Update on the Family Smoking Prevention and Tobacco Control Act Mike Freiberg & Joelle Lester National Association of Chronic Disease Directors General.

Slides:

Advertisements

Similar presentations

Foundations of Regulation

Advertisements

SUCCESSFUL SUMMER STRATEGIES SPRING 2009 Federal and State Administrative Research.

FDA’s Proposed Rule under FSMA for Preventive Controls

The Importance of Transparency in Regulatory Reform WTO Committee on Technical Barriers to Trade, Workshop on Good Regulatory Practice Panel on Internal.

COLLECTION HOT TOPICS WV HMFA Winter Educational Conference January 15, 2015.

Conference for FOOD PROTECTION Promoting Food Safety Through Collaboration.

11 FDA Regulation of Menthol in Tobacco Products Patricia Kovacevic Director, Regulatory Affairs & Associate General Counsel Director, Regulatory Affairs.

Recent Initiatives to Control Contraband: US & NY 2nd Bi-National Conference on Contraband Micah Berman, J.D. Director, Center for Public Health and Tobacco.

{ Emerging Best Practices for Future Collaboration in preventing Tobacco related disease Linn County Communities Putting Prevention to Work Jill Roeder,

© 2005 Notification and Reporting on Food Incidents: Irish Approach Food & Drugs Authority Bangkok Thailand Dorothy Guina-Dornan.

Recently Issued OHRP Documents: Guidance on Subject Withdrawal and Draft Revised FWA Secretary’s Advisory Committee on Human Research Protections October.

Federal Aviation Administration Commercial Space Transportation Human Space Flight Occupant Safety Telecon Telecon 7 – Medical Guidance for Crew & Spaceflight.

Introduction to Regulation

FDA Tobacco Regulations. During the 90’s  1998 Master Settlement Agreement  Tobacco companies charged.

1 Compliance Training for Retailers Required Warnings for Cigarette Advertising & Packaging July 26, 2011 Ele Ibarra-Pratt, R.N., MPH Group Leader, Promotion,

1 Compliance Training for Small Tobacco Manufacturers Required Warnings for Cigarette Packaging & Advertising Final Rule 21 CFR 1141 July 26, 2011 Ann.

WT North America Conference

 2011 Johns Hopkins Bloomberg School of Public Health Regulation of Tobacco Products Mitch Zeller, JD Pinney Associates.

Proposed Rule to Protect Food Against Intentional Adulteration 1.

© 2004 West Legal Studies in Business A Division of Thomson Learning 1 Chapter 43 Administrative Law Chapter 43 Administrative Law.

William H. Foster Assistant Administrator, Headquarters Operations October 27, 2008 NABCA Administrators Conference Product Labeling and Packaging.

DRAFT Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing Denise Sánchez, J.D.,

© 2004 West Legal Studies in Business A Division of Thomson Learning BUSINESS LAW Twomey Jennings 1 st Ed. Twomey & Jennings BUSINESS LAW Chapter 6 Administrative.

FDA’s Center for Tobacco Products Overview of FDA’s Authority and Current Enforcement Activities July 25, 2012.

The Board’s Fiduciary Role Presenter Insert Name Insert Organization.

Public Health Impact Smoking causes more than 440,000 deaths per year in the United States Each day over 3,800 youth under 18 smoke their first cigarette.

Rules of Operation – Legal Limitations & Options Leslie Zellers, J.D. Technical Assistance Legal Center (TALC) ;

EU Food/Feed Safety Rules Industry Information Session June 16, 2005 Presented by AAFC.

Earmark Grants: Background Information and the Award Process.

HHS Policy on the Use of Federal Funds Michele S. Walsh, M.Ed., CHES Associate Director for Policy and Communication Division of Population Health National.

Latham & Watkins operates as a limited liability partnership worldwide with affiliated limited liability partnerships conducting the practice in the United.

Affordable Care Act Family Smoking Prevention and Tobacco Control Act Taking it to the Streets Optional content goes here. Delete box if not using. Janet.

The New FDA Law: A Green Light for Local Policies?

