Tobacco Products Scientific Advisory Committee
Encyclopedia
The Tobacco Products Scientific Advisory Committee (TPSAC) is an advisory panel of the United States
Food and Drug Administration
organized to provide advice, information and recommendations to the FDA commissioner on matters related to the regulation of tobacco products
. It was created in accordance to the Family Smoking Prevention and Tobacco Control Act
, signed into law by President Barack Obama
on June 22, 2009. The Committee was inaugurated during its March 30-31, 2010 meeting.
at least 15 days before each meeting.
The Committee's purpose is to review and evaluate safety, dependence, and health issues relating to tobacco products and to provide appropriate advice, information and recommendations to the Commissioner of Food and Drugs on the following topics:
, and Benowitz to Pfizer
as well, both pharmaceutical firms that market smoking cessation
drugs. Their selection by the FDA has drawn criticism as "lax on conflict of interest" by the Boston Globe. Meanwhile, advocacy group Americans for Limited Government
has raised concerns about funding received by TPSAC chair Jonathan Samet from GlaxoSmithKline and other pharmaceutical companies. In January 2011, Gregory N. Connolly resigned from the committee following allegations of conflicts of interest citing payments to provide deposition or trial testimony in lawsuits against tobacco companies.
In Februrary 2011, Lorillard and R.J. Reynolds filed a federal lawsuit to try to block the advisory committee action or force the FDA to disregard its advice, stating three of the eight panel members had financial conflicts of interest from legal and consulting work against tobacco companies.
In March 2011, the tobacco industry released a report to the FDA in response to the TPSAC decision claiming menthol cigarettes are no riskier than regular cigarettes and should not be regulated differently.
on the TPSAC was established to allow interested members of the public to discuss the Committee's work. The IPD includes discussion forums on TPSAC sub-topics including Studies and Concepts Under Review, Member Statements and Committee Governance.
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
organized to provide advice, information and recommendations to the FDA commissioner on matters related to the regulation of tobacco products
Tobacco products
After tobacco has been processed, it is used to produce a number of different products.- Chewing tobacco :Chewing is one of the oldest ways of consuming tobacco leaves. Native Americans in both North and South America chewed the fresh leaves of the plant, frequently mixed with lime. Modern chewing...
. It was created in accordance to the Family Smoking Prevention and Tobacco Control Act
Family Smoking Prevention and Tobacco Control Act
The Family Smoking Prevention and Tobacco Control Act, is a United States federal law that gives the Food and Drug Administration the power to regulate the tobacco industry...
, signed into law by President Barack Obama
Barack Obama
Barack Hussein Obama II is the 44th and current President of the United States. He is the first African American to hold the office. Obama previously served as a United States Senator from Illinois, from January 2005 until he resigned following his victory in the 2008 presidential election.Born in...
on June 22, 2009. The Committee was inaugurated during its March 30-31, 2010 meeting.
Structure and mission
TPSAC consists of 12 members, including a chairperson, all of whom are selected by the FDA commissioner from among experts in medicine, medical ethics, science and technology related to the manufacture and use of tobacco products. Nine voting seats are held for academics and practitioners in the field of health care, while three non-voting seats are held for industry representatives. Members serve for overlapping terms of four years. Meetings are held approximately four times per year, with all meetings publicly announced in the Federal RegisterFederal Register
The Federal Register , abbreviated FR, or sometimes Fed. Reg.) is the official journal of the federal government of the United States that contains most routine publications and public notices of government agencies...
at least 15 days before each meeting.
The Committee's purpose is to review and evaluate safety, dependence, and health issues relating to tobacco products and to provide appropriate advice, information and recommendations to the Commissioner of Food and Drugs on the following topics:
- The impact of the use of menthol cigarettes on the public health, including use among children, African Americans, Hispanics and other racial and ethnic minorities
- The nature and impact of the use of dissolvable tobaccoDissolvable tobaccoDissolvable tobacco is a tobacco product. Unlike ordinary chewing tobacco, it dissolves in the mouth. Major tobacco manufacturers that sell dissolvable tobacco products include R. J. Reynolds Tobacco Company and Star Scientific...
products on the public health, including use by children - The effects of the alteration of nicotineNicotineNicotine is an alkaloid found in the nightshade family of plants that constitutes approximately 0.6–3.0% of the dry weight of tobacco, with biosynthesis taking place in the roots and accumulation occurring in the leaves...
levels in tobacco products - Whether, for any given tobacco product, there is a nicotine level low enough to preclude addiction
- Applications submitted by manufacturers for a modified-risk tobacco product
Membership
- Chair: Jonathan M. Samet, M.D., M.S., Term: 02/16/10 - 1/31/14
- Acting Designated Federal Official: Cristi L. Stark, M.S.
