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FDA’s draft guidance exempting tobacco products intended for investigational use from premarket submission requirements supports public health research, protects the health of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
November 12, 2015
The deeming rule that the FDA submitted to the Office of Management of Budget was leaked to the Tobacco Vapor Electronic Cigarette Association (tveca.org), together with the FDA guidance document on how the FDA plans to implement the rule,
TVECA made the guidance available on its website and I am including a copy here. (It is a 36 MB image, so downloading will take a while).
The TVECA has not made the deeming rule available on its website, reportedly because the FDA requested that they not post it on their site or share it with anyone, and they have complied with that request.
Given that the rule is in the hands of the industry, the FDA (really the Obama Administration) shold level the playing field and release the rule, as submitted to the OMB, to the public and public health community.
November 5, 2015
The recent paper “How does electronic cigarette access affect adolescent smoking” by Yale University economist Abagail Friedman [1] has attracted a lot of attention from e-cigarette advocates (see links at the end of this post) because of its conclusion that “Across the board … reducing e-cigarette access increases smoking among 12 to 17 year olds.”
The paper correlated cigarette use in six national cross-sectional (“snapshot”) survey waves of cigarette use collected between 2002 and 2013 with whether or not the respondents lived in states covered by laws restricting sales of e-cigarettes to kids. The paper showed declining cigarette use in all states, but after the laws passed, the levels of (declining) smoking were higher than predicted levels without the law.
In interpreting the results in this paper, it is important to keep in mind what it did not include in the analysis: e-cigarette use. As Dr. Friedman noted in her paper, “this analysis does not measure electronic cigarette use, and thus cannot speak to shifts in that behavior or its long run effects.” She also took care to note that the market had not yet reached equilibrium, which is particularly important when thinking about kids and e-cigarettes.