UPDATE ON PREMARKET TOBACCO PRODUCT AUTHORIZATION PATHWAY

Size: px
Start display at page:

Download "UPDATE ON PREMARKET TOBACCO PRODUCT AUTHORIZATION PATHWAY"

Transcription

1 UPDATE ON PREMARKET TOBACCO PRODUCT AUTHORIZATION PATHWAY Presented by Ii-Lun Chen, M.D Director Division of Individual Health Science Office of Science, CTP, FDA Disclaimer: This is not a formal dissemination of information by FDA and does not represent Agency position or policy. March 8, 2017

2 Swedish Match North America MRTPA and PMTA Decisions Focus on PMTA PMTA Informational Session Summary - October

3 BACKGROUND: PREMARKET TOBACCO APPLICATION (PMTA) Before a new tobacco product can be legally marketed (per Section 910(a)(2) of the FD&C Act), a premarket tobacco application must be submitted, reviewed by FDA, and determined to be appropriate for the protection of public health - unless the product is found to be substantially equivalent (SE) to a predicate tobacco product, or the product is found to be exempt from SE. 2

4 BACKGROUND: PMTA STATUTORY REQUIREMENTS In a PMTA, FDA must determine: Whether permitting this product to be marketed would be appropriate for the protection of the public health The risks and benefits to the population as a whole, including users and nonusers, and The increased or decreased likelihood that existing users of tobacco products will stop using such products and those who do not use tobacco products will start using such products. 3

5 BACKGROUND: PMTA STATUTORY REQUIREMENTS Per section 910(b)(1), a PMTA must contain: Full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations that have been made to show the health risks of the tobacco product and whether the tobacco product presents less risk than other tobacco products A full statement of the components, ingredients, additives, properties, and the principle or principles of operation, of such tobacco product A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such tobacco product 4

6 BACKGROUND: PMTA STATUTORY REQUIREMENTS (CONT.) An identifying reference to any tobacco product standard under section 907 that would be applicable to any aspect of the tobacco product, and either adequate information to show that the aspect of the tobacco product fully meets the tobacco product standard or adequate information to justify any deviation from the standard Specimens of the labeling proposed to be used for such tobacco product The samples of such tobacco product and of components thereof as the Secretary may reasonably require The other information relevant to the subject matter of the application as the Secretary may require 5

7 PMTA DRAFT GUIDANCES The PMTA draft guidances Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems and Applications for Premarket Review of New Tobacco Products describe FDA s recommendations on how to: Meet the statutory requirements for PMTA content under section 910(b)(1) Present information in a way that helps FDA make its decision on whether to issue a marketing order under 910(c)(1)(A)(i) of the FD&C Act When finalized, these guidances will represent FDA s current thinking on PMTAs for regulated products 6

8 SWEDISH MATCH NORTH AMERICA (SMNA) 7

9 GOALS FOR REVIEWING THE SMNA SUBMISSION The overall objective of authorizing new tobacco products to be marketed through the PMTA process is to reduce the morbidity and mortality associated with tobacco use. In evaluating how marketing authorization for these Swedish snus products impacts the current market, FDA considered the possibility that a PMTA order may increase use and initiation of snus due to its perceived favorable profile. Given this possibility, the products impact on health, impact on smoking cessation, impact on snus initiation and uptake, and impact on current ST users was considered in totality. 8

10 HEALTH IMPACT When used exclusively instead of cigarettes, these snus products offer lower risk of developing respiratory diseases (e.g., COPD, emphysema, chronic bronchitis) and certain cancers (e.g., lung). Assuming that the only users of these products are persons who would have used other ST (smokeless tobacco) products currently on the US market, individuals using these products with lower NNN levels could decrease their excess cancer risk by 90% compared use of moist snuff (market share: 82%), by 67% compared to use of chewing tobacco (market share:15%), by 38% compared to use of US-style snus, and by 92% compared to use of dry snuff. 9

11 POPULATION IMPACT Data indicate there is limited switching behaviors from exclusive smoking to exclusive smokeless tobacco use. Findings from Tam et al. indicate that in the US, switching from ST use to smoking is more common than switching from smoking to ST use. Nevertheless, limited data suggest that the adoption of snus use in the US is low and, therefore, unlikely to lead to use of other tobacco products. It is anticipated that with the marketing of the proposed products, as described in the PMTAs, there is a low likelihood of nonuser uptake of these products, decreased or delayed cessation, or other significant shifts in user demographics. 10

12 SCIENTIFIC RATIONALE: PMTA DECISION The products in the SMNA PMTAs may decrease the individual risk among current ST users due to their favorable toxicological profile without posing increased risk to the general population. Current ST users who choose to continue using tobacco products will have additional options for less toxic ST products, thereby potentially decreasing the negative health impact from tobacco product use. 11

13 PMTA INFORMATIONAL SEMINAR FOR ENDS PRODUCTS 12

14 PMTA INFORMATIONAL SEMINAR: OCTOBER 2016 OBJECTIVES The PMTA Informational Seminar was developed to assist manufacturers to better understand the scientific principles for evaluating electronic nicotine delivery systems (ENDS) products. The objective was to improve understanding of: FD&C Act requirements for a new tobacco product application General scientific principles and terminology relevant to evaluation of ENDS products as described in the draft guidance on PMTAs for ENDS 13

15 PMTA INFORMATIONAL SEMINAR: OVERVIEW The PMTA Informational Seminar was held on October 17-18, Specific seminar topics included: General administrative information Product science evaluation Data sources for potential use Health risk evaluation Role of human factors and labeling Addiction and abuse liability evaluation Impact of initiation, cessation and consumer perception 14

16 PMTA INFORMATIONAL SEMINAR: GENERAL INFORMATION ENDS PMTA draft guidance is not an FDA-implemented policy. The guidance, when finalized, will communicate FDA's recommendations for submitting a PMTA for ENDS products as well as the general procedures by which FDA intends to review a PMTA. To aid in a successful submission, meetings with the FDA, reviewing guidances, and referencing information in a tobacco product master file may be helpful. Bridging is one of the commonly-used tools that can be used to verify product characteristics through comparability. 15

