• March 2, 2024

In the CatBird Seat

 In the CatBird Seat
Photo: 22nd Century Group

A pioneer in nicotine reduction technology, 22nd Century Group is well-positioned as the FDA mulls a mandate for minimally addictive cigarettes.

By Taco Tuinstra

22nd Century Group appears to be a company whose time has come. With a fresh modified-risk tobacco product (MRTP) marketing order for its VLN (very-low-nicotine) cigarettes—the only such authorization granted to a combustible tobacco product to date—and a profound understanding of nicotine reduction technologies, the company is well positioned to benefit from the U.S. Food and Drug Administration’s plan to require tobacco companies to reduce the nicotine in their cigarettes to minimally addictive levels.

22nd Century Group’s hemp/cannabis business, too, has been on a roll, boosted by spreading legalization of the product and new acquisitions. Tobacco Reporter spoke with John Pritchard, 22nd Century Group’s vice president of regulatory science, about the MRTP process, the company’s plans for VLN cigarettes and the company’s views on tobacco harm reduction.

Congratulations on the MRTP marketing orders for your VLN cigarettes. What steps have you taken to commercialize the product since December? Please comment on your plans for the United States and South Korea. Why did you choose South Korea as your first foreign market? And what have you learned from your pilots in the U.S. and South Korea thus far?

Since April 2022, we have launched our VLN cigarettes in 159 Circle K stores as part of a pilot program. Here, we can test our marketing mix to understand what the most effective way to reach adult smokers with our authorized product claims. Based upon the results of the pilot market here in the United States, we will be working closely with Circle K, our launch partner in the convenience channel, to further develop how to take the brand nationally and best appropriately service the 68 percent of adult smokers who want to smoke less.

I am happy to report that some early learnings include: 1) A measurable percentage of VLN purchases are in the carton format, even within a high tax state. We believe this is because adult smokers who are committed to smoking less are believing in the brand proposition, understand the claims the FDA authorized VLN with and how the product can help them. 2) For many years, mainstream news publications have typically not or desired not to cover tobacco and nicotine products in their publications. However, given the unique proposition of VLN, it has received widespread coverage in the Chicago Tribune, Crain’s Chicago Business, Fox 32 Chicago, WBEZ and many other local publications. We were even acknowledged by the Chicago Medical Society’s president as a product that due to the FDA’s authorization and review of our materials is something doctors should be taking seriously with their patients.

Our introduction to the South Korean market was centered around a variety of commercial and demographic criteria where one in three adult men are smokers. This market is in its early phases, and I look forward to providing detail as we move ahead.

What other markets are you considering internationally? For example, are you eyeing New Zealand, which plans to mandate lower nicotine levels in cigarettes?

We have currently launched VLN in South Korea. We absolutely commend the progress of the New Zealand government and their plans to reduce the harm caused by smoking as well as the wider initiatives they are pursuing. While no cigarette is a safe cigarette, VLN contains 95 percent less nicotine, the addictive component of cigarettes, and our proprietary tobacco genetics ultimately make possible New Zealand’s forward-thinking approach to harm reduction as well as compliance with such product standards there or elsewhere.

That said, we are taking an iterative approach to our commercial expansion and [remain] focused on the importance of the U.S. pilot. Beyond that, we have identified numerous international markets that we are continuing to evaluate; at this point, we will not comment in detail about them just yet. We will, however, be attending the Intertabac Tradeshow in Dortmund, Germany, this fall and are looking forward to meeting with specialty tobacco distributors in attendance who would like to diversify their portfolio of products with a product authorized by the United States FDA to help adult smokers smoke less.

You had been anticipating MRTP designation for some time. What actions did you take in the run-up to authorization to prepare for increased production and sales? Please comment on the expansion of your low-nicotine, tobacco growing operations, the installation of new testing equipment, partnerships with retailers and your move to a new headquarters.

We were always highly confident that we would secure an FDA authorization, given the comprehensive scientific evidence base that has been established, both from our own research and the decades-long interest and clinical studies by health agencies and public health researchers. Moreover, we have established a strong regulatory and compliance function that has been fully supported by our executive team and board.

Drawing closer to the final marketing granted orders, we built out our commercial team, bringing on board highly experienced individuals with a unique blend of knowledge of the tobacco sector and emphatic support for how the product could help adult smokers. These hires include industry experts and disrupters for our commercialization team, including John J. Miller, previously with Swisher International and UST; John Ellegate, previously of Kretek International and R.J. Reynolds; and Sam Morales, previously [of] Cannadips, Swisher International and Drew Estate.

