22nd Century Group Regulatory Science VP Joins FDLI Tobacco and Nicotine Products Committee

Rhea-AI Summary

22nd Century Group announced that its VP of Regulatory Science, John Pritchard, will join the FDLI Tobacco and Nicotine Products Committee. This committee focuses on tobacco product regulation and aims to advance public health policy by discussing the FDA's proposed nicotine cap for cigarettes. The FDA's plan seeks to lower nicotine to 0.5 mg per gram, deemed minimally addictive. 22nd Century is confident in the final stages of its Modified Risk Tobacco Product application for its VLN® cigarettes, which contain 95% less nicotine than traditional cigarettes, potentially aiding millions in quitting smoking.

Positive

• John Pritchard's appointment to the FDLI Tobacco and Nicotine Products Committee enhances 22nd Century's regulatory influence.
• The FDA's proposed nicotine cap aligns with the company's existing VLN® product specifications.
• 22nd Century is confident in securing a Modified Risk Tobacco Product designation, which could boost sales and market visibility.
• Independent studies support VLN® cigarettes as effective tools for reducing nicotine dependence among smokers.

Negative

• None.

Another key indicator and milestone of the Increasing Importance of Reducing Cigarette Nicotine Content as Cornerstone of Public Health Policy

BUFFALO, N.Y., April 08, 2021 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, announced today that the Company’s Vice President of Regulatory Science, John Pritchard, will represent 22nd Century as a new member of the Food and Drug Law Institute’s (FDLI) Tobacco and Nicotine Products Committee. The Committee brings together a diverse group of stakeholders, including public health researchers, leaders of non-governmental organizations, and members of the U.S. Food and Drug Administration Center for Tobacco Products (CTP) to discuss tobacco product regulation and policy.

“We are proud that John has been invited to serve on the highly regarded FDLI Tobacco and Nicotine Product Committee and to represent 22nd Century in this forum,” said James A. Mish, chief executive officer of 22nd Century Group. “Our organization is fortunate to have a number of experts on our leadership team, and it is important that we play an active role in moving the tobacco industry forward to reduce the harm caused by smoking. The status quo of cigarette addiction must end, and we are delighted that John will serve on this committee to educate the industry about 22nd Century Group’s Modified Risk Tobacco Product (MRTP) application for our VLN^® reduced nicotine content cigarettes, which we are highly confident is in the final stages of review by the FDA. John will also spend this year supporting the committee’s programs and advocating for the FDA to implement the Agency’s proposed mandate to set a maximum level of nicotine in cigarettes of 0.5 milligrams of nicotine per gram of tobacco, a level already achieved in our VLN^® cigarettes, and previously deemed by the FDA to ‘minimize addictiveness’.”

The FDA’s proposed tobacco product standard for nicotine level of combustible cigarettes, which was published in March 2018 as an Advance Notice of Proposed Rulemaking (ANRPM), is the cornerstone of the FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation. The FDA’s plan seeks to lower the nicotine content of all cigarettes to a “minimally or non-addictive” level. The creation of a proposed nicotine cap could decrease the chances that future generations become addicted to cigarettes and could make it easier for currently addicted smokers to quit. Public health researchers project that the enactment of a nicotine cap would help more than five million people to quit smoking within the first year of implementation and save more than eight million American lives by the end of the century. A recent survey reported by the Centers for Disease Control and Prevention (CDC) found that 80% of adults in the United States are in favor of lowering nicotine levels in cigarettes to make them less addictive.

“With respiratory health front and center in everyone’s minds, there has never been a more critical time to advance effective public health policy and regulation in the area of tobacco control. Cigarette addiction is the leading cause of preventable death in the United States and having the opportunity for multi-stakeholder dialogue is an essential part of achieving this,” said Pritchard. “I have a tremendous amount of respect for the FDLI, and I look forward to contributing my experience to the organization.”

Pritchard started in his regulatory role at 22nd Century in 2019 and brings more than 20 years of scientific and regulatory experience in the tobacco and pharmaceutical industries, as well as public health experience, to the committee. At 22nd Century, he oversees global regulatory and compliance activities, which includes stewardship of the Company’s MRTP application for its VLN^® cigarettes.

Made from proprietary tobacco engineered by 22nd Century to contain 95% less nicotine than traditional cigarettes, VLN^® is the only combustible tobacco product that complies with the FDA’s proposed nicotine cap. Numerous independent scientific studies, funded largely by the FDA, the National Institutes of Health (NIH), and other U.S. federal government agencies, have demonstrated that using reduced nicotine content tobacco cigarettes helps smokers reduce their nicotine exposure and dependence, smoke fewer cigarettes per day, increase their number of smoke-free days, and double their quit attempts – all with minimal or no evidence of nicotine withdrawal or compensatory smoking.

The Company is highly confident that it is in the final stages of the FDA’s application process to obtain a MRTP designation for VLN^®. The designation will allow 22nd Century to communicate key features of VLN^® King and VLN^® Menthol King, including a headline claim of “95% less nicotine.” Although VLN^® contains just 0.5 milligrams of nicotine per gram of tobacco, VLN^® tastes, smells, and smokes like a conventional cigarette. This disruptive product is an innovative alternative to addictive, conventional cigarettes and will help adult smokers reduce their exposure to nicotine. 22nd Century is fully prepared and eager to launch its VLN^® cigarettes within 90 days of receiving authorization from the FDA and believes that a MRTP designation will serve as a catalyst for its VLN^® brand and tobacco franchise. The Company remains willing to license its technology to enable every cigarette manufacturer to comply with the FDA’s proposed nicotine cap that will significantly reduce the harm caused by smoking and protect future generations from ever becoming addicted to cigarettes.

About 22nd Century Group, Inc.
22nd Century Group, Inc. (NYSE American: XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing, and modern plant breeding. 22nd Century’s primary mission in tobacco is to reduce the harm caused by smoking through the Company’s proprietary reduced nicotine content tobacco cigarettes – containing 95% less nicotine than conventional cigarettes. The Company’s primary mission in hemp/cannabis is to develop and commercialize proprietary hemp/cannabis plants with valuable cannabinoid profiles and desirable agronomic traits.

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 the Company’s Annual Report on Form 10-K filed on March 11, 2021. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does 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 John Pritchard's appointment to the FDLI Tobacco and Nicotine Products Committee for XXII?

John Pritchard's appointment enhances 22nd Century's influence in tobacco regulation and positions the company to advocate for reduced nicotine standards.

How does 22nd Century's VLN® cigarette align with FDA nicotine regulations?

The VLN® cigarette contains 0.5 mg of nicotine per gram, compliant with the FDA's proposed nicotine cap aimed at reducing smoking addiction.

What is the expected impact of the Modified Risk Tobacco Product designation on XXII?

Securing a Modified Risk Tobacco Product designation could significantly increase consumer interest and sales for 22nd Century's VLN® brand.

What are the potential public health benefits of 22nd Century's VLN® cigarettes?

VLN® cigarettes could help millions quit smoking by providing a product with significantly lower nicotine levels, reducing addiction risks.