On 22 June 2009, the “Family Smoking Prevention and Tobacco Control Act” was signed into law by the President of the United States, Barack Obama. The Act grants the US Food and Drug Administration (FDA) the authority to regulate the production, sale and advertising of tobacco products.
In the Federal Register of 1 July 2009 (74 FR 31457), the FDA published a notice with a 90-day comment period to request comments on the implementation of the Tobacco Act. This 90-day comment period was extended a further 90 days and ended on 28 December 2009.
In response to the FDA notice, the president of the CORESTA Board, Dr Michael Ogden of R.J. Reynolds Tobacco Co., USA, submitted a comment on behalf of CORESTA on 23 December 2009.
The comment can be viewed on the US government regulations website (Docket ID: FDA-2009-N-0294; Document ID: FDA-2009-N-0294-1036) by clicking on the link below:
http://www.regulations.gov/#!documentDetail;D=FDA-2009-N-0294-1036
All other comments submitted by interested parties can be accessed via the following link:
http://www.regulations.gov/#!docketDetail;D=FDA-2009-N-0294
Further to the participation of Dr David Ashley, Director of the Office of Science at the Center for Tobacco Products (CTP) within the U.S. Food and Drug Administration, who opened the 2010 Congress in Edinburgh, CORESTA had proposed to pursue relations with this administration.
CORESTA was pleased to receive an invitation from Dr Christina Young, on behalf of Dr Ashley, “to discuss CORESTA and the organization's current method development and validation activities”. The meeting was held on 21 January, in Washington D.C.
The President of CORESTA, Dr Michael Ogden; the Presidents and Vice-President of the Scientific Commission, Dr Jean-Louis Verrier and Dr Derek Mariner; the President of the Smoke Science Study Group, Steve Purkis; and the Secretary General, Pierre-Marie Guitton, met a delegation of twelve chemists, biologists, analysts, toxicologists, led by Dr Ashley.
The presentation made by CORESTA at the meeting can be viewed by clicking on the link below.
The FDA asked for supplementary information on several points made during the presentation, and the following information was provided.
Presentation to FDA - Complementary comments *
The Center for Tobacco Products (CTP) organised a public, scientific workshop to obtain input from appropriate experts from academia, industry, government, and contract testing laboratories on analysis of tobacco products. The workshop was announced through the CTP website (http://www.fda.gov/TobaccoProducts/NewsEvents/ucm291530.htm) and a Federal Register notice.
Four major topics
were presented for discussion:
Topic 1: Availability, manufacture, and characterization of tobacco reference
products
Topic 2: Uses of reference products during analysis of tobacco products
Topic 3: Variability observed in measurements of tobacco reference products
Topic 4: Methods suitable for measuring the following in smoked and smokeless
tobacco products: pH, tobacco-specific nitrosamines, polycyclic aromatic
hydrocarbons, carbon monoxide, and metals
Some active participants in various CORESTA Sub-Groups and Task Forces were nominated by their own organisations and selected by the CTP to present papers at the Workshop.
The workshop was transmitted by live webcast, which was recorded and will be available shortly from the CTP website.
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