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Tobacco Performance Detail FY 2012 OPA

Table of Contents FY 2012 OPA

Long Term Objective: Establish an Effective Tobacco Regulation, Prevention, and Control Program
 
Measure
FY
Target
Result
280001: Protect the public health by developing and issuing regulations related to tobacco control and limiting access to tobacco products by youth. (Output)
 
2012
Conduct research on how to assess the public health impact of modified risk products, and continue to evaluate the impact of tobacco regulations on the public health.
Issue regulations to protect the public health.
January 2013
 2011
Select initial set of data and calculate baseline for long term assessment of public health impact of tobacco regulation and associated FDA programs.
Issue regulations to protect the public health.
January 2012
2010
Identify population-based data available to begin assessing impact of tobacco control regulations, their impact on youth and adult access to and use of tobacco products.
 
Issued regulations protecting the public health from the harmful effects of tobacco use including: prohibiting misleading descriptors, requiring new warning labels on smokeless tobacco products, and the “Reissued 1996 Rule.”
(Target Met)
Initiated or conducted research on the impact of tobacco control regulations.
(Target Met)
2009
NA
FDA has issued a ban on flavored cigarettes
2008
NA
NA
2007
NA
NA
 
Measure
Data Source
Data Validation
280001
CTP’s Office of Science
The data will be validated by the appropriate CTP offices and officials.   
 
 
Measure
FY
Target
Result
280002Develop a scientific base to understand and reduce harm from tobacco products by initiating a testing program to support tobacco product standards development, which will include a review of tobacco product ingredients. (Output)
 
2012
Establish a list of harmful and potentially harmful ingredients and constituents in tobacco products and tobacco smoke. TPSAC to issue a report on dissolvable tobacco products.
Issue a proposed rule or draft guidance that establishes requirements or contains recommendations regarding the scientific evidence required for assessment and ongoing review of modified risk products.
January 2013
2011
Select initial set of harmful ingredients and establish adequate testing methods
January 2012
2010
Identify potential set of harmful ingredients; establish criteria for evaluating testing methods
Held 6 TPSAC meetings focusing on the public health impact of menthol in cigarettes and establishing a list of harmful/potentially harmful constituents in tobacco products and smoke.
(Target Met)
2009
NA
N/A
2008
NA
NA
2007
NA
NA
 

Measure
Data Source
Data Validation
280002 
 CTP’s Office of Science
The data are validated by the appropriate CTP offices and officials.   

 
Measure
FY
Target
Result
280003Increase compliance with tobacco product regulation by increasing the percentage of States and Territories with which FDA has developed a contract program to support the enforcement and public health goals of the Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescent (formally known as the Re-Issued 1996 Rule) to assure that retailers refuse sales of cigarettes and smokeless tobacco products to adolescents under the age of 18.   (Outcome)
 
2012
95%
January 2013
2011
75%
January 2012 
2010
25%
27%
(Target Met)
2009
NA
0%
(Historical Actual)
2008
NA
NA
2007
NA
NA
 
Measure
Data Source
Data Validation
280003 
CTP’s Office of Regulations and Compliance
The data are validated by the appropriate CTP offices and officials.
 
Measure
FY
Target
Result
280004Educate stakeholders and the general public about the new tobacco products regulations and the health effects of tobacco use.
(Output)
2012
Continue to implement and improve programs designed to educate the public and industry.
January 2013
2011
Implement and refine education program directed to retailers and the general public, especially youth.
January 2012 
2010
Develop education program directed to retailers and the general public, especially youth.
Announced the Stakeholder Discussion Series
(Target Met)
Launched the “Break the Chain of Tobacco Addiction” campaign to educate retailers and the public about new tobacco regulations
(Target Met)
2009
NA
NA
2008
NA
NA
2007
NA
NA
 

Measure
Data Source
Data Validation
280004
CTP’s Office of Public Education and External Relations
The data are validated by the appropriate CTP offices and officials.

 
1.      Protect the public health by developing and issuing regulations related to tobacco control and limiting access to tobacco products by youth.  (280001)
 
Context:   A major goal of the tobacco program will be implementing policies and issuing regulations to protect the public health by reducing morbidity and mortality related to the use of tobacco products.   FDA needs to conduct research and evaluation studies to better understand how marketing and advertising of tobacco products influences use of tobacco products by various sectors of the public; to evaluate the early impact of the tobacco regulations issued in 2009 and 2010; and to develop baseline measures to better assess the impact of later provisions in the statute. This may include research on the behavioral effects of industry marketing methods, the impact of governmental and other tobacco-use risk educational programs, and the impact of minors’ access to tobacco products, tobacco marketing restrictions, and smokeless warning labels. These studies may be funded through contracts, grants, interagency agreements, or contracts, grants, or cooperative agreements with other entities such as universities or private foundations. 
 