On the operations side, we’ve planted a record crop acreage this year to be able to support our national launch plans. We have also made substantial investments elsewhere in our manufacturing base. Our factory, for example, utilizes state-of-the-art manufacturing equipment, robust manufacturing processes and quality measures to be able to produce VLN reduced-nicotine tobacco cigarettes at the same speed and scale as conventional high-nicotine cigarettes.

Please describe your experience going through the MRTP process. What was good about it, and what parts need improvement? What would you advise other players considering an MRTP application?

Well, it wasn’t particularly easy—a classic British understatement—as those whom I worked with on the MRTP project know only too well. The modified-risk tobacco product application process is certainly the most rigorous and scientific process I’ve ever been a part of in my tobacco career. While it is a long and multistep process, we acknowledge that FDA had a vast amount of scientific literature to review—much of which was done whilst FDA managed the needs and disruption caused by Covid. This attention to detail and thorough review is essential because it allows the industry, the trade and—with product introduction—the adult consumer to have confidence and trust in the statements authorized by the FDA and how we describe our product.

Since launching, we’ve seen numerous points of view published by the trade in regard to our product and its proposition to adult smokers—the rigor of the MRTP application process is incredibly important because it allows the FDA to have the loudest voice in the room, so to speak, and helps trade partners and adult smokers receive and understand messages which are truly based in science. I particularly enjoyed working with a range of subject matter experts and seeing their shared enthusiasm for what we were working to achieve. The profound public health impact of cigarette addiction in the U.S. and elsewhere was and remains a significant motivation for me and for the team.

As for advice to other companies, I remain fully committed to reducing the harm caused by smoking, and [I] encourage all companies with appropriate products to utilize the MRTP application pathway. We are not a large company when compared to most U.S. tobacco interests and yet were able to navigate the complexities and challenges to bring something new and needed to adult smokers. Adults need access to and choice of alternative products that are supported by a robust evidence base, and we believe that having more MRTP-authorized products in the market will enable the industry to more rapidly move adult smokers to smoking less or to switch to using less harmful products [and] thus ultimately help end cigarette addiction.

What, if anything, did you learn from the experiences of PMI and Swedish Match in the wake of their IQOS and General Snus MRTP authorizations? Will you market your product differently?

In considering other MRTP applications, it was apparent that while there are statutory requirements that are cross-cutting for all applications, each individual product that has been authorized or that is currently under review by FDA raised different public health and scientific questions. To that end, it was important to recognize what FDA’s concerns were or could be and ensure that we responded earnest[ly] and fully to these with appropriate evidence.

At the same time, we are grateful to the many researchers and experts within health agencies and academia for their meticulous work that contributed to the evidence base for our product, with many of such studies addressing key public health questions relating to reduced-nicotine content products.

As I am sure you have seen recently, PMI has made an offer to acquire Swedish Match, including both the innovative modern oral ZYN brand and the heritage General Snus brand—this leaves 22nd Century Group as the only other company in the world with an MRTP authorization from the FDA. The opportunity between General Snus versus VLN is entirely different. General Snus provides an offramp for interested adult smokers to continue with their nicotine consumption but changes their form factor or modality greatly, thereby reducing their exposure to combustion.

VLN provides a complete offramp from nicotine since each cigarette does not contain enough nicotine to create or sustain addiction, allowing the adult smoker to make the switch to VLN and to reduce their daily cigarette consumption. So in this regard, we do not see other MRTP products as direct competition so much as representing wider industry progress toward a future where cigarette addiction is no longer a public health disaster.

Where do you see VLN in the constellation of reduced-risk products? How will VLN cigarettes help reduce the public health toll of smoking?

It’s important to first understand that the industry has failed many adult smokers through its innovation to date. “But what about …?” I hear you say. Well, “one swallow does not a summer make,” and with over a billion smokers globally, there is clearly much to be done before the industry congratulates itself just yet.

Moreover, much innovation is sold to wealthy countries and excludes poorer countries where some companies seem entirely content to aggressively market highly addictive cigarettes. While product innovations containing nicotine—including vapor, pouches, gum, lozenges—and other modern oral products have gone some way to reducing smoking, general mistrust of the industry, contradictory corporate activity as well as willful misrepresentation of the science by some well-known anti-tobacco groups all work against the consumer and by extension the public health interest.

I am fully in favor of whatever means an adult smoker utilizes to help them reduce or cease their consumption of highly addictive combustible products. We should acknowledge that all responsible industry members share a similar end goal, but the path we take with our adult customers is demonstrably different; there is no “one size fits all.” I believe it is important that all product solutions that are backed by science and appropriately regulated must be made available to adult smokers to reduce the harm caused by cigarette addiction.

Some tobacco harm reduction advocates contend that VLN’s MRTP diverts smokers from better choices, stating that “people smoke for the nicotine but die from the tar.” What is your response to such criticism?

