22nd Century Group to Highlight its Reduced Nicotine Technology at The Food and Drug Law Institute’s Tobacco and Nicotine Products Regulation and Policy Conference

Rhea-AI Summary

22nd Century Group, Inc. (NYSE American: XXII) announced participation in the FDA’s Tobacco and Nicotine Products Regulation Conference, highlighting advancements in reduced nicotine technology.

Mitchell R. Zeller from the FDA will discuss the Comprehensive Plan on October 21, 2020, while 22nd Century's regulatory VP, John Pritchard, will speak on nicotine and harm reduction on October 22, 2020. Pritchard emphasized that limiting nicotine could help 5 million adult smokers quit within a year and save over 8 million lives by century's end. The company aims to support the FDA's efforts in reducing nicotine standards across the tobacco industry.

Positive

• Participation in FDA's tobacco conference emphasizes commitment to nicotine reduction.
• Potential for FDA approval of Modified Risk Tobacco Product (MRTP) applications for VLN cigarettes, which contain 95% less nicotine than traditional cigarettes.

Negative

• None.

The U.S. Food and Drug Administration to provide an update on the Agency’s Comprehensive Plan for Tobacco and Nicotine Regulation

WILLIAMSVILLE, N.Y., Oct. 19, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, life science company driven by next generation biotechnology, announced today that Mitchell R. Zeller, director of the Center for Tobacco Products (CTP) at the U.S. Food and Drug Administration (FDA), will provide an update on the FDA’s Comprehensive Plan for Tobacco and Nicotine Products at the Food and Drug Law Institute’s (FDLI) Tobacco and Nicotine Products Regulation and Policy Conference on Wednesday October 21, 2020 at 11:15 a.m. ET.  

In addition to Zeller’s presentation, 22nd Century’s Vice President of Regulatory Science, John Pritchard, will participate in the conference’s “Nicotine and Harm Reduction” panel on Thursday, October 22, 2020 at 1:15 p.m. ET. 22nd Century’s Michael Zercher, president and chief operating officer, and Steven Przybyla, general counsel and corporate secretary, will also be in attendance.   

“I am delighted to participate in this important conference and to support, with our reduced nicotine technology, FDA’s plan to implement a reduced nicotine product standard,” said Pritchard. “The science is clear. By limiting the nicotine content of all combustible cigarettes to levels achieved in our VLN^® cigarettes, the FDA projects that five million adult smokers would quit one year after implementation and over eight million American lives would be saved by the end of the century. Our goal for this conference, as in general, is to advance common-sense tobacco and nicotine regulation and unite against the tragic toll of cigarette addiction to improve public health in America.”

This year’s conference brings together a diverse group of stakeholders, including public health advocates, researchers, manufacturers, lawyers, consumer interest groups, entrepreneurs, governmental agencies, and others to discuss effective regulation across the broad spectrum of tobacco and nicotine products in the United States.

Nicotine remains a central part of the FDA’s landmark 2017 Comprehensive Plan for Tobacco and Nicotine Regulation, which addresses the root cause of nearly half a million American deaths each year, caused by highly addictive tobacco products. Upon announcing the FDA’s plan to substantially reduce the nicotine in cigarettes, former FDA Commissioner, Dr. Scott Gottlieb remarked: “The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users.”

Panelists will examine the public health impact of regulating nicotine content across the broad spectrum of tobacco and nicotine products; the ways in which policies can help minimize users' health risks; and the mitigation of potential unintended consequences. Pritchard will also discuss 22nd Century’s role in ensuring the adoption of the FDA’s proposed reduced nicotine product standard, requiring all cigarettes sold in the U.S. to be “minimally... or non-addictive.” 22nd Century is committed to making reduced nicotine technology available to the entire tobacco industry. Licensing the Company’s reduced nicotine technology to tobacco companies will allow the industry to deliver on their commitments to reduce combustible cigarette consumption and to comply with the FDA’s reduced nicotine standard.

22nd Century believes that the FDA is in the final stages of its decision-making process for the Company’s Modified Risk Tobacco Product (MRTP) Applications for VLN^®. An authorization decision by the FDA will bring to market the first and only combustible cigarettes available with 95% less nicotine compared to other cigarettes, further demonstrating the technical feasibility of the FDA’s generationally significant product standard.

Pritchard’s presentation will be accessible in the Investors section of 22nd Century’s website, under Events.

About 22nd Century Group, Inc.
22nd Century Group, Inc. (NYSE American: XXII) is a leading, plant-based, life science company that develops and provides disruptive, commercial solutions to the life science, consumer products, and pharmaceutical markets. Working with tobacco and hemp/cannabis plants, 22nd Century is dedicated to its mission of reducing the harm caused by smoking. The Company’s proprietary reduced nicotine VLN^® cigarettes contain 95% less nicotine than conventional brands and are poised to disrupt the more than $800 billion global tobacco market. 22nd Century owns or controls more than 200 issued and pending patents related to the tobacco and hemp/cannabis plants.

Learn more at xxiicentury.com, on Twitter @_xxiicentury and on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in “Risk Factors” in our Annual Report on Form 10-K filed on March 11, 2020 and in our subsequently filed Quarterly Report on Form 10-Q. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events, or otherwise, except as otherwise required by law.

All information provided in this release is as of the date hereof, and we assume no obligation to and do not intend to update these forward-looking statements, except as required by law.

Investor Relations & Media Contact:
Mei Kuo
Director, Communications & Investor Relations
22nd Century Group, Inc.
(716) 300-1221
mkuo@xxiicentury.com

FAQ

What is the significance of 22nd Century participating in the FDA tobacco conference?

22nd Century's participation indicates its commitment to reducing nicotine levels in tobacco products, aligning with public health goals and potential regulatory changes.

What are the expected impacts of the FDA's Comprehensive Plan for Tobacco and Nicotine Regulation?

The FDA's plan aims to reduce nicotine levels in cigarettes, which could lead to millions of smokers quitting and significant public health improvements.

When will the FDA provide an update on tobacco regulation?

The FDA will update its Comprehensive Plan on October 21, 2020, during the Tobacco and Nicotine Products Regulation Conference.

What are the benefits of 22nd Century's VLN cigarettes?

VLN cigarettes contain 95% less nicotine than conventional brands, potentially reducing addiction and related health risks for smokers.

Who from 22nd Century will speak at the FDA conference?

John Pritchard, Vice President of Regulatory Science, will speak on the nicotine and harm reduction panel on October 22, 2020.