FDA Lead Scientist Discusses 22nd Century’s SPECTRUM® Research Cigarettes in Public Webcast

FDA summarizes the compelling science supporting its plan to dramatically reduce nicotine in cigarettes

WILLIAMSVILLE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company focused on tobacco harm reduction and Very Low Nicotine tobacco, announced today that on October 11, 2018, Dr. Lynn Hull, Lead Pharmacologist at the United States Food and Drug Administration (FDA) Center for Tobacco Products, held a webcast highlighting and summarizing the published science supporting the FDA’s efforts to dramatically reduce nicotine in all cigarettes sold in the United States. Entitled “Science to Inform a Tobacco Product Standard for the Level of Nicotine in Combusted Cigarettes,” Dr. Hull’s presentation featured prominently many independent clinical trials conducted with 22nd Century’s Very Low Nicotine Content (VLNC) SPECTRUM® research cigarettes.

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22nd Century’s SPECTRUM cigarettes are featured prominently in the FDA’s summary of science supporti ...

22nd Century’s SPECTRUM cigarettes are featured prominently in the FDA’s summary of science supporting a VLNC cigarette mandate.

Dr. Hull contrasted VLNC cigarettes with so-called “light” cigarettes by clarifying that VLNC cigarettes contain minimally or non-addictive levels of nicotine as compared to traditional “light” cigarettes that contain just as much nicotine as traditional cigarettes.

Though Big Tobacco companies waged massive marketing campaigns, for decades, to persuade smokers that so-called “light” or “smooth” cigarettes contain less nicotine, this simply is not true. Major national cigarette brands that historically advertised “low nicotine,” “light,” “ultra-light” or “smooth” styles were referring to the smoking machine-measured nicotine yield of cigarettes – not the nicotine content of the tobacco in the 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” by smoking more cigarettes when using low nicotine yield cigarettes and do not actually achieve reduced nicotine intake.

In discussing “light” cigarettes, Dr. Hull remarked: “They are designed to appear ’light’ to the user, but can deliver as much nicotine as traditional cigarettes. These products have no benefit to public health.” (emphasis added)

For precisely this reason, the FDA banned the terms “light,” “ultra-light,” “low tar” and other terms from use with respect to combustible cigarettes so that Big Tobacco companies could no longer mislead consumers.

In contrast to the highly addictive tobacco cigarettes marketed by Big Tobacco companies, 22nd Century’s proprietary VLN TM tobacco and technology make possible tobacco cigarettes with a nicotine content of just 0.4mg/g, which is more than 95% less nicotine than conventional cigarettes (conventional cigarettes contain approximately 20 mg nicotine per gram of tobacco). The World Health Organization (WHO) Study Group on Tobacco Product Regulation, the FDA’s March 2018 Advanced Notice of Proposed Rulemaking, and highly respected, independent scientists across the United States have all pointed to tobacco with a nicotine content at or about 0.4mg/g as being “minimally or non-addictive.”

In her FDA webcast presentation, Dr. Hull also discussed the consistent scientific findings of numerous independent clinical studies that were conducted with VLNC cigarettes. In an overview of the compelling science supporting the FDA’s planned mandate that all cigarettes sold in the United States contain only minimally or non-addictive levels of nicotine, Dr. Hull presented the powerful benefits of VLNC cigarettes:

“Findings suggest that VLNC Cigarettes:

  • Do not increase the number of cigarettes [smoked] per day
  • May decrease dependence
  • May increase quit attempts
  • Have lower addiction potential than NNC [Normal Nicotine Content] cigarettes
  • May reduce exposure to nicotine and other Harmful and Potentially Harmful Constituents (HPHCs)
  • Either do not result in differences in how people smoke, or result in changes associated with reductions in tobacco smoker exposure (e.g., lower total puff volume)
  • Can suppress craving and withdrawal
  • Have not been found to increase adverse effects in smokers with symptoms of mental health disorders”

Dr. Hull continued her presentation with references to the special report by Dr. Benjamin Apelberg, et al: “Potential Public Health Effects of Reducing Nicotine Levels in Cigarettes in the United States,” published in the March 2018 issue of The New England Journal of Medicine. Dr. Apelberg’s Population Health Model uses empirical evidence and expert opinion to predict the results of implementing the FDA’s proposed new rule to require that all cigarettes sold in the United States contain only minimally or non-addictive levels of nicotine. Dr. Hull discussed the compelling conclusions reached by Dr. Apelberg’s team that are based on implementation of the FDA’s plan in the year 2020:

1) 5 million people would quit smoking in the first year, 13 million people would quit smoking in 5 years, and 33 million people would quit smoking or not become addicted to smoking by the year 2100

2) 8 million tobacco-attributable deaths would be prevented by 2100

3) 134 million life-years would be gained by 2100

Dr. Hull concluded: “It is FDA’s belief that rendering cigarettes minimally addictive by reducing their nicotine content could help current users quit and prevent future users from becoming addicted and escalating to regular use.”

“As evidenced by Dr. Hull’s October 11, 2018 webcast, the FDA is continuing to build systematically the regulatory framework necessary to implement a sweeping reduction of nicotine in combustible cigarettes,” explained Henry Sicignano III, President and Chief Executive Officer of 22nd Century Group. “The benefits of Very Low Nicotine Content cigarettes are compelling and impossible to ignore. Under the FDA’s nicotine reduction mandate, we look forward to providing our extraordinary products to every smoker in America.”

About SPECTRUM® Research Cigarettes

22nd Century developed SPECTRUM® research cigarettes in partnership with independent researchers and officials from the National Institute on Drug Abuse (NIDA), the U.S. Food and Drug Administration (FDA), the National Cancer Institute (NCI), and the Centers for Disease Control and Prevention (CDC). The main SPECTRUM® product line, uniquely produced by 22nd Century from its proprietary Very Low Nicotine tobacco plants, consists of a series of cigarette styles that vary nicotine contents from very low (more than 95% less nicotine than tobacco contained in conventional cigarette brands) to relatively high nicotine contents. SPECTRUM® features 24 styles, in both regular and menthol versions, with 8 different levels of nicotine.

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering and plant breeding. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in hemp/cannabis is to develop proprietary hemp/cannabis strains for important new medicines and agricultural crops. Visit www.xxiicentury.com and www.botanicalgenetics.com for more information.

Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2017, filed on March 7, 2018, including the section entitled “Risk Factors,” and our other reports filed with the U.S. Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.

22nd Century Group
James Vail, Director of Communications

Source: 22nd Century Group, Inc.