1 National Partners Webinar Updates from the Center for Tobacco Products Lawrence R. Deyton, M.S.P.H., M.D. Director, Center for Tobacco Products Ann Simoneau,

Towards an Industry Advisory Group An Open Round-Table Conversation 19 May 2009 Do not copy or reproduce without express written permission of Foresight.

LAW OF COMPUTER TECHNOLOGY FALL 2015 © 2015 MICHAEL I. SHAMOS Regulatory Law Michael I. Shamos, Ph.D., J.D. Institute for Software Research School of.

Overview of FDA's Regulatory Framework for PET Drugs

Analysis of FDA Draft Guidance on Direct-to-Consumer (DTC) Advertising Pharma Congress 2004 National Audio conference March 23, 2004 Michael Misocky, R.Ph.,

Administrative Law The Enactment of Rules and Regulations.

Chapter 6: Administrative Agencies

FDA Regulation of Tobacco Washington, DC October 21, 2015 The Impact of MRTP – A look at the MRTP process, and the impact on products Denny Henigan, Director,

Agricultural Marketing Service USDA Oversight of Beef Checkoff Program Agricultural Marketing Service.

Enforcement Litigation and Compliance Washington, DC December 9-10, 2015 Compliance Central with FDA Center Compliance Directors (Part I) Michael Roosevelt,

ACS Primary Authority Assured Advice James Lowman.

Changes to Contested Case Hearing Requirements and Procedures Janis Hudson Environmental Law Division Texas Commission on Environmental Quality Advanced.

FDA Regulation: The Impact on Product Development and Reporting Monica Graves Director – Marketing Operations Oversight RAI Services Company May 18, 2009.

Rulemaking by APHIS. What is a rule and when must APHIS conduct rulemaking? Under U.S. law, a rule is any requirement of general applicability and future.

CIPA (Children’s Internet Protection Act) Helping You Succeed Schools and Libraries Division Washington, DC Newark Atlanta Chicago Orlando.

November 17, Reena Raman, Esq. Associate Kleinfeld Kaplan & Becker LLP Washington, DC

Special Meeting on Procedures for Information Exchange November 7, 2007 Geneva Session 1 Anne Meininger United States USA WTO TBT Enquiry Point.

DEPARTMENT OF HEALTH CENTER FOR BIOLOGICS AND HUMAN SERVICESEVALUATION and RESEARCH AND HUMAN SERVICES EVALUATION and RESEARCH Update on OCTGT Guidance.

Federal Energy Regulatory Commission 1 Overview of the Federal Energy Regulatory Commission (FERC) Roland W. Wentworth Office of Markets, Tariffs and Rates.

Chapter 6 Administrative Agencies Twomey, Business Law and the Regulatory Environment (14th Ed.)

Making Comments Count for High-Impact Regulations and Guidelines in the US Virginia (Ginny) Beakes-Read Executive Director, Global Regulatory Policy and.

Biotech Regulations Modified by Georgia Agricultural Education Curriculum Office June, 2002.

Guidance Development Merton V. Smith, Ph.D., J.D. Director International Programs and Product Standards Center for Veterinary Medicine, FDA.

The American Experience in Regulatory Review and Reform Dominic J. Mancini, PhD. Office of Information and Regulatory Affairs U.S. Office of Management.

1 Changes to Regulations Governing Personal Conflicts of Interest and Organizational Conflicts of Interest Breakout Session # C08 Name: Barbara S. Kinosky,

Denise Chrysler, JD Director, Mid-States Region

NRC’s 10 CFR Part 37 Program Review of Radioactive Source Security

Food Additives Project

Modified by Georgia Agricultural Education Curriculum Office

U.S. WTO TBT Enquiry Point

HOW TO FULFILL STATUTORY REQUIREMENTS ON PRODUCT RELATED HEALTH INFORMATION Samina Qureshi, M.D. PSI INTERNATIONAL Inc.

