22nd Century Group is a plant biotechnology company focused on reducing nicotine in tobacco and creating new hemp/cannabis plants
Our Mission to Reduce Nicotine in Tobacco
We believe the best way to reduce the harm caused by smoking is for smokers to quit smoking and for non-smokers to never start smoking. While we believe there is no such thing as a safer cigarette, we believe smokers who cannot or will not quit smoking will benefit from the reduction of the nicotine content of cigarettes to non-addictive levels. Our proprietary genetic engineering technology and plant breeding expertise allow us to regulate the level of nicotine (and other nicotinic alkaloids) in the tobacco plant.
Using our proprietary, reduced-nicotine tobacco varieties, we have created a tobacco product that looks like a conventional cigarette, smokes like a conventional cigarette and tastes like a conventional cigarette, but that is surprisingly unconventional. When measured by independent laboratories, our reduced-nicotine tobacco cigarettes have been confirmed to contain at least 95% less nicotine than conventional cigarettes. Through our many patents covering the nicotine biosynthetic pathway in the tobacco plant, we have the proprietary technology that makes this achievement possible. After many years and tens of millions of dollars invested in research, development, intellectual property, and regulatory review, we are poised to make our reduced-nicotine content cigarettes available to smokers across the U.S.
In 2011, we developed our unique SPECTRUM® research cigarettes in partnership with independent researchers and officials from the National Institute on Drug Abuse (NIDA), which is part of the National Institutes of Health (NIH); the U.S. Food and Drug Administration (FDA); the National Cancer Institute (NCI); and the Centers for Disease Control and Prevention (CDC). Made with the Company’s proprietary, reduced nicotine tobacco, SPECTRUM® research cigarettes are used in independent clinical research to investigate the public health benefits of reduced nicotine content cigarettes. To date, we have manufactured more than 28 million SPECTRUM® research cigarettes for use in dozens of independent scientific clinical studies, at an estimated cost of more than $100 million. These studies, conducted by numerous independent researchers at universities and institutes around the world, as well as several agencies of the U.S. federal government, including FDA and NIH, show unequivocally the benefits of reduced nicotine content cigarettes for smokers and public health. Researchers have found that smokers – even those with no intention of quitting smoking – who use our reduced nicotine content cigarettes exclusively:
- smoke 50% fewer cigarettes per day, on average,
- show reduced levels of biomarkers of nicotine and other toxicants,
- show reduced nicotine dependence, with minimal evidence of nicotine withdrawal or compensatory smoking,
- have more days where they smoke no cigarettes (cigarette-free days), and
- increase their attempts to quit smoking.
FDA’s Plan to Reduce Nicotine in Cigarettes
The extensive, far-reaching and independent science on reduced-nicotine content cigarettes underlies and supports the FDA’s proposed plan to require the reduction of nicotine to minimally or non-addictive levels in all cigarettes sold in the U.S. The reduction of nicotine in combustible cigarettes can encourage and assist smokers to switch to potentially less harmful nicotine products like smokeless tobacco and electronic nicotine delivery systems, such as heated tobacco products and vape devices. Studies have shown that the FDA’s plan, which was first announced in July 2017, is supported by more than 80% of U.S. smokers. Since nearly 70% of U.S. smokers want to quit smoking and yet less than 5% are able to quit smoking each year, the FDA’s action to reduce nicotine in cigarettes to non-addictive levels is urgently needed. The FDA’s own assessment of its plan to regulate nicotine to levels already achieved by 22nd Century’s products states that it could lead to 5 million additional adult smokers quitting one year after implementation and over 8 million American lives potentially saved by the end of this century. Implementation of the FDA’s plan will be an important success for smokers, for public health and for 22nd Century Group.
22nd Century Group’s FDA Applications
The enormous body of clinical research that underlies FDA’s plan to reduce nicotine in all cigarettes also supports 22nd Century’s own applications seeking FDA’s authorization to sell and market our proprietary reduced nicotine content cigarettes to adult smokers across the U.S. In December 2018, 22nd Century submitted two applications to FDA using the regulatory pathways created by the U.S. Congress in 2009 in the Family Smoking Prevention and Tobacco Control Act, which gave to FDA regulatory oversight of tobacco products. Our Company’s Pre-Market Tobacco application (PMTA) requested that FDA authorize the sale of our reduced nicotine content cigarettes, while our Modified Risk Tobacco Product (MRTP) application requested that FDA authorize the marketing of our reduced-nicotine content cigarettes under the brand name VLN® with several claims, including “95% Less Nicotine.”
