Tag: 22nd Century Group

22nd Century Reports Quarterly Results

Photo: 22nd Century Group
22^nd Century Group reported net sales of $9 million for the first quarter of 2022, up 33 percent from the comparable 2021 quarter. The increase was due to increased contract manufacturing volumes in both filtered cigars and cigarettes, including products for export markets and pricing adjustments.
Gross profit for the first quarter was $500,000, compared to $600,000 million in the prior year first quarter. Gross margin in the first quarter was reduced by lower research cigarette sales volume compared with the prior year, and a Master Settlement Agreement adjustment of $200,000 recorded in the quarter.
Operating loss for the first quarter 2022 was $8.1 million, compared to an operating loss of $5.2 million in the prior year period. Net loss was $8.9 million.
“We are off to an exciting start with our VLN reduced nicotine content cigarette pilot launch at more than 150 Chicagoland Circle K stores,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement.
“The recently proposed menthol cigarette ban by the FDA could leave our VLN Menthol King reduced nicotine cigarettes as the only menthol cigarette on the market, helping adult menthol smokers find an off-ramp from nicotine addiction. Early sales in our Chicago pilot affirm the importance of this approach, with sales of VLN Menthol King already selling ahead of non-menthol in pilot stores. We fully anticipate an even more favorable regulatory environment as the FDA continues to advance the agency’s comprehensive plan, which includes requiring all cigarettes to be ‘minimally or non-addictive,’ a standard our VLN King and VLN® Menthol King cigarettes already meet.”
May 5, 2022
22nd Pilots its Low-Nicotine Brand in Illinois

Photo: 22nd Century Group
22nd Century Group’s VLN cigarettes are now available through a national pilot in select Chicagoland Circle K stores, the company announced in a press release.
Containing 95 percent less nicotine than conventional cigarettes, VLN cigarettes in December 2021 became the first combustible cigarettes to receive authorization from the U.S. Food and Drug Administration to be marketed as modified-risk tobacco products.
When choosing Chicagoland for the pilot, 22nd Century noted smokers are found within every segment of the population, many of whom are looking for alternatives. The Centers for Disease Control estimates 15.5 percent of Illinois adults aged 18 years or older smoke cigarettes, higher than the national average of 12.5 percent, according to 2018 state and 2020 national statistics.
A pack of VLN cigarettes will be similarly priced to full nicotine premium brands, approximately between $9 and $12, depending on tax. Illinois is the second most expensive cigarette retail market in the United States.
The three- to six-month pilot will be the first U.S. sales of VLN King and VLN Menthol King cigarettes. 22nd Century is also launching VLN cigarettes in South Korea, its first international market. Following the pilot, 22nd Century and Circle K intend to expand sales nationwide to more than 7,000 stores in 48 states.
On April 4, 2022, the Illinois Attorney General’s Tobacco Enforcement Bureau added 22nd Century Group’s VLN cigarettes to the Illinois Directory of Participating Manufacturers listing. The registration was the final step before 22nd Century could begin distribution.
.
April 18, 2022
Treat Joins 22nd Century as CSO
22nd Century Group has appointed Calvin Treat as chief scientific officer, effective May 23, 2022. In this new role, Treat will lead the expanding scientific, research and technological operations of the company, leveraging its expertise, IP and partnerships across all three of its alkaloid plant franchises toward becoming a global leader in specialty plant science.
“Dr. Treat brings a wealth of plant-based biotechnology and crop technology experience to 22nd Century at a pivotal time when we are rapidly expanding our global capabilities across all three of our alkaloid plant franchises—tobacco, hemp/cannabis and hops,” said James A. Mish, CEO of 22nd Century Group, in a statement.
“Dr. Treat has spent his career at the largest plant science names in the world, leading their innovations on major crops like corn, soybeans and cotton. We look forward to his leadership as we continue to leverage our extensive technology platform comprising hundreds of patents, extensive know-how and global partnerships supporting our leadership in plant genetics, breeding and cultivation underpinning our growth opportunities across a growing $1.3 trillion worldwide market opportunity.”
“22nd Century is rapidly establishing itself as the global alkaloid plant technology leader, bringing to bear an extensive upstream capability to optimize plant lines and enhance critical commercial traits that directly benefit quality, cost and consumer confidence in the end products. The company is leveraging the most advanced plant science techniques and building a global IP and capability set that may be unrivaled in their respective crops,” said Treat.
“I am excited to join 22nd Century at this pivotal moment to lead the company onto the global stage as more and more of the world’s leading alkaloid plant growers come to recognize the incredible value of 22nd Century’s portfolio.”
Treat previously served as senior vice president and head of crop technology for corn, soybean and cotton at Bayer, where he oversaw more than $2 billion in R&D spending dedicated to seeds, traits and crop protection while also driving tailored solutions to meet grower needs.
Previously, he was the technology lead for Monsanto’s global corn and soy crops, where he merged the soy and corn technology teams to garner synergies across the platforms. While part of the Monsanto teams, he was involved in the launches of multiple technologies, including Roundup Ready 2 Yield soybeans, Intacta RR2 Pro soybeans in South America and Roundup Ready 2 Xtend soybean technology across North America, one of Monsanto’s largest and most complex trait launches. His additional roles at Monsanto included global corn technology lead, global oilseeds technology lead and global soybean breeding lead, among others.

