$XXII FDA Submission News 22nd Century Group an
Post# of 22755
Posted On: 11/02/2016 2:58:24 PM
$XXII FDA Submission News
22nd Century Group announced they filed a “Modified Risk Tobacco Product” application with the FDA for the world’s lowest nicotine cigarettes. So why is this a big deal? Because big tobacco has been given notice by the U.S. government that they can no longer use words like “light” or “ultra-light” in their advertising.
Specifically:
“A manufacturer who seeks to claim that a product poses fewer risks than other tobacco products may submit a modified risk tobacco product (MRTP) application to the FDA with scientific evidence to support that claim. To date, the FDA has not issued any orders permitting the introduction of modified risk tobacco products into interstate commerce.”
And the U.S. government is actively enforcing this regulation. Last year RJ Reynolds, among others, received warnings on this issue- see: “FDA warns 3 tobacco product makers over labeling.”
We believe XXII is the only cigarette company with the patented product capable of satisfying the FDA’s guidelines for a modified risk claim.
President and Chief Executive Officer of 22nd Century Group, Henry Sicignano stated:
“The scientific testing conducted in support of our submission to the FDA shows conclusively that BRAND A, as compared to conventional tobacco cigarettes, provides smokers with drastically reduced exposure to nicotine. We believe that the public health implications of a virtually nicotine-free tobacco cigarette are enormous and 22nd Century is excited about the prospect of introducing BRAND A into the U.S. market.”
It’s important for investors to know that the U.S. government has been buying XXII’s Spectrum Government Research Cigarettes (over 18 million of them in fact) over the last 2 years for their own studies. Additionally, XXII’s application to the FDA includes a comprehensive overview of the many independent clinical trials that have found that smoking 22nd Century’s VLN cigarettes delivers the sensory and behavioral experience associated with conventional cigarettes while providing only minimal exposure to the most addictive component of tobacco.
According to research done by JP Morgan, 90% of smokers would also be willing to try a new brand if it were “safer” than their usual brand. In fact “light” cigarettes had 83.5% of the market prior to the Tobacco Control Act in 2009 that banned the use of that term. Roughly 45 million American’s smoke and retail sales of cigarettes in the U.S. were approximately $75 billion in 2014.
A product that appeals to 90% of a $75 billion/year market (from a $98 million market cap company) is just one reason why we believe XXII will have a breakout year in 2016, regardless of short term market turmoil.
22nd Century Group announced they filed a “Modified Risk Tobacco Product” application with the FDA for the world’s lowest nicotine cigarettes. So why is this a big deal? Because big tobacco has been given notice by the U.S. government that they can no longer use words like “light” or “ultra-light” in their advertising.
Specifically:
“A manufacturer who seeks to claim that a product poses fewer risks than other tobacco products may submit a modified risk tobacco product (MRTP) application to the FDA with scientific evidence to support that claim. To date, the FDA has not issued any orders permitting the introduction of modified risk tobacco products into interstate commerce.”
And the U.S. government is actively enforcing this regulation. Last year RJ Reynolds, among others, received warnings on this issue- see: “FDA warns 3 tobacco product makers over labeling.”
We believe XXII is the only cigarette company with the patented product capable of satisfying the FDA’s guidelines for a modified risk claim.
President and Chief Executive Officer of 22nd Century Group, Henry Sicignano stated:
“The scientific testing conducted in support of our submission to the FDA shows conclusively that BRAND A, as compared to conventional tobacco cigarettes, provides smokers with drastically reduced exposure to nicotine. We believe that the public health implications of a virtually nicotine-free tobacco cigarette are enormous and 22nd Century is excited about the prospect of introducing BRAND A into the U.S. market.”
It’s important for investors to know that the U.S. government has been buying XXII’s Spectrum Government Research Cigarettes (over 18 million of them in fact) over the last 2 years for their own studies. Additionally, XXII’s application to the FDA includes a comprehensive overview of the many independent clinical trials that have found that smoking 22nd Century’s VLN cigarettes delivers the sensory and behavioral experience associated with conventional cigarettes while providing only minimal exposure to the most addictive component of tobacco.
According to research done by JP Morgan, 90% of smokers would also be willing to try a new brand if it were “safer” than their usual brand. In fact “light” cigarettes had 83.5% of the market prior to the Tobacco Control Act in 2009 that banned the use of that term. Roughly 45 million American’s smoke and retail sales of cigarettes in the U.S. were approximately $75 billion in 2014.
A product that appeals to 90% of a $75 billion/year market (from a $98 million market cap company) is just one reason why we believe XXII will have a breakout year in 2016, regardless of short term market turmoil.
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