industry documents in the Legacy Tobacco Document Library, documents obtained through India’s Right to Information
Act, and news reports.
Results Implementation of GHWLs in India reflects a complex interplay between the government and the cigarette and bidi industries, who have shared as well as
conflicting interests. Joint lobbying by national-level tobacco companies (that are foreign subsidiaries of multinationals) and local producers of other forms of
tobacco blocked GHWLs for decades and delayed the implementation of effective GHWLs after they were mandated in 2007. Tobacco control activists used public
interest lawsuits and the Right to Information Act to win government implementation of GHWLs on cigarette, bidi and smokeless tobacco packs in May 2009 and rotating GHWLs in December 2011.
June 20, 2014
Check it out at http://www.youtube.com/watch?v=QZRMumYtYFM
This is, of course, part of Lorillard/Blu's ongoing advertising campaign promoting harm reduction; for earlier efforts, click here.
June 15, 2014
The following letter, signed by 129 public health and medical experts from 31 countries, representing every WHO region, was delivered to WHO Director General Margaret Chan earlier today. (PDF of letter)
I also submitted the letter to the FDA dockett on e-cigs; the tracking number is 1jy-8cp3-dzmg.
June 16, 2014
Dr. Margaret Chan
Director General
World Health Organization
Geneva
Dear Dr. Chan,
We, the 129 signatories to this letter, are writing to express our support for WHO’s evidence-based approach to determine the best way forward for public health to respond to Electronic Nicotine Delivery Systems (ENDS), as expressed in WHO's June 3, 2014 statement.[1]