Performance:    The Tobacco Control Act requires regulations to be issued pursuant to certain timetables. FDA met all of the statutory deadlines required by the Tobacco Control Act for FY 2009 and 2010. FDA successfully issued “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.” FDA also issued regulations prohibiting the use of misleading descriptors, such as “light,” “low,” and “mild” without FDA approval, and issued regulations requiring new warning labels to be place on smokeless tobacco products. FDA will continue in to enforce these regulations in FY 2011. In FY 2011, FDA will continue to issue regulations to protect the public health from the harmful effects of tobacco use in accordance with the timelines set forth in the Tobacco Control Act. FDA has issued a proposed rule requiring new graphic health warning labels to be placed on cigarette packs and cigarette advertisements. FDA also conducted an 18,000 person consumer research study on the 36 images intended to demonstrate the negative health consequence of smoking contained in the proposed rule and published the study in the Federal Register for public comment. The final regulations will be issued in June 2011. Also, in FY 2011, FDA will also issue regulations to implement the exemptions from requirements to demonstrate substantial equivalence, and will issue regulations concerning the sale and distribution of tobacco products through means other than a face-to-face transaction. In FY 2012, FDA will issue regulations or guidance regarding:
  • The promotion/marketing of tobacco products through means other than a direct exchange;
  • The scientific evidence required for assessment and ongoing review of modified risk tobacco products; and
  • Regulations that permit the filing of a single application for a new tobacco product that is to be marketed as a modified risk tobacco product.
 
2.      Develop a scientific base to understand and reduce harm from tobacco products by initiating a testing program to support tobacco product standards development, which will include a review of tobacco product ingredients.   (280002)
 
Context: FDA is authorized to conduct research in support of its regulation of tobacco products. This effort is supported by one of the requirements of the Tobacco Control Act, which beginning in FY 2010, requires regulated industry to submit information to FDA on all ingredients used in cigarettes and some other tobacco products.  In order to begin the ongoing review of the population health effects of those ingredients and their impact on tobacco usage, FDA will need a substantial capacity to conduct laboratory research. In addition scientific information developed by FDA will be applied in developing ongoing controls for marketed products, such as Good Manufacturing Practices and inspection and testing procedures, and Tobacco Product Standards. FDA will also need scientific capacity to provide support for the future processes of reviewing applications for new tobacco products and products claimed to reduce the risks of tobacco use. While FDA may be able to provide some laboratory and research capability within the agency at the National Center for Toxicological Research and at some field laboratories (ORA), it is expected that a much larger capacity will be needed. Other public health agencies such as CDC and NIH clearly have the expertise and potential laboratory capacity to conduct research in many areas related to tobacco, and FDA is considering the possibility of utilizing the expertise of these Federal agencies as well as other expert scientific resources. FDA will implement research efforts using a potential combination of contracts, cooperative agreements, and inter-agency agreements, all funded from tobacco program funds. This work will inform future substantial equivalent tobacco product review activities, among other requirements of the Tobacco Control Act.
 
Performance:  In FY 2010, FDA established the Tobacco Products Scientific Advisory Committee (TPSAC). During the year, TPSAC considered the public health impact of menthol in cigarettes and the framework for establishing a list of harmful/potentially harmful constituents in tobacco products and smoke. FDA held six meetings of TPSAC in FY 2010 on these two topics. TPSAC has met three times in FY 2011 to consider menthol-related issues, and will continue to consider the public health impact of menthol in cigarettes as it prepared to issue its report on menthol in cigarettes to the Secretary of Health and Human Services in March 2011. FDA will also issue regulations and guidance to industry regarding substantial equivalence, and review substantial equivalence applications submitted by industry. In FY 2012, FDA will establish a list of harmful and potentially harmful ingredients and constituents in tobacco products and tobacco smoke.  FDA will also evaluate the report on dissolvable tobacco products that will be issued by TPSAC, and continue to build the scientific base for tobacco products regulation based on a population health standard.
 
