Public Comments

Comments to the FDA on Tobacco Industry’s Good Manufacturing Practices Proposal (2017)

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tclc-comment-good-manufacturing-practices-proposal-2017.pdf	9.26 MB

Comments to the FDA on Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delay

Comments to the FDA on Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delay

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Clarification-when-products-regulated-drugs-devices-delay-July2017.PDF	155.16 KB

Consortium Comment on FDA Draft Guidance (2016)

The Tobacco Control Legal Consortium's comment to the U.S. Food and Drug Administration (FDA) on the FDA’s draft guidance, “Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees.”

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Consortium-Comment-To-FDA-Nov2016.pdf	259.49 KB

Comments to HUD on Instituting Smoke-Free Public Housing (2016)

Public comments submitted by the Tobacco Control Legal Consortium to HUD on their proposed smoke-free public housing rule.

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tclc-HUD-Comment-smokefree-public-housing-2016.pdf	137.85 KB

Comments to FDA on Lorillard Petition for Enforcement Discretion Regarding Premarket Approval Requirements for New Tobacco Products (August 2014)

Consortium’s comments to FDA on Lorillard’s petition for enforcement discretion with respect to premarket approval requirements for new tobacco products.

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tclc-comments-fda-lorillard-petition-enforcement-premarket-approval-2014_0.pdf	668.94 KB

Comments on Lorillard Petition for Enforcement Discretion Regarding Premarket Approval Requirements for New Tobacco Products (August 2014)

Consortium’s comments to FDA on Lorillard’s petition for enforcement discretion with respect to premarket approval requirements for new tobacco products.

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tclc-comments-fda-lorillard-petition-enforcement-premarket-approval-2014.pdf	668.94 KB

Consortium's Comments to FDA on Proposed Deeming Regulation (August 2014)

Consortium's comments to the Food and Drug Administration's on the agency's proposed deeming regulation to assert jurisdiction over non-cigarette tobacco products (August 2014).

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tclc-comments-FDA-proposed-deeming-regulation-2014.pdf	928.1 KB

Consortium's Comments to FDA on Possible FDA Regulation of Menthol in Cigarettes (July 2014)

Consortium's comments to FDA on FDA's preliminary evaluation and data, research or other information that might informa regulatory actions the FDA might take regarding menthol in cigarettes.

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tclc-comments-FDA-preliminary-evaluation-menthol-2014.pdf	269.98 KB

Comments to FDA on Approaches to Evaluation of Modified Risk Tobacco Products (April 2014)

Comments to FDA on possible approaches for evaluating information on the risks and potential benefits of a proposed modified risk tobacco product to the health of individual tobacco users and to the population as a whole.

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tclc-comments-TPSAC-approaches-evaluation-modified-risk-tobacco-products-2014.pdf	432.61 KB

Comments to FDA on Experimental Study on Public Display of Lists of Harmful and Potentially Harmful Tobacco Constituents (August 2013)

Comments to FDA on the FDA's consumer research, "Experimental Study on the Public Display of Lists of Harmful and Potentially Harmful Tobacco Tobacco Constituents."

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tclc-comments-TPSAC-harmful-constituents-2013.pdf	278.49 KB

Comments to FDA on Evaluating Information on Proposed Modified Risk Tobacco Product (August 2013)

Comments to FDA on possible approaches for evaluating information on the risks and potential benefits of a proposed modified risk tobacco product to the population as a whole.

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tclc-comments-TPSAC-modified-risk-tobacco-products-2013.pdf	407.81 KB

Comments to FDA on the Collection of Health Documents (June 2013)

Comments to FDA on the collection of health documents created from June 22, 2009 through December 31, 2009, pursuant to the Food, Drug and Cosmetic Act (Sec. 904), as amended by the Family Smoking PRevention and Tobacco Control Act of 2009.

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tclc-comments-FDA-health-document-submission-2013.pdf	140.14 KB

Comments to FDA on Recommended Tobacco Product Manufacturing Practices (May 2013)

Comments to FDA on the recommendations for "current good manufacturing practices" for tobacco products, which were submitted to the FDA by thirteen tobacco companies.

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tclc-comments-FDA-tobacco-industry-product-manufacturing-practices-2013.pdf	302.13 KB

Consortium's Comments to FDA to Expand Its Jurisdiction Over Cigars (2012)

Consortium's comments on FDA Citizen Petition FDA-2011-P-0356 to expand the FDA's jurisdiction over cigars.

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tclc-comments-FDA-petition-rulemaking-jurisdiction-cigars-2012.pdf	337.27 KB

Comments to FDA on Modified Risk Tobacco Product Applications (June 2012)

Comments to FDA on guidance for industry on modified risk tobacco product applications.

