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 November 13, 2017.
Philip Morris International MRTP allocation for iQOS

PMI’s Own Data on Biomarkers of Potential Harm in Americans Show that IQOS is Not Detectably Different from Conventional Cigs
FDA needs to extend the public comment period on PM MRTP for iQOS for 180 days after the FULL application is public
FDA’s Proposed Collection of Information on the Experimental Study on Warning Statements for Cigarette Graphic Health Warnings
FDA’s Proposed Collection of Information on the Experimental Study on Warning Statements for Cigarette Graphic Health Warnings Should be Addressing the Graphic Images, not Merely the Textual Statements
Proposed NNN Product Standard
The FDA’s Proposed Tobacco Product Standard Limiting NNN Levels in Finished Smokeless Tobacco Products is Well-Justified, but the Regulatory Impact Analysis Understates Benefits and Overstates Costs
Tobacco industry request to extend comment period for NNN product standard for smokeless tobacco
FDA Should Not Extend the Comment Period for its Proposed Product Standard Limiting NNN Levels in Finished Smokeless Tobacco
FDA request for comments on Listing of Ingredients in Tobacco Products – Revised Draft Guidance for Industry
Listing of Ingredients in Tobacco Products – Revised Draft Guidance for Industry
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 Warning Label Requirements for Cigars
FDA’s Draft Guidance on Submission of Warning Plans for Cigars Exposes Shortcomings in Cigar Warnings Required by Final Rule
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RJ Reynold’s Unpublished Randomized Controlled Trial Finds that Camel Snus is Not Effective for Smoking Cessation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 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
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