3.      Increase compliance with tobacco product regulation by increasing the percentage of States and Territories with which FDA has developed a contract program to support the enforcement and public health goals of the 1996 rule to assure that retailers refuse sales of cigarettes and smokeless tobacco products to adolescents under the age of 18.   (280003)
 
Context:   The Tobacco Control Act requires FDA to reissue a rule by March 2010 that incorporates specific portions of the 1996 rules on tobacco aimed at limiting access by youths under age 18 to purchase tobacco products, and also limiting marketing practices and advertising aimed at youths. This rule will take effect in June 2010. A key element in deterring youth access to tobacco, as it was under the 1996 rule, will be contracts with U.S. States and Territories to conduct compliance checks to assure that retailers refuse sales of tobacco to adolescents under the age of 18. There are civil money penalties for illegally selling cigarettes or smokeless tobacco to minors. Ultimately, by reducing the sale, access, and allure of tobacco products to minors, this rule and its enforcement, as well as education and other efforts, will constitute a critical component of FDA’s contributions to the overall HHS goals of reducing disease and deaths caused by tobacco products.   
 
Performance: In order to enforce the requirements of the Tobacco Control Act and subsequent regulations, FDA began contracting with U.S. States for the purpose of conducting retail inspections. FDA contracted with 15 states in FY 2010. Those states were: Alabama, Arizona, Arkansas, Colorado, Idaho, Illinois, Kansas, Maine, Maryland, Massachusetts, Mississippi, Missouri, Pennsylvania, Tennessee, and Washington. These 15 states constitute 27 percent of U.S. States and Territories. This exceeds FDA’s FY 2010 goal of contracting with 25 percent of U.S. States and Territories. In FY 2011, FDA will continue to contract with U.S. States and Territories. FDA’s goal for FY 2011 is to have enforcement contracts with 75 percent of all U.S. States and Territories, and to have enforcement contracts with 95 percent of U.S. States and Territories in FY 2012.
 
4.      Educate stakeholders and the general public about the new tobacco products regulations and the health effects of tobacco use.   (280004)
 
Context:  FDA’s new authority to regulate tobacco products brings new transparency for the public about the ingredients, constituents, manufacturing and research processes for tobacco products, as well as about the risks associated with tobacco use. These new FDA authorities also mean new compliance requirements for those involved with the manufacture, distribution, marketing and sales of tobacco products. FDA’s new Center of Tobacco Products (CTP) will develop a comprehensive educational program that will help improve understanding and awareness among the industry, importers, retailers, health professionals, tobacco control groups, and the general public about the new regulations that FDA is implementing (and for the regulated industry, information on how to comply with these new requirements). FDA also plans to develop a broad program of tobacco control and prevention education and communications programs designed to reach the public with specific attention paid to as many racial, ethnic, cultural, and social elements of the population as possible. One of the primary ways to reduce the risks associated with tobacco use among youth is to increase educational efforts regarding the hazards of tobacco use, and specifically, to convey new information about tobacco product constituents, resulting from the information submitted to FDA by the industry and from the results of FDA's research activities. In FY 2011, FDA will continue its Stakeholder Discussion Series to fully explore ideas and options for overarching principles for the implementation of the Tobacco Control Act and the establishment of more effective communications mechanisms between and among FDA and various stakeholder groups.
 
Performance:  FDA began the “Break the Chain of Tobacco Addiction” campaign in FY 2010 in an effort to educate retailers and the general public about new tobacco product regulations aimed at restricting youth access to tobacco products. This campaign has used traditional, web, phone, and social media outreach methods to reach retailers, industry, and the general public. In FY 2011, FDA will continue the “Break the Chain” campaign, and continually evaluate and refine the campaign in order to reach stakeholders and the general public in the most effective manner. FDA announced the Stakeholder Listening Series in FY 2010. This series will allow FDA to engage with various Stakeholders, and take advantage of the knowledge, ideas, feedback, and suggestions from all stakeholders affected by tobacco product regulation. This series will allow FDA to more effectively implement the Tobacco Control Act. As of December 2010, FDA had held two listening sessions and has another five scheduled in FY 2011. In FY 2012 FDA will continue to implement and improve programs that will educate industry, retailers, and the general public about new tobacco regulations, and the harmful effects of tobacco product use.
 
Next page: Headquarters and Office of the Commissioner Performance Detail FY 2012 OPA