CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (XXII) (NYSE MKT:XXII) announced today that the Center for Tobacco Products (CTP) of the U.S. Food and Drug Administration (FDA) has granted the Company a meeting on November 12, 2014 to discuss the further development of the Companys potential modified risk tobacco product, code-named BRAND B (BB-1), which is a cigarette that is designed to provide an exceptionally low tar-to-nicotine yield ratio. As compared to other commercial low-yield cigarettes, the only differentiating factor of the BB-1 cigarette is that 22nd Centurys proprietary high-nicotine tobacco is used, which tobacco is planted, grown, harvested, cured, and processed in exactly the same manner as conventional commercial tobacco.
Pursuant to the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), the Company intends to demonstrate, through BB-1 exposure studies, compelling scientific evidence that 22nd Centurys cigarettes (i) reduce exposure to tobacco toxins and (ii) are reasonably likely to result in a measurable and substantial reduction in morbidity or mortality among individual tobacco users. The purpose of the Companys meeting with CTP will be to seek the Agencys concurrence that 22nd Centurys proposed BB-1 clinical study is adequate to support the development of BB-1 as a potential modified risk tobacco product.
22nd Century believes that BB-1 will allow smokers to obtain a satisfactory amount of nicotine per cigarette while inhaling less smoke, including tar and carbon monoxide. Commercial cigarette brands average a tar-to-nicotine ratio of approximately 13 to 1, meaning that the smoker must inhale 13 parts tar for every 1 part nicotine. The tar-to-nicotine ratio of BB-1 is approximately 6 to 1.
By utilizing a combination of 22nd Centurys proprietary high-nicotine content tobacco and a special low-yield cigarette design, BB-1 has the nicotine yield of a commercial full flavor cigarette, but the tar yield of an ultra-light commercial cigarette. Consequently, the Company expects that BB-1 cigarettes will curtail the compensatory smoking behaviors (such as taking bigger puffs and more puffs per cigarette) associated with what were formerly known in the United States as light and ultra-light cigarettes due to diluted nicotine amounts in the smoke, as compared to their full flavor (high yield) counterparts. The Tobacco Control Act banned the use of light, ultra-light and similar descriptors on the labeling and advertising of cigarettes since these types of cigarettes generally do not reduce smoke exposure.
Joseph Pandolfino, Founder and CEO of 22nd Century Group, explained, BB-1 is designed to deliver a conventional amount of nicotine to smokers with substantially less smoke. We look forward to working with the during the development of this exciting product. With FDA concurrence, 22nd Century will conduct an exposure study on BB-1 in the first quarter of 2015.