CLARENCE, N.Y. --(BUSINESS WIRE)-- 22nd Century Group, Inc. (OTCBB: XXII) announced today that its subsidiary, Goodrich Tobacco Company, LLC (Goodrich Tobacco) applied to the Alcohol and Tobacco Tax Trade Bureau of the United States Treasury Department (TTB) for a federal permit to manufacture its own tobacco products. Until now, Goodrich Tobacco has contracted with independent federally licensed tobacco manufacturers to produce its proprietary commercial products, RED SUN®, MAGIC® and SPECTRUM®. Goodrich Tobacco has always supplied its contract manufacturers with its own proprietary tobacco blends.
In parallel with becoming a federally licensed tobacco products manufacturer, Goodrich Tobacco is meeting with the National Association of Attorneys General (NAAG) to become a subsequent participating manufacturer (SPM) to the Tobacco Master Settlement Agreement, commonly referred to as the “MSA.” As an SPM producing its own tobacco products, Goodrich Tobacco will contribute funds in perpetuity to the MSA on every pack of cigarettes it sells and will agree to various restrictions on tobacco marketing practices required by the MSA.
By establishing its own manufacturing facility, Goodrich Tobacco will achieve additional flexibility in production, increased quality control, and a greater capacity for new product development. Besides becoming the manufacturing site for Goodrich Tobacco’s own commercial brands, RED SUN®, MAGIC® and SPECTRUM®, the new facility will also produce X-22, a very low nicotine cigarette currently going through the U.S. Food and Drug Administration (FDA) approval process as a prescription smoking cessation aid, and BRAND A and BRAND B, two potential less harmful cigarettes (as compared to leading brands) in development. Goodrich Tobacco expects to file a modified risk application with the FDA for BRAND A in the second quarter of 2013 and a modified risk application with the FDA for BRAND B in the third quarter of 2013. 22nd Century Group’s April 2012 press release describes the merits of BRAND A and BRAND B, Goodrich Tobacco’s potential modified risk cigarettes in development.
Hopefully the FDA won't stall on approving these applications, as I have been intrigued by the concept of Brand B for some time now. I am also looking forward to the day that I'll be able to actually try it out for myself.
The company’s management is looking forward to Goodrich Tobacco becoming a federally licensed tobacco product manufacturer and working with NAAG to become a member of the MSA. Goodrich Tobacco’s leased manufacturing facility is 6 miles from its headquarters in Clarence, New York. Henry Sicignano III, President of 22nd Century Group and Goodrich Tobacco, stated, “We believe our novel science-based tobacco products will emerge as highly distinctive brands among the sea of conventional cigarettes offered by our larger competitors. Due to 22nd Century’s groundbreaking proprietary technology, no other tobacco company in the world can duplicate our tobacco blends or match the product attributes of our highly differentiated super-premium cigarettes.”
About 22nd Century Group, Inc.
I suspect that becoming a member of the MSA will speed things along with the FDA approval process. It is all about the money, after all. As a side note, I have to say that it seems somewhat unfair to make an up and coming company (that is offering new and novel products such as Brand A and Brand B) pay what is presumably the same amount into the MSA as the existing majors that are still atoning for the sins of the past. Ah, but the price of doing business means that you have to get through the gatekeeper. For the sake of fairness, hopefully there's a provision in the MSA somewhere that allows for fee adjustments (for both new and existing companies) for products according to their level of risk.
22nd Century is a plant biotechnology company whose proprietary technology allows for the levels of nicotine and other nicotinic alkaloids (e.g., nornicotine, anatabine and anabasine) in the tobacco plant to be decreased or increased through genetic engineering and plant breeding. 22nd Century owns or is the exclusive licensee of 107 issued patents in 78 countries plus an additional 38 pending patent applications. Goodrich Tobacco and Hercules Pharmaceuticals, LLC and are wholly-owned subsidiaries of 22nd Century. Goodrich Tobacco is focused on commercial tobacco products and potential modified risk cigarettes. Hercules is focused on X-22, a prescription smoking cessation aid in development.
There have been a couple of conversations in the blogosphere that I have come across that mention the role of "other" nicotinic alkaloids in tobacco. It's not something that is mentioned or talked about often, as the center of attention (when it comes to the rewards and behavioral aspects associated with smoking) has almost always been on nicotine itself. What a lot of folks (including myself, up until now) don't realize is that these "other" nicotinic alkaloids can act as MAO inhibitors, which have been useful in treating depression and Parkinson's disease. Hence, there are many benefits that could come from varying/raising the levels of not only nicotine, but that of its associated alkaloids, which would presumably result in more of the "good stuff" and less of the "bad stuff" that has given smoking a bad name.
For additional information, please visit: www.xxiicentury.com
22nd Century Group Subsidiary, Goodrich Tobacco, Applies for Federal License to Manufacture Tobacco Products | Business Wire
The other story that caught my attention this morning was this one:
Tubb, a retired brigadier general, served three presidents in various White House capacities, including director of the White House Medical Unit and physician to the president. He retired from the White House in 2009. Tubb has been actively involved in the science and policy development of alternative nicotine products and tobacco harm reduction, BAT said.
I am delighted to be welcoming such a prominent and well respected expert in the field of tobacco harm reduction to our Board,” said BAT Chairman Richard Burrows. “This appointment further demonstrates our commitment to putting science at the heart of our business.
..Very promising indeed.
Former White House Doctor Joins BAT