CLARENCE, N.Y.--(BUSINESS WIRE)--22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced today that in a communication received by the Company, the Food and Drug Administration (FDA) has formally acknowledged receipt of the Company’s Modified Risk Tobacco Product (MRTP) application for BRAND A Very Low Nicotine tobacco cigarettes.
22nd Century’s BRAND A tobacco cigarettes contain less than 0.6 mg nicotine per cigarette and less than 0.05 mg nicotine yield per cigarette – a reduction in nicotine of at least 95% as compared to conventional cigarettes. With more than 200 patents relating to the genes in the tobacco plant responsible for nicotine production, 22nd Century is the only company in the world capable of growing virtually nicotine-free tobacco. Though Very Low Nicotine cigarettes have the taste and sensory characteristics of conventional cigarettes, smokers’ exposure to nicotine is drastically reduced.
As a part of its review process, the FDA has assigned the following Submission Tracking Numbers (STN) to 22nd Century’s historic MRTP application: MR0000047 and MR0000048. Though not yet publicly linked on FDA’s website, these tracking numbers will remain with the Company’s MRTP application throughout the FDA’s review and authorization process. After 22nd Century redacts all confidential information from its MRTP application, the document will be released to the public on FDA’s website at www.fda.gov
According to FDA guidance literature, the MRTP application process results in a “Final Review and Action” by FDA within the 360 days of the receipt of an application that contains the information required by Section 911 of the FD&C Act.
“The feedback received to date from the FDA on our MRTP application for BRAND A is as expected,” explained Gregg Gellman, Director of Business Development and Regulatory Affairs at 22nd Century Group. “22nd Century is committed to providing the FDA with any and all empirical data needed to support a marketing order for the Company’s novel Very Low Nicotine product. It is our intention to work collaboratively with FDA in order for 22nd Century to be allowed to offer millions of American smokers the first and only reduced exposure product choice.”
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants through genetic engineering and plant breeding. The Company’s primary mission is to reduce the harm caused by smoking. 22nd Century currently owns or exclusively controls more than 200 issued patents and more than 50 pending patent applications around the world. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com and www.magiccigarettes.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, 2015, filed on February 18, 2016, 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.