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

December 10, 2018 12:43:04
  • 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://nnw.fm/GRmq1). 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…

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