FDA Establishes Tobacco Products Scientific Advisory Committee and Requests Nominations for Members

By David B. Clissold & Ricardo Carvajal –

As required by the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”), FDA has established the Tobacco Products Scientific Advisory Committee (“TPSAC”) and is requesting nominations for voting and non-voting members.  The Commissioner will select the chair of the 12-member committee, which will consist of nine voting members (seven scientists, one government official, and one representative of the public) and three non-voting members that represent industry interests (one manufacturing industry representative, one small manufacturer representative, and one representative of tobacco growers). 

Establishment of the TPSAC is critical to FDA’s timely implementation of the Tobacco Act because the TPSAC may (and in some cases must) be involved in a wide range of regulatory activities, including actions on premarket approvals, approvals of modified risk tobacco products, establishment of tobacco product standards, and establishment of good manufacturing practice requirements.  In particular, “immediately upon the establishment of” the TPSAC, FDA must refer to it the politically and emotionally charged  “issue of the impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities.”  FDCA Sec. 907(e).  The TPSAC’s report and recommendations on this issue are due back to FDA within one year.  The TPSAC must also consider the impact of dissolvable tobacco products on the public health, including their use by children, and report back to FDA within two years.

Nominations for members of the TPSAC are due on October 13, 2009.  However, industry is being afforded the opportunity to select the three non-voting members of the TPSAC, and that process is moving on a different timetable.  Industry organizations interested in participating in the selection process must confirm their interest in writing and submit nominations by September 25, 2009.  Within 30 days of those submissions, FDA will provide a list of all nominees to participating industry organizations.  Within 60 days of the receipt of that list, industry organizations must confer and select nonvoting members or the Commissioner will do so.