The Development of Tobacco Products: Modern Trends and Future Innovations

As cigarette smoking rates decline in many countries and the tobacco industry undergoes consolidation, new nicotine livraison methods have emerged. These alternatives include electronic nicotine delivery systems (ENDS), heated tobacco products (HTPs), and oral nicotine products (ONPs). Over time, some of these products have evolved to deliver nicotine levels comparable to traditional cigarettes, potentially serving as viable substitutes for smokers. However, certain products, especially ENDS like JUUL, have gained popularity among youth and non-smokers, raising concerns about increasing nicotine use and addiction. The tobacco industry may eventually shift its focus from cigarettes to promoting ENDS, HTPs, and ONPs, although it currently continues to heavily market cigarettes in low and middle-income countries. Regulatory frameworks, which vary widely, will likely influence the prevalence of both traditional cigarettes and these newer products, determining the extent to which cigarettes may be replaced by ENDS, HTPs, and ONPs in the coming decade.

Global Decline in Tobacco Use and Industry Adaptation

Tobacco use among adults worldwide has seen a significant decrease, dropping from 33% in 2000 to 23.5% in 2018. Projections suggest that by 2025, only 20.9% of adults will be tobacco users. The vast majority of tobacco consumers—over 80%—are cigarette smokers, although various other tobacco products like snuff, chewing tobacco, cigars, water pipes, pipes, bidis, and kreteks are also available. This reduction in cigarette smoking has coincided with, and may have been influenced by, the consolidation of the tobacco industry into a few major corporations: Philip Morris International (PMI), British American Tobacco (BAT), and Japan Tobacco International (JTI). These companies have also been exploring and promoting alternative nicotine delivery systems.

Evolution of Tobacco Products

The decline in smoking rates has prompted cigarette manufacturers to innovate and diversify their product offerings. To retain their customer base, these companies have developed or acquired alternatives such as smokeless tobacco, heated tobacco products (HTPs), and e-cigarettes. The success of these initiatives has varied, as shown in the timeline in Figure 1, reflecting the ongoing adaptation of the tobacco industry to changing consumer habits and regulatory landscapes.

Evolution and Regulation of Electronic Nicotine Delivery Systems

In 2007, electronic nicotine delivery systems (ENDS), commonly known as e-cigarettes or vaping products, were introduced to the market. These devices typically feature a battery-powered heating element that aerosolizes a liquid containing nicotine, flavorings, and humectants. Over the past decade, ENDS have evolved significantly, transitioning from disposable cigalikes that mimic traditional cigarettes to rechargeable, customizable devices with refillable tanks, and more recently to sleek pod-style devices like JUUL.

Initially, ENDS were marketed by companies like Ruyan (later NJOY), but they gained popularity with the introduction of blu in 2009. JUUL, launched in 2015, quickly became the leading ENDS brand in the United States. By 2019, Altria had acquired a stake in JUUL. Today, ENDS are the second most popular tobacco product in the U.S., with 4.5% of adults reporting current use. Similar usage rates are seen in Europe, although there are regional variations, with Eastern Europe exhibiting higher prevalence than Western Europe. In contrast, ENDS use is less prevalent in Asia, with about 1.8% of adults in China using these products. ENDS are also present in the South African market, but their use remains lower in low and middle-income countries (LMICs) such as Bangladesh and Zambia.

The World Health Organization (WHO) advises regulating ENDS to prevent unverified health claims, reduce health risks, protect non-users from secondhand exposure, and discourage youth initiation through measures like advertising restrictions and flavor bans. Regulatory approaches vary globally; 32 countries have banned ENDS sales, and 79 have implemented at least one regulation, such as restrictions on public use, advertising, or health warnings. For instance, non-prescription nicotine-containing ENDS are illegal in countries like India, Japan, Chile, and Australia. In the European Union, the Tobacco Products Directive limits nicotine concentration to 20 mg/mL and sets standards for liquid container volume, packaging, and labeling.