Voting members
- Neal L. Benowitz, M.D. Term: 02/17/10 - 1/31/13
- Mark Stuart Clanton, M.D., M.P.H. Term: 02/17/10 -1/31/14
- Gregory Niles Connolly, D.M.D., M.P.H. Term: 02/16/10 - 1/31/12
- Karen L. DeLeeuw, M.S.W. Term: 02/16/10 - 1/31/13
- Dorothy K. Hatsukami, Ph.D. Term: 02/17/10 - 1/31/13
- Patricia Nez Henderson, M.P.H., M.D.
- Jack E. Henningfield, Ph.D. Term: 02/16/10 - 1/31/12
- Melanie Wakefield, Ph.D. Term: 02/16/10 - 1/31/14
Non-voting members
- Luby Arnold Hamm, Jr. Representative of the interests of tobacco growers. Term: 3/22/10 - 1/31/12
- Jonathan Daniel Heck, Ph.D., DABT Representative of the tobacco manufacturing industry. Term: 3/22/10 - 1/31/14
- John H. Lauterbach, Ph.D., DABT Representative for the interest of small business tobacco manufacturing industry. Term: 3/22/10 - 1/31/13
Controversy
On March 1, 2010, the Wall Street Journal reported that proposed committee members Jack Henningfield and Neal L. Benowitz, had served as consultants to GlaxoSmithKlineGlaxoSmithKline
GlaxoSmithKline plc is a global pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in London, United Kingdom...
, and Benowitz to Pfizer
Pfizer
Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...
as well, both pharmaceutical firms that market smoking cessation
Smoking cessation
Smoking cessation is the process of discontinuing the practice of inhaling a smoked substance. This article focuses exclusively on cessation of tobacco smoking; however, the methods described may apply to cessation of smoking other substances that can be difficult to stop using due to the...
drugs. Their selection by the FDA has drawn criticism as "lax on conflict of interest" by the Boston Globe. Meanwhile, advocacy group Americans for Limited Government
Americans for Limited Government
Americans for Limited Government describes itself as a non-partisan, nationwide network committed to advancing free-market reforms, private property rights and core American liberties...
has raised concerns about funding received by TPSAC chair Jonathan Samet from GlaxoSmithKline and other pharmaceutical companies. In January 2011, Gregory N. Connolly resigned from the committee following allegations of conflicts of interest citing payments to provide deposition or trial testimony in lawsuits against tobacco companies.
In Februrary 2011, Lorillard and R.J. Reynolds filed a federal lawsuit to try to block the advisory committee action or force the FDA to disregard its advice, stating three of the eight panel members had financial conflicts of interest from legal and consulting work against tobacco companies.
TPSAC Decision on Menthol Cigarettes
On March 18, 2011 the panel concluded that removing menthol cigarettes from the market would benefit public health in the United States, but stopped short of recommending that the FDA take any specific actions like restricting or banning the additive. A progress report on panel findings is expected in July 2011.In March 2011, the tobacco industry released a report to the FDA in response to the TPSAC decision claiming menthol cigarettes are no riskier than regular cigarettes and should not be regulated differently.
TPSAC Interactive Public Docket
An Interactive Public DocketInteractive Public Docket
The Interactive Public Docket is an eRulemaking tool created and managed by non governmental organizations that seek to provide the public with the capability to: 1) publicly post data and other materials pertaining to federal proceedings on a continuous basis, including after the close of the...
on the TPSAC was established to allow interested members of the public to discuss the Committee's work. The IPD includes discussion forums on TPSAC sub-topics including Studies and Concepts Under Review, Member Statements and Committee Governance.