TI JanFeb2016 • TPI Q1

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22 TOBACCO INTERNATIONAL JANUARY/FEBRUARY 2016 with minimal evidence of nicotine withdrawal, compensatory smoking, or serious adverse events.' "In a companion article of the same edition of The New England Journal of Medicine," Sicignano said, "Drs. Michael Fiore and Timothy B a k e r w r o t e t h a t ' R e d u c i n g t h e n i c o t i n e c o n t e n t o f c o m b u s t i b l e tobacco to levels that will not sustain dependence seems to us to be the most promising regulatory policy option for preventing—at least—20M premature deaths.' "The road from 22nd Century's inception in 1998 until now–including the growing scientific base supporting i t s V e r y L o w N i c o t i n e p r o d u c t – has been a challenging one. But the company never once gave up on its important mission which is to reduce the harm caused by smoking." We asked Sicignano about the company's plans for international distribution. "22nd Century currently markets Very Low Nicotine tobacco cigarettes i n S p a i n u n d e r t h e b r a n d n a m e 'MAGIC 0,'" Sicignano said. "The 'MAGIC 0' packaging is required to display the nicotine yield as '0.0 Nicotina.' In 2016, the company will introduce MAGIC Very Low Nicotine tobacco cigarettes in Holland, Italy, France and the UK. We have not yet publically disclosed our plans for further distribution." Sicignano also clarified where XXII fits in the broad continuum of alternative or emerging products. "If by 'emerging products' you mean e-cigarettes or 'heat-not-burn' technologies, then yes, the company has not pursued those," Sicignano explained. "That said, we are very happy to be the only company in the world capable of producing Very Low Nicotine tobacco—95 percent less nicotine than found in conventional tobaccos. Indeed, we believe that our Very Low Nicotine tobacco cigarettes will, upon FDA approval of 22nd Century's first MRTP application, m a k e i t p o s s i b l e f o r m i l l i o n s o f smokers to drastically reduce their exposure to nicotine. And for those seeking to quit, 22nd Century believes the company's Very Low Nicotine X-22 cigarettes in development will provide an effective and preferable path to smoking cessation." Addressing a popular concern with alternatives, we asked Sicignano what his feeling was about the use of TURN OF THE XXII CENTURY Simplified nicotine molecule. 22nd Century is a plant biotechnology company focused on harm reduction and increasing or decreasing the level of nicotine in tobacco plants.

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