Public Health Leaders Urge FDA to Issue Final Rule for Reducing Nicotine in Cigarettes by March 2019

22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology company that is a leader in tobacco harm reduction and Very Low Nicotine tobacco, announced today that 41 public health and medical organizations wrote an open letter to Dr. Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration (FDA), urging the FDA to quickly implement its plan to reduce nicotine in cigarettes to minimally or non-addictive levels.

22nd Century is the only company in the world that has grown commercial crops of proprietary tobacco with nicotine levels of just 0.4mg per gram of tobacco – a 95% reduction in nicotine as compared to tobacco used in conventional cigarettes. Independent clinical trials using 22nd Century’s proprietary SPECTRUM® research cigarettes have shown that Very Low Nicotine content cigarettes reduce cravings, reduce consumption of cigarettes, and increase quit attempts. The independent research conducted with 22nd Century’s SPECTRUM cigarettes provided the foundation for the FDA’s plan to mandate that all cigarettes sold in the United States contain only “minimally or non-addictive” levels of nicotine.

In their May 21, 2018 letter to Dr. Gottlieb, the American Heart Association, the American Cancer Association, the American Medical Association and dozens of other public health and medical organizations described the “massive public health benefits” that will result from the adoption of the FDA’s vital plan to dramatically reduce nicotine in cigarettes:

“Every day that passes means more kids moving from experimentation to addiction and more adults who want to quit and try to quit, but remain addicted to a lethal product. We urge FDA to issue a proposed rule within six months of its ANPRM (by September 16, 2018) and a final rule six months later (by March 16, 2019). We also urge that implementation of the rule be no later than the one-year period provided for in Section 907 of the Family Smoking Prevention and Tobacco Control Act, which would allow the rule to be implemented by March of 2020.” (emphasis added)

The letter also points to the FDA's estimates that a new cigarette product standard could enable an additional 5 million adult smokers to quit within just one year of implementation. And, by the end of the century, the FDA’s nicotine reduction policy could prevent more than 33 million people, mostly youth and young adults, from becoming regular smokers; further, there would be 8 million fewer smoking-related deaths within that time.