17 PMTA INFORMATIONAL SEMINAR: PRODUCT SCIENCE It is important to understand the: Chemistry information relevant to ENDS products, including: ingredients, additives, constituents, collection and analysis of constituents, and product stability Basic engineering principles of product design, product operation, and product manufacturing Toxicology profile of the ingredients in ENDS products, including: dose response, toxicity, routes of exposure, carcinogenicity, and risk assessment An Environmental Assessment is a PMTA requirement. 16

18 PMTA INFORMATIONAL SEMINAR: DATA SOURCES Data Sources for Potential Use An applicant can use publically available national e-cigarette data to supplement or complement other behavioral information that may be submitted in a PMTA. When performing a literature review, consider including the identification, evaluation, interpretation, and reporting of studies regarding ENDS products. 17

19 PMTA INFORMATIONAL SEMINAR: HEALTH RISKS Biomarkers of exposure and potential harm may be useful tools to enable a better understanding of potential health impacts within a shorter time frame. The human health impact should be assessed in both users and nonusers. It is important for FDA to understand how consumers and others are impacted by the availability of the product within the world of available tobacco products. 18

20 TOBACCO PRODUCT MARKET Marketed Tobacco Products Newly Deemed Tobacco Products ENDS Proposed ENDS 19

21 PMTA INFORMATIONAL SEMINAR: HUMAN FACTORS AND LABELING Consider the use environment, user and user interface when designing a product to maximize the likelihood of correct use and minimize the potential for unintended risk of product use. A PMTA must include a sampling of the proposed label for the new product. 20

22 PMTA INFORMATIONAL SEMINAR: ADDICTION AND ABUSE LIABILITY Traditional abuse liability assessments are designed to evaluate the likelihood of abuse of a drug, and can also assess the consequences of abuse. Determination of a product s abuse potential/abuse liability is accomplished through multiple lines of evidence. 21

23 PMTA INFORMATIONAL SEMINAR: INITIATION/ CESSATION General principles suggest that multiple lines of evidence would strengthen an argument related to the likelihood of tobacco product initiation and cessation. Initiation and cessation are defined in different ways. It is important that clear definitions and rationale are provided for how they are being defined in any particular setting in order to support meaningful interpretation of research findings. Youth are particularly susceptible to the initiation of tobacco products; therefore, one of CTP s top priorities is preventing youth from starting to use tobacco. 22

24 PMTA INFORMATIONAL SEMINAR: CONSUMER PERCEPTION Consumer perceptions are widely accepted in the scientific literature as precursors to use behavior, which may directly inform the likelihood of initiation/cessation among certain groups. Qualitative research provides richer information than what is available through other data collection methods such as surveys or experiments. It is a deeper dive into individuals thoughts, feelings, and behaviors and can help put other sources of data into context. 23

25 PMTA INFORMATIONAL SEMINAR: SUMMARY Applicants submitting a PMTA must respond to the statutory requirements specified by section 910 of the FD&C Act. FDA must consider whether permitting this product to be marketed would be appropriate for the protection of the public health. In order for FDA to review a tobacco product, it requires sufficient information to describe the product, how it is made, what is the impact if the product goes on the market, what is the impact on users and nonusers, and potential product switching behaviors. No specific studies are required for a PMTA; applicants can use publically available literature and nonclinical or clinical studies. Long-term health outcome studies are not required or expected. 24

26 QUESTIONS 25

MODIFIED RISK TOBACCO PRODUCT MARKETING DECISIONS

MODIFIED RISK TOBACCO PRODUCT MARKETING DECISIONS MODIFIED RISK TOBACCO PRODUCT MARKETING DECISIONS Presented by David Ashley, Ph.D. Rear Admiral (retired), US Public Health Service Director, Office of Science, CTP, FDA Disclaimer: This is not a formal

More information

TOBACCO PRODUCT OR MEDICAL PRODUCT?

TOBACCO PRODUCT OR MEDICAL PRODUCT? TOBACCO PRODUCT OR MEDICAL PRODUCT? Priscilla Callahan-Lyon, MD Deputy Director Division of Individual Health Science Office of Science, CTP Grail Sipes, JD Director Office of Regulatory Policy, CDER Disclaimer:

More information

The Tobacco Control Act s Premarket Review Authorities: Reports on Substantial Equivalence and Exemption Requests (905(j))

The Tobacco Control Act s Premarket Review Authorities: Reports on Substantial Equivalence and Exemption Requests (905(j)) The Tobacco Control Act s Premarket Review Authorities: Reports on Substantial Equivalence and Exemption Requests (905(j)) January 12, 2011 Cristi Stark, MS Senior Regulatory Health Project Manager Office

More information

FDA Center for Tobacco Products: Tobacco Research and the Population Assessment of Tobacco and Health (PATH) Study

FDA Center for Tobacco Products: Tobacco Research and the Population Assessment of Tobacco and Health (PATH) Study FDA Center for Tobacco Products: Tobacco Research and the Population Assessment of Tobacco and Health (PATH) Study Regulatory Public Laws Compliance & Education Policies Science & Enforcement & Communications

More information

Addressing the Challenge of ENDS Regulation. David Graham President & Managing Partner Reveritas Group

Addressing the Challenge of ENDS Regulation. David Graham President & Managing Partner Reveritas Group Addressing the Challenge of ENDS Regulation David Graham President & Managing Partner Reveritas Group Addressing the Challenge of ENDS Regulation 1. The context of conflict and effect of the crossfire

More information

Communicating the Risk of Nicotine Delivery Products

Communicating the Risk of Nicotine Delivery Products Communicating the Risk of Nicotine Delivery Products August 10, 2014 ACS National Meeting Jim Solyst June 24, 2014 1 Nicotine Background Key Points The popularity of e-cigarettes has increased the need

More information

FDLI Annual Conference

FDLI Annual Conference FDLI Annual Conference Panel Tobacco Harm Reduction: Opportunities & Regulatory Pathways to Achieve May 5, 2017 Joe Murillo Vice President, Regulatory Affairs Altria Client Services Panel Discussion at

