FDA Authority Over Tobacco

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Comments Submitted to the FDA by the Campaign for Tobacco-Free Kids and Partners

2024

• Comments of Tobacco-Free Kids on FDA-NIH meeting re smoking cessation products (Nov. 21, 2024)
• Comments by public health groups on proposed rule requiring submission of tracking numbers for e-cigarette imports (Oct. 15, 2024)
• Letter from public health groups urging FDA to ban remote sales of tobacco products (Aug. 21, 2024)
• Comments by public health groups on General Snus modified risk order renewal (Aug. 14, 2024)
• Letter to FDA from public health groups re relaunch in U.S. of PMI’s IQOS heated tobacco product (June 27, 2024)
• Public health letter to FDA re regulation of nicotine analogues (May 29, 2024)
• Letter from 78 groups urging FDA and other agencies to use all available enforcement tools to clear the market of unauthorized e-cigarette products (May 22, 2024)
• Letter from public health groups re regulation of nicotine pouch products (April 23, 2024)

2023

• Letter to President Biden on menthol cigarettes by organizations serving children (Dec. 19, 2023)
• Letter from public health and civil rights groups urging prompt OMB clearance of menthol cigarette rule (Dec. 5, 2023)
• Letter of public health groups re new JUUL PMTA (Sept. 25, 2023)
• Tobacco-Free Kids comments on FDA Strategic Planning Goals (Aug. 29, 2023)
• Letter to FDA regarding civil monetary penalties (June 30, 2023)
• Response of Campaign for Tobacco-Free Kids to Reagan-Udall Foundation Report (Feb 3, 2023)
• Response of Public Health Groups to American Vapor Manufacturers Citizen Petition (Jan. 24, 2023)

2022

• Letter to Expert Panel of Reagan-Udall Foundation for the FDA with recommendations for improvements in FDA tobacco program operation. (Nov. 7, 2022)
• Letter from Public Health Groups regarding deficiencies in the FDA Final Guidance for Industry on Tobacco Product Perception and Intention Studies (Oct. 14, 2022)
• Letter from public health groups re FDA enforcement policy toward illegal synthetic nicotine products  (Sept. 22, 2022)
• Coalition Letter in Support of a Nicotine Product Standard (Sept. 12, 2022)
• Comments to FDA by over 100 organizations supporting Proposed Rule for a Tobacco Product Standard for Menthol in Cigarettes (Aug. 2, 2022)
• Comments to FDA by over 100 organizations supporting Proposed Rule for a Tobacco Product Standard for Characterizing Flavors in Cigars (Aug. 2, 2022)
• Comments to FDA by 52 scientific experts on tobacco use and addiction supporting Tobacco Product Standard for Menthol in Cigarettes (July 29, 2022)
• Letter from public health groups re lack of FDA enforcement against products subject to marketing denial orders  (July 26, 2022)
• Letter to FDA transmitting data showing continued high level of sales of menthol e-cigarettes (June 9, 2022)
• Letter to FDA supporting denial of marketing orders to menthol e-cigarettes (June 8, 2022)
• Letter from public health groups requesting disclosure of the companies and products for which premarket applications were timely filed for synthetic products and undergoing premarket review (June 3, 2022)
• Letter to FDA re enforcement against companies with marketing denial order (April 22, 2022)
• Letter from public health groups opposing FDA marketing authorization for menthol e-cigarettes (April 5, 2022)
• Letter to FDA re FTC report on e-cigarette marketing (March 20, 2022)
• Letter from Public Health Groups asking FDA for Reconsideration of the VLN Modified Exposure Order (March 7, 2022)
• Letter of public health groups urging FDA to take immediate action on the pending applications for flavored e-cigarettes (Jan. 14, 2022)

