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

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

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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

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YOUTH ENGAGEMENT AND THE TOBACCO CONTROL ACT

Stacey Gagosian MAY 21, 2015

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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

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ADVOCACY IN THE RULEMAKING PROCESS

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ADVOCACY IN THE RULEMAKING PROCESS

  • Rules can affect people’s daily

lives more than laws do

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ADVOCACY IN THE RULEMAKING PROCESS

  • Rules can affect people’s daily lives

more than laws do

  • The rulemaking process should be an
  • pen process where the public has
  • pportunity to participate
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ADVOCACY IN THE RULEMAKING PROCESS

  • Rules can affect people’s daily lives

more than laws do

  • The rulemaking process should be an
  • pen process where the public has
  • pportunity to participate
  • It is critical for advocates to be involved in

the rulemaking process

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TOBACCO CONTROL VS. TOBACCO REGULATION

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ROLE OF FDA

Public Health Industry

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THE TOBACCO CONTROL ACT

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PRODUCTS CURRENTLY REGULATED BY FDA

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BEFORE AND AFTER 2009

BEFORE AFTER

  • Ingredients not reported
  • Products entered the

market whenever Industry wanted

  • Products marketed with

reduced risk claims like “light” or “low tar”

  • Ingredients reported to

FDA

  • New products can’t enter

the market without an

  • rder from FDA
  • Modified Risk claims

cannot be made without an order from FDA

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FSPTCA PROVIDED FDA A ROADMAP

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FSPTCA PROVIDED FDA A ROADMAP

August 2009 CTP Established Sept 2009 Flavored cigarettes banned March 2010 TPSAC Established June 22, 2010

  • List of ingredients required
  • Final Rule goes into effect
  • Warning labels for smokeless
  • Ban on “light”, “low”, and “mild”

Sept 2010 Enforcement plan and first round of State enforcement contracts issued Nov 2010 Issued Proposed Rule on Graphic Cigarette Warning labels March 2011 TPSAC Submits Menthol Report March 2012 TPSAC Submits Dissolvable Tobacco Report April 2012 Modified Risk Guidance issued; Harmful and Potentially Harmful constituents April 2013 HPHC regulations issued; reports to Congress Submitted July 2009 – User fees collected June 22, 2009 Becomes law; state ad restrictions removed

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FLAVORED CIGARETTES BANNED –

  • SEPT. 2009
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LIST OF INGREDIENTS REPORTED TO CTP

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SMOKELESS WARNING LABELS

BEFORE AFTER

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“LIGHT”/ “LOW TAR” PROHIBITION

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FINAL RULE

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COMPLIANCE CHECK INSPECTIONS

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MENTHOL

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

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MENTHOL

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GRAPHIC WARNING LABELS

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ARRIVED AT YOUR DESTINATION??

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ARE WE THERE YET?

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ARE WE THERE YET?

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OFF THE MAP

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FDA AUTHORITY: PROPOSED DEEMING REG

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PROVISIONS OF DEEMING PROPOSAL

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PROVISIONS OF DEEMING PROPOSAL

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PROVISIONS OF DEEMING REG

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THINGS NOT COVERED BY THE DEEMING PROPOSAL

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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

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STATE AND LOCAL ACTIONS

  • Smoke-free ordinances
  • Public education campaigns
  • State or Local excise taxes
  • Cessation programs
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OPPORTUNITIES FOR ADVOCACY IN THE REGULATORY PROCESS

Prelude

may include:

  • Solicit Public Input
  • Scientific Advisory

Committee, in this case, Tobacco Products Scientific Advisory Committee (TPSAC)

  • ANPRM
  • Petitions
  • Meetings &

workshops

Drafting

  • Considerations &

Consultation

  • Required analysis
  • OMB Review

Proposal

may include:

  • Publish in Federal

Register

  • Public Comment –

written &/or possibly a hearing

  • FDA considers all

comments

  • Considerations &

Consultation

  • Required analysis
  • Revise
  • OMB review

Final Rule

  • Publish in Federal

Register

  • Effective Date
  • Implementation
  • Potential litigation

RED text indicates key opportunities for citizen engagement

Graphic source: American Lung Association Presentation 2009

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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
  • pinions, but they need to be backed up

with facts

  • Follow instructions from agency
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WHAT TO INCLUDE IN COMMENTS

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WHAT TO INCLUDE IN COMMENTS

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WHAT TO INCLUDE IN COMMENTS

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MODIFIED RISK PROVISIONS

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CAMEL WHITES

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CAMEL WHITES

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PRESS/OP-EDS

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

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THANK YOU

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GENERIC RULEMAKING PROCESS

Congress Passes a Law Agency writes implementation regulation 90 day OMB Review Notice of Proposed Rulemaking (NPRM)

90 day public comment period

Agency analyses comments and reissues regulation 90 day OMB Review Final Rule (Major Rules must sit for 60 days) Possible: Congressional Action or Lawsuits

Source: James C. Capretta for the “Understanding the Regulatory Process” course by Capitol.net