More information

Tobacco-related risk perceptions in the regulation of tobacco products at the FDA Center for Tobacco Products

Tobacco-related risk perceptions in the regulation of tobacco products at the FDA Center for Tobacco Products Tobacco-related risk perceptions in the regulation of tobacco products at the FDA Center for Tobacco Products David B. Portnoy, PhD, MPH Conrad J. Choiniere, PhD Office of Science FDA, Center for Tobacco

More information

Mitch Zeller, Director, Center for Tobacco Products, FDA September 19, 2013 Kansas Public Health Association

Mitch Zeller, Director, Center for Tobacco Products, FDA September 19, 2013 Kansas Public Health Association Regulatory Public Laws Compliance & Education Policies Science & Enforcement & Communications The FDA Center for Tobacco Products (CTP): Its Role in Reducing Tobacco Use Mitch Zeller, Director, Center

More information

UNITED STATES REGULATION OF TOBACCO PRODUCTS. Presented by Mitch Zeller Center Director FDA Center for Tobacco Products

UNITED STATES REGULATION OF TOBACCO PRODUCTS. Presented by Mitch Zeller Center Director FDA Center for Tobacco Products UNITED STATES REGULATION OF TOBACCO PRODUCTS Presented by Mitch Zeller Center Director FDA Center for Tobacco Products May 24, 2016 OVERVIEW OF TODAY S PRESENTATION Highlights of the Deeming Final Rule

More information

UPDATES FROM THE FDA CENTER FOR TOBACCO PRODUCTS (CTP)

UPDATES FROM THE FDA CENTER FOR TOBACCO PRODUCTS (CTP) UPDATES FROM THE FDA CENTER FOR TOBACCO PRODUCTS (CTP) Mitch Zeller, J.D. Director, FDA May 4, 2017 CENTER FOR TOBACCO PRODUCTS AGENDA Update on Regulations and Guidances: Deeming Update on Science Update

More information

Regulatory Support for Tobacco Products. Feeling daunted by the regulatory process for tobacco products? Don t worry Battelle can help.

Regulatory Support for Tobacco Products. Feeling daunted by the regulatory process for tobacco products? Don t worry Battelle can help. Regulatory Support for Tobacco Products Feeling daunted by the regulatory process for tobacco products? Don t worry Battelle can help. PREMARKET TOBACCO (PMTA) HUMAN FACTORS STUDIES SUBSTANTIAL EQUIVALENCE

More information

FDA s Action Agenda to Reduce Tobacco Related-Cancer Incidence and Mortality

FDA s Action Agenda to Reduce Tobacco Related-Cancer Incidence and Mortality FDA s Action Agenda to Reduce Tobacco Related-Cancer Incidence and Mortality Lawrence Deyton, M.S.P.H., M.D. Director, FDA Center for Tobacco Products June 11, 2012 FDA s Vision To make tobaccorelated

More information

FDA S CENTER FOR TOBACCO PRODUCTS: AN UPDATE ON REGULATORY ACTIVITIES AND PRIORITIES

FDA S CENTER FOR TOBACCO PRODUCTS: AN UPDATE ON REGULATORY ACTIVITIES AND PRIORITIES FDA S CENTER FOR TOBACCO PRODUCTS: AN UPDATE ON REGULATORY ACTIVITIES AND PRIORITIES Mitch Zeller, J.D. (Director, FDA CTP) Matthew R. Holman, Ph.D. (Director, Office of Science, FDA CTP) Kathy Crosby

More information

FDLI s Enforcement, Litigation, and Compliance Conference. Center for Tobacco Products Office of Compliance and Enforcement 2017 Update

FDLI s Enforcement, Litigation, and Compliance Conference. Center for Tobacco Products Office of Compliance and Enforcement 2017 Update FDLI s Enforcement, Litigation, and Compliance Conference Center for Tobacco Products Office of Compliance and Enforcement 2017 Update Ann Simoneau, Director Office of Compliance and Enforcement Center

More information

Modified Risk Tobacco Product Applications A Succinct ENDS Industry Perspective

Modified Risk Tobacco Product Applications A Succinct ENDS Industry Perspective Modified Risk Tobacco Product Applications A Succinct ENDS Industry Perspective Patricia I. Kovacevic General Counsel, Chief Compliance Officer Presentation to the Food and Drug Law Institute Tobacco Conference,

More information

Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Products

Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Products Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Quick Facts Retailers that mix and prepare e-liquids or create or modify vaporizers

More information

Tobacco Product Applications: FDA Perspective

Tobacco Product Applications: FDA Perspective Tobacco Product Applications: FDA Perspective Matthew R. Holman, Ph.D. Director, Office of Science Center for Tobacco Products Disclaimer: This information is not a formal dissemination of information

More information

Menthol Cigarette Report

Menthol Cigarette Report Menthol Cigarette Report Tobacco Products Scientific Advisory Committee Meeting July 15, 2010 Corinne G. Husten, MD, MPH Senior Medical Advisor Center for Tobacco Products, FDA 1 Menthol Cigarette Report

More information

Understanding the Tobacco Control Act

Understanding the Tobacco Control Act Understanding the Tobacco Control Act An Overview of the Tobacco Control Act and Center for Tobacco Products for the National Native Network CAPT Gail Cherry-Peppers, Tribal Liaison Heather Althouse, Senior

More information

Introduction to Product Regulation Under the Family Smoking Prevention & Tobacco Control Act

Introduction to Product Regulation Under the Family Smoking Prevention & Tobacco Control Act Introduction to Product Regulation Under the Family Smoking Prevention & Tobacco Control Act Presentation for the Tobacco Merchants Association by John Manthei May 23, 2011 Latham & Watkins operates worldwide

More information

Assessment of the Tobacco Heating System (THS) 2.2, A Candidate Modified Risk Tobacco Product: From Concept to Early Clinical Data