Photo: Jacub Jirsak
April 11, 2022
22nd Century Reports Results

Photo: MIND AND I
22nd Century Group reported net sales of $30.9 million for 2021, up 10.1 percent from 2020. The increase was due to an increase in contract manufacturing sales. Gross profit for 2021 was $2.1 million compared to $1.4 million in the prior year. Gross margin in 2021 increased to 6.7 percent from 5.1 percent in the prior year.
Net sales for the fourth quarter of 2021 were $8 million, an increase of 8.9 percent over the prior year period. The increase was due to an increase in contract manufacturing sales. Gross profit for the fourth quarter of 2021 was $387,000 compared to $588,000 in the prior year period due to the favorable effect of a large customer order that benefitted the previous year’s fourth quarter.
“The past several months were incredible as 22nd Century transforms from a pure science and contract manufacturing company into a company selling branded VLN cigarettes, licensing valuable biotechnology IP and supplying highly specialized plant lines in large and dynamic global end markets,” said James A. Mish, CEO of 22nd Century Group, in a statement.
“We secured our highly anticipated FDA MRTP [modified-risk tobacco product] designation on Dec. 23, and immediately moved to launch our VLN pilot program by the end of March. The first VLN cigarettes packaged with the FDA’s added claim of ‘Helps You Smoke Less’ rolled off our manufacturing lines in late January.
“Additionally, we have finalized our point-of-sale materials to educate adult smokers about how to use VLN to change their relationship with highly addictive nicotine cigarettes, and we have worked alongside Circle K to prepare for our first launch in more than 150 metro Chicago stores before rolling VLN out nationwide. Our mission is to get this product as quickly as possible into the hands of adult smokers, 70 percent of whom want to quit and are looking for new and innovative products to help them smoke less.”
On Feb. 28, 22nd Century announced its VLN cigarettes would make their international debut in South Korea.
March 1, 2022
22nd Century to Launch VLN in South Korea

Photo: 22nd Century Group
South Korea will be the first international market to commence sales of 22nd Century’s VLN reduced nicotine content cigarettes, the company announced in a press release.
“South Korea is an ideal international launch market in many ways, with a high smoking rate among developed countries and a government strongly committed to smoking harm reduction. We expect the first sale of VLN reduced nicotine content cigarettes to our South Korean partner to occur by the end of March,” said 22nd Centur4y’s CEO, James A. Mish.
“Approximately one in three adult men in South Korea are smokers, and an estimated 6 percent of adult women smoke. The government has worked over the past two decades to promote smoking cessation through a variety of means, including heightened tobacco prices, and remains committed to advancing alternative products to help curb smoking activity in the country. We are excited to make VLN reduced nicotine content products available in South Korea to help break the nicotine addiction cycle and support this important effort.”
The company will continue its launch process in additional markets in Asia and Europe with limited regulatory barriers while also leveraging VLN’s modified-risk tobacco product (MRTP) authorization in the United States toward seeking approval in additional markets with higher regulatory barriers.
In addition to its first international launch of VLN reduced nicotine content cigarettes in the more than $800 billion global tobacco market, 22nd Century Group is actively moving forward to launch VLN in the $80 billion U.S. market.
The U.S. FDA authorized 22nd Century’s VLN reduced nicotine content cigarette products on Dec. 23, 2021. The company is currently executing its 90-day post-authorization plan to launch in its first U.S. pilot market.
February 28, 2022
Cannabis Research Breakthrough

