August 19, 2025
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 us to collect all the public comments that we have submitted to the FDA. We have also added comments submitted to other agencies on tobacco issues. We will update this posting as new comments are submitted. This post is current as of August 19, 2025.
August 2025: The National Youth Tobacco Survey and Proposed Emergency Regulations Implementing Assembly Bill 3218
November 2024: FDA and NIH Prioritization
July 2024: Department of Justice’s proposed transfer of marijuana from Schedule I to Schedule III of the Controlled Substances Act
June/July 2024: Swedish Match Snus 2024 MRTP Renewal Applicaton
August 2023: Developing FDA’s Center for Tobacco Products’ Strategic Plan
August 2023: Draft HHS 2023 Framework to Support and Accelerate Smoking Cessation
May 2023: Requirements for Tobacco Product Manufacturing Practice
June/August 2022: Tobacco Product Standard for Menthol in Cigarettes
June/August 2022: Tobacco Product Standard for Characterizing Flavors in Cigars
February 2022: Validation and Verification of Analytical Testing Methods Used for Tobacco Products: Guidance for Industry
December 2021: PMPSA’s supplemental modified risk tobacco product application for IQOS 3 does not adequately consider or address new published research on IQOS’s appeal to adolescents or young adults
October 2021: IQOS 3 supplemental MRTP does not does not adequately address new published research and information on emissions
September 2021: Letter Supporting Attorneys General's August 18, 2021 Letter to FDA
September 2021: FDA should not issue an exposure modification MRTP order for IQOS 3
July 2021: Request to extend the public comment period for the IQOS 3 MRTPA
July 2021: More Materials from IQOS 3 MRTP Application Posted, Comment Deadline Extended
March 2021: USPS Proposed Restriction on mailing e-cigarettes and components
December 2020: FDA's draft guidance on how to design and conduct Tobacco Product perception and intention studies
April 2020: Avoiding EVALI
February 2020: 22nd Century VLN MRTP Application
Letter to Mitch Zeller raising question about the VLM PMTA
November 2019: Premarket Tobacco Product Applications and Recordkeeping Requirements
Premarket Tobacco Product Applications and Recordkeeping Requirements -- Proposed Rule
October 2019: Comment on FDA's proposed text and graphic warning labels
October 2019: FDA request for comments on list of Harmful and Potentially Harmful Constituents
July 2019: FDA request for comment on cannabis
Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds
March 2019: FDA request for comment on changing the e-cigarette nonenforcement period
February/June 2019: FDA Request for How to Treat Youth Addicted to Nicotine
February 2019: CDC request for how to improve support for state and local tobacco control programs
January 2019: US Smokeless Tobacco (Altria) request to sell Copenhagen Snuff with reduced risk claims
September 2018/May 2019: Canadian Ministry of Health Comments on E-cigarettes
Comment by Physicians for a Smokefree Canada
August/September 2018: RJ Reynolds MRTP application for snus
Letter to Mitch Zeller et al. at FDA re questions we suggest FDA pose to TPSAC regarding Camel Snus MRTP application
Letter to FDA protesting the way that they are handling public comment in RJR snus MRTP
July 2018: Premium Cigars
July 2018: FDA Advanced Notice of Proposed Rulemaking on a Nicotine Product Standard
Tobacco Product Standard for Nicotine Level of Combusted Cigarettes
May 2018: FDA Advanced Notice of Proposed Rulemaking on Flavors
FDA should implement its proposed rule that manufacturers must present scientific evidence demonstrating that any flavored tobacco product is appropriate for the protection of the public health before receiving marketing authorization to use that flavor
April 2018: Nicotine Steering Committee
February 2018: FDA comprehensive nicotine policy
January 2018: FDA consideration of PMI IQOS premarket approval application
FDA should not grant PMI's Premarket Tobacco Product Application for IQOS
January 2018: CDC request for comments on strategies to improved smoking cessation
CDC should employ evidence-based strategies to help people quit using tobacco that support the initiation of quit attempts and maintaining long-term abstinence, including: social media interventions, clinician-extender or point-of-care technology tools, interactive voice response systems, market segmentation, insurance coverage for cessation treatment, tobacco-free policies in substance abuse treatment, mental health and other institutional settings including prisons and military settings.
December 2017: Tobacco Product Manufacturing Practice; Request for Comments
FDA should reject the tobacco industry’s efforts to guide e-cigarette manufacturing standards and instead formulate their own science-driven tough regulations to protect public health
2017-2020: Philip Morris International MRTP application for iQOS
Letter to FDA TPSAC urging them to delay action on IQOS until the record is closed and they can consider public comments
Public comment submitting Reuters story on PMI irregulatities in IQOS clinical studies to PMI MRTP docket
Letter to FDA protesting public comment period for IQOS; says comment period should be 180 days after full application is posted
Because PMI has not demonstrated that IQOS is associated with lower risks, FDA should not permit modified exposure claims, because such claims are likely to be misunderstood as modified risk claims
Detailed analysis of the Executive Summary (Section 2.7) submitted by Philip Morris International in support of its MRTP application for IQOS
The evidence cited in PMI’s MRTP Application indicates that the proposed labeling and warnings for IQOS will mislead consumers, particularly youth, about the product
PMI’s MRTP Application for IQOS Does Not Consider IQOS’s Appeal to Youth or Adolescents, or the Likelihood that Youth and Adolescents will Initiate Tobacco Use with IQOS or Use IQOS with Other Tobacco Products
PMI’s MRTP application for IQOS does not adequately evaluate potential for liver totoxicity risk
IQOS emissions create risks of immunosuppression and pulmonary toxicity, so FDA should not issue an order permitting IQOS to be labeled or marketed with reduced risk claims
Because PMI application did not report the full range of HPHCs in IQOS aerosol, characterize HPHCs in sidestream emissions, include a non-targeted analysis of chemicals in emissions, or conduct clinical studies to describe exposure to toxicants during dual use with other tobacco products, FDA must deny PMI’s application
Philip Morris’s Population Health Impact Model Based on Questionable Assumptions and Insufficient Health Impact Measures Does Not Adequately Support its MRTP Application
The evidence PMI presents in its MRTP application for IQOS is misleading and does not support the conclusion that IQOS will not harm endothelial function; independent research done in a more relevant physiological model shows that IQOS harms endothelial function as much as conventional cigarettes
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
November 2017-August 2018: California Regulations to Implement Legalized Marijuana
Incorporating best practices from tobacco control into California’s cannabis regulations is necessary to protect public health by restricting harmful product formulations, ensuring industry compliance and enforcement transparency, providing more complete and accurate information to consumers, and preventing abusive industry marketing tactics
BCC’s proposed daily limit is too permissive and will impose unnecessary risks on the health of Californians
Incorporating public health best practices from tobacco and alcohol regulation is necessary to protect public health by providing more information to consumers, restricting harmful formulations, and preventing abusive industry marketing tactics
May 2017: 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
March 2017: 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
February 2017: 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
November 2016- April 2018: FDA request for comments on Listing of Ingredients in Tobacco Products – Revised Draft Guidance for Industry
FDA should revise its new guidance on listing of ingredients in tobacco products to require disclosure of all ingredients that can become toxic during normal use
Listing of Ingredients in Tobacco Products – Revised Draft Guidance for Industry
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
September 2016: 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
January 2016: 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
December 2015: 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
November 2015: Investigational drug use of of tobacco products
UCSF comment on FDA draft guidance on investigational use of tobacco products
November 2015: 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
August 2015: 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
April 2015: 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
2014-2019: 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
2014: 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
2014: UCSF Comments on the Deeming Rule
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
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
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