What is harm reduction?

    The role of smoke-free products in tobacco harm reduction

    For current smokers, the best step they can take to reduce their risk of harm is to quit tobacco and nicotine use altogether. But most smokers don’t quit. The concept of harm reduction is based on the understanding that there are better options available to adult smokers who would otherwise continue to smoke. In recent years, an increasing number of smokers have switched from cigarettes to smoke-free alternatives to reduce the risk of harm to their health than if they had continued smoking. Developing products like these is the goal of Philip Morris International’s (PMI's) harm reduction strategy. 

    What is harm reduction?

    Harm reduction, also known as harm minimization, is an approach to public health which aims at reducing or mitigating the negative health and social consequences of high-risk behaviors rather than eliminating the behaviors completely. Harm reduction programs are developed using empirical and real-world evidence and take account of the complexities and realities of a given problem. These programs often combine different approaches rather than relying on single measures, such as bans or restrictions, alone.

    Harm reduction approaches have been applied in various sectors and regulatory contexts and have provided significant benefits to individuals and public health in areas including:

    • Encouraging the use of seatbelts in vehicles
    • Increasing the uptake of early cancer screenings
    • Supporting the use of bicycle helmets
    • Promoting the use of sunscreen and sun protection
    • Moving adult smokers who don’t quit from cigarettes to reduced-risk tobacco and nicotine-containing products, also known as smoke-free products

    How is harm reduction applied to cigarette smoking?

    In the case of cigarette smoking, harm reduction involves complementing traditional tobacco control measures (e.g., strict labelling requirements, bans on sales to minors, or restrictions on smoking in public places) with approaches which could help accelerate the decline in smoking intensity and/or prevalence and, as a result, reduce smoking-related diseases and deaths.

    Tobacco harm reduction has been described as focusing “on encouraging the use of less dangerous forms of tobacco/nicotine by those who prefer not to abstain at all from tobacco/nicotine products.” (Kiviniemi & Kozlowski, 2015). This approach is supported by mounting scientific evidence on the harm reduction potential of smoke-free products when compared with cigarettes (U.S. Food and Drug Administration (FDA), 2017; Public Health England (PHE), 2017; New Zealand Ministry of Health, 2021).

    An important insight into tobacco harm reduction is the understanding that nicotine, an addictive and not risk-free component of cigarette smoke, is a primary driver for continued smoking, but is not itself the main cause of smoking-related diseases. Rather, it is the chronic exposure to the harmful chemicals generated and emitted in cigarette smoke when the tobacco is burned that is the main cause of smoking-related diseases, such as lung cancer, chronic obstructive pulmonary disease, and cardiovascular disease.

    The U.S. Food and Drug Administration (FDA) has pointed out that “It’s the thousands of chemicals contained in tobacco and tobacco smoke that make tobacco use so deadly ... This toxic mix of chemicals—not nicotine—cause serious health effects among those who use tobacco products." 

    In fact, nicotine is an important part of tobacco harm reduction. Because nicotine is one of the reasons people smoke cigarettes, the presence of nicotine in products that are scientifically substantiated to be less harmful than cigarettes can help adult smokers who don’t quit switch to these alternatives instead of continuing smoking cigarettes.

    How does eliminating combustion reduce potential harm?

    Smoke-free products don’t burn tobacco, and so they don’t release the high levels of harmful chemicals found in cigarette smoke. When a cigarette is burned, it reaches temperatures above 400 °C, and as high as 800 °C or more at the tip. The high temperatures cause a chemical reaction called combustion, which produces cigarette smoke. This smoke contains more than 6,000 chemicals, around 100 of which have been classified by public health authorities as harmful and potentially harmful constituents (HPHCs).  

    We have shown through testing that if tobacco is heated to temperatures below the ignition temperature of the tobacco, as in our Tobacco Heating System (THS), similar amounts of nicotine to those found in cigarette smoke can be released without combustion.

    Because the tobacco is not burned, the levels of HPHCs generated and inhaled are greatly reduced. Research has shown an average reduction of 90-95% in the levels of HPHCs measured in the aerosol of THS compared with those found in the smoke of a standard research reference cigarette.*  

    Smoke-free products use a variety of different technologies and substrates. For example, e-vapor products vaporize a nicotine-containing e-liquid to produce an aerosol which is inhaled, while snus and nicotine pouches contain nicotine (either through tobacco or a nicotine powder) which is absorbed when the user places the pouch in their mouth, between the upper lip and gums. However, all smoke-free products, when scientifically substantiated, can provide nicotine to smokers while reducing the levels of harmful chemicals emitted or released.

    * Emits on average 90-95% lower levels of HPHCs depending on which regulatory authority list is used.

    A scientist in a lab coat and rubber gloves holds heated tobacco product.
    PRODUCTS

    Learn more about PMI's smoke-free products

    Our goal is to develop a portfolio of less harmful alternatives to smoking for those adults who don’t quit. We call them smoke-free products.