Photo: Elroi
22nd Century Group and KeyGene say they have made a breakthrough in hemp/cannabis plant research leading to the successful transformation of the hemp/cannabis plant genome using a proprietary plant transformation and regeneration technology and clear protein expression by the introduced genes.
“I cannot emphasize enough what an enormous achievement it is for our company to have cracked the code to show proof of genome transformation in the hemp/cannabis plant. This is the holy grail in plant science and places us in a commanding leadership position in the race to secure patents and other valuable intellectual property in the emerging hemp/cannabis genetics field,” said James A. Mish, CEO of 22nd Century Group, in a statement.
“These newest plant transformation discoveries unlock additional revenue opportunities for the company and accelerate our efforts to create new hemp/cannabis plant lines with much higher commercial value at accelerated rates, lower cost and lower risk to our customers.”
The plant transformation breakthrough unlocked by 22nd Century and KeyGene enables the desired DNA sequences to be inserted directly into or created from a plant’s existing genetic material, creating a more expedient and focused methodology to achieve the desired outcome.
In addition to its transformation capability, 22nd Century Group has exclusive access to a battery of gene-editing capabilities, based on meganuclease technology, directed to seven of the key enzymes for the biosynthesis of cannabinoids plus four patent families that cover vital enzymes. Unlike other more widely available gene-editing technologies like CRISPR-CAS-9, this technology is allowed for use in cannabis.
The breakthrough gene-editing and transformation technology will allow 22nd Century Group to target specific hemp/cannabis biosynthesis pathways and expand the ability to engineer the modification of cannabinoids in plants.
February 23, 2022
Appropriate for the Protection of Health?