2021

• Comments by Public Health Groups on Modified Risk Application for the IQOS 3 System Holder and Charge (Dec. 10, 2021)
• Letter from Public Health Groups re Global Marketing of Nicotine Pouch Products to Young People  (Nov. 29, 2021)
• Letter from public health groups to FDA on immediate need for FDA decisions denying PMTAs for flavored e-cigarettes (Sept. 24, 2021)
• Letter from public health groups urging FDA to immediately assert drug jurisdiction over synthetic nicotine e-cigarettes  (Sept. 2, 2021)
• Public Health Group Letter re Inadequacy of Various Restrictions and Conditions that Could be Imposed on Flavored E-cigarettes as Part of Marketing Orders  (Aug.11, 2021)
• Letter from Public Health Groups on Introduction of New Menthol Cigarettes and Flavored Cigars (Aug. 9, 2021)
• Letter by Public Health Groups Opposing SBA Advocacy Office Request for Extension of Court-Ordered One-Year Limit on Compliance Period During FDA Premarket Review of Deemed Tobacco Products  (June 17, 2021)
• Letter by Public Health Groups urging FDA to recognize the relevance to JUUL’s PMTA of the lawsuit against JUUL filed by the North Carolina Attorney General (June 15, 2021)
• Letter by Public Health Groups Opposing Premarket Tobacco Product Application Marketing Order for Juul Products (April 27, 2021)
• Comments of Public Health Groups on the Postal Service’s Proposed Rule Making E-Cigarettes Nonmailable (March 22, 2021)
• Letter by Public Health Groups urging FDA to take action on Puff Bar products and clarify regulatory status of Synthetic Nicotine (March 18, 2021)
• Letter from 79 organizations urging FDA to grant the pending Citizen Petition and commence rulemaking to prohibit menthol as a characterizing flavor in cigarettes, as well as take action to prohibit other flavored tobacco products (March 3, 2021)

2020

• Comments by Public Health Groups on FDA’s Tobacco Product Perception and Intention Studies Draft Guidance (Dec. 28, 2020)
• Letter from the Campaign for Tobacco-Free Kids and 45 Tobacco Use and Addiction Experts urging grant of Citizen Petition calling for prohibition of menthol as a characterizing flavor in cigarettes (Dec. 17, 2020)
• Comments of Public Health Groups Opposing Proposed HHS Rule on Sunset of Regulations  (Dec. 4, 2020)
• Letter from 68 public health and medical organizations to FDA urging grant of Citizen Petition calling for prohibition of menthol as characterizing flavor in cigarettes  (Nov. 9, 2020)
• Letter by Public Health Groups to FDA about Enforcement Priorities and Premarket Review of E-Cigarettes (Oct. 23, 2020)
• Letter from Public Health Groups re Role of the Tobacco Products Scientific Advisory Committee in Modified Risk Tobacco Product Proceedings (Oct. 19, 2020)
• Six leading health groups urge FDA to reject further delay in September 9, 2020, deadline for e-cigarette manufacturers to apply to keep products on the market  (Aug. 28, 2020)
• Principles to Guide FDA Premarket Review of E-Cigarettes and Other Deemed Products, submitted to FDA by 6 Leading Public Health and Medical Organizations (Aug. 10, 2020)
• Letter to FDA on Bluetooth Technology in Tobacco Products  (July 16, 2020)
• Letter to FDA on Puff Flow E-cigarettes (July 14, 2020)
• Comments of Public Health Groups Opposing 22nd Century VLN Modified Risk Tobacco Product Applications (May 18, 2020)
• Letter to FDA by 53 health and other groups urging disclosure of tobacco products for which premarket applications are filed by the court-ordered deadline (April 23, 2020)
• Campaign for Tobacco-Free Kids Comments to TPSAC on 22nd Century Group Inc.’s Modified Risk Tobacco Product Applications for VLN™ King and VLN™ Menthol King (Feb. 7, 2020)
• Public Health Group Comments on the Modified Risk Tobacco Application for Copenhagen Snuff Fine Cut (Jan. 21, 2020)

2019

• Comments of Public Health Groups on Proposed Rule for Premarket Tobacco Product Applications (Dec. 16, 2019)
• Comments of Public Health and Medical Organizations on Proposed Rule Requiring Graphic Health Warnings for Cigarettes (Oct. 15, 2019)
• Campaign for Tobacco-Free Kids Comments on 2019 Public Scientific Workshop on “Youth Tobacco Cessation: Science and Treatment Strategies” (May 31, 2019)
• Letter by public health groups to FDA about the youth-oriented marketing of the IQOS heated cigarette product in other countries (May 14, 2019)
• Public Health Group Comments on Modified Risk Tobacco Product Applications for Camel Snus Smokeless Tobacco Products (May 13, 2019)
• Public Health Group Comments on Modified Risk Tobacco Product Applications for Swedish Match Swedish Snus Products (May 13, 2019)
• Letter by six health groups urging FDA to investigate Juul for making unauthorized smoking cessation claims (May 09, 2019)
• Comments of Public Health Groups on FDA Draft Guidance Modifying Compliance Policy for E-cigarettes (April 30, 2019)
• Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products: Guidance for Industry (April 23, 2019)
• Letter by Public Health Groups to FDA about the Necessity of Adolescent Risk Perception Data in Modified Risk Tobacco Applications (Feb. 15, 2019)
• Health Groups’ Comments Urging FDA to Deny Modified Risk Tobacco Product Applications for IQOS (Feb. 11, 2019)
• Campaign for Tobacco-Free Kids Comments on Youth E-Cigarette Addiction and Cessation Therapies (Jan. 30, 2019)
• Campaign for Tobacco-Free Kids Comments to TPSAC on Altria/U.S. Smokeless Tobacco Company’s Modified Risk Application for Copenhagen Snuff Fine Cut (Jan. 22, 2019)

