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National Partners Webinar Updates from the Center for Tobacco Products. Lawrence R. Deyton, M.S.P.H., M.D. Director, Center for Tobacco Products Ann Simoneau, J.D Director, Office of Compliance and Enforcement May 26, 2011.

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National partners webinar updates from the center for tobacco products

National Partners WebinarUpdates from theCenter for Tobacco Products

Lawrence R. Deyton, M.S.P.H., M.D.

Director, Center for Tobacco Products

Ann Simoneau, J.D

Director, Office of Compliance and Enforcement

May 26, 2011


Vision statement center for tobacco products

To make tobacco-related death and disease part of America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

Vision Statement

Center for Tobacco Products

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Family Smoking Prevention and Tobacco Control Act America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

3

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Tobacco control
TOBACCO CONTROL America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.


  • Requiring ingredient reporting

  • Requiring health document reporting

  • Evaluating new products before they are marketed

  • Evaluating products claiming to be substantially equivalent

  • Evaluating the accuracy and impact of proposed modified risk claims

Product Regulation Means:


Product Regulation Does America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.Not Mean:

  • An end to the tobacco epidemic

  • An end to the need for good scientific studies

  • An end to the need for public health action

    Tobacco product regulation is one more tool to reduce the disease and death caused by tobacco use


The first 20 months of fda tobacco product regulation
The First 20 Months of FDA Tobacco Product Regulation America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

  • Establishing the regulatory framework for tobacco product regulation

  • FDA has met all statutory requirements

  • FDA has interacted with a number of stakeholders

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Listening to stakeholders
Listening to Stakeholders America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

  • Meaningful communication is important for a regulatory agency

  • Meaningful communication is important when implementing a new law

  • Trust can be improved in all directions

  • Everyone is new to tobacco product regulation called for in the Tobacco Control Act

  • FDA wants and needs input from every stakeholder including manufacturers, retailers, public health advocates, tobacco consumers, and all citizens

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Stakeholder discussions
Stakeholder Discussions America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

State and Local Tobacco Control Officials

October 3, 2010 (Atlanta, GA)

http://www.fda.gov/TobaccoProducts/NewsEvents/ucm224215.htm

Tobacco Product Manufacturers, Growers, and Warehousers

December 8, 2010 (Raleigh, NC)

http://www.fda.gov/TobaccoProducts/NewsEvents/ucm233921.htm

Minority Communities and Groups Affected by Tobacco-Related Health Disparities

February 8, 2011 (Oakland, CA)

http://www.fda.gov/TobaccoProducts/NewsEvents/ucm240182.htm

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Upcoming stakeholder discussions
Upcoming Stakeholder Discussions America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

  • Public Health Advocates

    – June 9, 2011 (Rockville, MD)

  • American Indians/Alaska Natives

    – June 28, 2011 (Gila River Indian Community, Near Phoenix, AZ)

  • Distributors, Importers, Retailers, Wholesalers

    • August 24, 2011 (Dallas, TX)

  • Youth

    • September 13, 2011 (Boston, MA)

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Status menthol
Status - Menthol America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

  • Critically important issue

  • Illustrates the complexities of tobacco product regulation

  • TPSAC Menthol report (advising FDA)

    • TPSAC does not set policy, it advises FDA


Tpsac findings in the menthol report
TPSAC Findings in the Menthol Report America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

  • TPSAC did not make any specific recommendations about what FDA actions would be most appropriate to achieve its findings:

  • Evidence most strongly supported that:

    • Menthol cigarettes increase experimentation and the transition to regular smoking.

    • Menthol cigarettes increase the likelihood of addiction and the degree of addiction in youth smokers.

    • Menthol cigarettes result in lower likelihood of smoking cessation success in African-Americans.

    • Menthol cigarettes increase the prevalence of smoking in the general population and African Americans.

    • Menthol cigarette marketing increases the prevalence of smoking for the whole population, youth and African Americans.

  • TPSAC concluded that, “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.”


