FDA and Tobacco

Congress empowered the Food and Drug Administration (FDA) to regulate the manufacturing and marketing of tobacco products with the Family Smoking Prevention and Tobacco Control Act of 2009 (FSPTCA) that became law on June 22, 2009. Since then, the FDA has adopted a number of measures to implement the law. As directed by FSPTCA, the agency established the Center for Tobacco Products (CTP) in August of 2009 and Tobacco Products Scientific Advisory Committee (TPSAC) in March of 2010. The objective of the Center for Tobacco Products (CTP) is to oversee the implementation of the FSPTCA.  The priority for the CTP is to keep young people from using tobacco products. To this end, it will employ and enforce a set of regulatory rules involving the manufacturing and marketing of tobacco products, and provide FDA information about the contents of tobacco products that are harmful or potentially harmful to public health as would be established by the TPSAC and approved by FDA. 

FDA Issue Briefs by CTGR

• Summary of the Family Smoking Prevention and Tobacco Control Act
• Center for Tobacco Products
• Tobacco Products Scientific Advisory Committee
• The Use of Menthol in Cigarettes

Links to More Information from the FDA Website

Full text of the Tobacco Control Act
The Center for Tobacco Products

World Health Organization’s Framework Convention on Tobacco Control (WHO FCTC)

The WHO FCTC is a global tobacco control treaty that was formally initiated at the 48th World Health Assembly in 1995.  After years of negotiations it was adopted at the 56th World Health Assembly on May 21, 2003, and entered into force on February 27, 2005.

• WHO FCTC website
• List of Parties
• WHO FCTC Text
• CTGR Issue Brief on the World Health Organization’s Framework Convention on Tobacco Control

Recent Articles Concerning FDA Regulation:

March 16, 2011. Strategies to Exploit Uncertainty in Tobacco, (Morningstar)

March 16, 2011. FDA Launches Spanish Web site To Aid Tobacco Compliance (Convenience Store Decisions)

March 15, 2011. FDA Weighs ban on Newports, other menthol cigarettes (USA Today)

February 25, 2011.  Lorillard and Reynolds Sue F.D.A. (New York Times)

November 20, 2010.  Take a Closer Look, New York Times

November 11, 2010. Tougher Health Warnings Are Free With Every Pack, Wall Street Journal

May 26, 2010: FDA Tobacco Regulator Promises Firm Approach, Open Mind (Wall Street Journal)

March 30, 2010: Effect of Menthol on Smoking Unclear (Wall Street Journal)

March 29, 2010: F.D.A. to Examine Menthol Cigarettes (New York Times)

 

Meetings

Watch meetings and view information from 2011 Meetings

March 17- 18, 2011
The Committee will continue to receive updates from the Menthol Report Subcommittee and discuss plans for finalizing the report regarding the impact of use of menthol in cigarettes on the public health.

That report is due March 23, 2011. The Committee is expected to produce a report and recommendations on the impact of the use of menthol in cigarettes on public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities. Once the report is received, FDA will consider the report and recommendations of the Committee, as well as other scientific evidence concerning menthol cigarettes and make a determination about what action(s), if any, are warranted. There is no required deadline or timeline for FDA to make such a determination.

March 2, 2011
The TPSAC continued receiving updates from the Menthol Report Subcommittee. In addition, the committee received and discussed presentations regarding the data requested by the Committee at its March 30-31, 2010 meeting. One of the presentations included the preliminary results from a Population Dynamics Model of the Consequences of Menthol Cigarettes for Smoking Prevalence and Disease Risks. Under various scenarios of initiation rate, cessation rate and other related parameters, preliminary estimates of cumulative excessive deaths due to menthol in cigarettes were presented. 

Another presentation at this meeting was about switching to and from Menthol and Non-menthol Cigarettes by age and other demographic characteristics of users. The presenter noted that switching among menthol brands appeared to favor an increasing market share by Newport with reductions for Salem and Kool brands. There was inconsistent evidence of the differences in menthol brand switching by gender. While there is substantial limitation in terms of analysis due to lack of data distinguishing menthol from non-menthol flavors within brands that produce both, the very small amount of data stratified by race/ethnicity, gender and age suggests that a majority of menthol brand switchers are white; a higher proportion of menthol switchers are female; age characteristics of switchers differs by brand.

In the public comment session, the committee heard a presentation on the future potential impact of a menthol ban on smoking prevalence and smoking‐attributable deaths using a validated smoking simulation model. Results suggest that a ban on the use of menthol in cigarettes will potentially avert deaths.

February 11, 2011
The Menthol Report Subcommittee of TPSAC heard Writing Groups’ presentation of the chapters of the upcoming Menthol report.

February 10, 2011
The Committee held closed and open sessions. In the closed session, only voting members of the committee hosted presentations on commercial confidential/trade secret information from industry document submissions and confidential FTC data.

In the open session, information that was not deemed commercial confidential or a trade secret was presented to the full committee. In this part of the meeting, the committee also received an update on the model of the impact of menthol on initiation and cessation. Furthermore, the committee held a public comment session and also discussed Chapters 1 and 2 of the upcoming Menthol Report.

January 10-11, 2011
The TPSAC continued receiving updates from the Menthol Report Subcommittee and hosting presentations on various issues related to menthol in cigarettes. One of the presentations was on a population dynamics model of menthol cigarettes smoking prevalence and health effects. The model was developed to make estimates of the health impact of menthol under various scenarios such as a policy measure banning use of menthol cigarettes.

In addition, the committee hosted a series of presentations, reviewing the results of menthol-related industry documents submitted by manufactures pursuant to FDA requests. The committee also received an update and discussed on the various chapters of the forthcoming Menthol Report, and also held public hearing sessions. Two such issues were population level effects associated with menthol use and the potential unintended consequences of a ban on menthol in cigarettes in terms of the expansion of the black market.

FDA
November 18, 2010

• On November 18, 2010, the committee received an update on the Menthol Report Subcommittee and received and discussed presentations regarding the data requested by the committee at the March 30 and 31, 2010, meeting of the Tobacco Products Scientific Advisory Committee.

Watch meetings and view information from past meetings.

WHO
November 15-20, 2010
The Conference of Parties decided that:

• Flavoring ingredients that increase attractiveness of tobacco products should be regulated in order to reduce the number of new smokers, especially among youth. However, there was no specific list of ingredients that was created.  All Parties were offered guidance on which ingredients to regulate but encouraged to develop their own lists and regulations.
• Smoking cessation services should be integrated into national health systems to make them more available for increasing number of smokers who wish to quit.
• Parties should establish an infrastructure and build capacity to support education, communication and training, thereby raising public awareness and promoting social change.
• Parties also decided to delay recommendations until further work could be done on the report on price and taxation policy of tobacco products economically sustainable agricultural alternatives to tobacco. The completion of guidelines on the illicit trade of tobacco products was also delayed until 2012.   
• Other areas where further work was mandated included the control and prevention of smokeless tobacco products and “electronic cigarettes”, liability with regard to the health effects of tobacco consumption, and cross-border advertisement.

Press Release

Decisions

Contact Us

Center for Tobacco Grower Research
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ctgr@utk.edu