2018

• Campaign for Tobacco-Free Kids Comments on Premarket Review of Tobacco Products (Dec. 7, 2018)
• Letter to Commissioner Gottlieb from Public Health Groups on Core Principles Essential to Reducing Tobacco Use (Nov. 10, 2018)
• Campaign for Tobacco-Free Kids Comments to TPSAC on Camel Snus Modified Risk Application (Aug. 29, 2018)
• Letter to CTP Director on “Social Media Marketing of iQOS in the United States by PMI” (Aug. 13, 2018)
• Letter by Six Public Health and Medical Groups Urging FDA to Stop Sales of E-cigarette Products Illegally Introduced Without FDA Review and Authorization(Aug. 7, 2018)
  • Appendix: Images of e-cigarette products introduced without FDA review
• Comments by 42 Public Health, Medical and Other Organizations Urging FDA to Continue to Regulate all Cigars (July 25, 2018)
• Comments by 47 public health, medical and other organizations to FDA supporting implementation of a rule to ban the sale of all flavored tobacco products, including menthol cigarettes(July 19, 2018)
  • Appendix: Examples
• Comments by 40 public health, medical and other organizations to FDA supporting a product standard to reduce nicotine in cigarettes and other combustible tobacco products to non-addictive or minimally addictive levels (July 16, 2018)
• Comments by 36 public health, medical and other organizations to FDA responding to draft concept paper on illicit trade in tobacco products after implementation of an FDA product standard (July 16, 2018)
• Letter from 41 public health, medical and other organizations to FDA supporting a product standard to reduce the nicotine level in cigarettes and other combustible tobacco products to non-addictive or minimally addictive levels (May 21, 2018)
• Letter by six public health and medical groups urging FDA to take immediate action to protect young people from Juul e-cigarettes (April 18, 2018)
• Letter to FDA about the global marketing of Philip Morris International’s iQOS heated tobacco product and its relevance to FDA consideration of whether to allow iQOS to be marketed in U.S.(March 23, 2018)
  • Examples of PMI’s Global Marketing of iQOS
• Letter to FDA about “FDA’s Approach to Evaluating Nicotine Replacement Therapies” (Feb. 15, 2018)
• Comments on modified risk tobacco product applications for Philip Morris iQOS system (Jan. 3, 2018)

2017

• Comments to FDA supporting proposed products standard limiting carcinogen NNN in smokeless tobacco (July 10, 2017) (with 28 other public health and medical groups)
• Letter to FDA Commissioner refuting arguments made in favor of weakening deeming rule as it applies to e-cigarettes (July 7, 2017)
• Letter to FDA Commissioner objecting to Memorandum of Agreement to settle warning letters re marketing of Natural American Spirit cigarettes (June 7, 2017) (with AAP, ACS CAN, AHA, ALA and Truth Initiative)
• Comments to FDA on proposed research re graphic health warnings for cigarettes (May 30, 2017) (with AAP, ACS CAN, ACS, AHA, ALA and Truth Initiative)
• Letter to HHS Secretary Price opposing any reconsideration of deeming rule by new administration (May 17, 2017) (with 50 other public health and medical groups)

2016

• Letter to FDA on "Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee" (Aug. 30, 2016)
• Letter from public health groups urging FDA to issue rule requiring graphic cigarette warnings, as required by 2009 law  (Aug. 3, 2016)
• Comments to FDA re Draft Guidance on Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (July 11, 2016) (with AHA and ALA)
• Letter to CTP Office of Enforcement re warning letters issued re Natural American Spirit cigarettes (May 26, 2016)
• Letter from 30 health groups to President Obama urging prompt action to finalize rule providing for FDA oversight of all tobacco products (April 13, 2016)
• Letter to FDA with New York City Dept. of Health urging action toward track and trace system to curb illegal market in cigarettes (April 5, 2016) (with 20 other public health and medical groups)
• Letter to FDA re marketing of tobacco products as “new” products without premarket orders (Feb. 26, 2016) (with 36 other public health and medical groups)
• Letter from Campaign for Tobacco-Free Kids and Truth Initiative urging FDA to issue product standards limiting levels of tobacco-specific nitrosamines in cigarettes and smokeless tobacco (Feb. 3, 2016)

