The No-Nicotine Niche

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By Nattira Medvedeva

Conventional wisdom for the past few decades has said that nicotine is highly addictive and thus has harmful effects on our health. Numerous scientific studies and research conducted seem to support this position. However, there have also been numerous studies and research that have reached the opposite conclusion – that nicotine, in fact, has beneficial qualities.

First and foremost, nicotine regulates mood and improves cognitive functioning, which is one of the main draws for tobacco smokers. Nicotine’s positive effects on cognitive function suggest that patients with Alzheimer’s disease may benefit from nicotine therapy. Also, studies have shown that nicotine treatment helps improves the clinical signs of Tourette’s syndrome as well as delay the progression of Parkinson’s disease. It has also been found that nicotine is a stimulant which raises the heart rate and increases the speed of sensory information processing, easing tension, and sharpening the mind.

Nevertheless, the debate on the effects of nicotine continues and consumers are bombarded with information from one new study or another frequently. Many would prefer to reduce their nicotine intake and are increasingly turning to nicotine-free or reduced-nicotine products instead of traditional tobacco or nicotine replacement products.

Some smokers choose to go to the other end of the spectrum and opt for nicotine-free products. There is an increasing number of nicotine-free products coming out to the market as manufacturers move to answer growing interest in this particular niche.

First Comes the Wrapping ...

Primal Brands, a Turning Point Brands company, produces and sells herbal products including wraps and cones. “Herbal presents a quality alternative to tobacco and consumers appreciate alternatives,” said Steve Clark, vice president of international sales, Turning Point Brands, National Tobacco Company. “Natural substrates such as yerba mate and chamomile are different from traditional tobacco products. Not all consumers of smoking products want nicotine. Look at the number of non-nicotine vaping products, for instance. We believe there are consumers who want to unwind without tobacco, nicotine, or electronic devices.  Primal serves that niche.”

The non-tobacco and nicotine-free Primal herbal wraps and cones are available in yerba mate, chamomile, sage, and cocoa bean. “We search the globe for herbal materials that create a slow burning, smooth, and flavorful smoking experience when combined with herbal smoking blends,” said Clark. “We use a patented, proprietary process to form our herbal sheets in Brazil. Consumers can customize their smoking experience by using whatever amount of herbal smoking material that they want. Cones are convenient, easy to pack.”

Primal herbal products entered the market in early 2016 and are now in distribution in several countries across Europe, and in Canada, Australia/New Zealand, Africa, and Latin America, with plans to focus on expanding into Asia this year as well.

…Then Comes the Filling

Realleaf is a 100% organic and natural herbal blend consisting of red raspberry, marshmallow, and mullein leaves. “We came to this mixture and blend after a few years of research,” said Eitan Davidson, Realleaf’s marketing manager. “We started it all by researching the most [widely-used plants for smoking] around the world and then we met with a lot of herbalists around the world and tobacco experts just to understand a) what the best plants were and b) how do we make a very natural and very enjoyable smoking experience.”

According to Davidson, Realleaf is not a tobacco substitute, but a new smoking experience. “The whole conception that we want to change in the market is that we don’t like that consumers see our products as substitutes. We want to make a new category of smoking experience. If you’re a substitute for anything you’ll never be as good.  We want the world to understand, there’s a new category right now. We don’t see tobacco as competition, we really think there’s a new niche in the market for this smoking experience.”

Since its launch in 2015 Realleaf has been steadily penetrating markets globally, now available on Amazon in the US and in Canada, and entering new markets like Brazil, Portugal, Italy, Greece, and the Netherlands with plans for Asia in the pipeline as well.

What the Future Holds

Both Primal Brands and Realleaf believe the future for nicotine-free products is bright. “There are very similar tobacco products on the market, whether it’s rolling paper or rolling cones or wraps, but with regard to the non-tobacco, non-nicotine wrap market there’s not much out there that I’ve seen,” said Primal Brands’ Clark. There are some hemp products that I’ve seen in Canada and some in Europe but there’s not a lot of presence at this time. So, I see that there’s a real emerging segment or sub-segment, if you will.

“People like alternatives. Especially millennials, they want choices,” adds Clark. “I’ve been in the tobacco business over 30 years and I’m a consumer, too. And we’ll try anything new if it’s appealing to us and the price is right and it captures our attention. We’re willing to try new products by nature. If that product satisfies us or meets our expectations then we’re likely to buy it again. I think  that’s where we’ve really done well with Primal because it is a very smooth alternative and delivers against expectations, and that’s why sales are growing because it meets consumers’ needs.”