In the United States, ENDS manufacturers had to submit premarket tobacco applications in 2020 for FDA review to determine if their products could stay on the market. Concerns over JUUL’s youth appeal and rising youth ENDS usage have led to restrictions on flavored ENDS sales, impacting JUUL’s market share and allowing competitors like Puff Bar to gain ground. Enhanced market monitoring is essential to understand the industry’s tactics in promoting ENDS as alternatives to traditional tobacco cessation.

Evolution and Market Impact of Heated Tobacco Products (HTPs)

Heated tobacco products (HTPs) heat tobacco to temperatures below combustion to create a nicotine-containing aerosol. This technology began with RJ Reynolds’ (RJR) Premier in 1988. The Premier used a charcoal tip to produce heat, which, when passing through the device, generated an aerosol that released nicotine and flavors from flavor beads and a small amount of tobacco. Despite its innovative approach, Premier failed commercially and was withdrawn in 1989. RJR reintroduced a redesigned version called Eclipse in 1996.

Philip Morris (PM) entered the market in 1998 with Accord, a new design featuring an external heat source into which users inserted small cigarettes made from a specially formulated reconstituted tobacco mix. These two technological approaches—charcoal tips and external heat sources—laid the groundwork for subsequent HTP models like RJR’s Revo (launched in 2014 and withdrawn in 2015) and PM’s Heatbar (launched in 2007 and withdrawn in 2008). These early models were short-lived, often withdrawn from the market within a few years of their introduction.

In recent years, HTPs have gained more acceptance among smokers. Significant models include JTI’s Ploom (launched in 2007), Philip Morris International’s (PMI) IQOS (launched internationally in 2014 and in the USA by Altria in 2020), BAT’s iFuse (launched in 2015), and KTG’s glo (launched in 2016). These newer products have captured a substantial global market, particularly in the WHO Western Pacific Region.

HTPs are most popular in certain Asian countries and have also gained traction in parts of Europe, the USA, and other regions. For instance, HTP use in Japan rose from 0.2% in 2015 to 10%-15% in 2019, and 4.4% of adults in Korea currently use an HTP. In Europe, prevalence has been lower but is increasing in some markets, with current use in Italy at 1.1% in 2019 and in England at 1.2%. In the USA, Canada, and Australia, HTP use prevalence remains below 1%, though estimates indicate a rise in the USA from 0.5% in 2016 to 1.1% in 2017. Awareness and usage data in Mexico and Guatemala are limited.

Japan’s particular popularity with HTPs may be due to significant restrictions on ENDS (electronic nicotine delivery systems) in that market. In the USA, the IQOS has been authorized as a modified risk tobacco product under an exposure modification order. In the EU, HTPs are regulated under the Tobacco Products Directive as a novel tobacco product.

Oral Nicotine and Tobacco Products

Nicotine can be consumed through various non-combustible means, with oral delivery being a prevalent method. This includes traditional forms such as chewing tobacco and moist snuff, popular in regions like North America, Scandinavia, Asia, and Africa. For this discussion, we define oral tobacco products (OTP) as those containing cut tobacco leaf material (e.g., snus) and oral nicotine products (ONP) as those that do not contain tobacco leaf material (e.g., dissolvable tablets).

Smokeless tobacco (ST) companies have sought to expand their market share by targeting OTPs towards smokers. For instance, in 2001, Swedish Match introduced Exalt, and the US Smokeless Tobacco Company (USSTC) launched Revel, both portioned snus products designed to attract users who did not prefer traditional smokeless tobacco. Recognizing this market opportunity, US cigarette companies began acquiring smokeless tobacco businesses or developing their own products. In 2006, RJR acquired Conwood and introduced Camel Snus. Philip Morris (PM) also entered the market with Marlboro Snus, Marlboro Snuff, and Taboka before acquiring USSTC.

The early 2000s also saw the emergence of ONPs, starting with the 2001 launch of Ariva, a dissolvable pellet, followed by Stonewall, a larger pellet aimed at ST users. Although Ariva and Stonewall exited the market in 2012, other products continued to develop. PM and RJR launched Camel orbs, strips, and sticks (compressed dissolvable tobacco) in 2009, which were withdrawn in 2013. They also introduced Marlboro/Skoal sticks in 2011 and Revel (now Velo) nicotine lozenges in 2019.

