Good morning members,
How often do you see the FDA respond to an application from a biotech company within a couple of days and set a meeting within two weeks? This one is a must read for our members.
Let's talk about modified risk labeling and cigarettes. If you are a current or previous smoker you may have noticed labeling changes with big tobacco brands such as the conversion of light and ultra light Marlboro brands to color coded white and silver packaging.
The light and ultra light labels are banned due to the fact there is no proof that those brands have less risk to your health than a full flavor cigarette.
The patents 22nd Century Group Inc. (NYSE-MKT: XXII) holds could change that which in our opinion makes them a takeover target for anyone of the big tobacco players.
In the October 1, 2015 edition of The New England Journal of Medicine, Drs. Michael Fiore and Timothy Baker wrote: “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.”
We recently covered the value of the proprietary technology that 22nd Century Group holds. Now they are in talks with the FDA about modified risk labeling. This could get very interesting real soon.
We emplore everyone to read the recent press that (NYSE-MKT: XXII) has issued. Below is another important excerpt.
The FDA contacted 22nd Century immediately upon receiving the Company’s MRTP application and facilitated – less than 14 days after the Company’s submission – a meeting at FDA headquarters to discuss the application and the review process. In attendance were nine members of 22nd Century’s team, including executive management, consultants and attorneys, along with 22 FDA staff members; more than 20 additional FDA staff members attended telephonically.
Conclusive independent laboratory testing proves that 22nd Century’s BRAND A cigarettes contain less than 0.6 mg nicotine per cigarette and less than 0.05 mg 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 Natural American Spirit®. The Company’s Modified Risk Tobacco Product application to the FDA requests that BRAND A packaging and marketing be allowed to disclose to consumers that the product contains 95% less nicotine than conventional brands and drastically reduces smokers’ exposure to nicotine.
“I am very pleased with the FDA’s prompt attention to our MRTP application,” stated Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “For U.S. smokers who wish to reduce their exposure to nicotine, 22nd Century’s Very Low Nicotine cigarettes are an incredibly important product. Consumers deserve a Very Low Nicotine product choice.”
Under the 2009 Tobacco Control Act, the FDA cannot ban conventional tobacco products, such as cigarettes and smokeless tobacco, or require the total elimination of nicotine in tobacco products. However, the FDA has the authority to order the reduction of nicotine to non-addictive levels in some or all cigarettes sold in the United States.
Mr. Sicignano explained, “Besides paving the way for the world’s first reduced exposure cigarette, 22nd Century’s proprietary technology gives the FDA an invaluable tool if the FDA desires to require all U.S. cigarette brands to offer consumers a Very Low Nicotine brand style at non-addictive levels… a very exciting prospect for public health, to say the least.”
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. The finished cigarettes containing 22nd Century’s proprietary Very Low Nicotine tobacco have the taste and sensory characteristics of conventional cigarettes, but contain only trace amounts of nicotine. The Company looks forward to continuing to work closely with the FDA in the MRTP application process in order to secure a marketing order that will facilitate reduced exposure labelling for BRAND A Very Low Nicotine cigarettes.
The quick response from the FDA just shows how many lives are at stake and that they are taking this very seriously.
We will have more soon.
The Team
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