from congress to california communities: the … · from congress to california communities: the...

From Congress to California Communities: The Federal Tobacco Control Act

March 2012 

 Agenda The Tobacco Control Act: what it regulates, how it’s being enforced Ann Simoneau, Center for Tobacco Products, FDA

 Agenda The Tobacco Control Act: what it regulates, how it’s being enforced Ann Simoneau, Center for Tobacco Products, FDA

Legal challenges to the Act Elisa Laird-Metke, PHLP

 Agenda The Tobacco Control Act: what it regulates, how it’s being enforced Ann Simoneau, Center for Tobacco Products, FDA

Legal challenges to the Act Elisa Laird-Metke, PHLP

Creating new local laws Vanessa Marvin, The Center

 Agenda The Tobacco Control Act: what it regulates, how it’s being enforced Ann Simoneau, Center for Tobacco Products, FDA

Legal challenges to the Act Elisa Laird-Metke, PHLP

Creating new local laws Vanessa Marvin, The Center

Anne Pearson, Seattle-King County

 Agenda The Tobacco Control Act: what it regulates, how it’s being enforced Ann Simoneau, Center for Tobacco Products, FDA

Legal challenges to the Act Elisa Laird-Metke, PHLP

Creating new local laws Vanessa Marvin, The Center

Anne Pearson, Seattle-King County

Janie Burkhart, Santa Clara County

Presenters

Leslie Zellers Director of Programs Public Health Law & Policy

Ann Simoneau Director

Office of Compliance and Enforcement Center for Tobacco Products

U.S. Food and Drug Administration

Presenters

Vanessa Marvin Director

Center for Tobacco Policy and Organizing

Elisa Laird-Metke Staff Attorney Public Health Law & Policy

Presenters

Anne Pearson Policy Advisor Seattle – King County Department of Public Health

Janie Burkhart Tobacco Programs Manager

Santa Clara County Public Health Chronic Disease and Injury Prevention

Tobacco Control Act: Regulation and Enforcement

Speaking: Ann Simoneau, Director Office of Compliance and Enforcement Center for Tobacco Products U.S. Food and Drug Administration

Tobacco Control Act: Legal Challenges

Elisa Laird-Metke Staff Attorney

Public Health Law & Policy

1. Marketing • Sampling • Sponsorship • Black and white ads 

FDA Authority

1. Marketing • Sampling • Sponsorship • Black and white ads 

 2. Youth access  • No sales to minors • Vending machine restrictions • No self service displays 

FDA Authority

3.  Tobacco product standards • No flavored cigarettes • Ingredient lists provided to FDA • FDA review of new/modified products  

FDA Authority

3.  Tobacco product standards • No flavored cigarettes • Ingredient lists provided to FDA • FDA review of new/modified products  

4.  More accurate information for consumers  • New warning labels • No “light” “low” “mild” 

FDA Authority

FDA Authority Covered:    

Not Covered:    

FDA Authority Covered:    

Not Covered:    

FDA may create additional regulations   

FDA Authority

FDA may create additional regulations  Example: Created graphic warning labels 

FDA Authority

Two lawsuits challenge federal restrictions:

Legal Challenges

Two lawsuits challenge federal restrictions: 1. Challenge to 11 provisions of the Tobacco

Control Act

Legal Challenges

Two lawsuits challenge federal restrictions: 1. Challenge to 11 provisions of the Tobacco

Control Act

2. Challenge to the FDA’s regulation specifying what the new graphic warning labels look like

Legal Challenges

First Lawsuit challenges 11 provisions of the Act: 1. Tombstone advertising requirements

Legal Challenges

First Lawsuit challenges 11 provisions of the Act: 1. Tombstone advertising requirements 2. Ban on saying tobacco is “approved by the FDA”

Legal Challenges

First Lawsuit challenges 11 provisions of the Act: 1. Tombstone advertising requirements 2. Ban on saying tobacco is “approved by the FDA”

3. Ban on outdoor advertising (not yet enacted)

Legal Challenges

First Lawsuit challenges 11 provisions of the Act: 1. Tombstone advertising requirements 2. Ban on saying tobacco is “approved by the FDA”

3. Ban on outdoor advertising (not yet enacted)

4. New package warning labels (requirement and size)

Legal Challenges

First Lawsuit challenges 11 provisions of the Act: 1. Tombstone advertising requirements 2. Ban on saying tobacco is “approved by the FDA”

3. Ban on outdoor advertising (not yet enacted)

4. New package warning labels (requirement and size)

5. Restrictions on sponsorship

Legal Challenges

First Lawsuit challenges 11 provisions of the Act: 1. Tombstone advertising requirements 2. Ban on saying tobacco is “approved by the FDA”

3. Ban on outdoor advertising (not yet enacted)

4. New package warning labels (requirement and size)

5. Restrictions on sponsorship 6. Restrictions on sampling

Legal Challenges

First Lawsuit challenges 11 provisions of the Act: 7. Ban on brand name merchandise

Legal Challenges

First Lawsuit challenges 11 provisions of the Act: 7. Ban on brand name merchandise 8. Ban on promotional items with purchase

Legal Challenges

First Lawsuit challenges 11 provisions of the Act: 7. Ban on brand name merchandise 8. Ban on promotional items with purchase 9. Ban on marketing tobacco with other

products regulated by the FDA

Legal Challenges

First Lawsuit challenges 11 provisions of the Act: 7. Ban on brand name merchandise 8. Ban on promotional items with purchase 9. Ban on marketing tobacco with other

products regulated by the FDA 10. “Reduced harm” claims about certain 

products

Legal Challenges

First Lawsuit challenges 11 provisions of the Act: 7. Ban on brand name merchandise 8. Ban on promotional items with purchase 9. Ban on marketing tobacco with other

products regulated by the FDA 10. “Reduced harm” claims about certain 

products 11. Right to create further restrictions on

advertising and promotions

Legal Challenges

The court struck down just TWO provisions:

Legal Challenges

The court struck down just TWO provisions: • Tombstone advertising requirements

Legal Challenges

The court struck down just TWO provisions: • Tombstone advertising requirements • Ban on saying tobacco is “approved by the FDA”

Legal Challenges

The court struck down just TWO provisions: • Tombstone advertising requirements • Ban on saying tobacco is “approved by the FDA”

Also not currently enforced (for other reasons):

Legal Challenges

The court struck down just TWO provisions: • Tombstone advertising requirements • Ban on saying tobacco is “approved by the FDA”

Also not currently enforced (for other reasons): • Ban on outdoor advertising

Legal Challenges

The court struck down just TWO provisions: • Tombstone advertising requirements • Ban on saying tobacco is “approved by the FDA”

Also not currently enforced (for other reasons): • Ban on outdoor advertising • New package warning labels

Legal Challenges

2. Challenge to the FDA’s regulation specifying what the new graphic warning labels look like  

Legal Challenges

Implications for communities right now:

Legal Challenges

Implications for communities right now:

• It is still legal to pursue local policies in any of the challenged areas—there is no impact on California unless the Supreme Court makes a ruling in the case

Legal Challenges

Implications for communities right now:

• It is still legal to pursue local policies in any of the challenged areas—there is no impact on California unless the Supreme Court makes a ruling in the case

• If the Supreme Court ultimately rules any federal tobacco restriction unconstitutional, similar local laws would become unenforceable

Legal Challenges

Local Ordinances: Filling in the Gaps

Vanessa Marvin

Center for Tobacco Policy & Organizing American Lung Association in California

No new significant retailers  

No sales near schools 

No sales in pharmacies 

Density restrictions 

Penalties for violations of drug paraphernalia  

No sales of little cigars and cigarillos  Ban on flavored 

tobacco 

No sampling 

Penalties for signage violations 

No license for bars and restaurants 

No sales of look alike products 

Penalties for age‐specific law violations 

TOBACCO RETAILER LICENSING PLUG‐INS 

No new significant retailers  

No sales near schools 

No sales in pharmacies 

Density restrictions 

Penalties for violations of drug paraphernalia  

No sales of little cigars and cigarillos  Ban on flavored 

tobacco 

No sampling 

Penalties for signage violations 

No license for bars and restaurants 

TOBACCO RETAILER LICENSING PLUG‐INS 

WITH MODEL ORDINANCE LANGUAGE 

No sales of look alike products 

Penalties for age‐specific law violations 

No new significant retailers  

No sales near schools 

No sales in pharmacies 

Density restrictions 

Penalties for violations of drug paraphernalia  

No sales of little cigars and cigarillos  Ban on flavored 

tobacco 

No sampling 

Penalties for signage violations 

No license for bars and restaurants 

TOBACCO RETAILER LICENSING PLUG‐INS 

No sales of look alike products 

Penalties for age‐specific law violations 

COVERED IN NOVEMBER WEBINAR 

No new significant retailers  

No sales near schools 

No sales in pharmacies 

Density restrictions 

Penalties for violations of drug paraphernalia  

No sales of little cigars and cigarillos  Ban on flavored 

tobacco 

No sampling 

Penalties for signage violations 

No license for bars and restaurants 

TOBACCO RETAILER LICENSING PLUG‐INS 

No sales of look alike products 

Penalties for age‐specific law violations 

COVERED ON TODAY’S WEBINAR 

FDA implemented a ban on flavored 

cigarettes… (went into effect  

September 22, 2009) 

www.trinketsandtrash.org 

FDA implemented a ban on flavored 

cigarettes… (went into effect  

September 22, 2009) 

www.trinketsandtrash.org 

…but not on flavored tobacco products 

TWO LOCAL BANS ON  FLAVORED TOBACCO PRODUCTS 

Santa Clara County  New York City 

New York City 

New York City  

Anne Pearson, JD, MA  Policy Advisor  Public Health ‐ Seattle & King County  401 5th Avenue, Suite 900  Seattle, WA  98104  (206) 263‐9411  anne.pearson@kingcounty.gov  

Santa Clara County  New York City 

TWO LOCAL BANS ON  FLAVORED TOBACCO PRODUCTS 

Santa Clara County 

Santa Clara County 

Janie Burkhart, MPH Tobacco Programs Manager Santa Clara County Public Health Chronic Disease and Injury Prevention 1400 Parkmoor Ave.  Suite 120B San Jose, CA 95126 (408) 793‐2736 (408) 793‐2731 janie.burkhart@phd.sccgov.org 

The Fine Print

The information provided in this seminar is for informational purposes only, and does not constitute legal advice. Public Health Law & Policy does not enter into attorney‐client relationships.  The primary purpose of this training is to address legal and policy options to improve public health. There is no intent to reflect a view on specific legislation. PHLP incorporates objective non‐partisan analysis, study, and research in all our work.   

 This material cannot be copied or reproduced without permission. © 2012 

Vanessa Marvin American Lung Association in California 

(916) 554‐5864  www.Center4TobaccoPolicy.org 

Elisa Laird‐Metke Public Health Law & Policy 

www.phlpnet.org/tobaccoquestions 

FDA Enforcement Questions AskCTP@fda.hhs.gov