“Tobacco-free” ONPs are making a comeback in the USA and Europe, with products like ZYN (Swedish Match), On! (Altria), and Velo (RJR Vapor). In Europe, 46 brands have been identified, with 27 new nicotine pouch brands launched in 2020. These products seem to bypass the EU ban on snus and the existing Tobacco Products Directive, although German regulators have prohibited their sale. Few recent studies have focused on these products, but one report indicates low usage in the Netherlands (<1%). These products are also marketed in Pakistan, Kenya, and Tanzania, although data on their adoption is scarce. Nicotine pouches are illegal for sale in Australia (except by prescription) but are allowed in New Zealand.

Addictiveness and Appeal of Electronic Nicotine Delivery Systems (ENDS), Heated Tobacco Products (HTPs), and Oral Nicotine Products (ONPs)

Nicotine Delivery and Absorption Mechanisms

Nicotine, the primary addictive component in tobacco, is highly volatile and the most abundant tobacco alkaloid. It can be absorbed through the mouth, upper airways, and lungs. When inhaled from ENDS and HTPs, nicotine is efficiently absorbed in the lungs, quickly entering the pulmonary venous circulation, passing through the heart, and entering arterial circulation before crossing the blood-brain barrier. Although buccal absorption from ONPs is rapid, the increase in brain nicotine levels is slower compared to inhalable products. Once in the brain, nicotine binds to nicotinic acetylcholine receptors, releasing neurotransmitters like dopamine, norepinephrine, serotonin, GABA, glutamate, and endorphins. Dopamine, in particular, is associated with pleasure and appetite suppression, playing a significant role in nicotine’s addictive and dependence-inducing effects.

Aerosol Characteristics and User Behavior

The aerosol from ENDS and HTPs consists of liquid particles suspended in air. Factors such as device design and user behavior (e.g., puffing patterns) influence the nicotine yield and dose delivered to the user. The nicotine yield in ENDS aerosols depends on device power, nicotine concentration, and solvent type. While early ENDS devices did not effectively deliver nicotine, newer models produce more aerosol and consistent nicotine yields. Studies have shown that modern ENDS can generate nicotine yields comparable to, and sometimes exceeding, those of a tobacco cigarette. Industry-funded research on ONPs indicates these products deliver nicotine as quickly and effectively as existing smokeless products.

Influence of pH on Nicotine Bioavailability

The pH of inhaled aerosol from ENDS and HTPs significantly impacts nicotine bioavailability. Higher pH levels result in more unprotonated (“free-base”) nicotine, making it more volatile. This increases absorption in the oral cavity and upper respiratory tract but also causes more irritation and an unpleasant taste. Conversely, lower pH levels result in more nicotine in the liquid phase, leading to reduced irritation and allowing deeper inhalation and increased lung deposition of aerosol. Pod-based ENDS devices, introduced in the mid-2010s, contain high concentrations of nicotine salts (nicotine conjugated with a weak acid), which have a lower pH and less harshness. The introduction of JUUL in 2015, containing a 5% nicotine salt solution, exemplifies this trend. The availability of high-concentration nicotine salt solutions is growing, with reports indicating over 70 US ENDS brands containing more than 5% nicotine.

Consumer Appeal of ENDS, HTPs, and ONPs

Despite extensive research and development, smokers often rate the sensory properties of cigarette alternatives lower than traditional cigarettes. For instance, HTPs may reduce the urge to smoke to some extent, but their sensory properties and ease of use are typically rated lower than conventional cigarettes. However, ENDS, HTPs, and ONPs share characteristics that can increase their appeal, particularly in high-income countries with strong tobacco control programs, product regulations, and public awareness about the risks of smoking. These products are often perceived to pose less severe health risks than cigarettes, making them attractive to health-conscious smokers. Nevertheless, this perception can lead consumers to mistakenly believe that these products are risk-free or that reducing exposure can be achieved without completely quitting smoking.

