YOUTH ENGAGEMENT AND THE TOBACCO CONTROL ACT Stacey Gagosian MAY - PowerPoint PPT Presentation

YOUTH ENGAGEMENT AND THE TOBACCO CONTROL ACT Stacey Gagosian MAY 21, 2015

PRESENTATION OVERVIEW • Role of Activists in the Regulatory Process • Overview of Family Smoking Prevention and Tobacco Control Act • Overview of Deeming Regulation • How to Get Involved in the Regulatory Process 2

ADVOCACY IN THE RULEMAKING PROCESS 3

ADVOCACY IN THE RULEMAKING PROCESS •Rules can affect people’s daily lives more than laws do 4

ADVOCACY IN THE RULEMAKING PROCESS •Rules can affect people’s daily lives more than laws do • The rulemaking process should be an open process where the public has opportunity to participate 5

ADVOCACY IN THE RULEMAKING PROCESS •Rules can affect people’s daily lives more than laws do • The rulemaking process should be an open process where the public has opportunity to participate • It is critical for advocates to be involved in the rulemaking process 6

TOBACCO CONTROL VS. TOBACCO REGULATION 7

ROLE OF FDA Industry Public Health 8

THE TOBACCO CONTROL ACT 9

PRODUCTS CURRENTLY REGULATED BY FDA 10

BEFORE AND AFTER 2009 AFTER BEFORE • Ingredients not reported • Ingredients reported to FDA • Products entered the • New products can’t enter market whenever the market without an Industry wanted order from FDA • Products marketed with • Modified Risk claims reduced risk claims like cannot be made without “light” or “low tar” an order from FDA 11

FSPTCA PROVIDED FDA A ROADMAP 12

FSPTCA PROVIDED FDA A ROADMAP June 22, 2009 Becomes law; July 2009 – User fees state ad restrictions removed collected August 2009 CTP Sept 2009 Flavored cigarettes Established banned March 2010 TPSAC June 22, 2010 Established - List of ingredients required - Final Rule goes into effect Sept 2010 Enforcement plan and - Warning labels for smokeless first round of State enforcement - Ban on “light”, “low”, and “mild” contracts issued Nov 2010 Issued Proposed Rule on Graphic Cigarette Warning labels March 2011 TPSAC Submits Menthol Report March 2012 TPSAC Submits April 2012 Modified Risk Dissolvable Tobacco Report Guidance issued; Harmful and Potentially Harmful constituents April 2013 HPHC regulations issued; reports to Congress Submitted 13

FLAVORED CIGARETTES BANNED – SEPT. 2009 14

LIST OF INGREDIENTS REPORTED TO CTP 15

SMOKELESS WARNING LABELS AFTER BEFORE 16

“LIGHT”/ “LOW TAR” PROHIBITION 17

FINAL RULE 18

COMPLIANCE CHECK INSPECTIONS 19

MENTHOL “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.” 20

MENTHOL 21

GRAPHIC WARNING LABELS 22

ARRIVED AT YOUR DESTINATION?? 23

ARE WE THERE YET? 24

ARE WE THERE YET? 25

OFF THE MAP 26

FDA AUTHORITY: PROPOSED DEEMING REG 27

PROVISIONS OF DEEMING PROPOSAL 28

PROVISIONS OF DEEMING PROPOSAL 29

PROVISIONS OF DEEMING REG 30

THINGS NOT COVERED BY THE DEEMING PROPOSAL 31

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STATE AND LOCAL ACTIONS • Licensing retailers to sell tobacco products • Restricting where tobacco advertisements may be placed in a store • Prohibiting pharmacies or other types of stores from selling tobacco • Requiring all products (not just cigarettes and smokeless products) to be behind the counter 33

STATE AND LOCAL ACTIONS • Smoke-free ordinances • Public education campaigns • State or Local excise taxes • Cessation programs 34

OPPORTUNITIES FOR ADVOCACY IN THE REGULATORY PROCESS Final Prelude Proposal Drafting Rule may include: may include: • Solicit Public Input • Considerations & • Publish in Federal • Publish in Federal Consultation Register Register • Scientific Advisory Committee, in this • Required analysis • Public Comment – • Effective Date case, Tobacco written &/or • OMB Review • Implementation Products Scientific possibly a hearing • Potential litigation Advisory Committee • FDA considers all (TPSAC) comments • ANPRM • Considerations & • Petitions Consultation • Meetings & • Required analysis workshops • Revise • OMB review RED text indicates key opportunities Graphic source: American Lung for citizen engagement Association Presentation 2009 35

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WHAT TO INCLUDE IN COMMENTS • Fact based ◦ Does not have to be peer-reviewed • New scientific findings • Experiences from the field • Simple Opinion is not as helpful ◦ Comments can certainly express opinions, but they need to be backed up with facts • Follow instructions from agency 37

WHAT TO INCLUDE IN COMMENTS 38

WHAT TO INCLUDE IN COMMENTS 39

WHAT TO INCLUDE IN COMMENTS 40

MODIFIED RISK PROVISIONS 41

CAMEL WHITES 42

CAMEL WHITES 43

PRESS/OP-EDS 44

Contact information - Stacey Gagosian 202-454-5774; sgagosian@legacyforhealth.org 45

THANK YOU

GENERIC RULEMAKING PROCESS Agency writes Congress Passes a implementation 90 day OMB Review Law regulation 90 day public Agency analyses Notice of Proposed comment comments and Rulemaking (NPRM) reissues regulation period Final Rule (Major Possible: 90 day OMB Review Rules must sit for Congressional 60 days) Action or Lawsuits Source: James C. Capretta for the “Understanding the 47 Regulatory Process” course by Capitol.net