22nd Century has a very important mission: To Reduce the Harm Caused by Smoking. 22nd Century is a plant biotechnology company focused on technology that allows it to increase or decrease the level of nicotine in tobacco plants and the levels of cannabinoids in hemp/cannabis plants through genetic engineering and plant breeding. 22nd Century has an extensive intellectual property portfolio of issued patents and patent applications relating to the tobacco and hemp/cannabis plants.
In tobacco, 22nd Century has developed unique and proprietary Very Low Nicotine (“VLN”) tobacco plants that grow with 95% less nicotine than tobacco used in conventional cigarettes. Since 2011, 22nd Century has provided more than 24 million research cigarettes containing its proprietary tobaccos for use in numerous independent clinical studies, with agencies of the U.S. federal government investing more than $100 million in such independent clinical studies. The results of these independent clinical studies have been published in peer-reviewed publications and demonstrate that 22nd Century’s VLN tobacco has been associated with reductions in smoking, nicotine exposure, and nicotine dependence, with minimal evidence of nicotine withdrawal, compensatory smoking, or serious adverse events. The results of numerous completed and on-going clinical studies on 22nd Century’s VLN tobacco provide independent scientific support for the public announcement on July 28, 2017 by the U.S. Food and Drug Administration (“FDA”) that the FDA plans to require that all combustible cigarettes sold in the United States contain only minimally or non-addictive levels of nicotine. 22nd Century is investigating the potential use of its VLN tobacco in its own products that will be intended to comply with the new FDA regulations, as well as 22nd Century is investigating the potential license of the use of its VLN tobacco by third-parties. 22nd Century is also investigating potential opportunities relating to its VLN tobacco outside of the United States.
In hemp, 22nd Century is developing proprietary hemp strains for potential important new medicines and agricultural crops. 22nd Century’s current activities involve only work with legal hemp in full compliance with federal and state laws. 22nd Century has developed hemp plants with zero (-0-) amounts of delta-9-tetrahydrocannabinol (“THC”). 22nd Century’s ZERO-THC hemp plants will not develop THC above the legal limits for hemp. In the United States, 22nd Century is working with the University of Virginia (“UVA”) to (i) create unique industrial hemp plants with guaranteed levels of THC below the legal limits for optimal growth in Virginia, (ii) optimize other desirable hemp plant characteristics to improve the plant’s suitability for growing in Virginia and in similar legacy tobacco regions of the United States, (iii) utilize high-value medical cannabinoid hemp varieties and specialized cannabinoid extraction processes for use in human therapeutics, and (iv) use its unique hemp plants for phytoremediation to clean up and reclaim polluted soils. 22nd Century has also obtained a license in the State of New York to research and grow hemp in response to the numerous public announcements by New York Governor Andrew Cuomo that New York State intends to become a leading grower and producer of hemp and hemp-derived products. In Canada, 22nd Century conducts sponsored research on the hemp plant in full compliance with Canadian regulations.
22nd Century is primarily involved in the following activities:
· Facilitating the timely implementation of the plan by the FDA to require that all combustible cigarettes sold in the United States contain only minimally or non-addictive levels of nicotine;
· Continuing to work on a Modified Risk Tobacco Product (“MRTP”) application to be resubmitted to the FDA to obtain a reduced exposure marketing authorization for its “BRAND A” Very Low Nicotine cigarettes to be marketed in the United States as “less addictive” and/or containing 95% less nicotine than conventional tobacco cigarettes;
· Seeking multiple, substantial licensing agreements for its tobacco technology and/or its proprietary tobaccos;
· Continuing to produce SPECTRUM® research cigarettes for the National Institute on Drug Abuse (“NIDA”), which is part of the National Institutes of Health (“NIH”), for use in independent clinical studies;
· Continuing to research and develop other novel tobacco plant varieties; and
· Continuing to expand its legal hemp activities and development of unique plant varieties of hemp, including (i) hemp plants with other desirable agronomic traits in addition to low to no amounts of THC for the legal hemp industry, and (ii) hemp plants with high levels of cannabidiol (“CBD”) and other non-THC cannabinoids for the legal medical cannabinoid markets;