    Discover our smoke-free products

    What is the risk continuum and how can it help reduce harm from smoking?

    The best way to reduce the risk from smoking is to quit using tobacco and nicotine products altogether. However, according to World Health Organization (WHO) estimates, there are about 1 billion smokers in the world to date and, according to the WHO, this number will not significantly decrease in the coming years. 

    Most smoke-free alternatives, including e-vapor products, heated tobacco products, nicotine pouches, and snus still contain nicotine, which is addictive and is not risk free. However, switching to a smoke-free alternative that is scientifically substantiated to be less harmful than continued smoking could reduce the risk of harm. 

    In fact, not all tobacco and nicotine products are the same. Their use exists on a continuum of risk, with combusted products at the high-risk end of the spectrum and cessation on the low end. Alternative, smoke-free products that deliver nicotine without combustion and with far lower levels of toxicants than cigarettes are closer on the spectrum to cessation than combusted products (WHO, 2018; FDA's Center for Tobacco Products).

    The continuum of risk shows that noncombustible products are lower risk than cigarettes. Combustible products include cigarettes, cigars, and cigarillos.

    Noncombustible products include e-vapor products, heated tobacco products, pouches, and snus. Nicotine replacement therapy (NRT) products include patches and gums.

    Understanding this risk continuum also helps us to better understand how to reduce tobacco-related harm at the population level. This depends on two factors:  

    • Smoke-free alternatives must have significantly lower risk compared with cigarettes.
    • Significant numbers of smokers must switch to these alternatives.

    The Harm Reduction Equation. Successful harm reduction requires that adult smokers be offered a range of less harmful alternatives so that acceptance by the users can be best fulfilled.

    Both parts of the equation are important in achieving harm reduction at a population level. In addition, the greater the number of adult smokers who switch to lower risk alternatives instead of continuing to smoke cigarettes, the greater the impact on reducing population harm. This is why smoker acceptance is an important component of the harm reduction equation. After all, even a very low risk product will not reduce harm if no one uses it.  

    Smoker acceptance of smoke-free alternatives requires products that are satisfying for current adult smokers so that if they don’t quit, they completely switch.  

    The overall goal, therefore, is to develop smoke-free alternatives that present significantly less risk of harm than continued smoking, that are acceptable to current adult smokers who would otherwise continue to smoke cigarettes, and do not appeal to unintended audiences, including youth, nonsmokers, and former smokers. 

    HARM REDUCTION

    Learn more about harm reduction

    Watch Patrick Picavet explain what harm reduction is. Or you can download the harm reduction issue of our Scientific Update below.

    Scientific evidence for the potential lower risk of smoke-free products

    Scientific evidence supports the risk reduction potential of smoke-free products compared with cigarettes (FDA, 2017; PHE, 2015). To identify the extent of this reduction, PMI uses a robust scientific assessment program. This program has generated 541 publications since 2008, most of which are open access.  

    At each step of our assessment program, we apply rigorous standards, according to internationally recognized research guidelines, principles, and practices, and the program is aligned with the 2012 draft guidance for modified risk tobacco product (MRTP) applications issued by the FDA’s Center for Tobacco Products. 

    Assessing the risk reduction potential of a smoke-free product involves five “steps,” although each product progresses through the assessment program differently. These steps include: 

    • Aerosol chemistry and physics studies to confirm that combustion does not take place and to confirm for each product that the resulting aerosol contains lower levels of HPHCs compared with cigarette smoke.  
    • Toxicology research to determine whether smoke-free product emissions or releases are toxic to cells and other model systems compared with cigarettes, and to allow scientists to understand the biological processes that lead from exposure to the onset of smoking-related disease. 
    • Clinical research to provide human data on the use and acceptance of our smoke-free products as well as their potential to reduce exposure to HPHCs, and the potential to reduce the risk of smoking-related disease as compared with continued smoking.  
    • Perception and behavior research for insights on how people perceive and use smoke-free products, which can impact population health. 
    • Long-term research which tracks the impact of each product on population health over time. 

    Smoke-free products as part of a comprehensive harm reduction strategy

    For those adults who do not quit tobacco and nicotine altogether, which is always the best option, switching to a scientifically substantiated smoke-free alternative is a better choice for reducing the risk of smoking-related harm than continuing to smoke cigarettes.

    Conceptual depiction of the cumulated risk of smoking and the effect of cessation over time.

    Note that the straight lines used in this figure are for illustration purposes only as the accumulation of disease risk and the reduction upon cessation and switching to a smoke-free product follow different trajectories for specific diseases.

    In recent years, an increasing number of adult smokers have switched from cigarettes to smoke-free alternatives such as e-vapor, heated tobacco, or oral tobacco products to reduce the risk of harm to their health compared with continued smoking. These smoke-free alternatives can complement existing tobacco control efforts, including smoking prevention and the encouragement of cessation. As such, they could be an important part of an overall harm reduction strategy and a benefit to public health.

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    Reduced Risk Products ("RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.