CANNAINVESTOR Magazine August 2016 - Page 73

The Company opened its own fully-outfitted molecular biology laboratories on the Buffalo Niagara Medical Campus. At the same time, the Company launched a groundbreaking new initiative to produce medically-important marijuana cannabinoids in tobacco plants. The Company believes that this tobacco-based approach (that is proprietary to 22nd Century) has a possibility of “leap-frogging” existing cannabis biotechnology and yielding commercial medical products far more rapidly than traditional cannabis breeding programs. The Company also continues to work on a very low-THC hemp plant under its sponsored research with Anandia Labs in Vancouver, Canada for the world-wide commercial hemp market.

Following the introduction of new “deeming regulations” by the FDA’s Center for Tobacco Products affecting tobacco products other than cigarettes (i.e. premium cigars, filtered cigars, loose tobacco and other products), our Company developed a comprehensive strategy to continue to legally make competitive 3+lb filtered cigars. If our forthcoming Substantial Equivalence (S.E.) applications to the FDA relating to filtered cigars are approved, our NASCO manufacturing facility may secure a competitive advantage in the production of filtered cigars. Indeed, our strategy to navigate the complex new FDA deeming regulations has already resulted in obtaining 8 new contract manufacturing customers for NASCO that will begin production at various times throughout 2017.

The Centers for Disease Control and Prevention (CDC) published a detailed characterization of the Company’s SPECTRUM® variable nicotine research cigarettes identifying 22nd Century’s proprietary cigarettes as an important tool for investigating reduced nicotine cigarettes on nicotine addiction.

Several new independent clinical studies were published providing further evidence that Very Low Nicotine cigarettes reduce the harm of smoking, even among groups of at-risk people. Notably, the Cancer Epidemiology Biomarkers and Prevention (CEBP) journal published a study on April 17, 2016 which found that using 22nd Century’s proprietary Very Low Nicotine tobacco cigarettes “may reduce harm exposure.” The researchers concluded that the study’s data provide “further support of reduced smoking and exposure with very low nicotine content cigarettes.” Another study published in the journal Alcoholism: Clinical and Experimental Research concluded that switching to the Company’s Very Low Nicotine cigarettes may lead not only to a reduction in smoking, but also to a reduction in alcohol use. The 403-subject study concluded that a national “nicotine reduction standard could further improve public health by reducing alcohol use among individuals who reduce their nicotine exposure and smoking rate.”

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