BRAND A cigarettes have 95% less nicotine than “Big Tobacco” cigarettes.
On Dec. 31, 2015, Goodrich Tobacco Co., a wholly owned subsidiary of 22nd Century Group, Inc., submitted a Modified Risk Tobacco Product (MRTP) application to the U.S. Food and Drug Administration (FDA) seeking a reduced exposure order. The move was made so that 22nd Century’s “BRAND A” Very Low Nicotine (VLN) cigarettes may be introduced into commerce in the U.S.
The application to the FDA requests that BRAND A packaging and marketing be allowed to disclose to consumers that the Company’s proprietary Very Low Nicotine cigarettes reduce smokers’ exposure to nicotine.
The World’s Lowest Nicotine Tobacco Cigarettes
BRAND A cigarettes contain less than 0.6 milligrams of nicotine per cigarette and less than 0.05 milligrams nicotine yield per cigarette. In each case, this represents a reduction of at least 95% less nicotine relative to “Big Tobacco” cigarette brands, including Marlboro, Camel, Newport and American Spirit. With more than 200 patents relating to the genes in the tobacco plant responsible for nicotine production, 22nd Century is the only company in the world capable of producing virtually nicotine-free tobacco. Without any artificial extraction or chemical processes, 22nd Century’s BRAND A cigarettes are made with the Company’s proprietary VLN tobacco that is grown on independently-owned farms in the U.S. The finished cigarettes have the taste and sensory characteristics of conventional cigarettes, but contain only trace amounts of nicotine so that smokers’ exposure to nicotine is drastically reduced.
Under Section 911 of the federal Food, Drug and Cosmetic Act, a tobacco product may not be introduced for commerce in the U.S. if the label or advertising represents that the tobacco product contains a reduced level of a substance or a reduced exposure to a substance unless given specific approval to do so by the FDA.
“The scientific testing conducted in support of our submission to the FDA shows conclusively that BRAND A, as compared to conventional tobacco cigarettes, provides smokers with drastically reduced exposure to nicotine,” explained Henry Sicignano, III, president and CEO of 22nd Century Group. “We believe that the public health implications of a virtually nicotine-free tobacco cigarette are enormous and 22nd Century is excited about the prospect of introducing BRAND A into the U.S. market.”
It has been well established that cigarette smoking is toxic and poses health risks to smokers. Cigarette smoking is a complex behavior that is sustained primarily by the pharmacological properties of nicotine. Accordingly, many public health officials believe it is a critically important health need to provide consumers with a product that reduces exposure to nicotine. This fact echoes former U.S. FDA commissioner David Kessler’s recommendation that “the FDA should quickly move to reduce nicotine levels in cigarettes to non-addictive levels… It is the ultimate harm reduction strategy.”
Unlike so-called “light” or “ultra-light” cigarettes (which terms are now banned by the FDA from labeling and marketing in the U.S.), 22nd Century’s proprietary BRAND A cigarettes are designed to deliver greatly reduced ratios of nicotine to other smoke components. The Company’s application to the FDA provides a comprehensive overview of the many independent clinical trials that have found that smoking 22nd Century’s VLN cigarettes delivers the sensory and behavioral experience associated with conventional cigarettes while providing only minimal exposure to the most addictive component of tobacco.
Most recently, in October 2015, The New England Journal of Medicine published a landmark clinical study led by the Center for the Evaluation of Nicotine in Cigarettes. The double-blind, parallel, randomized clinical trial by Donny et al involved 840 smokers at ten locations who were randomly assigned to smoke for six weeks either their usual brand of cigarettes or one of six types of investigational cigarettes. The researchers concluded that:
As compared with cigarettes of conventional nicotine content, 22nd Century’s proprietary Very Low Nicotine cigarettes were “associated with reductions in smoking, nicotine exposure and nicotine dependence, with minimal evidence of nicotine withdrawal, compensatory smoking or serious adverse events.”
“The current study by Donny and colleagues adds to a growing literature supporting the feasibility and potential benefits of a national nicotine reduction policy…” explained public health policy reform advocates, Michael Fiore and Timothy Baker in a companion article in the same issue of The New England Journal of Medicine. “Reducing the nicotine content of combustible tobacco to levels that will not sustain dependence seems to us to be the most promising regulatory policy option for preventing [at least] 20 million premature deaths.”
The available scientific literature shows that smoking 22nd Century’s VLN cigarettes results in reduced nicotine exposure with minimal compensatory smoking behavior and no greater exposure to harmful or potentially harmful toxicants, particularly when exposure is maintained for longer than one week. Similarly the prolonged use of VLN cigarettes seems to result in a decrease in dependence.
“It is the goal of the U.S. Department of Health and Human Services, as outlined in the program Healthy People 2010, to reduce cigarette smoking in the U.S. to 12% by the year 2020,” explained Gregg Gellman, 22nd Century’s director of regulatory affairs. “Based on the scientific rationale and clinical data referenced in our application to the FDA, we believe 22nd Century’s proprietary Very Low Nicotine cigarettes could be an invaluable tool in helping to drastically reduce smokers’ exposure to nicotine and thereby greatly reducing cravings for, and consumption of, cigarettes.”
With approximately 277 billion cigarettes manufactured in the U.S. in 2014 – representing more than $80 billion in sales – the cigarette market in the U.S. remains enormous. At present, however, the U.S. is completely devoid of any “reduced exposure cigarette” option. If 22nd Century’s application to the FDA is successful, the Company’s VLN cigarettes will offer millions of American smokers a distinct reduced exposure product choice.