FDA Authorized VLN® Products from 22nd Century Group Provide Key Support to Menthol Ban and Reduced Nicotine Content Policies Currently Advancing in the U.S.
Decades of Clinical Research Affirm the Strength of Proposed FDA Policies in Reducing the Harms of Smoking
Opposes Efforts by Tobacco Interests to Interfere with Advancement of FDA Policies to Reduce Adult Smoking
BUFFALO, N.Y., May 25, 2023 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a leading biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis and hops advanced plant technologies, today provided comments following the recent Tobacco Centers of Regulatory Science (TCORS) Symposium and attempts to use funding limitations to inhibit actions by the U.S. Food and Drug Administration to advance its top tobacco harm reduction policies.
The FDA’s proposed tobacco policies include a federal ban on menthol as a flavoring agent, slated for final rule status in August 2023, and a proposed national reduced nicotine content standard that would require all tobacco products sold be made minimally or non-addictive. Together, these policies are expected to dramatically reduce the rates of smoking in the U.S., saving millions of lives and countless healthcare dollars.
A recent TCORS Symposium titled “Computational Modeling in Tobacco Regulatory Science: Nicotine Reduction and Flavor Restrictions” provided two days of sessions dedicated to modelling the substantial public health benefits of these proposed FDA policies, strong statements from public health researchers and policy makers in support of the health benefits to be won from implementation, and references to 22nd Century’s leadership in bringing the first and only FDA authorized reduced nicotine content products to market, now in the first stages of commercial launch.
Speaking at the forum, Dr. Brian King, Director of the FDA’s Center for Tobacco Products (CTP), noted: “CTP is also in the process of considering a proposed rule to cap the amount of nicotine in cigarettes and certain other combustibles. It’s really groundbreaking that we’re at the precipice of making this happen. FDA has announced its intent to propose the rule, and I will tell you that is priority #3 after the other two product standards (bans on menthol and flavored cigars) to get out as soon as possible.”
Decades of clear and compelling research support both of FDA’s proposed policies and underpin the importance of VLN® products in supporting their implementation.
In particular, research indicates that a nationwide menthol ban would not only reduce the harms of smoking, but also provide significant benefit to minority communities where the rate of menthol smoking is particularly prevalent. Specifically, a menthol ban in conjunction with the availability of a non-addictive off-ramp products, like the Company’s VLN® Menthol King cigarettes, will encourage adult smokers to reduce their smoking habit, or even quit all together through the use of appropriately labelled FDA authorized products. Off-ramp products have been clinically shown to be an important component in achieving a true reduction in smoking rates, rather than adult smokers merely switching to other addictive products.
Extensive clinical research also documents that reduced nicotine content cigarettes increase cessation, decrease consumption, decrease dependence and reduce toxicants, leading to an overall reduction in population smoking activity. The FDA’s proposed mandate to require only nonaddictive levels of nicotine in cigarettes is similar to the policy recently enacted by New Zealand. Reducing nicotine to nonaddictive levels is a groundbreaking public health mandate and perhaps the single most impactful policy to reduce the rates of smoking worldwide. In recognizing this important turning point in public health, the FDA also recently executed an agreement with the government of New Zealand enabling the governments to share confidential data as the policies advance.
Additionally, 22nd Century opposes the tobacco industry’s attempts to influence congress and interfere with the U.S. Food and Drug Administration’s (FDA) plans to advance these policies. Though unlikely to become law, if passed, specific language included in SEC. 768 and SEC. 769 of the proposed Agriculture Appropriations bill would seek to interfere with FDA’s plans to remove menthol from cigarettes, presently expected to reach final rule status in August.
22nd Century believes that while these efforts by Big Tobacco to micromanage the FDA will ultimately be futile, they speak clearly to the strength of FDA’s proposed policies in reducing the rate of smoking.
“As a Company, 22nd Century stands in support of the FDA and members of Congress in the fight to end the harms of highly addictive tobacco products,” said John Miller, president of tobacco products for 22nd Century Group. “The tobacco industry’s attempted interference with the FDA’s funding exemplifies the significance of these harm reduction proposals, which could be the most influential and impactful public health policies in a generation. Decades of clinical research demonstrate that eliminating menthol and reducing nicotine to non-addictive levels can dramatically reduce smoking rates, and it is long past time we act on good science to create better health outcomes for all Americans.”
Additional VLN® Background
22nd Century Group's VLN® brand cigarettes are the first and only combustible cigarettes that the FDA has authorized as Modified Risk Tobacco Products (MRTP). The Company's VLN® King and VLN® Menthol King contain 95% less nicotine than traditional addictive cigarettes, a level considered to be minimally or non-addictive. Reduced nicotine content cigarettes, such as VLN®, have been studied extensively by federal health agencies, documenting their ability to help smokers smoke less. To inform adult smokers of the product's distinctive purpose, the FDA requires 22nd Century to include the statement "Helps You Smoke Less" on every package of VLN® sold.
As demonstrated by leading independent scientists, reducing the nicotine level in cigarettes has the potential to substantially reduce the enormous burden of smoking-related death and disease. It is estimated that a nicotine product standard to a level that is 95% less than the level of nicotine contained in U.S. conventional cigarettes could save millions of lives and tens of millions of life-years over the next several decades.
About 22nd Century Group, Inc.
22nd Century Group, Inc. (Nasdaq: XXII) is a leading biotechnology company focused on utilizing advanced alkaloid plant technologies to improve health and wellness through tobacco harm reduction, reduced nicotine tobacco, hemp/cannabis and hops. 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. The Company received the first and only FDA Modified Risk Tobacco Product (MRTP) authorization for a combustible cigarette in December 2021. 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 about VLN® at tryvln.com.
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 9, 2023. 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.
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