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.

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.  Oral presentations from the public, which will be picked by lottery, are scheduled between 10:45am and 11:45am on February 14, 2020. For those unable to attend in person, the meeting will also be webcast and will be available at the following link: https://collaboration.fda.gov/tpsac021420/.

Since 2011, the Company has supplied more than 28 million SPECTRUM® research cigarettes made with 22nd Century’s VLNC tobacco for use in numerous independent scientific studies funded by the National Institutes of Health (NIH) and other U.S. federal government agencies. Collectively, these studies show that smokers who use 22nd Century’s VLNC cigarettes (i) reduce their nicotine exposure and dependence, (ii) smoke fewer cigarettes per day, (iii) experience reduced withdrawal symptoms, (iv) increase their number of smoke-free days, and (v) double their quit attempts.

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. By the year 2100, the model estimates that approximately 33 million people would either quit smoking or not start smoking. The model further predicts that 8.5 million deaths will be averted, and 134.4 million life-years will be gained by the year 2100.

"Our regulatory team is very proud of the FDA’s decision on December 17, 2019, to issue marketing orders under our Company’s Premarket Tobacco Product Application (PMTA) permitting our Company’s  Moonlight® and Moonlight® menthol cigarettes to be marketed and sold in the United States," said John Pritchard, Vice President of Regulatory Science at 22nd Century Group. "We are excited by the opportunity to present to TPSAC our MRTP application and to taking another step toward driving meaningful change in the tobacco industry.”

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology that allows it to decrease the level of nicotine in tobacco plants and to modify the level of cannabinoids in hemp/cannabis plants through genetic engineering and modern plant breeding. 22nd Century’s growth strategies are focused on meaningful, long-term, shareholder value creation. The Company’s first strategic growth objective is to drive change in the tobacco industry by reducing the harm caused by smoking through the commercialization of its proprietary Very Low Nicotine Content tobacco and related intellectual property. The Company’s second strategic growth objective is to build a leading, profitable business in the fast-growing, emerging, legal hemp/cannabis space by leveraging the Company’s leadership in cannabis plant research, comprehensive expertise in FDA-regulated spaces, leadership team with deep experience in consumer-packaged goods, and strong and flexible balance sheet. To learn more about, 22nd Century please visit www.xxiicentury.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2018, filed on March 6, 2019, including the section entitled “Risk Factors,” and our other reports filed with the U.S. Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.

James Vail
22nd Century Group, Inc.
7162701523
jvail@xxiicentury.com

Source: 22nd Century Group, Inc.