22nd Century Announces the Immediate Feasibility of the FDA’s Nicotine Reduction Plan - Seite 2

In preparation for the prompt implementation of the new FDA rule, 22nd Century is already growing increased amounts of the Company’s VLN™ tobacco in order to be able to supply a sufficient quantity of the Company’s proprietary VLN™ tobacco seeds to grow enough VLN™ tobacco for the entire U.S. tobacco industry in just one growing season.

In contrast, Reynolds American (a subsidiary of British American Tobacco) is apparently incapable of matching 22nd Century’s achievements and meeting a standard for minimally or non-addictive tobacco cigarettes. In Reynolds American’s July 13, 2018 response to the FDA’s ANPRM , Michael Ogden, Ph.D., Senior Vice President of RAI Services (which is part of Reynolds American), explains:

“At the present time… the science lags behind on this important issue and additional methods, possibly used in conjunction with traditional breeding practices, would need to be developed. RAIS believes that the industry is at least 20 years away from producing tobacco at a commercial scale that would meet the range of low-level nicotine discussed in the ANPRM.”

Conversely, 22nd Century already has an extensive portfolio of patented technologies and unique VLN™ tobacco plants in burley and flue-cured varieties and is continuing to develop new VLN™ varieties with improved agronomic traits. RAIS’ comments on the ANPRM went on to recognize 22nd Century’s leadership in creating tobaccos with very low levels of nicotine:

“Commercialization of such products [tobaccos with very low levels of nicotine] is also made difficult by: (1) the fact that genome editing technology (CRISPR-cas9) currently does not appear to be available to tobacco companies; and (2) the various patent restrictions on the use of certain genetic-engineering techniques (the patents on nicotine synthesis pathway genes, for example, are held almost exclusively by 22nd Century Group).” (emphasis added)

Reynolds American is not the first to suggest that it will take multi-national tobacco companies 20-years to develop tobacco with very low levels of nicotine. As reported by Sam Chambers of Bloomberg Business, Rolf Lutz, Director of Product Policy at Philip Morris International Inc. estimated “it would cost the company $10 billion to $12 billion to extract nicotine from all the cigarettes it sells across the European Union.” Chambers went on to report: “Lutz said the cost could be minimized by genetically modifying tobacco plants, but this would take about 20 years.” (emphasis added)