22nd Century Highlights Public Comments to the FDA’s Nicotine Reduction Plan

22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is a leader in tobacco harm reduction and Very Low Nicotine tobacco, today called attention to comments submitted to the U.S. Food and Drug Administration (FDA) in response to the FDA’s Advance Notice of Proposed Rulemaking (ANPRM) to develop a nicotine product standard in cigarettes that will lower nicotine to minimally or non-addictive levels. The open comment period on the FDA’s ANPRM ends July 16, 2018. To date, major medical associations, government agencies, tobacco insiders, and the public at large have submitted nearly 3,000 public comments to the FDA. Although some companies in the tobacco industry have requested a 90-day extension of the comment period and have facilitated hundreds of “form letter” comments, the responses from scientists and regulators have been overwhelmingly in favor of the FDA’s plan to dramatically reduce the nicotine content of cigarettes. As the only company in the world growing multiple varieties of Very Low Nicotine flue-cured and burley tobacco varieties, 22nd Century makes possible the FDA’s vital new plan.

Below is a summary of some of the most important comments that the FDA has received to date in response to the ANPRM:

“Given the immense public health benefits predicted by the FDA, the ACC strongly supports the implementation of a nicotine product standard in cigarettes to a minimally addictive or non-addictive level.”
“The FDA should move quickly to develop and issue a final regulation to maximize the number of lives saved.”

American College of Cardiology, June 5, 2018

“American Society of Addiction Medicine urges the FDA to move forward with a proposed rule within six months after release of its ANPRM and final rule six months after. In addition, we urge the FDA to establish the tobacco product standard no later than one year after publication, as provided in Section 907 of the Family Smoking Prevention and Tobacco Control Act.”

American Society of Addiction Medicine, June 14 2018

“I am encouraged by the strong actions that the FDA is pursuing to improve the health of our nation, facilitate quitting among smokers who are currently struggling with their addiction, and prevent a future generation from becoming addicted to a highly toxic tobacco product.”

Dorothy K. Hatsukami, PhD, Professor of Psychiatry, University of Minnesota, June 11, 2018

“Immediate nicotine reduction is likely to have the largest public health benefit.”

American Psychological Association, College on Problems of Drug Dependence, Society for Research on Nicotine and Tobacco June 12, 2018