Increasing restrictions on indoor use, sales, advertising, and packaging have also made cigarettes less attractive and convenient. For example, in Europe, Canada, and the USA, characterizing flavors other than tobacco have been banned in cigarettes but not in most other tobacco and nicotine products.

While adults might use ENDS to quit or reduce smoking, adolescents and young adults are often drawn to them out of novelty and curiosity. Flavors, in particular, attract both youth and adults to use ENDS by decreasing harm perceptions and increasing the willingness to try and initiate use. Other appealing features include variety and choice of design, nicotine levels, adjustable device settings, producing ‘clouds’, packaging, price (especially relative to cigarettes), avoidance of smoking restrictions, positive sensory and physical experiences, social acceptability, and perceived safety for bystanders. Pod-style devices, with their attractive design, user-friendliness, less aversive vaping experiences, desirable flavors, and discreetness, have become especially popular among adolescents.

Many observations about ENDS apply to HTPs as well. Common marketing terms for HTPs include ‘reduced-risk’, ‘alternative’, ‘clean’, ‘smoke-free’, ‘innovative’, ‘chic’, and ‘pure’. HTPs are sold online and in high-end concept stores and are available in non-tobacco flavors in several markets. Other attractive features include less throat discomfort, appealing packaging, cleanliness, lack of ash and smoke, and more social acceptability compared to conventional cigarettes. Users often cite health concerns, costs, enjoyment, satisfaction, ease of use, and social aspects as reasons for using HTPs. Overall, HTPs are perceived as upscale, high-demand products for tech-savvy users, distinct from the image of cigarettes. The price of HTP tobacco inserts is similar to cigarettes, and the devices are expensive. Unlike cigarette packs in some markets, HTPs do not yet require graphic warning labels with explicit color pictures.

ONPs have emerged more recently and are primarily marketed online as non-combustible alternatives to tobacco and nicotine products. Although data on perceptions are limited, a recent survey in the Netherlands found that users perceive nicotine pouches as less harmful but not less addictive than other tobacco and nicotine products, including cigarettes. Nicotine pouches are available in various flavors, such as fruit, mint, cinnamon, and coffee, and they contain sweeteners. They are perceived as effective for quitting smoking and are easy and discreet to use, particularly in places where smoking is banned. Reported reasons for using ONPs include reduced relative health risks, ease of use, and discreteness. Concerningly, 40% of never-users were curious to see what using ONPs was like. The costs of ONPs are slightly lower or comparable to a pack of cigarettes in the USA. ONPs have the potential to displace traditional smokeless tobacco products, particularly in regions like South Asia and Africa, where they are newly marketed. Currently, ONPs account for approximately 4% of the total smokeless tobacco market in the USA.

The Future of Tobacco and Nicotine Products

The Shift to Harm Reduction

Major multinational tobacco companies are increasingly focusing on harm reduction by transitioning away from traditional combustible cigarettes to promote a ‘smoke-free world’. For instance, Philip Morris International (PMI) established a foundation to advocate for this idea, though its independence is debated. Many leading companies are now emphasizing electronic nicotine delivery systems (ENDS), heated tobacco products (HTPs), and oral nicotine products (ONPs), targeting these innovations at current smokers. Companies are keen to enhance product appeal and broaden their market reach, learning from past product failures.

New Product Developments

British American Tobacco (BAT) plans to launch Vuse Zero, an ENDS product without nicotine, alongside new strengths, flavors, and formats for their ONP, Velo. Additionally, they are developing Neo Core, a carbon tip HTP. PMI has developed four platforms of ‘smoke-free’ nicotine products, including both HTPs and ENDS. Platform 1 includes products like IQOS and Marlboro Heatsticks, which use a ceramic heating blade. PMI is set to expand this line with the IQOS ILUMA, utilizing Smartcore induction technology. Platform 2 features charcoal-heated products that don’t require batteries, similar to RJR’s Eclipse from the late 1990s, branded as TEEPS. Platforms 3 and 4 are nicotine-containing ENDS with different heating sources, including a nicotine salt heater and an e-liquid MESH heater for consistent flavor delivery. PMI is also blurring the lines between HTPs and ENDS with the promotion of IQOS VEEV. While PMI is less involved in ONPs, its US subsidiary, Altria, has acquired the oral nicotine pouch, On!.

