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

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

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