- The VLN® is the world’s first and only combustible cigarette to receive the FDA’s MRTP designation
- FDA includes “Helps you smoke less” statement in company-requested claims
- VLN® cigarettes with 95% reduced nicotine content to be launched in the US within 90 days
- The VLN® will be launched outside the US in the first quarter of 2022
BUFFALO, N.Y., Dec. 29, 2021 (GLOBE NEWSWIRE) — O 22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural biotechnology company focused on reducing the harm caused by tobacco, low nicotine tobacco and improving health and well-being through modern phytotechnology, today announced that the US Food and Drug Administration (FDA) authorized the commercialization of the company’s VLN® King and VLN® Menthol King Low Nicotine Cigarettes as Modified Hazard Tobacco Products (MRTPs). In doing so, the Agency found that VLN® – with the smoke, taste and smell of conventional cigarettes, but with 95% less nicotine than highly addictive conventional cigarettes – “helps reduce smokers’ nicotine exposure and consumption” .
“Today’s decision to authorize the application of MRTP from the VLN® unites the FDA and 22nd Century at the forefront of transforming the tobacco industry. With 60% of adult smokers in our US market research telling us they are likely to experience VLN®, this is a complete game-changer for the 22nd Century, the tobacco industry, public health and adult smokers seeking change your relationship with nicotine – the addictive chemical found in all tobacco products. This is the first and likely will be the only combustible cigarette to have the FDA’s MRTP designation. The FDA’s decision to require the additional statement of the statement “It helps you smoke less” along with the requested statement of “95% less nicotine” provides adult smokers with a clear reason to replace the conventional and highly addictive cigarette with VLN® ,” said James A. Mish, CEO of the 22nd Century Group.
“Our mission is to find ways to stop tobacco-related illnesses and deaths. Three out of four adult smokers want to quit, and data on these products show that they can help addicted adult smokers make the transition from smoking highly addictive fuel cigarettes.” he said Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products. “Options like those of products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine addiction, can help adult smokers. Adult smokers less addicted to combustible cigarettes would likely smoke less and be less exposed to harmful chemicals that cause tobacco-related illness and death.”
“With the obtaining of FDA marketing authorization, we are ready to launch the VLN® with selected retail and marketing partners in our US lead markets in the next 90 days and in the first global markets by the end of Q1 2022 We are also in discussions with additional retail, marketing and strategic partners to scale VLN® sales in the US and other countries, including through possible licensing of our technology to facilitate the broader industry transition to VLN products. RNC. We will provide more details on strategic partners and VLN® deployment in the coming months,” said Mish.
The FDA has authorized the marketing of VLN® with the following MRTP claims:
- “It helps you smoke less”.
- “95% less nicotine”.
- “It helps you reduce your nicotine consumption.”
- “…It greatly reduces the consumption of nicotine”.
The FDA’s decision to authorize the Company’s MRTP claims and require the additional statement of “Helps you smoke less” on every VLN® package and advertisement where any of the other authorized claims are also used was based on an extensive set from dozens of independent scientific and clinical studies on reduced nicotine tobacco (RNC) cigarette use from the 22nd Century. These studies, funded in large part by the FDA, the National Institutes of Health (NIH) and other US federal government agencies, as well as studies funded by the 22nd Century, show that smokers who use RNC cigarettes – even those with no intention of quitting at baseline – reduce their nicotine exposure and dependence, smoke fewer cigarettes per day, increase their number of days off, and double their attempts to quit – all with little or no evidence of nicotine withdrawal symptoms or compensatory smoking.
No announcement of its decision today, the FDA explained: “The data also showed that the use of these products is reasonably likely to reduce nicotine dependence, which should lead to long-term reductions in exposure to tobacco-related toxins associated with morbidity and mortality , leading to a reduction in smoking. Published studies indicate that a significant reduction in the number of cigarettes smoked per day is associated with a lower risk of lung cancer and death, with greater reductions in cigarettes per day resulting in lower risk. In addition, as required for authorization, the FDA found that the requests were based on consumer understanding of claims that VLN® cigarettes contain much lower levels of nicotine than other cigarettes.”
The VLN® is also the first and only combustible cigarette to reach the market and comply with the FDA’s proposed nicotine limit for conventional cigarettes in its Comprehensive Tobacco and Nicotine Planas well as the recently proposed New Zealand’s reduced nicotine mandate.
