22nd Century Group, Inc. (NYSE American: XXII) Approaching Commercialization of Very Low Nicotine Cigarettes with Premarket Application to FDA

• FDA now regulates the tobacco industry
• 22nd Century files Premarket Tobacco Application (PMTA) with the FDA
• Company receives order for 3.6 million SPECTRUM U.S. government research cigarettes

Since the Family Smoking Prevention and Tobacco Control Act was signed into law by President Barack Obama on June 22, 2009, the playing field for tobacco companies has changed. The Act definitively gives the Food and Drug Administration (FDA) the power to regulate tobacco products, authority which the Supreme Court said in FDA v. Brown & Williamson Tobacco Corp. (2000) that the agency did not have. As a result, the FDA has taken up the banner “as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products” in the U.S. It has exercised that mandate by proposing new rules to lower the nicotine content of tobacco products to less addictive levels. On December 5, 2018, 22nd Century Group, Inc. (NYSE American: XXII) filed an application under those new rules seeking authorization to commercialize certain cigarette products with the proposed brand name VLN (http://ibn.fm/M5jp6). 22nd Century says that it is “the only company in the world capable of growing tobacco with non-addictive levels of nicotine.” It may also be the first company in the world winning FDA approval to market a combustible cigarette as a Modified Risk Tobacco Product (MRTP).

22nd Century Group is a plant biotechnology company that has been focusing its research efforts on developing reduced risk tobacco products, particularly by modifying the nicotine content in tobacco plants through genetic engineering and plant breeding. The company has submitted a Premarket Tobacco Application (PMTA) to the U.S. Food and Drug Administration (FDA) seeking authorization to commercialize its “BRAND A” cigarette products under the proposed brand name VLN (for Very Low Nicotine).

A PMTA is now the first step toward the commercialization of any new tobacco product in the United States. It precedes the more comprehensive Modified Risk Tobacco Product (MRTP), which will request FDA authorization to state on packaging and advertising that, among other things, the proposed VLN cigarettes contain just 0.5 mg of nicotine per gram of tobacco. This proportion of nicotine is substantially below the average level of 19.4 mg of nicotine per gram of tobacco found in leading brands.

A survey of the top 100 leading cigarette brands in the United States showed that conventional and highly addictive cigarettes currently sold in the United States contain an average of 19.4 mg of nicotine per gram of tobacco, with an actual nicotine range of 14.7 mg to 33.2 mg per gram of tobacco. In its Advance Notice of Proposed Rulemaking (ANPRM) to lower nicotine in cigarettes to minimally or non-addictive levels published on March 16, 2018, the FDA cited independent research (http://ibn.fm/RkrPi) that found “an absolute limit of 0.4 to 0.5 mg of nicotine per cigarette should be adequate to prevent or limit the development of addiction in most young people.”

The VLN cigarettes that are the subject of 22nd Century’s PMTA are a version of its widely accepted Very Low Nicotine Content (VLNC) SPECTRUM research cigarettes. Indeed, the PMTA refers to more than 50 independent studies that used the company’s proprietary SPECTRUM research cigarettes, while the World Health Organization (WHO) Study Group on Tobacco Product Regulation has recommended that all member countries limit the nicotine content of cigarettes to the level found in VLNC SPECTRUM cigarettes. Earlier this year, the National Institute on Drug Abuse (NIDA), the U.S. Food and Drug Administration (FDA) and public health researchers requested a further 3.6 million of 22nd Century’s proprietary SPECTRUM research cigarettes (http://ibn.fm/HPO9V).

Despite its achievements in the tobacco space, 22nd Century is not resting on its laurels. The company has been applying the same approach to cannabis sativa plants to alter the levels of cannabinoids for new medicines. With an extensive intellectual property portfolio of issued patents and patent applications relating to the botanical properties of tobacco and hemp/cannabis plants, 22nd Century won’t be surprised if Big Tobacco comes knocking on its door.

For more information, visit the company’s website at www.XXIICentury.com

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