Assessment of the Tobacco Heating System (THS) 2.2, A Candidate Modified Risk Tobacco Product: From Concept to Early Clinical Data Assessment of the Tobacco Heating System (THS) 2.2, A Candidate Modified Risk Tobacco Product: From Concept to Early Clinical Data Global Forum on Nicotine 2015 Bruce D. Clark PhD Philip Morris International

More information

Public consultation on SCENIHR preliminary report on "Health Effects of Smokeless Tobacco Products"

Public consultation on SCENIHR preliminary report on Health Effects of Smokeless Tobacco Products Public consultation on SCENIHR preliminary report on "Health Effects of Smokeless Tobacco Products" Please find below the questions posed by the Commission and the answers given by the Committee. These

More information

Heat-not-Burn Products: Scientific Assessment of Risk Reduction

Heat-not-Burn Products: Scientific Assessment of Risk Reduction Heat-not-Burn Products: Scientific Assessment of Risk Reduction Tobacco Merchants Association 2015 Annual Meeting Moira Gilchrist PhD Philip Morris International R&D May 20th 2015 The Objective is Harm

More information

OVERALL HEALTH EFFECTS OF SWEDISH MATCH SNUS PRODUCTS

OVERALL HEALTH EFFECTS OF SWEDISH MATCH SNUS PRODUCTS OVERALL HEALTH EFFECTS OF SWEDISH MATCH SNUS PRODUCTS Lester Jao Lacorte, MD, CCRP Medical Officer Office of Science Center for Tobacco Products U.S. Food and Drug Administration DISCLAIMER 1 The information

More information

RE: Docket No. FDA-2014-N , Electronic Cigarettes and the Public Health

RE: Docket No. FDA-2014-N , Electronic Cigarettes and the Public Health VIA ELECTRONIC SUBMISSION June 30, 2015 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 RE: Docket No. FDA-2014-N-1936-0001, Electronic

More information

SNUS ON THE LOOSE: Big Tobacco s s latest attempt to make nicotine more attractive

SNUS ON THE LOOSE: Big Tobacco s s latest attempt to make nicotine more attractive SNUS ON THE LOOSE: Big Tobacco s s latest attempt to make nicotine more attractive U.S. Smokeless Tobacco Market Historically the preserve of smaller, specialized companies: Conwood U.S. U.S. Smokeless

More information

Philip Morris USA Inc. v. FDA

Philip Morris USA Inc. v. FDA Philip Morris USA Inc. v. FDA STACY L. EHRLICH * AND JAMES WILLIAM WOODLEE ** WHY IT MADE THE LIST Philip Morris v. FDA 1 represents the latest in a string of (generally successful) industry challenges

More information

Heated Tobacco Technology: Science, Behavior and Avoiding Unintended Consequences

Heated Tobacco Technology: Science, Behavior and Avoiding Unintended Consequences Heated Tobacco Technology: Science, Behavior and Avoiding Unintended Consequences Global Forum on Nicotine 2017 Moira Gilchrist PhD Philip Morris International June 16th 2017 Important Information Reduced-Risk

More information

Modeling the Population Health Effects of Camel Snus with Reduced Risk Information

Modeling the Population Health Effects of Camel Snus with Reduced Risk Information Modeling the Population Health Effects of Camel Snus with Reduced Risk Information Geoffrey Curtin, Ph.D. - RAI Services Company Annette Bachand, Ph.D., Sandra Sulsky, Ph.D. - Ramboll Environ; Saul Shiffman,

More information

The Legal Resource Center for Public Health Policy provides information and technical assistance on issues related to public health in Maryland.

The Legal Resource Center for Public Health Policy provides information and technical assistance on issues related to public health in Maryland. October 17, 2016 The Legal Resource Center for Public Health Policy provides information and technical assistance on issues related to public health in Maryland. The legal information and assistance does

More information

SNUS and the GOTHIATEK STANDARD

SNUS and the GOTHIATEK STANDARD SNUS and the GOTHIATEK STANDARD Inger Wahlberg Consulting 1 SNUS 2 SNUS 3 Snus Swedish snus A moist to semi-moist oral tobacco product, traditionally produced and used in Sweden. Contains finely ground,

More information

Smokeless Tobacco Use in the US Military

Smokeless Tobacco Use in the US Military Murtha Cancer Center The DoD Cancer Center of Excellence Accelerating Progress against Cancer through Collaboration Smokeless Tobacco Use in the US Military 23 Jun 2014 Dr. S. Steve Lee Dr. Kangmin Zhu

More information

Tobacco Harm Reduction Brad Rodu

Tobacco Harm Reduction Brad Rodu Tobacco Harm Reduction Brad Rodu Professor, Department of Medicine James Graham Brown Cancer Center University of Louisville The Smoking Status Quo: Unacceptable The American Anti-Smoking Campaign is 45

More information

Proposed Deeming Regulations: What s the Path Forward?

Proposed Deeming Regulations: What s the Path Forward? Proposed Deeming Regulations: What s the Path Forward? Gal Cohen, Ph.D. Head of Scientific and Regulatory Affairs Ploom, Inc. James & Adam Vision and mission Vaporization technology company Obsolete combustion

More information

Peter G. Shields, MD Tobacco Products Scientific Advisory Committee (TPSAC) August 16, 2013

Peter G. Shields, MD Tobacco Products Scientific Advisory Committee (TPSAC) August 16, 2013 Peter G. Shields, MD Tobacco Products Scientific Advisory Committee (TPSAC) August 16, 2013 Conceptual Framework for Evaluating MRTPs: Objectives Provide a framework for evaluating all tobacco products

More information

COMMENT PREPARED AFTER THE TPSAC MEETIING ON CAMEL SNUS. significantly reduce harm to individuals or benefit population health.

COMMENT PREPARED AFTER THE TPSAC MEETIING ON CAMEL SNUS. significantly reduce harm to individuals or benefit population health. 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.