Photo: 22nd Century Group
The FDA’s focus on nicotine is coming at the expense of true harm reduction.
Cheryl K. Olson
I was gobsmacked last December when the U.S. Food and Drug Administration issued modified-risk tobacco product (MRTP) authorizations for two reduced-nicotine combustible cigarettes, 22nd Century Group’s VLN King and VLN Menthol King. Both contain non-GMO tobacco that’s very low in nicotine (VLN). If 22nd Century Group can reduce the disastrous health effects of smoking by offering low-nicotine combustible cigarettes, that’s great. What took me aback was the implicit message from the FDA on its priorities.
VLN products such as these were supposed to be part of a smoking harm reduction landscape—one that includes approaches proven to reduce the risks of illness and death among cigarette smokers, such as vaping, heat-not-burn and smokeless tobacco. But this ideal, data-driven society in which addicted smokers bob gently down the famous continuum of risk via the path they prefer (perhaps starting with VLN cigarettes, perhaps with another product and ultimately landing at their low-risk nicotine maintenance or tobacco-free destiny) isn’t where we’re living.
Such a Candide-like world would feature a rainbow of reduced-risk products that match the needs of individual smokers and smokers and people who influence them (such as doctors) fully aware of these products and of how and why they’re lower risk. They’d also know that traditional approaches to quitting (hello, “cold turkey” and nicotine-replacement therapy) have proved depressingly ineffective, especially among heavily addicted, low-income, longtime smokers: the folks who need our help the most.
The FDA claimed to envision such an environment when Scott Gottlieb, then the agency’s commissioner, stated in 2017 that “Nicotine lives at the core of both the problem and, ultimately, the solution to the question of addiction and the harm caused by combustible forms of tobacco. … So, how can we take a new and comprehensive approach to nicotine?”
Gottlieb continued, “Armed with the recognition of the risk continuum, and the reality that all roads lead back to cigarettes as the primary cause of the current problem, we need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels. And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them.”
Instead, the FDA prioritized very low-nicotine cigarettes and dropped the ball on that last, essential part: the “less harmful alternative forms.” Those products, despite considerable and growing scientific evidence of their real-world effectiveness, have been left in limbo.
A Passing Grade on the Wrong Test
What exactly happened? An MRTP is simply a request to the FDA that a tobacco-related company be allowed to make some specified changes in how it describes a product or set of products to the general public through its packaging, marketing, advertising and other forms of promotion and communication.
In this case, 22nd Century Group wanted to state that each of its products contains “95 percent less nicotine,” “helps reduce your nicotine consumption” and “VLN smells, burns and tastes like a conventional cigarette but greatly reduces your nicotine consumption.” They provided the scientific evidence to back up those claims.
Among the hurdles for a successful MRTP authorization is that the manufacturer demonstrates that the product is “appropriate for the protection of the public health,” or APPH. In other words, that the requested modifications do or have the potential to do more good than harm if approved. That’s a core question that needs to be addressed in any tobacco-related application or authorization request to the FDA.
The Tobacco Control Act of 2009 begins with the words, “To protect the public health ….” That shows the clear focus and intent of the legislation. While the phrase “appropriate for the protection of the public health” appears several times in the act, it’s frustratingly vague and subject to interpretation.
What’s clear, however, is that the FDA should prioritize those aspects of smoking that are the most harmful to individual and public health. While reducing nicotine intake is appropriate for the protection of the public health, it should be nowhere near the top of the list.
It’s Not the Nicotine That Kills
Morbidity and mortality among smokers, including cancers and heart disease, are caused by the “tars” and other byproducts of combustion—what researchers often call harmful and potentially harmful constituents (HPHC). Because it’s addictive, nicotine is also considered an HPHC. As Michael Russell famously put it, “People smoke for the nicotine, but they die from the tar.”¹
In its February 2020 presentation on its products to an FDA Tobacco Products Scientific Advisory Committee panel, 22nd Century Group clearly states, “VLN cigarettes yield essentially the same HPHCs as conventional cigarettes. The benefits of VLN accrue from reduced cigarettes per day and reduced abuse liability.” That’s consistent with their authorization request since they’re only claiming a reduction in the amount of nicotine.
Think about that for a moment. The premise that reduced nicotine in combustible cigarettes will reduce harm is based on an assumption that the number of cigarettes smoked will decrease. That’s because the other HPHCs—the substances that lead to illness and death—are the same in the very low-nicotine and the regular cigarettes. Will they?
Compensatory Smoking
Maybe. Maybe not. It’s an empirical question that requires research with these specific products. Researchers studying smokers who switched to earlier generations of low tar and low nicotine cigarettes, known as low-yield cigarettes, found that many engaged in what’s known as compensatory smoking.
According to the Centers for Disease Control, “Most people who smoke are addicted to nicotine. They may compensate when smoking low-yield cigarettes in order to take in more nicotine.”⁵
A historical review of tobacco industry approaches to marketing low-yield cigarettes concluded, “Unfortunately for the industry, smokers did not care much for the taste of reduced tar cigarettes and, as expected, the lower nicotine levels became a problem as well. Smokers were not receiving the same nicotine ‘satisfaction’ and therefore began to compensate for the reduction in nicotine by smoking more cigarettes, thus increasing their health risk.”²
These earlier studies were conducted on combustible cigarettes with significantly higher levels of nicotine than the VLN products. Some well-respected smoking harm reduction experts such as Clive Bates theorize that the nicotine levels in this generation of cigarettes is so low that compensatory smoking will not be a problem. But how, then, is this different from the low success cold turkey approach? Also, what about dual use? There is nothing to prevent a smoker from using both types of products.
What’s the Real Harm?
But this distracts from the fundamental problem. The FDA’s focus is on the wrong chemical: nicotine. It’s often the first or only chemical most people can name when describing tobacco. That’s one of the reasons why the addictive quality of nicotine is so often conflated with combustible tobacco’s relationship with heart disease and cancer.
Several studies of physicians’ knowledge about the clinical effects of nicotine find misperceptions are frustratingly common. Roughly four out of five doctors surveyed incorrectly linked nicotine to cardiovascular disease (83.2 percent), chronic obstructive pulmonary disease (80.9 percent) and cancer (80.5 percent).⁹ They should know better.
This distortion of the role of nicotine among smokers, and some of the people who counsel them when they try to quit or at least reduce their medical risk, can interfere with their motivation to use some of the proven pathways away from combusted tobacco.
This focus on nicotine reduction and the misunderstanding of its risks may be precluding addicted smokers from switching to products that significantly reduce harm. According to Public Health England, “One assessment of the published data on emissions from cigarettes and e-cigarettes calculated the lifetime cancer risks. It concluded that the cancer potencies of e-cigarettes were largely under 0.5 percent of the risk of smoking. Comparative risks of cardiovascular disease and lung disease have not been quantified but are likely to be also substantially below the risks of smoking. Among e-cigarette users, two studies of biomarker data for acrolein, a potent respiratory irritant, found levels consistent with nonsmoking levels.”
My frustration is that the FDA, through its priorities and recent actions, is inadvertently reinforcing misinformation that interferes with the goal of protecting the public health by focusing on nicotine reduction at the expense of true harm reduction.
Last year, I interviewed former industry scientist Justine Shaw Jackson for another Tobacco Reporter column; she spoke of the need to give people nicotine “without all the nasties in the smoke.” That phrase stuck in my head, creating a mashup of her words and Russell’s insight: “It’s not the nicotine that kills—it’s the nasties in the smoke.” Let’s embroider that phrase on pillows and send one to every doctor and nurse in the world.
Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors. She spent 15 years on the faculty of Harvard Medical School.

