June 12, 2014
We just submitted this public comment to FDA. The comment tracking number is 1jy-8cmm-et0a
FDA’s Proposed Warning Statements Are Weak and Ineffective both in Form and Content and Should Be Replaced with Effective Messages
Docket No. FDA-2014-N-0189
ML Roditis1, BL Halpern-Felsher2, LK Lempert1, SA Glantz1, L Ppopva1, JK Cataldo1
1Center for Tobacco Control Research and Education
University of California San Francisco
2Department of Pediatrics, Stanford University
June 10, 2014
The FDA needs to make evidence-based changes to the current proposed required warning statements both in form and content by doing the following:
1) Remove the word WARNING from the messages.
2) Increase the suggested size of warning messages from 30% to at least 50%.
3) Change the warning message color from black and white to bright yellow background with black text or, in instances where the package is yellow, bright orange with black text and include a black border around the text.
June 11, 2014
Clayton Velicer, Lauren Lempert and I just published "Cigarette company trade secrets are not secret: an analysis of reverse engineering reports in internal tobacco industry documents released as a result of litigation" in Tobacco Control.
Here is the abstract:
Objectives Use previously secret tobacco industry documents to assess tobacco companies’ routine claims of trade secret protection for information on cigarette ingredients, additives and construction made to regulatory agencies, as well as the companies’ refusal to publicly disclose this information.
June 10, 2014
This public comment has been submitted to the FDA.
The “Continuum of Risk” Must Include Cardiovascular Disease
Comment Submitted in Response to FDA Regarding Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products
Docket No. FDA-2014-N-0189
Suzaynn F. Schick, PhD, Ganna Kostygina, PhD and Carolyn Calfee, MD
University of California, San Francisco
June 9, 2014
Most of the discussion of “continuum of risk” that the FDA states that it intends to use in its rulemaking (p 23144) has been focused on cancer. While e-cigarettes deliver lower levels of carcinogens than conventional cigarettes, the ultrafine particles and nicotine that these products deliver have important effects on the development of cardiovascular disease and triggering of cardiac events that are likely to be as large as for inhalation of combusted tobacco products.
June 10, 2014
Sara Marini and colleagues just published an interesting paper, "Short-term effects of electronic and tobacco cigarettes on exhaled nitric oxide," in Toxicology and Applied Pharmacology that shows that, among smokers, inhaling e-cigarette aerosol has the same effect on the production of exhaled nitric oxide as inhaling a cigarette whether the e-cigarette has nicotine or not.
They also provide another confirmation that e-cigarettes produce more and smaller particles than conventional cigaretttes.
Nitric oxide (NO) is important because it makes smooth mucle relax and the fact that exposure to e-cigarette aerosol reduces exhaled NO in the lungs may help explain why people who use e-cigarettes have a drop in lung function. (The fact that smoke reduces NO production in arteries is an important reason that smoking and passive smoking contribute to heart attacks.)
The results in this paper are also evidence that the fact that e-cigarettes and cigarettes generate the aerosol differently doesn't matter in terms of this biological effect.
Here is the abstract of the paper:
June 10, 2014
We just submitted this comment to the FDA. (The figures are in the PDF of the comment that is tied to this link.)
FDA Should Restrict E-cigarette Marketing to Protect Youth as Part of the Currently Proposed Regulation
Docket No. FDA-2014-N-0189
LM Dutra, ScD1; RA Grana, PhD1; L Lempert, JD1; JK Cataldo, RN, PhD1; SA Glantz, PhD1; BL Halpern-Felsher, PhD2; PM Ling, MD1; L Popova, PhD1; M Walsh, EdD1
1 Center for Tobacco Control Research and Education
University of California San Francisco
2 Department of Pediatrics, Stanford University
June 10, 2014