Regulatory overview on smoke-free products

Tobacco harm reduction as a part of regulatory approach

Looking back at how governments have tackled the issue of smoking, the focus has primarily been on traditional prevention and cessation strategies. Although, the idea of regulating tobacco products originated in the 1960s with reports from the U.K. Royal College of Physicians and U.S. Surgeon General on Smoking and Health, regulatory policies have since then followed identifiable trends, including advertising restrictions, limiting the areas where one may use such products, health warnings, taxation, and more. 

During the late 1990s, a group of global tobacco control experts was convened by the World Health Organization (WHO) and asked to explore how to strengthen efforts to reduce the harm caused by smoking. This group recommended that complementing prevention measures and cessation support programs with a harm reduction approach would significantly reduce smoking-related harm in future generations. A harm reduction approach can help adult smokers who would otherwise continue to smoke to have access to scientifically substantiated smoke-free products that are available today as a result of significant advances in technology and science. 

More and more governments around the world have adopted the principles of harm reduction in their tobacco policies and have recognized that smoke-free products can have a role to play in reducing the harm caused by smoking. These governments are complementing traditional tobacco control measures such as those intended to discourage initiation and encourage cessation of smoking, with harm reduction approaches such as providing adult smokers that do not quit with information about, and access to, scientifically substantiated smoke-free products to accelerate the move away from cigarettes. Countries such as New Zealand and Czechia officially embraced a harm reduction approach as a complementary policy to address the issue of smoking and accelerate its decline. In the U.S., Italy, Bulgaria, Cyprus, Portugal, and Greece, regulators have adopted regulatory frameworks defining the scientific requirements for the communication towards the consumers about reduced-risk or reduced-harm effects of innovative tobacco products compared with smoking.   

Categorizing smoke-free products

Many countries have updated their existing regulatory frameworks to regulate novel smoke-free products under unique or dedicated product categories. These categories include a level of differentiation compared with combustible tobacco products, including differentiated health warnings, flavor and packaging requirements, and others. This approach recognizes that not all tobacco products are equally harmful. Indeed, nicotine-containing products fall on a continuum of harm, with cigarettes at the highest end of the continuum.  

Heated tobacco products (HTPs) have a significant potential to serve as an acceptable alternative for adults who would otherwise continue to smoke. HTPs, also known as heat-not-burn products, are a category of products that heat the tobacco instead of burning it. The aim is to substantially reduce the emission of harmful chemicals in HTPs compared as with cigarette smoke. This innovative and evolving category includes products that vary with respect to temperature, heating source, or the way the tobacco may be processed. While not risk free, HTPs can be a better alternative to smoking, and they should be made available to adult smokers who would otherwise continue to smoke. 

Following a similar trend, e-vapor products are also classified as a unique product in many countries and regions. New Zealand or the EU—which has implemented the Tobacco Products Directive (TPD)—are examples of countries or regions which acknowledge that HTPs and  e-vapor products are different from cigarettes.  

However, there are also countries that take a more excessive approach and ban smoke-free products altogether, effectively allowing in the market only the most harmful form of consuming nicotine, i.e., cigarettes. Examples include India, Turkey, or Brazil.   

On the other hand, there are also  countries which have taken the approach of regulating smoke-free products the same as combustible products. This approach limits or outright bans the communication with adult smokers, which makes their informed decision making very difficult. These approaches disregard the potential role of scientifically substantiated smoke-free products can have in moving adult smokers who don’t quit away from cigarettes, the most harmful way of nicotine consumption.  

Some countries take other unique approaches. In Australia, for example, nicotine is restricted and classified as a 'dangerous poison' by law. If it is used for therapeutic purposes, i.e., quitting smoking, nicotine products have to be registered under the Therapeutic Goods Act (1989). Therefore, with the exception of cigarettes, products containing nicotine are only recognized for use as smoking cessation therapy and require a prescription from a registered Australian medical practitioner. Regulatory mechanisms under this classification make it more difficult for adult smokers who don’t quit to access products whose risk profile is different from cigarettes.  

Nicotine pouches, yet another smoke-free product category, don’t involve a device, heating, or the inhalation of an aerosol. Instead, these pouches are designed to be placed between the upper lip and gum, allowing nicotine absorption through oral mucous membranes before entering the bloodstream.  

From a regulatory point of view, the approach to oral nicotine pouches varies. They are commercialized in the U.S., the U.K., and various countries in Europe. In the EU, the regulatory classification of nicotine pouches is not harmonized (i.e., not subject to EU directives) with some EU countries, explicitly or implicitly, banning the commercialization of nicotine pouches altogether (Belgium and the Netherlands), while others regulate them such as Czechia, Slovakia, Sweden, Denmark, Iceland, and Norway. Pending regulations are in progress in various countries across Europe such as Finland to more clearly integrate nicotine pouches within the tobacco product regulations. 

An evolving regulatory landscape

New technologies continue to emerge, and regulations must continue to adapt at a rapid pace. In the heat-not-burn category, new products have been introduced which contain nicotine without tobacco, or which are based on other ingredients and do not contain either nicotine or tobacco. New production methods have even made it feasible for some companies to produce products with synthetic nicotine, or even which contain nicotine analogues like metatin, placing them outside the regulatory framework in some countries.  

Priorities among health agencies and countries continue to change in response to these emerging products. The global discussion on tobacco regulation has seen a shift from a focus on tobacco and its health harms to zero in on nicotine instead. Nicotine is indeed addictive and not risk free, but it is not the primary cause of smoking-related disease. Refocusing regulatory attention to the primary cause of the health harms of smoking, which is combustion, and the ways these harms can be mitigated could have a positive impact on public health.  

Another priority shift, or perhaps inconsistency, that has been seen is the promotion of public health policies that outright ignores tobacco harm reduction approaches. Consider the WHO Framework Convention on Tobacco Control (FCTC), where harm reduction is defined as a strategy of tobacco control. Despite this definition, harm reduction is absent from the recommendations of the WHO. 

One important aspect of public health which several countries are already addressing is the importance of regulation that safeguards against access to tobacco and nicotine-containing products for underage users. These regulations will require the precision to balance these safeguards while ensuring that adult smokers who don’t quit are not prevented from accessing products that are better than continued smoking. 

In the midst of this changing regulatory landscape, the primary role of regulation remains the same: protecting the health of the public. The reliance on data and scientific evidence to make informed policy decisions, and a harm reduction approach that sees the most harmful products being subject to the most restrictive regulations, have the potential to see the greatest impact on public health.   

Looking ahead, policymakers and regulators will continue to update tobacco legislation in response to emerging tobacco and nicotine alternatives. Here are some examples of countries that are regulating smoke-free products or integrating the concept of tobacco harm reduction within their regulations.