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tclc-comments-FDA-guidance-modified-risk-tobacco-product-applications-2012.pdf	989.91 KB

Comments to FDA on Testing for Harmful Constituents in Tobacco Products and Tobacco Smoke (June 2012)

Comments to FDA on guidance for the tobacco industry on reporting harmful and potentially harmful constituents in tobacco products and tobacco smoke.

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TCLC-comments-FDA-testing-harmful-constituents-2012.pdf	172.41 KB

PHLC and PHLP Comments to Interagency Working Group on Food Marketed to Children (2011)

PDF, 717.61 KB

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phlc-iwgcomments-phlpnutritionsts-firstamendantitrust-2011.pdf	717.61 KB

PHLC Comments to Interagency Working Group on Proposed Nutrition Principles and Marketing Definitions (2011)

283.76 KB

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phlc-comments-iwg-nutritionstdsandmarketingdefs-2011.pdf	283.76 KB

PHLP and Consortium Comments to FDA on Sale and Distribution of Cigarettes & Smokeless Tobacco (May 2011)

PHLP and Consortium comments to FDA on draft guidance regarding compliance with regulations estricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents.

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tclc-fdacomments-cigarsinsamplingrestrictions-2011.pdf	96.54 KB

Consortium's Comments to FDA on Required Warnings for Cigarette Packages and Advertisements (Jan. 2011)

Consortium's comments to FDA addressing its proposed 2010 rule regarding required warnings for cigarette packages and advertisements.

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tclc-fdacomments-graphicwarnings-2011.pdf	326.9 KB

Consortium's Comments to FDA on Impact of Dissolvable Tobacco Use on Public Health (Sept. 2010)

Consortium comments to FDA on weaknesses in the regulation of dissolvable tobacco products at the state and federal level.

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tclc-regcommentfda-dissolvables-2010.pdf	125.22 KB

Comments to FTC on Information Requests to Marketers of Electronic Cigarettes (2015)

Comments on the Federal Trade Commission’s (FTC) request for comment on proposed information requests to marketers of electronic cigarettes, or electronic nicotine delivery systems (ENDS).

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Comment-to-FTC-on-ENDS-report.pdf	481.37 KB

Comments to FDA on Smokeless Tobacco Product Warning Statements (2013)

Comments from twenty-four national organizations on what changes, if any, to the current statutory warnings on smokeless tobacco products would promote greater public understanding of the risks associated with the use of smokeless tobacco products.

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tclc-fdacomments-smokeless-warnings-2013.pdf	616.7 KB

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Public Comments

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Comments to the FDA on Tobacco Industry’s Good Manufacturing Practices Proposal (2017)

Comments to the FDA on Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delay

Consortium Comment on FDA Draft Guidance (2016)

Comments to HUD on Instituting Smoke-Free Public Housing (2016)

Comments to FDA on Lorillard Petition for Enforcement Discretion Regarding Premarket Approval Requirements for New Tobacco Products (August 2014)

Comments on Lorillard Petition for Enforcement Discretion Regarding Premarket Approval Requirements for New Tobacco Products (August 2014)

Consortium's Comments to FDA on Proposed Deeming Regulation (August 2014)

Consortium's Comments to FDA on Possible FDA Regulation of Menthol in Cigarettes (July 2014)

Comments to FDA on Approaches to Evaluation of Modified Risk Tobacco Products (April 2014)

Comments to FDA on Experimental Study on Public Display of Lists of Harmful and Potentially Harmful Tobacco Constituents (August 2013)

Comments to FDA on Evaluating Information on Proposed Modified Risk Tobacco Product (August 2013)

Comments to FDA on the Collection of Health Documents (June 2013)

Comments to FDA on Recommended Tobacco Product Manufacturing Practices (May 2013)

Consortium's Comments to FDA to Expand Its Jurisdiction Over Cigars (2012)

Comments to FDA on Modified Risk Tobacco Product Applications (June 2012)

Comments to FDA on Testing for Harmful Constituents in Tobacco Products and Tobacco Smoke (June 2012)

PHLC and PHLP Comments to Interagency Working Group on Food Marketed to Children (2011)

PHLC Comments to Interagency Working Group on Proposed Nutrition Principles and Marketing Definitions (2011)

PHLP and Consortium Comments to FDA on Sale and Distribution of Cigarettes & Smokeless Tobacco (May 2011)

Consortium's Comments to FDA on Required Warnings for Cigarette Packages and Advertisements (Jan. 2011)

Consortium's Comments to FDA on Impact of Dissolvable Tobacco Use on Public Health (Sept. 2010)

Comments to FTC on Information Requests to Marketers of Electronic Cigarettes (2015)

Comments to FDA on Smokeless Tobacco Product Warning Statements (2013)