22nd Century Group to Present its Modified Risk Tobacco Product Application to FDA’s Tobacco Products Scientific Advisory Committee

Meeting is next official step toward possible marketing authorization for 22nd Century Group’s VLN product in the United States

Williamsville, NY, Dec. 23, 2019 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is a leader in tobacco harm reduction, Very Low Nicotine Content (VLNC) tobacco and hemp/cannabis research, announced today that the U.S. Food and Drug Administration's (FDA) Tobacco Products Scientific Advisory Committee (TPSAC) will conduct a public hearing on Friday, February 14, 2020, regarding 22nd Century Group’s Modified Risk Tobacco Product (MRTP) application for its VLNC cigarettes under the proposed brand name of VLN cigarettes.

“We welcome the opportunity to publicly present our MRTP application and detail the science and evidence supporting the reduced exposure claims for VLN cigarettes,” said Michael Zercher, President and Chief Operating Officer of 22nd Century Group. “This public meeting is an important milestone for 22nd Century Group and for adult smokers who want to reduce their exposure to nicotine. 

“We believe that the authorization of our MRTP application would support the FDA’s goal to advance and implement a product standard to reduce the level of nicotine in all cigarettes sold in the U.S. to non-addictive levels. Authorization of our MRTP application for our proprietary VLN cigarettes also would be further proof of the scientific and technical achievability of the FDA’s proposed product standard to improve public health and save millions of lives.”

On July 17, 2019, the FDA accepted and filed for substantive scientific review the Company’s MRTP application for its unique VLN cigarettes made from the Company’s proprietary VLNC tobacco. The MRTP application seeks a reduced exposure marketing authorization from the FDA to allow VLN cigarettes to be marketed with the claim that they contain 95% less nicotine than conventional tobacco cigarettes, as well as other related claims.

22nd Century’s shareholders and the general public are invited to provide comments in support of 22nd Century’s MRTP application on the FDA’s official website at the following link: https://www.regulations.gov/comment?D=FDA-2019-N-0994-0001

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.