The Rulemaking Process

Essentials of the legal environment today, 5e

MIPC Proposal – <INSERT TITLE> for <INSERT INDUSTRY>

DATA DISASTER RECOVERY PLAN

SaaS DISASTER RECOVERY PLAN

IT DISASTER RECOVERY PLAN

Presentation transcript:

Update on the Family Smoking Prevention and Tobacco Control Act Mike Freiberg & Joelle Lester National Association of Chronic Disease Directors General Members Call May 24, 2012

Agenda 1.Introduction to the Consortium 2.Overview of the Tobacco Control Act 3.Role of Tobacco Control Advocates 4.Engaging with the FDA 5.Legal Challenges to the Law

The Tobacco Control Legal Consortium The legal network for tobacco control policy.

What the law does 1.Requires tobacco industry to disclose information to government

What the law does 1.Requires tobacco industry to disclose information to government 2.Restricts tobacco marketing

What the law does 1.Requires tobacco industry to disclose information to government 2.Restricts tobacco marketing 3.Strengthens restrictions on sales to youth

What the law does 1.Requires tobacco industry to disclose information to government 2.Restricts tobacco marketing 3.Strengthens restrictions on sales to youth 4.More accurately informs consumers

What the law does 1.Requires tobacco industry to disclose information to government 2.Restricts tobacco marketing 3.Strengthens restrictions on sales to youth 4.More accurately informs consumers 5.Regulates the contents of the products

What the law does 1.Requires tobacco industry to disclose information to government 2.Restricts tobacco marketing 3.Strengthens restrictions on sales to youth 4.More accurately informs consumers 5.Regulates the contents of the products 6.Articulates balance with state authority

Role of Tobacco Control Advocates 1.Report Violations

Role of Tobacco Control Advocates 1.Report Violations CTP-1373 For General Inquiries: For flavored smokeless and cigars: Mail reports (photos accepted) to: FDA Center for Tobacco Products 9200 Corporate Boulevard Rockville, MD

Role of Tobacco Control Advocates 1.Report Violations 2.State and Local Ordinances

Role of Tobacco Control Advocates 1.Report Violations 2.State and Local Ordinances 3.Submit Comments to the FDA

What is Rulemaking? Method by which agencies create federal laws Many requirements to process, including public comment Mandated by Congress vs. Initiated by Agency Steps to Process: Notice -> Comments -> Final Rule

Guidance Documents Do not carry the weight of law. Represent FDA’s current thinking on a topic. Used by FDA as intermediary step before enacting certain regulations

Commenting ≠ Lobbying Commenting on proposed regulations is probably not lobbying under federal law. “The term ‘lobbying contact’ does not include a communication that is … made in response to a notice in the Federal Register … soliciting communications from the public and directed to the agency official specifically designated in the notice to receive such communications …” Lobbying Disclosure Act of 1995, 2 U.S.C. § 1602(8)(B)(x) Each organization must consider its own limitations based on its legal structure, funding sources and relevant law.

What kind of information will help the FDA?

How do I submit comments?

How detailed should my comments be?

How are my comments used? Agency addresses comments Substantially similar rule goes into effect Significantly changed rules require further comments.

Current Open Dockets 1.Draft guidance document on harmful and potentially harmful constituents (HPHC) 2.Draft guidance document on modified risk tobacco products (MRTP) Deadline for both: June 4, 2012

Legal Challenges to Rules Successful legal challenges must show that: –The rule is arbitrary and capricious or unsupported by the record –The rule exceeds statutory authority, or –The rule is a “bolt out of the blue”

Legal Challenges to the Law 1.Discount Tobacco City v. FDA

Legal Challenges to the Law 1.Discount Tobacco City v. FDA 2.R.J. Reynolds Tobacco Company v. FDA [graphic warning labels]

Legal Challenges to the Law 1.Discount Tobacco City v. FDA 2.R.J. Reynolds Tobacco Company v. FDA [graphic warning labels] 3.BBK Tobacco & Foods v. FDA [flavored rolling papers]

Legal Challenges to the Law 1.Discount Tobacco City v. FDA 2.R.J. Reynolds Tobacco Company v. FDA [graphic warning labels] 3.BBK Tobacco & Foods v. FDA [flavored rolling papers] 4.Lorillard v. FDA [TPSAC membership]

Consortium Resources on Tobacco Regulation Presentations  Conferences  Webinars Publications Website action center alerts

FDA Tobacco Action Center

Questions? Contact us: (651) (651)