More information

Might Smoking Rates go up in Flames? Dr John Schoonbee, Chief Medical Officer, Swiss Re

Might Smoking Rates go up in Flames? Dr John Schoonbee, Chief Medical Officer, Swiss Re Might Smoking Rates go up in Flames? Dr John Schoonbee, Chief Medical Officer, Swiss Re 2 Agenda Smoking is still a problem Stopping is hard Electronic cigarettes Reduced Risk tobacco products Males >15yr

More information

How to Regulate E-Cigarettes? Are we asking the right questions?

How to Regulate E-Cigarettes? Are we asking the right questions? How to Regulate E-Cigarettes? Are we asking the right questions? Eric N. Lindblom Director, Tobacco Control and Food & Drug Law O Neill Institute for National & Global Health Law Georgetown University

More information

WHO Framework Convention on Tobacco Control

WHO Framework Convention on Tobacco Control WHO Framework Convention on Tobacco Control When WHO was established in 1948, its Member States incorporated the power to negotiate treaties into its Constitution. This power remained dormant until 1996,

More information

The concept that not all tobacco and nicotine products

The concept that not all tobacco and nicotine products A Model Risk Continuum for Tobacco and Nicotine Products by Chris Proctor, Sudhanshu Patwardhan, and James Murphy The concept that not all tobacco and nicotine products present the same risks to human

More information

Actual Use Study of the Potential Reduced-Risk Product (RRP): Tobacco Heating System (THS)

Actual Use Study of the Potential Reduced-Risk Product (RRP): Tobacco Heating System (THS) Actual Use Study of the Potential Reduced-Risk Product (RRP): Tobacco Heating System (THS) S. Roulet 1, P. Magnani 1, G. Kallischnigg 2, A. Dugan 3, C. Gage 3, C. Kanitscheider 4, M. Apecechea 4, A. Ramazzotti

More information

Responsible Practice in E-Vapour Products (EVP) Product Stewardship

Responsible Practice in E-Vapour Products (EVP) Product Stewardship Responsible Practice in E-Vapour Products (EVP) Product Stewardship Tanvir Walele, MSc, ERT 11 October 2016 1 Responsible Practice Responsible practice can be divided in to 3 areas: Pre-market product

More information

TMA Annual Conference, Williamsburg, May 20-22, Public Health. The Swedish Experience

TMA Annual Conference, Williamsburg, May 20-22, Public Health. The Swedish Experience TMA Annual Conference, Williamsburg, May 20-22, 2012 Effects of Snus Use on Public Health The Swedish Experience Lars M. Ramström PhD Director, Institute for Tobacco Studies Stockholm, Sweden Email: lars.ramstrom@tobaccostudies.com

More information

Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the

Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the This document is scheduled to be published in the Federal Register on 05/15/2017 and available online at https://federalregister.gov/d/2017-09754, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN

More information

Low-Nitrosamine Dissolvable Tobacco Products Star Scientific, Inc. Part III Initiation and Cessation

Low-Nitrosamine Dissolvable Tobacco Products Star Scientific, Inc. Part III Initiation and Cessation Low-Nitrosamine Dissolvable Tobacco Products Star Scientific, Inc. Part III Initiation and Cessation Using science to reduce tobacco-related harm at every level of the population 1 Summary - Parts I &

More information

Toxic Contents and Emissions in Smokeless Tobacco Products

Toxic Contents and Emissions in Smokeless Tobacco Products Article 9 and 10 Toxic Contents and Emissions in Smokeless Tobacco Products www.untobaccocontrol.org/kh/smokeless-tobacco/ Article 9 and 10 Contents What is Article 9 & 10. Current Status Regarding Implementation

More information

AN UPDATE ON FDA S COMPREHENSIVE PLAN ON TOBACCO AND NICOTINE

AN UPDATE ON FDA S COMPREHENSIVE PLAN ON TOBACCO AND NICOTINE AN UPDATE ON FDA S COMPREHENSIVE PLAN ON TOBACCO AND NICOTINE Mitch Zeller, J.D. Director, FDA May 3, 2018 CENTER FOR TOBACCO PRODUCTS HOW CAN WE MAKE THE GREATEST IMPACT? We truly find ourselves at a

More information

Sample Evaluation Plan. Indicator 4.1.1

Sample Evaluation Plan. Indicator 4.1.1 Sample Evaluation Plan Indicator 4.1.1 Number of culturally and linguistically appropriate behavior modification-based tobacco cessation services that are available and well utilized in the community Objective:

More information

Providing a Science Base for the Evaluation of. Tobacco Products

Providing a Science Base for the Evaluation of. Tobacco Products Providing a Science Base for the Evaluation of Tobacco Products Peter G. Shields MD, Greg Connolly DMD,MPH, K. Michael Cummings PhD, Mirjana V. Djordjevic PhD, Dorothy K. Hatsukami PhD, Jack E. Henningfield

More information

Dissolvable Tobacco Products

Dissolvable Tobacco Products Dissolvable Tobacco Products James E. Dillard Senior Vice President, Regulatory Affairs Altria Client Services 1 l Altria Client Services (on behalf of PM USA and USSTC) I Presentation to the Tobacco Products

More information

E-Cigs, Etc.: Policy Options for Regulating Nicotine Delivery Devices. Indiana Local Boards of Health Webinar Feb. 12, 2015

E-Cigs, Etc.: Policy Options for Regulating Nicotine Delivery Devices. Indiana Local Boards of Health Webinar Feb. 12, 2015 E-Cigs, Etc.: Policy Options for Regulating Nicotine Delivery Devices Indiana Local Boards of Health Webinar Feb. 12, 2015 How to Use Webex If you can hear us through your computer, you do not need to

More information

ELEVEN REASONS WHY S IS BAD PUBLIC POLICY. Clinton Admin. FY00 budget request for FDA tobacco regulation was $34 million.

