Comments Deadline Set for 22nd Century’s Modified-Risk Application

The U.S. Food and Drug Administration (FDA) has set May 18, 2020, as the deadline for the submission of public comments on 22nd Century Group’s Modified Risk Tobacco Product (MRTP) application.

The application seeks authorization from the FDA to allow 22nd Century to market its reduced nicotine content cigarettes under the brand name VLN, with packs and advertising stating that the product contains 95 percent 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 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 reduce their nicotine exposure and dependence, smoke fewer cigarettes per day, experience reduced withdrawal symptoms, increase their number of smoke-free days, and 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 5 million adult smokers would quit one year after implementation and more than 8 million American lives would be saved by the end of the century.