22nd Century Group Applauds Califf Nomination as FDA Commissioner

Rhea-AI Summary

22nd Century Group (Nasdaq: XXII) expresses strong support for Dr. Robert Califf’s nomination as FDA Commissioner. Califf, a proponent of tobacco control, emphasizes a nicotine cap as a crucial priority for public health. The company’s reduced nicotine cigarette, VLN®, aligns with FDA's proposed nicotine mandate, which could significantly assist over five million smokers in quitting within the first year. With MRTP designation for VLN® being a top priority, the company is poised for a U.S. launch within 90 days post-approval, aiming for international expansion in early 2022.

Positive

• Support for Dr. Robert Califf's nomination could lead to favorable regulatory changes for 22nd Century Group.
• VLN® reduced nicotine cigarette aligns with FDA's nicotine cap proposal, positioning the company for potential market growth.
• Projected benefits from a nicotine cap include helping over five million smokers quit within the first year.

Negative

• None.

• Califf Is a Longtime Proponent of Tobacco Control; Indicated Nicotine Mandate Should Be Key Priority For FDA
• MRTP Authorization And Launch of VLN^® Will Serve as Vanguard for FDA’s Proposed Nicotine Cap

BUFFALO, N.Y., Nov. 15, 2021 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco, and improving health and wellness through plant science, announced today that it strongly supports the nomination of Dr. Robert Califf as the next commissioner of the U.S. Food and Drug Administration (FDA). Califf is known to be a longtime proponent of tobacco control and supporter of the Agency’s Comprehensive Plan for Tobacco and Nicotine Regulation.

“We are thrilled to hear that Dr. Califf has been nominated to FDA’s top position as Commissioner. This is positive news for 22nd Century Group as he is a longtime proponent of aggressive measures to reduce the harm caused by smoking and is fully supportive of the Agency’s plans to render all cigarettes ‘minimally or non-addictive,’” said James A. Mish, chief executive officer of 22nd Century Group. “Califf has previously indicated that a nicotine cap should be a key priority for the FDA. We look forward to the implementation of a nicotine mandate – which we believe is the single greatest opportunity to change the trajectory of public health. Our reduced nicotine content cigarette, VLN^®, is the only combustible tobacco product that meets the nicotine levels proposed in FDA’s nicotine mandate. We stand ready to support FDA on this critical public health initiative.”

Califf was one of the FDA officials at the center of the Agency’s plans for Tobacco and Nicotine Regulation under the Obama Administration. In a 2019 blog post for the Association of American Medical Colleges, Califf laid out his plans for regulating tobacco products, including the requirement for the tobacco industry to lower the amount of nicotine in its products to sub-addictive levels levels using selective breeding, a feat 22nd Century has already achieved in its VLN^® product.

In recent months, Califf has directly urged the Biden Administration to get tough on tobacco companies. During a March panel discussion hosted by STAT, he stated: “Tobacco use is becoming one of the most important markers of disparities in our economy and our health care system. I hope that this administration will have the courage to fight what will be tough battles.”

More than 16 million Americans are currently living with diseases caused by smoking, and with every delay in action, even more people will die from smoking. Introducing a nicotine cap could significantly decrease the chances of youth becoming addicted to cigarettes and could make it easier for currently addicted smokers to quit.

Public health research projects that the enactment of a nicotine cap at 0.5 mg of nicotine per gram of tobacco – a level already achieved by 22nd Century’s VLN^® reduced nicotine content tobacco cigarette – would help more than five million people to quit smoking within the first year of implementation, save more than eight million American lives by the end of the century, and gain more than 134 million life-years by 2100.

In support of the FDA’s plan, 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.

Securing MRTP designation for VLN^® remains 22nd Century’s highest priority. The Company held a successful meeting with the FDA regarding its MRTP application October 14, 2021. Following the meeting, and in conjunction with recent Center for Tobacco Products (CTP) activity, the Company’s confidence in a positive outcome for its MRTP application and timing is at its highest level to date. 22nd Century’s MRTP authorization and the launch of VLN^® will serve as a vanguard for the FDA’s proposed mandate to cap the levels of nicotine in combustible cigarettes. The Company’s U.S. pilot program and manufacturing capabilities are in place to launch VLN^® in the U.S. within 90 days of receiving MRTP designation. Additionally, the Company is advancing its plans to launch VLN^® in select international markets beginning in the first quarter of 2022.

About 22nd Century Group, Inc.
22nd Century Group, Inc. (Nasdaq: XXII) is a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco and improving health and wellness through plant science. With dozens of patents allowing it to control nicotine biosynthesis in the tobacco plant, the Company has developed proprietary reduced nicotine content (RNC) tobacco plants and cigarettes, which have become the cornerstone of the FDA’s Comprehensive Plan to address the widespread death and disease caused by smoking. In tobacco, hemp/cannabis, and hop plants, 22nd Century uses modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding to deliver solutions for the life science and consumer products industries by creating new, proprietary plants with optimized alkaloid and flavonoid profiles as well as improved yields and valuable 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

How does Dr. Robert Califf's nomination impact 22nd Century Group (XXII)?

Dr. Califf's nomination is viewed positively by 22nd Century Group as he supports tobacco control measures, which could favor regulatory changes benefitting the company.

What is the significance of the VLN® cigarette for 22nd Century Group?

VLN® is significant for 22nd Century Group as it meets the proposed nicotine cap by the FDA, providing a competitive advantage in the reduced nicotine market.

When does 22nd Century Group plan to launch VLN® in the U.S.?

22nd Century Group plans to launch VLN® within 90 days of receiving MRTP designation from the FDA.

How many smokers could potentially quit due to the nicotine cap proposal?

Research suggests that over five million smokers could quit smoking within the first year of implementing a nicotine cap set at 0.5 mg per gram of tobacco.