It’s always painful to see the industry as a whole posture and seek to create black and white narratives around an issue that is everything but binary. Nicotine gum was developed back in the 1970s and has doubtless helped many smokers even with the low efficacy of the product—and yet there are still more than $700 billion a year worth of cigarettes sold globally. The same can be said of vape technology, which has existed in multiple formats for over a decade. While millions have switched to vape, tens of millions of Americans still smoke highly addictive cigarettes.

So for us, VLN addresses a unique adult smoker need, which is not asking the adult smoker to switch to a new form factor or modality in their journey but simply asking them to make a switch to [a] product that contains significantly less of the addictive substance in cigarettes. With over 50 clinical studies, and now the authorization by the FDA that VLN helps adult smokers smoke less, it is quite clear to me that the criticism is not based on the science of our product.

Criticism of our product approach or other options by some industry voices or their familiars may play well with the gallery at conferences or other echo chambers but does not serve the interests of the individual smoker and so is ultimately self-defeating, despite their self-styled tobacco harm reduction approach. You know who you are.

I would encourage all adult smokers to use whichever product or products they feel will best help them end their use of highly addictive cigarettes and, as always, people concerned about their cigarette addiction should speak with their healthcare providers – as they can provide access to a range of other Rx product options. Our goal is simple: to make VLN available as a choice to adult smokers alongside other appropriately regulated alternative products that make up the MRTP set; people want and deserve options not dogmatic opinions.

22nd Century has repeatedly said it is willing to license its reduced-nicotine tobacco technology to other cigarette manufacturers. Has the industry expressed interest?

You’ll appreciate that at this time, I will not be sharing specific details. What I can say is that since the FDA has announced its intention to ban menthol cigarettes along with flavors in other tobacco products, we have had an incredible amount of outreach from the industry and trade. It’s really exciting to see new participants, such as convenience chains, drug stores and grocery stores, from across the United States paying attention to the FDA, the FDA’s goals and ultimately products like ours that align with the FDA’s goals as well as their corporate ethos. We are committed, as ever, that when the United States and other countries bring in limits for nicotine content in cigarettes, we will license our tobacco genetics to the industry to enable their compliance with such requirements.

After announcing its intention to reduce nicotine levels to minimally addictive levels in 2017 and again referring to the concept when it first announced plans to ban menthol in the spring of 2021, the FDA appears to have gone quiet on the plan again. Do you expect the FDA to enact a nicotine standard in the near future, and how important is such a standard to the success of VLN cigarettes?

While I cannot speak directly or indirectly for the FDA, I believe the FDA is taking the appropriate steps by focusing its efforts on the ban of high-nicotine menthol cigarettes. While some parts of industry will doubtless challenge this, they should recall that their own actions have led to the need for such regulation to be considered in the first place.

I believe the elimination from menthol in highly addictive cigarettes is an important step to reducing the attractiveness of highly addictive tobacco or nicotine to youth, a view which should be shared by industry participants as a key concern as it is for the FDA.

I am confident that we will see a nicotine standard in the coming years as appropriately regulated alternative products become increasingly available as well as a shift in public health messaging relating to such products. At this juncture, we see that our genetics and intellectual property are uniquely able to support such forward-thinking and pioneering harm reduction effort, which will save millions of lives, and we are excited to play our part in this vast public health opportunity.

In a press note dated April 29, 22nd Century Group said it expected its VLN Menthol King reduced-nicotine cigarette to be exempted from the FDA’s proposed ban on menthol cigarettes. Please explain why you expect this to happen.

We expect that the FDA will allow for a reduced-nicotine menthol cigarette to stay on the market in order to provide an offramp for adult smokers who currently use menthol cigarettes. In authorizing our MRTP applications, FDA was clear that such products have a role to play in both menthol and nonmenthol product styles to reduce their consumption of nicotine-containing products. With so many individuals smoking menthol cigarettes, we think it is prudent for the FDA to allow those smokers more options and not less to help reduce their exposure to nicotine and products containing nicotine.

Where do you see 22nd Century Group five years from now? What are the challenges that need to be overcome to achieve that vision?

Most people know the company for its leadership in reduced-nicotine tobacco technology; however, this is only one part of our business. Recently, we acquired GVB Biopharma, a contract development and manufacturing organization. GVB is one of the largest providers of hemp-derived active ingredients for the pharmaceutical and consumer goods industries worldwide based on total tonnage. GVB’s strengths complement 22nd Century’s existing upstream and downstream value chains, which includes expertise in cannabinoid receptor science with CannaMetrix, plant research and proprietary genetics through its KeyGene partnership, breeding expertise with Extractas and cultivation capabilities at Needle Rock Farms. The combination with 22nd Century establishes a global one-of-a-kind company to serve the rapidly growing hemp/cannabis ingredient market.