ELEVEN REASONS WHY S IS BAD PUBLIC POLICY. Clinton Admin. FY00 budget request for FDA tobacco regulation was $34 million. ELEVEN REASONS WHY S. 2461 IS BAD PUBLIC POLICY 1. Creates New Bureaucracy. Clinton Admin. FY00 budget request for FDA tobacco regulation was $34 million. S.2461 includes a tax increase of $300 million

More information

University of California San Francisco TCORS. Georgia State University 2. Stanford University. January 16, 2019

University of California San Francisco TCORS. Georgia State University 2. Stanford University. January 16, 2019 The revised Swedish Match modified risk tobacco product application for General Snus fails to provide evidence that the claim is not misleading and will have a beneficial effect on the population as a

More information

Sacramento City College Smoke/Tobacco/Vape (STV) Free Environmental Standard

Sacramento City College Smoke/Tobacco/Vape (STV) Free Environmental Standard Sacramento City College Smoke/Tobacco/Vape (STV) Free Environmental Standard In the interest of promoting a healthy learning and working environment for its students and employees, Sacramento City College

More information

BASIC SKILLS FOR WORKING WITH SMOKERS

BASIC SKILLS FOR WORKING WITH SMOKERS BASIC SKILLS FOR WORKING WITH SMOKERS Course Description Goals and Learning Objectives 55 Lave Ave No, Worcester, MA 01655 www.umassmed.edu/tobacco 2016 Basic Skills for Working with Smokers 1 Table of

More information

REGULATIONS OF THE PLYMOUTH BOARD OF HEALTH FOR TOBACCO SALES IN CERTAIN PLACES & SALE OF TOBACCO PRODUCTS TO MINORS

REGULATIONS OF THE PLYMOUTH BOARD OF HEALTH FOR TOBACCO SALES IN CERTAIN PLACES & SALE OF TOBACCO PRODUCTS TO MINORS REGULATIONS OF THE PLYMOUTH BOARD OF HEALTH FOR TOBACCO SALES IN CERTAIN PLACES & SALE OF TOBACCO PRODUCTS TO MINORS A. Statement of Purpose: Whereas there exists conclusive evidence that tobacco smoke

More information

Policy making at the American Chemical Society (ACS) - developing a statement on scientific integrity

Policy making at the American Chemical Society (ACS) - developing a statement on scientific integrity Policy making at the American Chemical Society (ACS) - developing a statement on scientific integrity Chris Proctor and Sarah Cooney CINF seminar, Boston, August 18, 2015 Overview Why scientific integrity

More information

The FDA s Premarket Review of Tobacco Products Fails to Fully Protect Public Health

The FDA s Premarket Review of Tobacco Products Fails to Fully Protect Public Health Premarket Review of Tobacco Products / 1 FDA$Tobacco$Project$ The FDA s Premarket Review of Tobacco Products Fails to Fully Protect Public Health The Family Smoking Prevention and Tobacco Control Act gives

More information

Should FDA try to move smokers to e-cigarettes or other less harmful tobacco-nicotine products and, if so, how?

Should FDA try to move smokers to e-cigarettes or other less harmful tobacco-nicotine products and, if so, how? Should FDA try to move smokers to e-cigarettes or other less harmful tobacco-nicotine products and, if so, how? Jeff Weiss General Counsel/EVP of Gov. Affairs of NJOY, LLC FDLI - October 20, 2017 FDA s

More information

HHS Public Access Author manuscript J Patient Cent Res Rev. Author manuscript; available in PMC 2016 February 04.

HHS Public Access Author manuscript J Patient Cent Res Rev. Author manuscript; available in PMC 2016 February 04. In adult smokers unwilling or unable to quit, does changing from tobacco cigarettes to electronic cigarettes decrease the incidence of negative health effects associated with smoking tobacco? A Clin-IQ

More information

Tobacco endgames in Australia

Tobacco endgames in Australia Tobacco endgames in Australia Coral Gartner and Wayne Hall University of Queensland SMOKING PREVALENCE IN AUSTRALIA 1945-2013 80 70 2.7M smokers aged 14+ in Australia in 2013 60 50 40 30 20 10 males females

More information

Smoking, e-cigs and reduced risk products. Dr John Schoonbee, IMS November 2017

Smoking, e-cigs and reduced risk products. Dr John Schoonbee, IMS November 2017 Smoking, e-cigs and reduced risk products Dr John Schoonbee, IMS November 2017 2 The storyline smoking is bad yet many folks still smoke because quitting is very hard is it better, if one cannot quit,

More information

Model Comprehensive Tobacco-Free School Policy

Model Comprehensive Tobacco-Free School Policy Model Comprehensive Tobacco-Free School Policy Findings a) Tobacco use is the single most preventable cause of death in the United States 1 b) The use of tobacco products by the nation s children is a

More information

Planning For The FDA s 'Deeming Rule' For E- Cigarettes

Planning For The FDA s 'Deeming Rule' For E- Cigarettes Law360, New York (September 21, 2015, 3:39 PM ET) -- The 2009 Family Smoking Prevention and Tobacco Control Act (TCA)[1] gave the U.S. Food and Drug Administration the authority to oversee the manufacture,

More information

Dissolvable Tobacco Products: Chemistry & Toxicology

Dissolvable Tobacco Products: Chemistry & Toxicology Dissolvable Tobacco Products: Chemistry & Toxicology Tobacco Products Scientific Advisory Committee July 21-22, 2011 Charles D. Garner, Ph.D., DABT, CIH Sr. Director, Regulatory Oversight Presentation

More information

The Family Smoking Prevention and Tobacco Control Act s Grant of Authority to the FDA and the Impact on the Grower

The Family Smoking Prevention and Tobacco Control Act s Grant of Authority to the FDA and the Impact on the Grower The Family Smoking Prevention and Tobacco Control Act s Grant of Authority to the FDA and the Impact on the Grower Victor L. Moldovan McGuireWoods, LLP The Act The Act governs all manufacturers and importers

More information

Centers for Disease Control and Prevention

Centers for Disease Control and Prevention This document is scheduled to be published in the Federal Register on 12/11/2018 and available online at https://federalregister.gov/d/2018-26708, and on govinfo.gov Billing Code: 4163-18-P DEPARTMENT