Market Expansion Strategies

Tobacco companies are also aiming to expand their market presence by strategically targeting different countries and demographics. Imperial Brands, for example, plans to market closed vapor products in the USA, open vapor products in the UK, and HTPs in Germany. In the USA, Altria has introduced IQOS and Heatsticks in several states. Currently, IQOS is the only HTP approved for sale in the US market. However, PMI is facing lawsuits in both the USA and Germany filed by BAT, alleging patent infringement on heating technology. BAT’s US subsidiary, Reynolds American, seeks an importation ban on IQOS, claiming PMI copied technology developed for BAT products like Glo, Vuse Vibe, and Vuse Solo. Despite these legal challenges, PMI argues that excluding IQOS from the market would hinder efforts to reduce smoking.

The tobacco industry’s future lies in innovative harm reduction strategies, with a strong focus on developing and promoting smoke-free nicotine products. As companies navigate market expansion and legal disputes, their priority remains on creating appealing, safer alternatives to traditional cigarettes.

Transitioning Smokers to Alternative Nicotine Products

The effectiveness of explicit harm reduction claims in encouraging smokers to switch to other nicotine delivery methods remains uncertain. In the United States, Swedish Match’s eight snus products were the first tobacco products to receive authorization as modified risk tobacco products (MRTP). Similarly, IQOS with Marlboro Heatsticks received this designation in 2020, while applications for Camel Snus, Copenhagen moist snuff, and Moonlight low-nicotine cigarettes are still pending. However, no electronic nicotine delivery systems (ENDS) or oral nicotine products (ONPs) have publicly confirmed submitting MRTP applications.

ONPs, which often resemble pharmaceutical nicotine replacement therapies (NRT), pose unique regulatory challenges. For instance, oral nicotine lozenges may look similar to NRT lozenges but are typically sold at higher concentrations (8 mg vs. 4 mg) and with more appealing flavors, marketing, and packaging, lacking NRT’s extensive labeling of potential side effects or usage instructions. This ambiguity complicates the regulatory process, especially when determining if a product qualifies as a drug. The introduction of products using synthetic nicotine also raises important questions about public perception and regulatory impact.

Policy Developments and Regulatory Challenges

Recent policy changes could significantly influence the nicotine product market. In April 2021, the Biden administration committed to banning menthol cigarettes and cigars in the U.S. and revisited plans to introduce a nicotine standard for cigarettes. This follows similar menthol bans in Canada, the EU, and other countries. Since 2016, the EU has banned characterizing flavors other than menthol in cigarettes, with menthol added to the ban in 2020 due to its facilitation of inhalation. Some member states, like Germany and Finland, prohibit menthol use at any level for this reason. However, other tobacco products such as cigars, cigarillos, and snus are exempt, although member states are increasingly banning flavors in ENDS. Menthol bans might push smokers towards heated tobacco products (HTPs), ENDS, or ONPs if these regulations do not apply to them.

Regulatory actions concerning new products sometimes lead to litigation. In 2021, the World Health Organization (WHO) identified over 80 such cases. Manufacturers may challenge whether existing laws apply to their products, seek regulatory loopholes, or argue for marketing based on relative risk compared to cigarettes. The emergence of products containing synthetic nicotine in the past few years, driven by regulatory definitions of tobacco products, further complicates regulation. Courts’ rulings on these products could present ongoing challenges, making it necessary for regulators to test the provenance of nicotine as part of their oversight.

Despite the decline of cigarette smoking in affluent nations and among educated populations within countries, global efforts in tobacco control are far from complete. It’s crucial to consider cultural, regional, and socioeconomic disparities in tobacco consumption. Electronic nicotine delivery systems (ENDS), heated tobacco products (HTPs), and oral nicotine products (ONPs) are predominantly marketed in high-income countries, contrasting sharply with the continued heavy promotion of cigarettes in low- and middle-income countries (LMICs).

