22nd Century Committed to Advancing FDA’s Nicotine Mandate

22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company focused on tobacco harm reduction and Very Low Nicotine tobacco, announced today that the Company is committed to working collaboratively with the U.S. Food and Drug Administration (FDA) on the FDA’s planned nicotine reduction mandate despite the fact that, last week, regulations.gov published requests from Altria Group, Inc. (MO) and Reynolds American Inc., a subsidiary of British American Tobacco (BTI), petitioning the FDA for an additional 90-days beyond the original public comment period that is currently set to end on June 14, 2018.

22nd Century has publicly stated that since it is universally accepted that nicotine is the primary addictive component of cigarettes, the tobacco industry and public health officials must logically support the FDA’s plan to mandate that all cigarettes sold in the United States contain only “minimally or non-addictive” levels of nicotine. FDA Commissioner Dr. Scott Gottlieb has built a strong case for this bold policy: “…we’ll solve the tobacco crisis by addressing the root issue of tobacco addiction: nicotine…. [We] could save millions of lives.”

As investors have begun to realize that the FDA is, in fact, truly committed to its nicotine reduction plan, the share prices for Altria Group, Philip Morris International (PM), and British American Tobacco all continue to fall and are substantially lower today than they were last June before the FDA’s nicotine reduction plan was publicly announced in July 2017.

Nevertheless, misconceptions continue to abound regarding the definition of “Very Low Nicotine;” i.e. tobacco with nicotine content at minimally or non-addictive levels. Many American smokers erroneously believe that Big Tobacco companies already offer Very Low Nicotine content brand styles. This simply is not true. National tobacco brands that advertised “low nicotine” or “light” styles in the past were referring to the smoking machine-measured nicotine yield of cigarettes. The FDA, the Federal Trade Commission (FTC), and the public health community at large have determined that the yield method of nicotine measurement is wholly unreliable and gives no indication of actual nicotine intake because smokers engage in “compensatory behavior” when using low yield products and do not actually achieve reduced nicotine intake. For precisely this reason, the FDA banned the terms “light” and “ultra-light” from being used with respect to combustible cigarettes so that tobacco companies could not mislead consumers with these terms.