May 29, 2014

Stanton A. Glantz, PhD

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 January 16, 2019.

US Smokeless Tobacco (Altria) request to sell Copenhagen Snuff with reduced risk claims

FDA should not permit the U.S. Smokeless Tobacco Company to market Copenhagen Snuff with modified risk claims

Canadian Ministry of Health Proposed Marketing Statements for E-cigarettes

Canadian Ministry of Health proposes to authorize e-cig sellers to make claims that ignore recent understanding of health risks

Comment by Physicians for a Smokefree Canada

Premium Cigars

FDA Should Not Create a Separate Category for So-Called “Premium Cigars” Because it has Already Correctly Concluded that there is No Appropriate Public Health Justification to Exclude Premium Cigars from Regulation

FDA Advanced Notice of Proposed Rulemaking on a Nicotine Product Standard

FDA Tobacco Product Standard for Nicotine Level of Combusted Cigarettes: Protecting Against Unintended Consequences by Expanding the Scope of the Rule to All Inhaled Recreational Nicotine Products

FDA Should Set a Nicotine Product Standard Level to be Achieved in a Single Step for All Combusted Tobacco Products

The FDA needs to look beyond nicotine alone in developing its standard for nicotine delivery in tobacco products

Tobacco Product Standard for Nicotine Level of Combusted Cigarettes

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
 
Nicotine Steering Committee

FDA’s Nicotine Steering Committee should develop policies, regulations, and procedures that promote cessation and increase the use of proven therapies

FDA Should Facilitate Investigational New Drug Applications (IND) for Commercially Available Electronic Nicotine Delivery Devices

FDA comprehensive nicotine policy

The FDA should not adopt the nicotine “harm reduction” paradigm because doing so is likely to increase the amount of smoking-caused disease and death

FDA consideration of PMI IQOS premarket approval application

FDA should not grant PMI's Premarket Tobacco Product Application for IQOS

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.
 
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
 
RJ Reynolds MRTP application for snus

COMMENT PREPARED AFTER THE TPSAC MEETIING ON CAMEL SNUS: RJR failed to demonstrate that Camel Snus, as actually used by consumers, will significantly reduce harm to individuals or benefit population health.  FDA should not issue an MRTP order allowing RJR to market Camel Snus with modified risk claims

Summary of the 5 public comments UCSF TCORS submitted to FDA on why FDA should not approve allowing RJR to claim Camel Snus is a less dangerous product

Clinical Trials and Observational Epidemiology Indicate that Allowing Snus to be Marketed with Modified Risk Claims is Unlikely to Confer Population Benefit and May Cause Harm by Depressing Smoking Cessation

Reynolds’ own data do not support their claim that because exclusive users of Camel Snus experience lower levels of exposure to some toxicants, they will reduce their risk of harm from lung cancer, oral cancer, respiratory disease, and heart disease

R.J. Reynolds Tobacco Company’s Application for Six Camel SNUS Smokeless Tobacco Minimizes its Appeal to Adolescents and the Likelihood that Youth and Adolescents Will Initiate Smokeless Tobacco or Smokeless Tobacco with Other Products

RJR consumer perceptions studies are poorly designed and fail to provide sufficient evidence to evaluate the effects the proposed modified risk advertisements on consumer comprehension and behavioral intentions

The Dynamic Population Modeler (+1) Used to Show Population Health Benefits Does Not Justify Issuing a MRTP Order for Camel SNUS Products

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
 
Philip Morris International MRTP application for iQOS

PMI’s 6-month study “Evaluation of Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 for 26 Weeks (ZRHR-ERS-09 US) submitted in  PMI IQOS MRTP June 8, 2018 amendment to FDA-2017-D-3001-0002 does not support claims of reduced risk

PMI’s December 22, 2017 amendment to its IQOS MRTP application failed to address concerns about dual use, flavors, risk perceptions, and its Population Health Impact Model  

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

Comments from Outside UCSF

Re: Docket No. FDA-2017-N-5994, Tobacco Products Scientific Advisory Committee, Modified Risk Tobacco Product Applications: Applications for iQOS system with Marlboro Heatsticks, iQOS system with Marlboro Smooth Menthol Heatsticks, and iQOS system with Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris Products S.A. (letter to TPSAC)
 
California Regulations to Implement Legalized Marijuana

Incorporating best practices from public administration and public-health oriented restrictions into California’s cannabis regulations is necessary to protect public health by restricting conflicts of interest and revolving door abuses, imposing environmentally sound exit packaging requirements limiting the use of single-use plastic products, and clarifying the daily sale limit for edibles containing concentrates

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
 
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

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
 
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

Swedish Match's revised MRTP application didn't adequately address FDA's questions; FDA should deny its application to make reduced risk claims

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

Add new comment

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.