In an important move, FDA authorized 22nd Century’s PMTA in December 2019. Having successfully navigated the PMTA regulatory process, 22nd Century is now the first and only company to have ever successfully applied for and received an FDA authorization to sell a new combustible cigarette in the U.S. 22nd Century’s reduced-nicotine content cigarettes are now the only combustible cigarettes to have been – and likely ever to be – found “appropriate for the protection of public health,” which is the standard that every new tobacco product must meet before it can be authorized for sale in the U.S. With the PMTA authorization now in hand, 22nd Century looks towards FDA’s authorization of our MRTP application for VLN® cigarettes which will allow our Company to explain to adult smokers the reduced nicotine content of our VLN® cigarettes and how adult smokers can benefit from them.
Importantly, the Company has also requested in its MRTP the authorization to include a voluntary consumer warning in all labeling and advertising stating: “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.”
22nd Century Group is Driving Change in the Tobacco Industry
22nd Century believes that FDA’s authorization of our Company’s reduced nicotine content cigarettes will be a major milestone in pursuit of FDA’s goal to require all cigarettes in the U.S. to be made non-addictive. Long-term, consistent and strong interest from adult smokers in 22nd Century’s reduced nicotine products has led our Company to believe that when our reduced-nicotine content cigarettes are commercially available, demand from adult smokers will be robust. Just as many consumers have switched to coffee without caffeine, and beer without alcohol, smokers are seeking alternatives to conventional cigarettes. Many smokers have tried nicotine patches, nicotine gum, pharmaceuticals and various electronic nicotine delivery systems, yet 34 million adults in the U.S. and 1 billion people in the world continue to smoke – a testament to the powerful, addictive nature of conventional cigarettes.
22nd Century believes that our ground-breaking products will disrupt and remake the entire tobacco industry. After many years and tens of millions of dollars invested in research, development and regulatory review, we are poised to bring our reduced nicotine content to smokers across the U.S. – and eventually around the world
Our Mission to Create New Hemp/Cannabis Plants
In our own labs and in partnership with some of the world’s leading plant scientists, 22nd Century is developing new hemp/cannabis research technologies, patents, and plant varieties. Leveraging our extensive knowledge and expertise in plant biotechnology, intellectual property, regulatory affairs and consumer packaged goods, we have created and we are working to continue to create hemp/cannabis plants with valuable new traits, such as zero-THC content, higher levels of CBD, and higher levels of many of the one hundred or more minor cannabinoids found naturally in the hemp/cannabis plant. Cannabinoids are biologically active and are rapidly proving to be a treasure trove of important medical and wellness applications. The Company’s new hemp/cannabis plants with optimized cannabinoid profiles, superior agronomic traits and the resulting intellectual property protecting these plants and the technology of producing such unique plants, will enable important clinical research, drive down costs across the hemp/cannabis value chain, and make possible the introduction of valuable new hemp-derived, cannabinoid products for consumers.
22nd Century Group’s Leading Hemp/Cannabis Plant Science and Patents
22nd Century entered the hemp/cannabis plant research field in 2014 through a research partnership with Anandia Labs, a Canadian company founded by Jonathan Page, PhD, a former researcher with the National Research Council of Canada who was involved in reduced nicotine tobacco and hemp/cannabis plant research. A multi-year hemp/cannabis plant research partnership with Anandia yielded important new breakthroughs for 22nd Century Group. First, our Company received the U.S. rights from Anandia to key patents covering the cannabinoid biosynthetic pathway in hemp/cannabis plants and in other organisms. Second, Anandia created for us a number of new hemp/cannabis plant lines with valuable cannabinoid profiles, including lines with zero-THC and other lines with high levels of cannabinoids, such as CBD and CBG. These novel plant lines continue in our plant development pipeline today.
Today, our most important hemp/cannabis research partnership is with KeyGene. KeyGene is a world leader in plant research, specializing in modern plant breeding techniques for numerous horticultural crops. KeyGene uses its proprietary gene-editing and other modern plant breeding techniques to rapidly create new plants with significant commercial value. Through an exclusive, global partnership with 22nd Century, KeyGene is now applying its significant capabilities to hemp/cannabis plants. 22nd Century will solely own all of the new plants and patents created by KeyGene in hemp/cannabis.
Differentiation through Plant Science
22nd Century is a leading company in the hemp/cannabis field because of our Company’s hemp/cannabis genetics, intellectual property and proprietary plant breeding and genetic engineering expertise. Our Company intends to bring to market our new and unique hemp/cannabis plants in development and to commercialize our developing hemp/cannabis intellectual property portfolio through a series of synergistic business partnerships. The first of these important partnerships is with Panacea Life Sciences, a fast-growing, vertically integrated, hemp/CBD company based in Golden, Colorado that produces many types of hemp-derived cannabinoid products. In December 2019, 22nd Century made an initial investment in Panacea with plans for continued investment as Panacea’s business grows. In this way, with the help of strategically-placed partners, 22nd Century looks to enhance and expand upon its leadership position in this emerging field through our science-driven activities.