FDA Accepts and Files 22nd Century Group’s Modified Risk Tobacco Product Application for VLN™ Cigarettes

WILLIAMSVILLE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is a world leader in tobacco harm reduction, announced today that the U.S. Food and Drug Administration (FDA) accepted and filed for substantive scientific review the Company’s Modified Risk Tobacco Product (MRTP) application for its exclusive Very Low Nicotine Content (VLNC) cigarettes under the proposed brand name of VLNTM. 22nd Century’s proposed VLNTM cigarettes are made with the Company’s proprietary VLNC tobacco and, as a result, contain very low levels of nicotine.

“FDA acceptance and filing of our MRTP application marks an important milestone in our mission to reduce the harm caused by smoking,” explained Michael Zercher, Chief Operating Officer of 22nd Century Group. “We look forward to working with FDA as the agency enters the next phase of its review process for our historic application.”

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology which 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. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in hemp/cannabis is to develop proprietary hemp/cannabis plants for important new medicines and agricultural crops. Visit www.xxiicentury.com for more information.

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.

22nd Century Group
James Vail, Director of Communications
716-270-1523
jvail@xxiicentury.com

Source: 22nd Century Group, Inc.