More information

TUPAC Five-Year Action Plan

TUPAC Five-Year Action Plan TUPAC Five-Year Action Plan 2015-2020 New Mexico Department of Health Tobacco Use Prevention and Control Program 5301 Central Avenue NE, Suite 800, Albuquerque, NM 87108 505.841.5845 nmtupac.com TUPAC

More information

ACHIEVING SMOKEFREE AOTEAROA BY2025

ACHIEVING SMOKEFREE AOTEAROA BY2025 ACHIEVING SMOKEFREE AOTEAROA BY2025 Monitoring and evaluation plan CONTENTS Acknowledgements 1 Introduction 2 Logic model 3 Sources of information 4 Monitoring progress towards the SFA 2025 goal 4 System

More information

BASIC SKILLS FOR WORKING WITH SMOKERS

BASIC SKILLS FOR WORKING WITH SMOKERS BASIC SKILLS FOR WORKING WITH SMOKERS Course Description Goals and Learning Objectives 368 Plantation Street, Worcester, MA 01605 www.umassmed.edu/tobacco 2018 Basic Skills for Working with Smokers 1 Table

More information

6/2/2015. Welcome to VAPE U! Module V: Legal Challenges in the E-Liquid Market

6/2/2015. Welcome to VAPE U! Module V: Legal Challenges in the E-Liquid Market Welcome to VAPE U! Module V: Legal Challenges in the E-Liquid Market 1 Your Instructor: Azim Chowdhury, Esq. Specialist in food, drug, tobacco & e-vapor law. Spearheaded the FDA Tobacco and Electronic

More information

Challenges and Opportunities: Implementing the Tobacco Control Act

Challenges and Opportunities: Implementing the Tobacco Control Act Challenges and Opportunities: Implementing the Tobacco Control Act Lawrence R. Deyton, M.S.P.H., M.D. Director, Center for Tobacco Products April 5, 2011 1 To make tobaccorelated death and disease part

More information

Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry

Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding

More information

Rationale for Establishing Tobacco Product Regulation

Rationale for Establishing Tobacco Product Regulation Rationale for Establishing Tobacco Product Regulation Erik Dybing, MD, PhD Conference of the Parties Technical Briefing Geneva, 7 February 2006 WHO Strategy for Tobacco Control Preventing uptake of tobacco

More information

16851 Mount Wolfe Road Caledon ON L7E 3P or 1 (855)

16851 Mount Wolfe Road Caledon ON L7E 3P or 1 (855) 2 Copyright 2015, Canadian Network for Respiratory Care 16851 Mount Wolfe Road Caledon ON L7E 3P6 905 880-1092 or 1 (855) 355-4672 www.cnrchome.net www.cnrchome.net Contents 1 Health Promotion and Tobacco

More information

How Might Medicinal Regulators Evolve in their Expectations for ENDS? David M Graham Chief Impact Officer - NJOY

How Might Medicinal Regulators Evolve in their Expectations for ENDS? David M Graham Chief Impact Officer - NJOY How Might Medicinal Regulators Evolve in their Expectations for ENDS? David M Graham Chief Impact Officer - NJOY 4 Years Ago The Regulation of Nicotine-Containing Products Jeremy Mean 2015 The fact that

More information

SPIT TOBACCO & SPITLESS TOBACCO

SPIT TOBACCO & SPITLESS TOBACCO SPIT TOBACCO & SPITLESS TOBACCO Spit tobacco (often called smokeless by the tobacco industry) is being marketed as a safe alternative to smoking, but SMOKELESS IS NOT HARMLESS! Spit Tobacco Chewing tobacco

More information

BEST PRACTICE CHANGE CONTROL : DECIDING WHEN TO SUBMIT A 510(K) FOR A DEVICE CHANGE. Yuan Xu 18- JAN- 2018

BEST PRACTICE CHANGE CONTROL : DECIDING WHEN TO SUBMIT A 510(K) FOR A DEVICE CHANGE. Yuan Xu 18- JAN- 2018 BEST PRACTICE CHANGE CONTROL : DECIDING WHEN TO SUBMIT A 510(K) FOR A DEVICE CHANGE Yuan Xu 18- JAN- 2018 Background AGENDA What is Medical Device? What is 510(k)? Principles of best practices of device

More information

SMOKELESS TOBACCO IN THE CONTEXT OF TOBACCO HARM REDUCTION

SMOKELESS TOBACCO IN THE CONTEXT OF TOBACCO HARM REDUCTION SMOKELESS TOBACCO IN THE CONTEXT OF TOBACCO HARM REDUCTION U.S. Smokeless Tobacco Company Presentation to LSRO Reduced Risk Review Project Core Committee Meeting July 14, 2005 1 Introduction Presentation

More information

The gateway theory. Pr Jean-François ETTER PhD (political science) E-cigarette Summit London, November 17, Competing interests: none

The gateway theory. Pr Jean-François ETTER PhD (political science) E-cigarette Summit London, November 17, Competing interests: none The gateway theory Pr Jean-François ETTER PhD (political science) E-cigarette Summit London, November 17, 2016 Competing interests: none Enormous political influence Since 1970s: used to support the idea

More information

FDLI Tobacco Products Regulation and Policy Conference Joe Murillo Vice President, Regulatory Affairs October 27, 2017

FDLI Tobacco Products Regulation and Policy Conference Joe Murillo Vice President, Regulatory Affairs October 27, 2017 FDLI Tobacco Products Regulation and Policy Conference Joe Murillo Vice President, Regulatory Affairs October 27, 2017 Altria Client Services Vice President, Regulatory Affairs FDLI Presentation Oct. 27,

More information

consistent with the industry documents we note in our September letter.

consistent with the industry documents we note in our September letter. February 18, 2010 Division of Dockets Management (HFA-305) Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane, Room 1061 Rockville, MD 20852 RE: Docket Number FDA-2010-N-0020

More information

Components of a Successful Policy

Components of a Successful Policy Components of a Successful Policy 1. Include the rationale for developing and implementing the policy Include the reasons for having a policy: health effects of tobacco (first-hand and secondhand smoke),