Fda s actions underway menthol
FDA’s Actions Underway - Menthol America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

FDA’s scientific review activities have been underway for months and include:

  • An analysis of health documents that were submitted by the tobacco industry.

  • An examination of the peer-reviewed science-based literature.

  • An independent analysis of available large-scale and national studies.

    If the science dictates action, the TCA gives FDA many options to protect public health


Status dissolvable tobacco products
Status – Dissolvable Tobacco Products America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

  • Tobacco Control Act requires the FDA to review and allow the marketing of tobacco products introduced after February 15, 2007

    • Feb. 2010 FDA requested information from Star Scientific and RJR on dissolvables (received in March)

    • March 2010 FDA opened a docket requesting comments on the nature, use and impact of dissolvable use on the public health; research and data on ways these products are used by children/youth; how the risks are perceived by users and non-users; and how they affect health


Dissolvable tobacco products cont d
Dissolvable Tobacco Products (cont’d) America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

  • Oct 2010 FDA announced intention to require tobacco companies to submit their internal documents relating to marketing practices and research on health, toxicological, behavioral and physiological effect of dissolvables

  • Tobacco Control requires the TPSAC to study and issue a report by March 2012 on the issue of the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children.


  • Status e cigarettes
    Status – E-Cigarettes America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    • U.S. Court of Appeals decision – e-cigarettes and other products “made or derived from tobacco” can be regulated as “tobacco products” and are not/drugs/devices unless they are marketed for therapeutic purposes

    • Tobacco products other than cigarettes, smokeless tobacco and roll-your-own tobacco are not currently regulated by FDA


    Status e cigarettes cont d
    Status – E-Cigarettes (cont’d) America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    • Letter to Stakeholders issued April 25, 2011 outlining FDA’s intended actions:

      • Proposing a regulation extending the Agency’s “tobacco product” authorities

      • Considering whether to issue a guidance and/or a regulation on “therapeutic claims”

      • Finalizing a draft guidance on prohibition of marketing of “tobacco products” in combination with other FDA regulated products

      • Issued draft guidance to manufacturers on requesting a determination for “grandfathered” product


    Status graphic health warnings
    Status – Graphic Health Warnings America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    • Proposed rule issued on November 12, 2010

    • Issuance of final rule is required by June 22, 2011

    • FDA plans to assess the impact of the required warnings via comprehensive research and evaluation mechanisms to enable us to adapt and enhance effectiveness of messaging


    Status new product review
    Status – New Product Review America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    • New tobacco product defined as:

      • “Any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007;” or

      • “Any modification*. . . of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007” (section 910(a)(1))

        * including change in design, any component, any part or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient


    New product review cont d
    New Product Review (cont’d) America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    • Pathways for legally marketing tobacco products:

      • Grandfathered products – 2/15/2007

      • 3 potential pathways to market a “new tobacco product”

        • Substantial equivalence (SE) reports

        • SE exemption (pursuant to regulation)

        • Premarket tobacco product applications (PMTA)

    • Pathway for legally marketing tobacco products with modified risk claims:

      • Modified risk tobacco product applications (MRTP)

        • Separate guidance or regulation


    Office of compliance and enforcement
    Office of Compliance and Enforcement America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    Ann Simoneau, Director

    • Enforcement and Manufacturing Group

      • Joanna Weitershausen, Acting Group Leader

    • Promotion, Advertising, and Labeling Group

      • Ele Ibarra-Pratt, Group Leader

    • State Programs Group

      • Terry McDonald, Group Leader


    State programs
    State Programs America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    • Coordinates implementation of FDA tobacco retailer inspection contracts

    • Provides commissioning and training for inspectors

    • Reviews results from compliance check inspections

    • Initiates enforcement actions for violations


    Fda tobacco retail inspection contracts
    FDA Tobacco Retail Inspection Contracts America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    • 15 States were awarded 1 year contracts in FY 2010