A significant question going forward is whether ENDS, HTPs, or ONPs might appeal to users of non-cigarette combusted tobacco products like cigars, pipes, waterpipes, bidi, and kretek, as well as users of traditional smokeless tobacco products with higher nitrosamine content. This is especially pertinent in markets where such products are widely used, such as India, Indonesia, and the Eastern Mediterranean, where their use poses substantial public health risks. The barriers to adoption of ENDS, HTPs, or ONPs in LMICs—whether related to costs, appeal, or regulatory frameworks—are not yet clear.

Diverse policy orientations and principles—such as harm reduction versus the precautionary principle—play a role in shaping regulatory approaches. Different stakeholders, including advocates and regulators, may prioritize distinct populations or health concerns, such as smokers versus youth, addiction among young people versus chronic diseases in adults, or specific health risks like cancer versus cardiovascular diseases, each having varying dose-response dynamics.

For instance, one country may prioritize preventing novel products from entering the market to curb overall tobacco use expansion, while another might reduce market entry barriers as part of a strategy to specifically reduce smoking rates. In both scenarios, regulatory mechanisms to withdraw problematic products from the market should be implemented as a safeguard.

Knowledge Gaps and Recommendations for Future Research

Looking ahead to the next decade, a critical challenge lies in effectively studying the expansive and dynamic vaping marketplace. There is a notable absence of research focused on individual products, which is crucial for informing decisions by policymakers and regulators. Compounding this issue is the rapid evolution in product design, marketing strategies, and usage patterns, making comprehensive research difficult to conduct.

To address these challenges, there is a pressing need for advancements in data collection and surveillance methodologies. Anticipatory approaches, akin to early warning systems utilized in drug abuse monitoring, could significantly benefit this field. This includes employing techniques such as trend watching in marketing, monitoring social media, and analyzing search trends to identify emerging products like the next ‘JUUL’.

The current pace of surveillance efforts is inadequate, particularly with large-scale national surveys that are slow to adapt to the fast-changing landscape of vaping products. This disparity is even more pronounced in lower- and middle-income countries (LMICs) that often lack resources for robust surveillance and research. Here, technical support from wealthier nations, civil society, or organizations like the WHO could prove invaluable.

Moreover, existing questionnaires and frameworks for understanding tobacco use are predominantly derived from traditional cigarettes. As such, they may not effectively capture the nuances of new products, such as electronic nicotine delivery systems (ENDS), which are used throughout the day rather than in discrete sessions. The rise of polytobacco use further complicates this landscape, necessitating comprehensive survey methods that account for multiple product usage patterns.

Additionally, current research methods primarily designed for cigarettes may overlook new toxicants present in emerging products. Thus, there is a clear need for untargeted screening methods to identify potential novel contents and emissions that may pose health risks.

Lastly, as technology increasingly integrates into the tobacco market (e.g., Bluetooth-enabled vaping devices), collaboration between tobacco regulators and other consumer goods regulators becomes essential. Issues like data privacy, security, and the implications of product-user interactions (e.g., data retention, geofencing) must be carefully considered to ensure regulatory effectiveness and public safety. Understanding these technological dynamics will be crucial for regulators aiming to stay ahead of market innovations and potential risks.

Conclusion 

The global tobacco market remains dynamic and expansive, characterized by ongoing shifts and expansions. While several tobacco companies are exploring reduced-risk alternatives by promoting alternative nicotine sources, this does not signify a departure from the cigarette market. JTI emphasizes their belief in adults’ freedom to choose. Moreover, Imperial Tobacco, BAT, and JTI have reported revenue growth from their cigarette brands and show no immediate intentions to transition to a cigarette-free future, unlike Altria, PMI, and Swedish Match, which have explicitly declared such plans. It is crucial to investigate the public health impact of new products amid diverse regulatory landscapes and varying stages of the tobacco epidemic worldwide. Ensuring full compliance with the Framework Convention on Tobacco Control (FCTC) and safeguarding against tobacco industry interference are critical imperatives.