22nd Century Group Applauds Appointment of Califf as FDA Commissioner | Your money

Califf is a long-time supporter of tobacco control; The stated nicotine mandate is expected to be a key priority for FDAMRTP clearance and the launch of VLN® will serve as a pioneer for the nicotine plug proposed by the FDA

BUFFALO, NY, November 15, 2021 (GLOBE NEWSWIRE) – 22nd Century Group, Inc. (Nasdaq: XXII ), a leading agricultural biotechnology company focused on reducing the harm of tobacco, reducing nicotine smoking, and improving health and wellness through plant science, announced today that it strongly supports the appointment of Dr. Robert Califf as the next Commissioner of the United States Food and Drug Administration. (FDA). Califf is known to be a long-time supporter of tobacco control and a supporter of the Agency Comprehensive Tobacco and Nicotine Regulatory Plan.

“We are delighted to hear that Dr. Califf has been appointed to the post of Commissioner of the FDA. This is positive news for 22nd Century Group as it is a longtime supporter of aggressive measures to reduce the damage caused by smoking and fully supports the Agency’s plans to make all cigarettes “weak or low. non-addictive, ”said James A. Mish, CEO of 22nd Century Group. “Califor previously indicated that a nicotine capsule should be a key priority for the FDA. We look forward to the implementation of a mandate on nicotine – which we believe is the greatest opportunity to change the trajectory of public health. Our reduced nicotine cigarette, VLN®, is the only combustible tobacco product that meets the nicotine levels proposed in the FDA’s nicotine mandate. We are ready to support the FDA in this critical public health initiative. “

Califf was one of the FDA officials at the center of the Tobacco and Nicotine Regulatory Agency’s plans under the Obama administration. In a Blog 2019 post for the Association of American Medical Colleges, Califf outlined his plans to regulate tobacco products, including requiring the tobacco industry to reduce the amount of nicotine in its products to sub-addictive levels by using selective breeding, a feat of the 22nd century has already achieved in its product VLN®.

In recent months, Califf has directly urged the Biden administration to get tough on tobacco companies. During a round table in March organized by STAT, he said: “Tobacco use is emerging as one of the most important markers of disparities in our economy and our health system. I hope this administration will have the courage to fight difficult battles. “

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

Public health research projects that adopting a nicotine cap of 0.5 mg of nicotine per gram of tobacco – a level already achieved by the 22nd century VLN® nicotine-reduced tobacco cigarette – would help more of five million people to quit smoking in the first year. 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 plan, numerous independent scientific studies, funded in large part by the FDA, the National Institutes of Health (NIH), and other US federal government agencies, have shown that the use of cigarettes from nicotine-reduced tobacco helps smokers reduce their nicotine exposure and addiction, smoke fewer cigarettes per day, increase their number of smoke-free days, and double their quit attempts – all with little or no evidence of nicotine withdrawal or compensatory smoking.

Securing the MRTP designation for VLN® remains the highest priority of the 22nd century. The Company held a successful meeting with the FDA regarding its MRTP application on October 14, 2021. As a result of the meeting, and in conjunction with the recent activity of the Center for Tobacco Products (CTP), the Company’s confidence in a positive result for its MRTP application and the schedule is at its highest level to date. 22nd Century’s MRTP clearance and launch of VLN® will serve as a pioneer for the FDA’s proposed mandate to cap nicotine levels in combustible cigarettes. The company’s pilot program and manufacturing capabilities in the United States are in place to launch VLN® in the United States within 90 days of receiving the MRTP designation. In addition, the Company is advancing its plans to launch VLN® in certain international markets from the first quarter of 2022.

About 22nd Century Group, Inc. 22nd Century Group, Inc. (Nasdaq: XXII ) is a leading agricultural biotechnology company focused on reducing the harm of tobacco, reducing nicotine tobacco, and improving health and wellness through plant science. With dozens of patents allowing it to control the biosynthesis of nicotine in the tobacco plant, the Company has developed proprietary reduced nicotine (RNC) tobacco plants and cigarettes, which have become the cornerstone of the Global FDA Plan to combat 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 provide solutions for the life science industries. and consumer products by creating new proprietary plants with optimized alkaloid and flavonoid profiles as well as improved yields and valuable agronomic traits.

Learn more about xxiicentury.com, to Twitter @ —xxiiisiècle, and on LinkedIn.

Caution Regarding Forward-Looking Statements Except for historical information, all statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements generally contain words such as “anticipate”, “believe”, “consider”, “continue”, “could”, “estimate”, “hope”, “explore”, “foresee”, “objective”, ” “Orientation”, “intend”, “probable”, “may”, “plan”, “potential”, “predict”, “preliminary”, “probable”, “project”, “promising”, “seek” , “should,” “will”, “would” and similar expressions. Actual results may differ materially from those expressed or implied in forward-looking statements. Important factors that could cause actual results to differ materially are set out in the “Risk Factors” section of the Company’s Annual Report on Form 10-K filed on March 11, 2021. All information provided in this press release is to the date hereof, and the Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Investor Relations and Media Contact: Mei Kuo Director, Communications and Investor Relations 22nd Century Group, Inc. (716) 300-1221 [email protected]

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