Today, the Food and Drug Administration Center for Tobacco Products (CTP) announced that it will hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on July 21 and 22, 2011 to address comments on its Menthol Report and to begin its review of dissolvable tobacco products.
On the morning of July 21, TPSAC will consider feedback and potential changes to the Menthol Report issued on March 18, 2011. The March 18 version of the report admitted that the report contained gaps, and public health observers and industry have also publicly disagreed with several portions of the report. The meeting announcement does not preview the proposed changes, but indicates that TPSAC members have already proposed certain changes, which will be publicly released no less than 2 two days prior to the meeting. The proposed edits likely are aimed at resolving at least some of the known issues with the March report. The public is invited to provide written or oral comments on the report for the committee's consideration on July 21.
The TPSAC will then spend the afternoon of July 21 and all day on July 22 to begin the process of creating its statutorily mandated report regarding dissolvable tobacco products. Similar to the Menthol Report, the dissolvable tobacco report will consider i) risks and benefits to the population as a whole; ii) the impact of dissolvable products on the likelihood of tobacco use cessation; and iii) the impact of dissolvable products on the likelihood of tobacco use initiation. TPSAC is required to deliver the dissolvable tobacco report to CTP by March 23, 2012.
Written comments on the Menthol Report or on dissolvable tobacco products must be submitted to FDA by July 5, 2011. Requests to speak during the public hearing sessions on either topic must be received by June 27, 2011.