    • Up to 75% of U.S. States/Territories in FY 2011

    • Currently reviewing contract proposals submitted by States for FY 2011

    • Contracts will be awarded to all jurisdictions that wish to participate in FY 2012


    States awarded fda tobacco enforcement contracts in fy 2010
    States Awarded FDA Tobacco Enforcement Contracts in FY 2010 America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    (Alabama, Arkansas, Arizona, Colorado, Idaho, Kansas, Maine, Maryland, Massachusetts, Mississippi, Missouri, Illinois, Pennsylvania, Tennessee, and Washington)


    Inspection results enforcement actions
    Inspection Results/Enforcement Actions America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    • A warning letter will be issued by FDA if violations are found during the first time compliance check inspection of a retailer

    • All warning letters are posted on the FDA website

    • A list of retailers that were inspected and where no violations are found is posted on the FDA website


    Inspection results enforcement actions1
    Inspection Results/Enforcement Actions America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    • After a tobacco retailer receives a warning letter, FDA intends to conduct follow-up compliance check inspections at that outlet

    • If violations are found during follow-up compliance check inspections at that retail outlet, FDA will seek civil money penalties

    • Other enforcement actions may include no-tobacco-sale orders, seizures, and/or injunctions


    Compliance check inspections
    Compliance Check Inspections America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    As of May 19, 2011:

    • Total Number of retailer compliance check inspections: 9,418

    • Total number of warning letters

      issued to retailers: 337


    Enforcement actions
    Enforcement Actions America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    • Ban on flavored cigarettes

      • 30 Warning Letters

    • Light, low, or mild cigarettes

      • 11 Warning Letters

      • Tobacco-Related Health Fraud


    Compliance training for tobacco retailers
    Compliance Training for Tobacco Retailers America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    FDA is committed to finding more ways to educate tobacco retailers

    Tobacco retailers make up a large and diverse community – often with no experience with FDA

    Tobacco retailers need information and education about the Tobacco Control Act

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    Compliance training for tobacco retailers1
    Compliance Training for Tobacco Retailers America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    In FY 2010, OCE held five training retailer sessions held in Boston, Atlanta, Chicago, Dallas, and Los Angeles

    Over 1,000 retailers, their representatives and trade associations attended in person, via live webcasting and/or telephone

    Sessions provided information about how to comply with the law and opportunity to ask questions on federal tobacco product regulations

    30

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    Compliance training for tobacco retailers2
    Compliance Training for Tobacco Retailers America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    FY 2011 Tobacco Retailer Compliance Webinars

    Upcoming: June 28, July 26, September 20

    Topics include warning letters for violations; civil money penalties; age, access, and promotional restrictions, impersonal modes of sale, smokeless tobacco packaging and advertising

    FDA will also solicit stakeholders for topics to be covered in future webinars

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    Working with fda
    Working with FDA America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    • Educate retailers on the Tobacco Control Act and its implementing regulations using the information on our website

    • Report potential violations


    Reporting tobacco related complaints violations to ctp
    Reporting Tobacco-Related Complaints/Violations to CTP America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    • 1.877.CTP.1373 (press #3 to report a violation)

    • Email: [email protected]

    • Correspondence: CTP’s Office of Compliance and Enforcement

    • Electronic Tobacco Violations Reporting Form (in development)


    Looking ahead
    Looking Ahead America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    June 2011

    • Issue final rule on graphic health warnings

    • CTP will issue a status report on menthol

    • Issue FY2011 State contract awards (thru Sept. 2011)

      March 2012

    • TPSAC report on dissolvable tobacco products to be submitted to FDA

      April 2012

    • Establish list of harmful/potentially harmful constituents

    • Issue guidance or regulations on scientific evidence to be used in assessing modified risk products (to be developed in consultation with the Institute of Medicine)

      September 2012

    • Graphic health warning regulations takes effect

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    U.S. Food and Drug Administration America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.

    Center for Tobacco Products

    http://www.fda.gov/tobaccoproducts

    1-877-CTP-1373

    For Formal Correspondence

    Email: [email protected]


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