2015

• Letter from public health groups urging FDA’s Center for Drug Evaluation and Research to investigate therapeutic claims made by manufacturers and sellers of electronic cigarettes and related products (Oct. 14, 2015)
• Comments on advance notice of proposed rulemaking on nicotine exposure warnings and child-resistant packaging for liquid nicotine (Sept. 29, 2015) (joined comments filed on behalf of 37 public health and medical groups)
• Comments on amendments made to Swedish Match modified risk applications (Aug. 25, 2015) (with TCLC)
• Letter from public health groups urging FDA action against Natural American Spirit cigarettes for marketing cigarettes as “natural,” “additive-free” and “organic” (Aug. 24, 2015)
• Comments of Campaign for Tobacco-Free Kids on Electronic Cigarettes and Public Health (July 2, 2015)
• Letter to HHS Secretary re importance of premarket review of new tobacco products and opposing any change to “grandfather date” for tobacco products (Jan. 29, 2015) (with 30 other public health and medical organizations)

2014

• Campaign for Tobacco-Free Kids and Tobacco Control Legal Consortium submit comments on modified risk tobacco product applications submitted by Swedish Match North America, Inc. (Nov. 25, 2014)
• Letter from public health groups urging FDA to issue new rule requiring graphic cigarette warnings (Aug. 14, 2014)
• 24 public health and medical groups submit comments on the FDA’s proposed rule deeming various tobacco products subject to FDA regulation (Aug. 8, 2014)
• Campaign for Tobacco-Free Kids comments on the FDA’s proposed rule deeming various tobacco products subject to FDA regulation (Aug. 8, 2014)
• Letter to HHS Secretary urging issuance of final deeming rule 12 months after proposed rule (June 4, 2014) (with ACS CAN, AHA, ALA and Legacy)
• Public Health and Medical Groups Letter to FDA opposing extension for deeming comments (May 9, 2014)
• Comments to Tobacco Products Scientific Advisory Committee on evaluation of risks and potential benefits of proposed modified risk tobacco products (April 2, 2014) (with ACS CAN, ALA and TCLC)
• Letter to President Barack Obama urging completion of OMB review of proposed deeming rule (April 1, 2014) (with AAP, ACS CAN, AHA, ALA and Legacy)
• Public Health and Medical Groups Letter to FDA on Tobacco Product Standards (March 27, 2014)

2013

• Campaign for Tobacco-Free Kids Letter to FDA on Canadian Warning Label Study (Nov. 25, 2013)
• Public Health and Medical Groups Comments on Menthol in Tobacco Products (Nov. 22, 2013)
• Campaign for Tobacco Free Kids Comments on Tobacco Product Analysis (Sept. 30, 2013)
• Letter to President Barack Obama urging issuance of deeming rule (Sept. 19, 2013) (with chief executives of 15 other public health and medical groups)
• Comments to Tobacco Products Scientific Advisory Committee (TPSAC) re evaluation of population-wide risks vs. benefits of proposed modified risk tobacco products (Aug. 1, 2013) (with ACS-CAN, AHA, ALA, APHA, AACR and TCLC)
• Public Health Group Comments on FDA Collection of Tobacco Industry Health Documents (June 10, 2013)
• Public health groups Comments on Tobacco Manufacturers’ Submission of Proposed “Good Manufacturing Practices” (May 20, 2013)
• Comments to Tobacco Products Scientific Advisory Committee on TPSAC process on modified risk tobacco product applications (April 23, 2013)
• Tobacco Control Legal Consortium and Public Health Groups Citizen Petition on Menthol Cigarettes (April 12, 2013)
• Comments on smokeless tobacco warning labels (April 1, 2013) (with 22 public health and medical groups)
• Public health and medical groups Comments on Smokeless Tobacco Product Warning Statements (April 1, 2013)
• Statement of Matthew L. Myers before FDA Third Party Governance of Industry Sponsored Research Tobacco Product Workshop, (March 19, 2013)
• Citizen Petition filed by New York City and Public Health Groups to Implement Track and Trace System (March 6, 2013)
• Citizen Petition to implement track and trace system (March 6, 2013) (with NYC Dept. of Health and Mental Hygiene and ACS-CAN, AHA, ALA, Legacy, TCLC and Public Citizen)
• Public health groups Comments in Response to Submissions of Other Parties on Demonstrating Substantial Equivalence for Tobacco Product (Jan. 28, 2013)
• Campaign for Tobacco-Free Kids Comments on Actions Related to Nicotine Replacement Therapies and Smoking Cessation Products (Jan. 16, 2013)