February 1, 2022
James Mish Appointed to 22nd Century Board

Photo: Bill Gallery
22nd Century Group has appointed James A. Mish to its board of directors.
“The board of directors is very pleased to appoint Jim to the board, recognizing his exceptional leadership in developing and executing the business strategy leading to the commercial launches of our modified-risk tobacco products as well as our hemp/cannabis lines,” said Nora B. Sullivan, chairperson of the board of directors, in a statement.
“Bringing him onto the board further enhances our direct scientific, manufacturing and operational experience in these critically important end markets during a transformative time for our company. His contributions in the board room will also enhance the ongoing development of our strategies and ensure alignment and support for the execution of the strategic initiatives of the company.”
Mish has served as 22nd Century Group’s CEO since June 2020. Trained as a chemist, he brings a detailed understanding of molecular, organic and formulation sciences to the board—particularly in botanical products and consumer product innovation. He also brings deep experience navigating the regulatory matters related to product approvals and clinical trials, particularly with the U.S. Food and Drug Administration, European Medicines Agency and European Food Safety Authority.
Prior to joining 22nd Century, Mish led the private equity carve out of Noramco from Johnson & Johnson/Janssen Pharmaceuticals and the subsequent spinoff of Purisys from Noramco. Mish served as president and CEO of Purisys, leading its pharmaceutically derived cannabinoid API, ingredients and solutions business, including full-scale commercial production of cannabinoid APIs for various market segments, including pharmaceuticals, medical OTC and consumer packaged goods.
Mish began his career at the multinational pharmaceutical firm Pfizer in research and development before holding positions of increasing responsibility at several companies.
January 21, 2022
22nd Century to Launch VLN Cigarettes in U.S.