Realleaf’s Davidson also believes there is a growing market for nicotine-free products. “[In many] countries you can see a lot of regulations on tobacco which kind of turns you off from smoking tobacco,  but people are still looking for something to smoke.  They understand they need to reduce tobacco smoking and that’s where we come in. As I told you before we don’t want to replace [tobacco smoking], but in cases where people want to quit then definitely we’ll be there to help them. We’re enriching their tobacco experience rather than being an alternative to it.”

Reduced Nicotine Products

In between the two ends of the spectrum of traditional tobacco and nicotine-free products are reduced nicotine products from 22nd Century Group.

“Our mission at 22nd Century is to reduce the harm caused by smoking,” said Henry Sicignano III, president and chief executive officer.  “We are committed to this mission and acknowledge that though the best way to achieve widespread harm reduction is to reduce smoking rates around the world, an equally important strategy – that addresses the needs of smokers who do not wish to quit – is or to provide a choice of combustible products with the potential to reduce harm. Our company’s cornerstone technology – the ability to naturally grow tobacco plants which contain only a tiny fraction of the nicotine typically found in tobacco – allows us to produce the world’s lowest nicotine tobacco cigarettes.  Our very low nicotine (VLN) cigarettes smoke, taste, and feel like conventional cigarettes, yet contain only 0.4mg nicotine per gram of tobacco and yield only 0.04mg nicotine per stick – a 95% reduction.

“Numerous completed and on-going, independent clinical trials, with a combined [and growing] total of more than 4,000 study participants, have confirmed our belief that VLN tobacco cigarettes drastically reduce smokers’ exposure to nicotine and effectively reduce the harm caused by smoking.”

In addition to its VLN cigarettes, 22nd Century also produces Moonlight, a low tar-to-nicotine cigarette which contains tobacco with relatively high nicotine while at the same time yielding very low tar levels per unit of nicotine.  

“While the harm reduction theory behind a [VLN] cigarette that provides nicotine to smokers at non-addictive levels is easy to understand, the development of a high nicotine cigarette may seem counter-intuitive,” said Sicignano. “However, we believe that both approaches serve to reduce the harm caused by smoking, though for very different reasons.”

According to him, it has been hypothesized for many years that a high nicotine tobacco – when combined with a low tar yield cigarette design – will result in smokers inhaling far less smoke and far less “tar”, both considered to be the primary disease-causing agents of cigarettes. 

“In other words, as smokers make the adjustment to a higher nicotine cigarette, they naturally consume less tar and less smoke – primarily because the nicotine their bodies crave is more readily and more efficiently available when smoking a high nicotine tobacco cigarette,” said Sicignano. “And with less smoke consumption, the risks for heart disease, lung disease, and cancer also lessen.

“So, for smokers who wish to reduce their exposure to nicotine and/or to quit smoking altogether, 22nd Century has developed naturally growing tobacco with the world’s lowest nicotine content.  At the same time, for smokers who accept the risks associated with smoking, do not wish to quit, and who are not concerned with decreasing their exposure to nicotine, our company has created low tar-to-nicotine cigarettes like Moonlight –  to deliver nicotine more efficiently than conventional cigarettes with a reduced exposure to the smoke and “tar.”

22nd Century has also developed its Brand A cigarettes, currently waiting for FDA approval.

“We are currently investigating the introduction of Brand A cigarettes in international markets where we are allowed to disclose their nearly zero-nicotine content,” said Sicignano. “For the US market, we anticipate filing later this year a revised modified risk tobacco product [MRTP] application and its related pre market tobacco [PMT] application with the FDA’s Center for Tobacco Products for Brand A very low nicotine cigarettes.  We are currently in the process of assembling the information requested by the FDA and putting together more expansive and robust PMT and MRTP applications.  We will introduce into the US market our Brand A very low nicotine cigarettes after FDA has reviewed and approved our applications.”

For those who want to quit smoking, 22nd Century has developed the X22 smoking cessation aid, a VLT-based botanical medical product for smoking cessation. Independent clinical studies have demonstrated that combustible cigarettes containing 22nd Century’s VLN tobacco with non-addictive levels (0.04mg/stick yield per machine smoking) of nicotine enable smokers to disassociate the act of smoking from the rapid intake of nicotine.  X-22 involves the same smoking behavior as conventional cigarettes and does not expose the smoker to any new drugs or new side effects.  22nd Century has an active investigational new drug (IND) application with the US Food and Drug Administration (FDA) relating to the X-22 smoking cessation product.

“Importantly,” said Sicignano, “unlike Pfizer’s market-leading drug Chantix,  X-22 seems to pose no new side effects to smokers. What’s more, smokers that we have surveyed overwhelmingly prefer the idea of quitting with a combustible cigarette rather than using a pill, nicotine patch, lozenge, or gum. Indeed, we believe that our X-22 smoking cessation product in development may, in fact, prove to be the world’s most effective smoking cessation aid.”