Regulatory Affairs

US Food & Drug Administration (FDA)

CORESTA Comments on FDA’s proposed NNN Standard

On 23 January 2017, the FDA proposed a tobacco product standard for N-Nitrosonornicotine (NNN) in smokeless tobacco products. All measurements of NNN would need to be performed with a new standard test method validated by the FDA.

CORESTA took advantage of the public comment period to state that this method has not been evaluated in a robust collaborative study involving stakeholders.  It therefore lacks repeatability and reproducibility values, unlike CORESTA Recommended Method (CRM) 72, which is used on an annual basis in large international collaborative studies since 2011. The CORESTA letter further lists 16 arguments that highlight the weaknesses and disadvantages of the proposed FDA method (LIB 4620) compared to CRM 72.

The comment can be viewed on the US government regulations website (Docket ID: FDA-2016-N-2527; Document ID: FDA-2016-N-2527-0969) by clicking on the link below:

https://www.regulations.gov/document?D=FDA-2016-N-2527-0969

All other comments submitted by interested parties can be accessed via the following link:

https://www.regulations.gov/docket?D=FDA-2016-N-2527

FDA CTP Workshop on Biomarkers of Potential Harm - A Public Workshop

4-5 April 2016

The FDA Center for Tobacco Products (CTP) hosted its second biomarker workshop on 4-5 April 2016. This workshop was designed to "open the discussion on how to identify and implement the use of biomarkers for the purposes of tobacco product regulation." The objectives of the workshop were to identify "(1) approaches to assessing and selecting biomarkers of potential harm; (2) the processes of identifying biomarkers of potential harm that may be useful in tobacco product regulation; and (3) areas of research which may further strengthen knowledge about biomarkers of potential harm."

CORESTA was given the opportunity to present, during the public comment session, the work it does on biomarkers with a presentation entitled:
      CORESTA Biomarkers Sub-Group - A Platform for Scientific Collaboration on Tobacco-Related Biomarkers

The archived webcast of the workshop is available from the CTP website (see Day 2, Part 1):

      http://www.fda.gov/TobaccoProducts/NewsEvents/ucm481513.htm

FDA CTP Workshops on Electronic Cigarettes and the Public Health

1-2 June 2015

The Center for Tobacco Products (CTP) held its final public workshop on e-cigarettes on 1-2 June 2015. The aim of this third workshop was to obtain information on "the impact of e-cigarettes on population health" and topics addressed included "(1) prevalence and patterns of use; (2) impacts on the use of current tobacco products; (3) uptake of e-cigarette use by non-users of tobacco products; (4) health effects of e-cigarettes in non-users and (5) knowledge, attitudes, beliefs, and perceptions about e-cigarette products."

Webcasts and transcripts of the Workshop are available from the CTP website:

    http://www.fda.gov/TobaccoProducts/NewsEvents/ucm439029.htm

9-10 March 2015

The Center for Tobacco Products (CTP) held its second workshop, intended to obtain information on e-cigarettes, on 9-10 March 2015. The focus of the workshop was "the impact of e-cigarettes on individual health. Topics addressed included exposures and toxicological considerations, topography, clinical pharmacology and abuse liability, health effects in users, considerations for high risk or vulnerable populations, and human factors."

The workshop was transmitted by live webcast, which was recorded and is available from the CTP website:

    http://www.fda.gov/TobaccoProducts/NewsEvents/ucm428317.htm

10-11 December 2014

The Center for Tobacco Products (CTP) held a public workshop from 10-11 December 2014 to “gather scientific information and stimulate discussion among scientists about electronic cigarettes (e-cigarettes)." The FDA website states that the focus of this first workshop was "product science (specifically device designs and characteristics, and e-liquid and aerosol constituents), product packaging, constituent labeling and environmental impact" and that future workshops will be organised "to address the individual health and population health effects of e-cigarettes."

CORESTA was given the opportunity to discuss the work it has undertaken on e-cigarettes and a presentation was made by the Secretary of the CORESTA ECIG Task Force:  CORESTA Electronic Cigarette Task Force

The workshop was transmitted by live webcast, which was recorded and is available from the CTP website:

    http://www.fda.gov/TobaccoProducts/NewsEvents/ucm414814.htm

The CORESTA paper is under the 10 December links, Part 2 (1:25:00).


FDA CTP Tobacco Product Analysis Scientific Workshop

The Center for Tobacco Products (CTP) organised a public, scientific workshop from 30-31 July 2013 to “discuss and obtain input on the chemical analysis of tobacco products". Tobacco product analysis experts from academia, industry, government, and contract testing laboratories shared information on "understanding the testing of cigarette smoke and tobacco filler from cigarettes, roll-your-own (RYO) tobacco, and smokeless tobacco products for tar, nicotine, and carbon monoxide (TNCO), tobacco-specific nitrosamines (TSNAs), and polycyclic aromatic hydrocarbons (PAHs)”.

A number of topics were presented for discussion:

  • TNCO in cigarette smoke
  • TSNAs and PAHs in cigarette smoke and tobacco filler (cigarette, RYO, and smokeless)
  • General method testing for TNCO, TSNAs, and PAHs
  • Validation or method performance for TNCO, TSNAs, and PAHs

Three papers were submitted by CORESTA, accepted for presentation at the Workshop, and presented by the relevant CORESTA Sub-Group Coordinators:

The workshop was transmitted by live webcast, which was recorded and is available from the CTP website:

    http://www.fda.gov/TobaccoProducts/NewsEvents/ucm355041.htm

The BaP paper is in Day 1, Part 1 (00:07:45); TSNA is in Day 1, Part 4 (00:00:00); and TNCO/Smoking Machines is in Day 2, Part 1 (00:00:00).


FDA CTP Reference Products Scientific Workshop

The Center for Tobacco Products (CTP) organised a public, scientific workshop from 11-12 April 2012 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 is available from the CTP website.


CORESTA meets with FDA, Office of Science

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.

CORESTA Presentation to FDA

The FDA asked for supplementary information on several points made during the presentation, and the following information was provided.

CORESTA Presentation to FDA - Complementary comments


FDA Regulation

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