YOUTH ENGAGEMENT AND THE TOBACCO CONTROL...
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YOUTH ENGAGEMENT AND THE TOBACCO CONTROL ACT Stacey Gagosian MAY 21, 2015
Transcript of YOUTH ENGAGEMENT AND THE TOBACCO CONTROL...
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
open process where the public has
opportunity 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
open process where the public has
opportunity 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 order 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
opinions, 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
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
