List of public comments to FDA and other agencies by UCSF faculty and fellows (and others) with links to the comments

Several people have asked me to collect all the public comments that we have submitted to the FDA.  I have also added comments submitted to other agencies on tobacco issues.  I will update this posting as new comments are submitted.  This post is current as of April 22, 2016.
 
FDA request for comments on waterpipes and waterpipe tobacco
 
FDA should regulate the manufacturing and marketing of hookah tobacco to prevent misperceptions of harm and widespread use among youth and young adults
 
FDA Request for Information on Psychosocial Predictors of Uptake of Tobacco and Other Products
 
RJ Reynold’s Unpublished Randomized Controlled Trial Finds that Camel Snus is Not Effective for Smoking Cessation
 
HUD proposal to make public housing smokefree
 
Comment on HUD’s proposed rule Instituting smoke-free public housing Docket No. FR 5597-P-02
 
Comment on Regulatory Impact Analysis for HUD Proposed Rule Instituting Smoke-Free Public Housing Docket No. FR 5597-P-02
 
FTC collection and release of data on e-cigarette marketing and promotion
 
Detailed information and reports on electronic cigarette marketing and sales is essential for understanding the skyrocketing popularity and use of various electronic cigarette products among youth and young adults
 
Investigational drug use of of tobacco products
 
UCSF comment on FDA draft guidance on investigational use of tobacco products
 
Which part of FDA should be responsible for regulating different tobacco products
 
UCSF TCORS public comment to FDA on when tobacco products should be regulated as drugs/devices or by CTP
 
Liquid nicotine in e-cigarettes and nicotine in other novel products
 
UCSF and California Poison Control Centers response to FDA questions on liquid nicotine products
 
FDA's list of questions regarding e-cigarettes
 
UCSF TCORS Responses to FDA Questions on E-Cigarettes and Public Health (Docket Number FDA-2014-N-1936)
 
Two more studies show ecigs depress quitting
 
UCSF public comments to FDA on Swedish Match MRTP application
 
FDA should require that all communications from tobacco manufacturers on MRTPs be done in a way that narrowly target smokers
 
Swedish Match’s Consumer Perception Study Provides No Evidence for the Population-Level Effects of Modified Snus Labels
 
FDA should deny Swedish Match request to change snus warning label: US is not Sweden
 
Swedish Match’s claim that perceptions of health risks of snus are exaggerated is likely incorrect
 
UCSF comments on the deeming rule (comments from elsewhere that have been sent to me for posting are listed after these comments)
 
Doonesbury figured out that big tobacco would benefit from OIRA's cost-benefit models 19 years ago
 
Entire 1995 Doonesbury series on Mr. Butts and Regulatory Reform (series of comics)
 
FDA Should Use the Public Health Standard Mandated by Congress, Not a Cost-Benefit Analysis, to Evaluate Proposed Regulations
 
FDA Should Prohibit Flavors in all Tobacco Products including Electronic Cigarettes (new data)
 
Recent Research, some conducted by the FDA, Reinforces Need for Regulation of ALL Tobacco Products to Protect Health
 
FDA should prohibit of use of flavors in deemed tobacco products as part of the current rulemaking (includes new data on high school athletes)
 
FDA Should Prohibit All Non-Face-to-Face (Including Internet) Sales of Tobacco Products as FDA Originally Proposed to the OMB
 
E-Cigarette Makers Are in an Arms Race for Exotic Vapor Flavors
 
FDA Should Not Exclude Accessories from the Scope of the Deeming Rule
 
The Regulatory Impact Analysis Must Consider the Benefits of the Likelihood that the Regulated Companies will Pass the Costs of Compliance on to Smokers, which Will Raise the Cost of the Regulated Products, thereby Reducing Consumption and Improving Health
 
The Regulatory Impact Analysis Fails to Adequately Document the Sources for the Benefit and Cost Estimates upon Which it is Based
 
FDA Should Deem Hookah Tobacco, Hookah Device, and Hookah Charcoal as a Tobacco Product
 
Child resistant packaging of electronic cigarette devices and refill liquid containers containing nicotine to prevent childhood poisoning
 
More evidence against “continuum of risk” related to heart disease
 
The FDA should follow the advice of the 129 public health and medical authorities outlined in the attached letter that they sent to WHO Director General Margaret Chan regarding making evidence-based decisions about regulation of e-cigarettes. 
 
