FDA Tobacco Products Scientific Advisory Committee will conduct a public hearing regarding 22nd Century Group’s modified risk tobacco product application for its VLN cigarettes.

22nd Century Group, Inc. a plant biotechnology company that is a leader in tobacco harm reduction, Very Low Nicotine Content (VLNC) tobacco and hemp/cannabis research, announced that the FDA Tobacco Products Scientific Advisory Committee (TPSAC) will conduct a public hearing on Friday, 14 February 2020, regarding 22nd Century Group’s Modified Risk Tobacco Product (MRTP) application for its VLNC cigarettes under the proposed brand name of VLN cigarettes. During the upcoming TPSAC meeting, representatives from the FDA’s Center for Tobacco Products’ Office of Science and 22nd Century Group will present information about the Company’s MRTP application currently under FDA scientific review. TPSAC members will discuss the available scientific evidence related to the issues and questions posed to TPSAC by FDA about the Company’s MRTP application. TPSAC voting members will vote on specific issues and questions presented by the FDA and on other topics that arise during the committee’s public hearing. The TPSAC meeting is a required step in the FDA’s review of 22nd Century Group’s request to commercialize VLN cigarettes in the United States as a “Modified Risk Tobacco Product.” While the advice to the FDA from TPSAC is not binding, FDA nevertheless takes into consideration the insights from TPSAC members, together with public comments and other information made available to the FDA, before making a determination on an MRTP application. TPSAC consists of representatives from public health and non-voting members from the tobacco industry. The meeting will be open to the general public, and the FDA is accepting written submissions from the public until February 7, 2020. Nicotine has long been known as the primary addictive chemical in cigarettes. 22nd Century’s VLN cigarettes, with at least 95% less nicotine as compared to conventional cigarettes sold in the United States, greatly diminish nicotine exposure versus conventional cigarettes that contain highly addictive levels of nicotine. In a Special Report published in the May 2018 issue of the New England Journal of Medicine, a statistical model funded by the FDA predicted that if all cigarettes in the United States were required to have very low nicotine content, approximately 5 million smokers would quit smoking within a year and that number would increase to a total of 13.0 million within 5 years.