22nd Century Group to File Modified Risk Cigarette Applications with the FDA

CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (OTCBB: XXII), a company focused on tobacco harm reduction and smoking cessation, announced that applications will be filed with the FDA for two types of modified risk cigarettes in accordance with the FDA’s March 30, 2012 Draft Guidance on Modified Risk Tobacco Product Applications. 22nd Century also issued the following comments on the FDA’s draft guidance, including the company’s position that availability of less hazardous cigarettes should complement efforts to prevent the initiation of tobacco use and encourage smoking cessation in the interest of promoting public health.

The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) requires the U.S. Food and Drug Administration (FDA) to evaluate modified risk (potentially “safer” or less hazardous) tobacco products that reduce exposure to harmful substances, as compared to leading brands. Upon demonstrating compelling scientific evidence of reduced exposure and that a reduction in morbidity and mortality is probable, the advantages of a modified risk tobacco product may then be conveyed to consumers (pursuant to the statutory requirements of the Tobacco Control Act).

The FDA’s Draft Guidance on Modified Risk Tobacco Product Applications provides the framework for applicants to submit data for modified risk product candidates. Goodrich Tobacco Company, 22nd Century’s subsidiary, has developed two types of revolutionary modified risk tobacco cigarettes and applications for these cigarettes will be filed with the FDA in the second half of 2012.

The first proprietary cigarette, referred to as BRAND A, is a very low nicotine (VLN) cigarette containing approximately 95 percent less nicotine than the leading U.S. cigarette brands. Brand A is patented in dozens of countries and contains the world’s lowest nicotine tobacco. 22nd Century’s recent Phase II-B clinical trial and studies by independent researchers (Hatsukami et al, 2010) have demonstrated that smoke exposure (and cigarettes per day) are significantly reduced with VLN cigarettes.

The second proprietary cigarette, referred to as BRAND B, is a low-tar cigarette with a relatively higher nicotine content, effectively the world’s lowest tar-to-nicotine ratio cigarette. Unlike low-tar/low-nicotine brands currently on the market (previously labeled “light” or “ultra- light” before these descriptors were banned in the U.S. by the Tobacco Control Act in 2010), the nicotine yield of BRAND B is not reduced. Studies have demonstrated that compensatory smoking (e.g., more and/or larger puffs per cigarette) of low-tar research cigarettes, similar to BRAND B, is greatly curtailed (Russell MAH 2000).

Dr. Michael Moynihan, 22nd Century’s vice president of R&D, stated, “Our company strongly believes that, as stated in the FDA’s guidance, ‘Modified risk tobacco product provisions of the FD&C Act may be valuable tools in the effort to promote public health by reducing the morbidity and mortality associated with tobacco use.’ The FDA’s guidance concerning the types of scientific evidence needed to support a modified risk application is an important step toward making those tools truly useful for promoting public health.”

On March 30, 2012, the FDA also released Draft Guidance on Harmful and Potentially Harmful Constituents in Tobacco Products. Although 22nd Century applauds the FDA’s requirement that tobacco companies will be required to report levels of 93 harmful and potentially harmful constituents (HPHCs) for every tobacco product sold in the U.S., there are more than 7000 constituents in tobacco smoke. Estimates of the risk from exposure to individual smoke constituents that have been analyzed show that many different compounds contribute to the risk of smoking, and even complete removal of any one compound or class of compounds, such as NNK or all tobacco specific nitrosamines (TSNAs), would do little, if anything, to reduce the risks from smoking (Pankow et al. 2007; Watanabe et al. 2009; Haussmann 2012).

There is a clear dose-response relationship between the level of tobacco smoke and disease; the higher the dose of tobacco smoke, the greater the incidence of disease. 22nd Century believes that the only types of cigarettes that may significantly reduce risks from smoking are those that reduce exposure to the complex mixture of the thousands of compounds in tobacco smoke through consumption of fewer cigarettes per day and/or inhalations of less smoke per cigarette.

22nd Century’s CEO, Joseph Pandolfino stated, “We expect to demonstrate to the FDA that BRAND A and BRAND B reduce exposure to tobacco smoke. If the dose of smoke inhaled is reduced significantly, reduced risk is expected.”

Although there is an overwhelming scientific, medical, public-health and tobacco-industry consensus that use of smokeless tobacco products (such as snus, snuff, chewing tobacco and dissolvable tobacco products) are less hazardous than smoking cigarettes, 22nd Century strongly believes that the Tobacco Control Act will be limited in promoting public health unless a proactive and aggressive approach is taken by the FDA to mandate less hazardous cigarettes.

There are 6 times more cigarette smokers in the U.S. than users of smokeless tobacco products. According to the U.S. Centers for Disease Control and Prevention, approximately 45 million or 20 percent of adults smoke cigarettes. Only 3.5 percent of adults use smokeless tobacco products. Among certain demographics, smokeless tobacco products are barely used in the U.S. For example, 0.3 percent of women and 1 percent of African Americans use smokeless tobacco products.

22nd Century and everybody in the public health community agree that core strategies to reduce tobacco-related harm should be focused on discouraging initiation of tobacco use and promoting cessation. However, some believe that the next best public-health strategy is to encourage smokers to switch to smokeless tobacco products, rather than strategies that encourage the availability of less hazardous cigarettes. 22nd Century strongly believes the latter will prove much more effective in reducing tobacco-related harm in the U.S. since cigarette smoking is the most hazardous, and by far, the most common form of tobacco consumption.

The vast majority of smokers and virtually all women smokers have no interest in using smokeless tobacco products (McClave-Regan et al. 2011). Mr. Pandolfino added, “The idea that converting smokers to smokeless tobacco products can be a more effective policy for tobacco harm reduction rather than focusing on the availability of less hazardous cigarettes is a straw man fallacy. The U.S. and global tobacco markets are dominated by cigarettes and will continue to be for decades.”

For additional information on 22nd Century Group, please visit: www.xxiicentury.com

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Redington, Inc.
Tom Redington, 203-222-7399

Source: 22nd Century Group, Inc.