New addition brings design and commercialization experience with multiple FDA regulated products
CLARENCE, N.Y.--22nd Century Group, Inc. ($XXII), a leader in tobacco harm reduction, announced today the appointment of Gregg M. Gellman as the Company’s Director of Business Development and Regulatory Affairs. Hired for his experience in achieving FDA compliance approval for various types of products, Mr. Gellman will be tasked with driving 22nd Century’s regulatory affairs strategies for the Company’s two modified risk cigarettes in development: “BRAND A,” the world’s lowest nicotine tobacco cigarette, and “BRAND B,” the world’s lowest tar-to-nicotine ratio cigarette.
“Unlike some of our larger competitors, who market their products with implied health claims, 22nd Century is committed to working collaboratively with the FDA to demonstrate that our Very Low Nicotine cigarettes and our Low Tar-to-Nicotine Ratio cigarettes are legitimate – and enormously important – modified risk tobacco products.”
Throughout his career, Mr. Gellman has worked intimately with the FDA to ensure products in his charge are designed and tested to be compliant with all FDA regulations. As a development and medical device manager at Greatbatch, Inc. ($GB), Mr. Gellman managed the design process and commercialization of multiple FDA-regulated products. Mr. Gellman has also proven himself an innovator in the development of new products and has amassed extensive experience in technical and clinical sales training for products ultimately approved by the FDA. Mr. Gellman is a graduate of the State University of New York at Buffalo and is certified in Quality Systems for Medical Devices (FDA’s QSR and ISO 13485) and in Global Product Submissions Directive Requirements (510(k), PMA, CE Mark).
“Hiring Gregg Gellman represents another important step in 22nd Century’s mission to bring reduced exposure cigarettes to American smokers,” explained Henry Sicignano, III, CEO and President. “Unlike some of our larger competitors, who market their products with implied health claims, 22nd Century is committed to working collaboratively with the FDA to demonstrate that our Very Low Nicotine cigarettes and our Low Tar-to-Nicotine Ratio cigarettes are legitimate – and enormously important – modified risk tobacco products.”
Aiming to become the first company in the world authorized by the FDA to market reduced exposure combustible cigarettes, 22nd Century intends to submit its application for “BRAND A” to the FDA this fall. At the same time, because regulatory pre-approval is not required to label Very Low Nicotine cigarettes outside of the United States, the Company will expand distribution of its MAGIC 0 Very Low Nicotine cigarettes in Europe. As sufficient funds are secured for additional exposure studies, the Company intends to submit in 2016 an application to the FDA for “BRAND B.”
22nd Century’s 185 issued patents make possible the Company’s two modified risk cigarettes in development. Without a license from 22nd Century, no other company can grow, make, or buy 22nd Century’s proprietary Very Low Nicotine tobacco (95% less nicotine content than conventional tobacco), or 22nd Century’s proprietary Very High Nicotine tobacco leaf that will make possible “BRAND B,” the world’s lowest tar-to-nicotine ratio cigarette.
About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants through genetic engineering and plant breeding. The Company’s mission is to reduce the harm caused by smoking. 22nd Century currently owns or exclusively controls more than 185 issued patents and more than an additional 54 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 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. 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 year ended December 31, 2014, filed on February 6, 2015, 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.
For 22nd Century Group, Inc.
Andrew Haag, 866-976-4784
Tom Redington, 203-222-7399
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