FDA Announces Deadline to Submit Comments on 22nd Century Group’s MRTP Application
22nd Century Group achieves another important milestone in the FDA’s scientific review of the Company’s MRTP application for its reduced nicotine content cigarettes
WILLIAMSVILLE, NY, April 17, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII) (“22nd Century” or “the Company”), a leading plant biotechnology company focused on reduced nicotine content tobacco and hemp/cannabis plant genetics research and development, announced today that the U.S. Food and Drug Administration (FDA) has set May 18, 2020 as the deadline for the submission of public comments on the Company’s Modified Risk Tobacco Product (MRTP) Application.
22nd Century’s MRTP application seeks authorization from the FDA to allow the Company to market its reduced nicotine content cigarettes under the brand name VLN®, with pack and advertising claims stating that the product contains 95% less nicotine than conventional tobacco cigarettes, as well as related claims regarding reduced nicotine exposure.
“We are very pleased with the progress our team continues to make towards receiving FDA authorization to market our VLN® reduced nicotine content cigarettes,” said Michael Zercher, President and Chief Operating Officer of 22nd Century Group. “With the imminent closing of the public comment period, we are hopeful that we will receive a positive decision from FDA allowing us to introduce our reduced nicotine content cigarettes to adult smokers looking to reduce their exposure to nicotine.”
22nd Century’s reduced nicotine content cigarettes enable adult smokers to experience the same taste and smell as conventional cigarettes but with minimal exposure to nicotine. Numerous independent scientific studies funded by the National Institutes of Health (NIH) and other U.S. federal government agencies using the Company’s reduced nicotine content cigarettes studies show that smokers who use 22nd Century’s reduced nicotine content cigarettes (i) reduce their nicotine exposure and dependence, (ii) smoke fewer cigarettes per day, (iii) experience reduced withdrawal symptoms, (iv) increase their number of smoke-free days, and (v) double their quit attempts.
The Company believes that bringing its reduced nicotine content cigarettes to market will be an important step towards the implementation of the FDA’s proposed plan to require all cigarettes sold in the U.S. to be made “minimally or non-addictive.” By limiting the nicotine content of all combustible cigarettes to just 0.5 milligrams of nicotine per gram of tobacco, a level already achieved in VLN®, FDA projects that five million adult smokers would quit one year after implementation and over eight million American lives would be saved by the end of the century.
About 22nd Century Group, Inc.
22nd Century Group, Inc. (NYSE AMERICAN: XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing and modern plant breeding. The Company’s primary mission in tobacco is to reduce the harm caused by smoking by bringing its proprietary reduced nicotine content cigarettes with 95% less nicotine than conventional cigarettes to adult smokers in the U.S. and international markets. The Company’s primary mission in hemp/cannabis is to develop proprietary hemp/cannabis plants with unique cannabinoid profiles and desirable agronomic traits and to commercialize those plants through a synergistic portfolio of strategic partnerships in the hemp/cannabis industry.
Mei Kuo 22nd Century Group, Inc. (716) 300-1221 firstname.lastname@example.org Cory Ziskind ICR (646) 277-1232 email@example.comSource: 22nd Century Group, Inc.
Released April 17, 2020