“We believe that today’s FDA announcement is a clear indication that the FDA is moving forward with its Plan to address the incredible harm caused by smoking. This plan includes the authorization of less toxic tobacco products, such as electronic cigarettes and other non-combustible products, along with a maximum limit of 0.5 mg of nicotine per gram of tobacco in combustible tobacco products. This level of nicotine content, which the FDA has described as being “minimal or non-addictive”, has already been achieved by the 22nd Century in their VLN® products,” Mish said.
The FDA reiterated in its announcement of today that it is “committed to moving forward with the process of creating rules to ban menthol as a characteristic flavor in cigarettes and all characteristic flavors in cigars, and is on track to issue proposed rules by mid 2022” and that cigarettes VLN® King and VLN® Menthol King “can help addicted cigarette smokers reduce their nicotine consumption and the number of cigarettes they smoke per day.”
“As the FDA is also trying to ban menthol in highly addictive cigarettes, we hope the FDA will allow our VLN® Menthol cigarette, which offers little appeal to youth and former smokers due to its low nicotine content, to be cleared by the FDA. to remain in the market as an exit ramp for adult smokers of menthol cigarettes,” added Mish.
The FDA’s decision is still based on researches who project that an industry product standard for reducing the nicotine content of cigarettes to minimal or non-addictive levels would significantly change the trajectory of cigarette addiction, which is the leading cause of preventable illness and death in the US. Approximately five million adult smokers would give up smoking within just one year of its implementation, more than 33 million people would avoid becoming regular smokers, and more than eight million premature tobacco deaths could be prevented. With nearly half a million Americans dying from tobacco use and more than $300 billion spent each year on tobacco-related illnesses, there is a clear and urgent need for substantial change in the tobacco industry.
22nd Century is ready to bring to market tobacco and finished RNC products, such as VLN®, to enable both 22nd Century and other manufacturers to comply with proposed nicotine limits in the US, New Zealand and other countries, with the adoption of this innovative and highly effective approach to reducing tobacco harm, proposed by WHO in 2015. 22nd Century plant-based technology and products are superior to similar expensive extraction and denicotinization technologies because these technologies typically use chemicals that remove flavor and aroma compounds in addition to nicotine, resulting in a product deemed unacceptable by smokers do not like the final product. On the other hand, 22nd Century reduced nicotine tobacco grows naturally with very low levels of nicotine, resulting in products that smoke, taste and smell like conventional cigarettes, but with 95% less nicotine than conventional, highly addictive cigarettes. . This is critical to creating an acceptable, exiting solution for smokers who are looking to change their relationship with nicotine.
22nd Century remains committed to licensing its technology and products to all manufacturers to enable industry compliance with proposed limits for nicotine.
About 22nd Century Group, Inc.
O 22nd Century Group, Inc. (Nasdaq: XXII) a leading agricultural biotechnology company focused on reducing the harm caused by tobacco, low nicotine tobacco and improving health and well-being through modern phytotechnology. With dozens of patents to control the biosynthesis of nicotine in the tobacco plant, the Company has developed proprietary low nicotine tobacco (RNC) tobacco plants and cigarettes, which have become the cornerstone of FDA Comprehensive Plan to address death and widespread disease caused by smoking. In tobacco, hemp/cannabis and hops, the 22nd Century uses modern plant improvement technologies including genetic engineering, gene editing and molecular enhancement to provide solutions for the life sciences and consumer products industries creating new and proprietary with optimized alkaloid and flavonoid profiles, as well as improved yields and valuable agronomic characteristics.
Learn more at xxiicentury.com, no Twitter @_xxiicentury, e LinkedIn.
Learn more about VLN® at tryvln.com.
Cautionary note about forecast statements
With the exception of historical information, all statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements often contain terms such as “anticipate”, “believe”, “consider”, “continue”, “could”, “estimate”, “expect”, “explore”, “anticipate”, “objective”, “guidance “, “intend”, “likely”, “may”, “plan”, “potential”, “predict”, “preliminary”, “likely”, “project”, “promising”, “search”, “should”, “will”, “would” and similar expressions. Actual results may differ materially from results expressed or implied in the forward-looking statements. Important factors that could cause actual results to differ materially can be found in the “Risk Factors” of the Company’s Annual Report on Form 10-K filed March 11, 2021. All information provided in this release is effective as of as of the date hereof, and the Company assumes no obligation and does not intend to update these forward-looking statements except as required by law.
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Director, Communications and Investor Relations
22nd Century Group, Inc.
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