2012

• Public health and medical groups comments to FDA on Petition of R.J. Reynolds Tobacco Company and American Snuff Company for Rulemaking to Adjust Statutory Smokeless Tobacco Warning (Nov. 16, 2012)
• Campaign for Tobacco-Free Kids letter to FDA concerning misbranding of roll-your-own tobacco as pipe tobacco (Aug. 3, 2012)
• Public Health Groups Comments to FDA on Guidance for Industry on Modified Risk Tobacco Product Applications (June 4, 2012)
• Public Health Groups Comments to FDA on proposed collection of information re FDA publication of list of harmful tobacco constituents (Feb. 13, 2012)
• Public Health and Medical Groups Comments to FDA on advance notice of proposed rulemaking on non-face-to-face sale and distribution of tobacco products and related promotion and marketing (Jan. 19, 2012)

2011

• Public Health and Medical Groups Comments to FDA on Draft Guidance regarding Applications for Premarket Review of New Tobacco Products (Dec. 27, 2011)
• Public Health and Medical Groups Comments on Draft Guidance entitled “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions” (Nov. 8, 2011)
• Public Health Groups Comments to FDA on list of harmful and potentially harmful tobacco constituents (Oct. 11, 2011)
• Public health and medical groups letter to the FDA regarding large, graphic warning labels on cigarette packs(Jan. 11, 2011)
  • Redline: Public health and medical groups letter to the FDA regarding large, graphic warning labels on cigarette packs (Jan. 11, 2011)

2010

• Campaign for Tobacco-Free Kids letter to the FDA on draft guidance concerning money penalties and no-tobacco-sale orders for tobacco retailers (Oct. 27, 2010)
• Public health and medical groups letter to the FDA on the public health impact of dissolvable smokeless tobacco products (Sept. 20, 2010)
• Campaign for Tobacco-Free Kids letter to the FDA on tobacco retailer training programs (Sept. 14, 2010)
• Campaign for Tobacco-Free Kids letter to the FDA concerning Philip Morris and U.S. Smokeless Tobacco Co. comments on harmful and potentially harmful constituents in tobacco products (Sept. 8, 2010)
• Campaign for Tobacco-Free Kids letter to the FDA concerning effective communications about tobacco products and the dangers of tobacco use (Sept. 7, 2010)
• Public health groups petition to the FDA requesting that it re-evaluate its approach to reviewing tobacco-cessation products (Aug 26, 2010)
• Campaign for Tobacco-Free Kids letter to the FDA on harmful and potentially harmful constituents in tobacco products (Aug. 25, 2010)
• Public health and medical groups' letter to the FDA regarding rotational warning plans for smokeless tobacco products (Aug. 5, 2010)
• Public health and medical groups' letter to the FDA regarding tobacco industry marketing to youth and racial and ethnic minorities(July 26, 2010)
  • Appendix: Examples of cigarette advertising (including menthol-specific ads) appealing to youth and minorities.
• Public health groups' letter to the FDA regarding outdoor tobacco advertising (July 19, 2010)
• Public health groups' letter to the FDA regarding the public health impacts of menthol tobacco products (March 22, 2010)
• Public health groups’ letter to the FDA regarding industry efforts to circumvent the "light" and "low" ban (Feb. 18, 2010)
• Campaign for Tobacco Free Kids' letter to the FDA regarding penalties for retailers who sell tobacco products to youth under 18 (Jan. 8, 2010)
• U.S. Judge Upholds Requirements of FDA Law (Jan. 5, 2010)

2009

• Campaign for Tobacco-Free Kids' letter to the FDA regarding smokers' and youths' misperceptions about the gravity of smoking risks (Dec. 28, 2009)
• Campaign for Tobacco-Free Kids' letter to the FDA regarding roll-your-own tobacco (Dec. 23, 2009)
• Campaign for Tobacco-Free Kids' letter to the FDA summarizing scientific research that supports the new law (Dec. 17, 2009)
• Public Health Groups' letter to the FDA regarding tobacco industry disclosure of product ingredients (Nov. 13, 2009)
• Public health groups letters to the FDA regarding industry efforts to circumvent the "light" and "low" ban (Sept. 10, 2009)
• Public Health Groups' letter to the FDA regarding the ban on flavored cigarettes (Aug. 27, 2009)

Last Updated Nov. 21, 2024