December 4, 2015
The Department of Housing and Urban Development has issued a draft rule making some public housing (cigarette and cigar) smokefree, including the required “regulatory impact analysis” (RIA, cost-benefit analysis in plain English). Like similar analyses that the Obama Administration FDA has produced, it wildly overstates costs and understates benefits.
My colleagues and I at UCSF will be putting in a formal public comment on both the rule itself as well as the cost-benefit analysis, but I thought it would be worth sharing my preliminary thoughts on the regulatory impact analysis in case this information would be helpful to others.
The biggest issues are:
November 24, 2015
Hollywood's animated characters are smoking less — a lot less.
From 2002 to 2011, Breathe California's Thumbs Up! Thumbs Down! data shows that 27 percent of top-grossing animated films featured tobacco. The top three in terms of audience exposure:
#1. Rango (PG, 2011, Viacom) with more than fifty tobacco incidents on screen, delivered 948 million domestic tobacco impressions.
#2. The Incredibles (PG, 2004, Disney) with more than twenty tobacco incidents, delivered 925 million tobacco impressions.
#3. The Simpsons Movie (PG-13, 2007, Fox), also with more than twenty tobacco incidents, delivered 586 million tobacco impressions.
Other animated films delivering more than 100 million tobacco impressions each:
Bee Movie (PG, 2007, Viacom)
Corpse Bride (PG, 2005, Time Warner)
Fantastic Mr. Fox (PG, 2009, Fox)
Scooby-Doo 2: Monsters Unleashed (PG, 2004, Time Warner)
The Ant Bully (PG, 2006, Time Warner)
November 19, 2015
Comment on
Use of Investigational Tobacco Products: Guidance for Industry and Investigators
Docket No. FDA-2014-D-1939
UCSF TCORS[1]
November 19th, 2015
FDA’s draft guidance exempting tobacco products intended for investigational use from premarket submission requirements supports public health research, protects the health of human subjects, and ensures that investigational tobacco products are not commercialized
We support FDA’s understanding that academic and public health researchers, in their efforts to protect the public health, need to conduct studies involving new tobacco products (some of which may not have marketing authorization or do not comply with an applicable tobacco product standard) and investigational tobacco products (ITPs).
November 18, 2015
The UCSF TCORS has just submitted the following public comment to the FDA:
Comment on
FDA’s Proposed Regulations: Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
Docket No. FDA-2015-N-2002
UCSF TCORS[1]
November 18, 2015
Cessation and “satisfaction” claims cause confusion for consumers, so any products making such claims should be regulated under FDA’s drug/device authorities.
November 15, 2015
Randy Uang, Hekki Hiilamo, and I just published "Accelerated Adoption of Smoke-Free Laws After Ratification of the World Health Organization Framework Convention on Tobacco Control" in American Journal of Public Health. As the title indicates, the FCTC had a measureable effect on implementation of smokefree laws around the world, but the effect is fading. It is time for renewed efforts to pass and implement smokefree laws. Well-implemented smokefree laws are the most effective tobacco control intervention because they signifify perminant social change.*
Objectives. We sought to evaluate the effect of ratifying the World Health Organization Framework Convention on Tobacco Control (FCTC) on countries enacting smoke-free laws covering indoor workplaces, restaurants, and bars.
Methods. We compared adoption of smoke-free indoor workplace, restaurant, and bar laws in countries that did versus did not ratify the FCTC, accounting for years since the ratification of the FCTC and for countries’ World Bank income group.
Results. Ratification of the FCTC significantly (P