Photo: 22nd Century
22nd Century Group plans to launch its VLN reduced-nicotine cigarettes in a major U.S. metropolitan market by March 2022. The debut will be followed by a nationwide launch.
On Dec. 23, 2021, the U.S. Food and Drug Administration authorized 22nd Century Group’s VLN King and VLN Menthol King as the first reduced-nicotine content cigarettes under the agency’s modified-risk tobacco product designation. Scientific studies show the company’s VLN reduced-nicotine content cigarettes “help you smoke less.”
“The FDA’s MRTP authorization of VLN ushered in a new reality—a combustible cigarette carrying an authorized harm reduction claim supported by extensive scientific and clinical studies, most of which were funded by federal health agencies,” said James A. Mish, CEO of 22nd Century, in a statement.
“VLN is the only reduced harm product of its kind, and we are confident based on the research that it can absolutely be successful on its own or in combination with other harm reduction products. With an estimated 1,300 deaths per day associated with U.S. smoking, our products that can help people smoke less offer a truly game-changing prospect for millions of American adults who currently smoke.”
During the pilot phase, 22nd Century Group will test and optimize its marketing mix. The pilot will help the company better understand how adult smokers will use this product prior to advancing to national distribution, providing an unmatched tool for helping adult smokers find an off-ramp from nicotine addiction.
“22nd Century has secured a well-known national retail partner for VLN’s pilot market launch phase,” said Mish. “We intend to deploy and test a wide array of marketing materials aimed at adult smokers looking for ways to help them smoke less. These will include marketing at the point of sale, direct materials sent to self-identified adult smokers interested in VLN and online resources, such as our new product site at tryvln.com.”
While 22nd Century owns or controls the intellectual property that makes VLN tobacco possible, the company has reiterated its willingness and expectation to license the technology to strategic partners.
January 18, 2022
Modified-Risk Marketing Orders for 22nd Century
Photo: 22nd Century Group
The U.S. Food and Drug Administration has authorized the marketing of 22nd Century Group VLN King and VLN Menthol King combusted, filtered cigarettes as modified risk tobacco products (MRTPs), which help reduce exposure to, and consumption of, nicotine for smokers who use them. These are the first combusted cigarettes to be authorized as MRTPs and the second tobacco products overall to receive “exposure modification” orders, which allows them to be marketed as having a reduced level of, or presenting a reduced exposure to, a substance.
“Our mission is to find ways to stop tobacco-related disease and death. We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in a statement.
“Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers. If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death.”
The exposure modification orders specifically authorize the manufacturer to market VLN King and VLN Menthol King with certain reduced exposure claims regarding nicotine, including:
95 percent less nicotine
Helps reduce your nicotine consumption
Greatly reduces your nicotine consumption
When using any of the reduced exposure claims in the product label, labeling or advertising, the company must include, “Helps you smoke less.” The FDA also recommends that the labeling and advertising include the statement, “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.” The manufacturer is also required to label the packages with one of four warning statements for cigarettes as required by the Federal Cigarette Labeling and Advertising Act; for example, “Surgeon General’s Warning: Smoking Causes Lung Cancer, Heart Disease, Emphysema, And May Complicate Pregnancy.”
Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers.
Mitch Zeller, director, FDA Center for Tobacco Products
In the review of 22nd Century Group’s MRTP applications, the FDA evaluated data from both the company and FDA testing and found that nicotine levels in tobacco and mainstream smoke of VLN cigarettes are at least 96 percent lower than the majority of marketed and market-leading conventional cigarette brands.
Furthermore, the FDA’s behavioral and clinical pharmacology review found that by exclusively smoking cigarettes with the same or similarly reduced nicotine content as VLN cigarettes, consumers could reduce their exposure to nicotine by approximately 95 percent. The data also showed it is reasonably likely that using these products reduces nicotine dependence, which is anticipated to lead to long-term reductions in exposure to the smoking-related toxicants associated with morbidity and mortality by reducing smoking.
Published studies have shown that significantly reducing the number of cigarettes smoked per day is associated with lower risk of lung cancer and death, with greater reductions in cigarettes per day resulting in less risk. Additionally, as required for authorization, the FDA found that the applications supported consumer understanding of the claims that VLN cigarettes contain much lower levels of nicotine than other cigarettes.
The authorization for these products requires the company to conduct post-market surveillance and studies to determine whether the authorization criteria for these exposure modification orders continue to be met, including assessing use among youth.
These products are also subject to the post-market requirements and restrictions previously imposed in their December 2019 premarket tobacco product marketing granted orders. In particular, to limit youth access to the products and to limit youth exposure to advertising and promotion, the marketing granted orders placed stringent restrictions on how the products are marketed–especially via websites and through social media platforms—by including requirements that advertising be targeted to adults of legal age to purchase tobacco products.
The company must request and receive authorization from the FDA to continue marketing the products with the same modified exposure information after the initial exposure modification orders expire in five years. The FDA also may withdraw the initial, and any potential subsequent, exposure modification orders if the agency determines that, among other things, the orders are no longer expected to benefit the health of the population as a whole; for example, as a result of an uptake in use of the products by youth or former smokers, or a decrease in the number of current smokers who completely switch to the products.
In reaching today’s determination, the FDA considered both the current legal status of menthol cigarettes and the available science demonstrating that these particular products could help addicted cigarette smokers reduce their nicotine consumption and the number of cigarettes they smoke per day. The FDA is committed to moving forward with the rulemaking process to ban menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars and remains on track to issue proposed rules in the spring of 2022.
22nd Century Group welcomed the FDA decision. “Today’s decision to authorize VLN’s MRTP application places the FDA and 22nd Century together at the vanguard of transforming the tobacco industry,” said James A. Mish, chief executive officer at 22nd Century Group, in a statement.
“With 60 percent of adult smokers in our U.S. market research telling us they are likely to try VLN, this is a complete game-changer for 22nd Century, the tobacco industry, public health, and adult smokers looking to change their relationship with nicotine–the addictive chemical found in all tobacco products.
“This is the first, and most likely will be the only, combustible cigarette to ever carry the FDA’s MRTP designation. The FDA’s decision to require the additional headline claim ‘Helps You Smoke Less’ alongside our requested headline claim of ’95 percent Less Nicotine’ gives adult smokers a crystal-clear reason to replace their conventional and highly addictive cigarettes with VLN.”
December 23, 2021