FDA Should Not Extend the Compliance Period for Marketing Applications and Other Submissions
 
FDA should not make regulatory decisions based on the "continuum of risk" theory until it has affirmative evidence that, as actually used, e-cigarettes or other tobacco products lower population risk
 
Evidence that e-cigarette aerosol has the same effects on an important measure of lung function as cigarette smoke undermines the assumption that e-cigarettes are uniformly less risky than conventional cigarettes
 
The FDA’s Proposed Warnings on Addiction are Inadequate and Do Not Reflect Current Understanding of Appropriate Messaging on Addiction
 
FDA’s Proposed Warning Statements Are Weak and Ineffective both in Form and Content and Should Be Replaced with Effective Messages
 
The “Continuum of Risk” Must Include Cardiovascular Disease
 
FDA Should Restrict E-cigarette Marketing to Protect Youth as Part of the Currently Proposed Regulation
 
Responses to common undocumented assertions about e-cigarettes for harm reduction
 
FDA’s Proposed Exception for Premium Cigars and Weak Warning Labels for Cigars Do Not Protect the Public Health
 
The Proposed Two Year Phase in for Requiring Premarket Approval of Newly Deemed Tobacco Products is Too Long; 6 Months Would be More Appropriate
 
FDA Should Prohibit Flavors in all Tobacco Products in the Current Rule Making
 
FDA Should Prohibit E-cigarette Marketing that Promotes False Health Claims
 
Resubmission of 2013 comment documenting ecigarette cessation claims in their marketing
 
FDA’s Proposed Exception for Premium Cigars (Option 2) Does Not Protect the Public Health and Should Be Rejected
 
Broad Range of Economists Agree that FDA's Use of Consumer Surplus Is Wrong, Including Jonathan Gruber, Whose Work FDA Cites as Justification for Doing So
 
Lorillard Admits Flavored E-Cigarettes Attract Youth; FDA Should Prohibit Flavors As Part Of The Current Rulemaking
 
FDA inappropriately discounts health benefits of regulating ecigs and cigars by 70% because of lost pleasure of smoking
 
FDA should deny industry requests to extend public comment on deeming; granting industry request = 26,000 more kids trying ecigs
 
UCSF economists critique FDA cost-benefit analysis of FDA deeming rule
 
FDA to kids: Not 18? No problem! Buy your e-cigs (and cigars and other tobacco products) online!
 
FDA ignored information on internet sales submitted in response to 2011 ANPRM in deeming rule
 
Summary of scientific evidence on e-cigarettes submitted to FDA
 
FDA economic model used in Regulatory Impact Analysis underestimates benefits by ignoring short term effects of smoking
 
Contradicting the science it cites, FDA decides against warning cigar users about reproductive dangers
 
FDA should use information in the 2014 Surgeon General Report when finalizing its deeming rule
 
Public comments submitted by other health authoritieson the FDA deeming rule (that were also sent to me for distribution):
 
Obama Administration should deny tobacco's request to extend public comment period on FDA deeming rule (Campaign for Tobacco Free Kids and other major health groups)
 
Excellent series of FDA public comments on ecig marketing, together with large collections of advertising images available  (Stanford Professor Robert Jackler)
 
FDA Should Restrict Internet Sales of All Tobacco Products Including E-Cigarettes (Stanford Professor Bonnie Halpern-Felsher)
 
Super High” Nicotine Youth Appealing Electronic Cigarette Flavors (Maya Ben-Efraim and Professor Robert Jacker from Stanford)
 
An Evaluation of FDA’s Analysis of the Costs and Benefits of the Graphic Warning Label Regulation (Frank Chaloupka and other leading economists)
 
Tobacco Teachings Up in Smoke?  [Consumer Surplus] (Lisa Heinzerling, George Washington Univeristy Law School)
 
Legacy Foundation
 
24 Health Groups (led by Campaign for Tobacco Free Kids)
 
29 State Attorneys General
 
California Department of Public Health
 
Center for Effective Government (on consumer surplus)
 
Center for Science in the Public Interest and others (on consumer surplus)
 
David Carpenter (on incompatability of cost-benefit analysis and the provisions of the Family Smoking Prevention and Tobacco Control Act) (Harvard Law School)
 
Members of the Senate and House
 
San Francisco Department of Public Health
 
Public Citizen (on consumer surplus)
 
Tobacco Control Legal Consortium
 
Members of Senate and House on Consumer Surplus and Problems with FDA/OMB-OIRA Cost-Benefit Analysis
 
FDA Should Regulate All E-Cigarettes, Electronic Nicotine Delivery Systems (ENDS), Zero Nicotine Electronic Devices (ZNEDS), and Associated Parts and Components as Covered Tobacco Products (Shanta Dube, et al, Georgia State University)
 
FDA Should Regulate E-Cigarettes as a Covered Tobacco Product to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act (Martha C. Engstrom, et al, Georgia State University