More information

510(k) submissions. Getting US FDA clearance for your device: Improving

510(k) submissions. Getting US FDA clearance for your device: Improving Getting US FDA clearance for your device: Improving 510(k) submissions Audrey Swearingen, RAC Director, Regulatory Affairs Telephone: +1 512.222.0263 Email: aswearingen@emergogroup.com Download this white

More information

Study Summary Study THS-PBA-02-US

Study Summary Study THS-PBA-02-US Page 1 Study Summary Study THS-PBA-02-US Study Title: Sponsor: Qualitative Study to Develop THS 2.2 Hypothetical Product Messages Philip Morris International Management S.A. Avenue de Rhodanie, 50 1007

More information

PUBLIC CONSULTATION DOCUMENT

PUBLIC CONSULTATION DOCUMENT EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate C Public Health and Risk Assessment POSSIBLE REVISION OF THE TOBACCO PRODUCTS DIRECTIVE 2001/37/EC PUBLIC CONSULTATION DOCUMENT

More information

In Vitro Diagnostic Testing for Direct Oral Anticoagulants- Premarket Review

In Vitro Diagnostic Testing for Direct Oral Anticoagulants- Premarket Review In Vitro Diagnostic Testing for Direct Oral Anticoagulants- Premarket Review Cardiac Safety Research Consortium December 3, 2015 Lea Carrington Division of Immunology and Hematology Devices Office of In

More information

Welcome to TMA s 97. Annual Meeting & Conference

Welcome to TMA s 97. Annual Meeting & Conference Welcome to TMA s 97 th Annual Meeting & Conference May 20-22 22, 2012 Williamsburg, Virginia Farrell Delman President Tobacco Merchants Association Williamsburg VII Evidence-Based Science & Regulation

More information

Overview of Regulatory Science of Food Contact Substances

Overview of Regulatory Science of Food Contact Substances Overview of Regulatory Science of Food Contact Substances Michael A. Adams, PhD Deputy Director, Office of Food Additive Safety FDA, Center for Food Safety and Applied Nutrition 5001 Campus Drive, College

More information

Quality ID #404: Anesthesiology Smoking Abstinence National Quality Strategy Domain: Effective Clinical Care

Quality ID #404: Anesthesiology Smoking Abstinence National Quality Strategy Domain: Effective Clinical Care Quality ID #404: Anesthesiology Smoking Abstinence National Quality Strategy Domain: Effective Clinical Care 2018 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY MEASURE TYPE: Intermediate Outcome DESCRIPTION:

More information

POSSIBLE REVISION OF THE TOBACCO PRODUCTS DIRECTIVE 2001/37/EC PUBLIC CONSULTATION DOCUMENT

POSSIBLE REVISION OF THE TOBACCO PRODUCTS DIRECTIVE 2001/37/EC PUBLIC CONSULTATION DOCUMENT POSSIBLE REVISION OF THE TOBACCO PRODUCTS DIRECTIVE 2001/37/EC DG SANCO 2010 PUBLIC CONSULTATION DOCUMENT Answer given by the General Direction of Public Health of the Spanish Ministry of Health and Social

More information

Tobacco Surveillance in the United States

Tobacco Surveillance in the United States Tobacco Surveillance in the United States Gary Giovino Roswell Park Cancer Institute National Conference on Tobacco OR Health San Francisco, California November 20, 2002 Outline of Presentation Public

More information

E-Cigarettes: Current Perspective

E-Cigarettes: Current Perspective E-Cigarettes: Current Perspective Aruni Bhatnagar, Ph.D. Professor of Medicine University of Louisville Louisville, KY Electronic Cigarettes E-cigarettes are electronic nicotine delivery systems (ENDS),

More information

The Effects of Smoking. Best tip: DONT START

The Effects of Smoking. Best tip: DONT START The Effects of Smoking Best tip: DONT START Why do people start? Feel older Feel cool Feel different Peer pressure Fit in Fun Media: advertising, TV, movies, music Friends / family Relieve stress / relax

More information

2. No person shall, at any time, possess, distribute or use any alcohol product or illegal substance in any area defined in Section A.1.

2. No person shall, at any time, possess, distribute or use any alcohol product or illegal substance in any area defined in Section A.1. GOVERNANCE SUBSTANCE ABUSE AND TOBACCO CONTROL A. APPLICATION: 1. These regulations apply to any person present in or upon any property owned, leased or operated by the West Virginia Department of Education,

More information

Measure #404: Anesthesiology Smoking Abstinence National Quality Strategy Domain: Effective Clinical Care

Measure #404: Anesthesiology Smoking Abstinence National Quality Strategy Domain: Effective Clinical Care Measure #404: Anesthesiology Smoking Abstinence National Quality Strategy Domain: Effective Clinical Care 2017 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY MEASURE TYPE: Intermediate Outcome DESCRIPTION:

More information

THE STATE OF TOBACCO CONTROL LAW & POLICY THE NATIONAL LANDSCAPE OF FEDERAL, STATE AND LOCAL REGULATION

THE STATE OF TOBACCO CONTROL LAW & POLICY THE NATIONAL LANDSCAPE OF FEDERAL, STATE AND LOCAL REGULATION THE STATE OF TOBACCO CONTROL LAW & POLICY THE NATIONAL LANDSCAPE OF FEDERAL, STATE AND LOCAL REGULATION 1 THE PUBLIC HEALTH LAW CENTER 2 ROADMAP Brief history of tobacco control law and policy Evolution

More information

Electronic Cigarettes, Nicotine and Policy Implications

Electronic Cigarettes, Nicotine and Policy Implications Electronic Cigarettes, Nicotine and Policy Implications Neal L Benowitz MD University of California San Francisco The E-Cigarette Summit The Royal Society London November 17, 2016 Disclosures Dr Benowitz

More information

A Coach s Guide to Spit Tobacco Education

A Coach s Guide to Spit Tobacco Education OUTLINE Goal Coaches, players and parents will understand that spit tobacco can lead to use of cigarettes, increases the chances of experimentation with other substances and other unhealthy choices. Objectives

More information