The role of smoke-free products in tobacco harm reduction

Quitting tobacco and nicotine altogether is the gold standard for tobacco harm reduction 

When someone stops smoking, their risk of developing smoking-related health problems and diseases will not disappear overnight, but it will decrease with time. The longer they’ve smoked, and the more cigarettes they smoke during that time, the bigger their health risks. This is why it’s so important for a smoker to quit smoking as soon as possible. 

What scientific evidence is available on the risk profile of our smoke-free products? 

The best option for smokers concerned about their health is to quit tobacco and nicotine use altogether. Our portfolio of smoke-free products is designed for adult smokers who would otherwise continue to smoke. The primary goal of developing smoke-free products is to reduce the risk of developing smoking-related diseases compared with continued smoking. 

However, smoke-free products are not risk-free, and they contain nicotine, which is addictive. To identify the extent of reduction in risk compared to continued smoking, we are evaluating the risk profile of our smoke-free products using a robust scientific assessment program. 

Assessing risk reduction

Our assessment program covers a wide spectrum of activities from initial product development to the monitoring of these products once they are on the market.

Assessing the risk reduction potential of a smoke-free product relies on the quality of the initial product design and on strict manufacturing controls to ensure that the product develops a consistent aerosol. By eliminating combustion, we aim to reduce the level and numbers of toxicants the product delivers, which should be verified on a product-by-product basis. We also verify the potential of the smoke-free product’s aerosol to reduce the risk compared to cigarette smoke by measuring a reduction in toxicity as well as a reduction in risk using laboratory models. If they are reduced significantly, we move onto clinical trials.

We conduct clinical studies with adult smokers to understand whether switching to smoke-free products reduces their exposure to toxic compounds. We also determine whether this leads to a favorable change in clinical risk markers associated with smoking-related diseases. 

We conduct several types of perception and behavior studies to better understand a smoke-free product’s potential to benefit public health. And we monitor and research the use of smoke-free products once they are on the market.

Our scientific assessment program applies well-recognized practices in toxicology, as well as an innovative Systems Toxicology-based approach to risk assessment. Our program is in line with the draft guidance from the U.S. Food and Drug Administration for a Modified Risk Tobacco Product Application (MRTPA).

We conduct our research in accordance with international standards and practices, such as the internationally accepted Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). 

PMI’s smoke-free products

We have shown through testing our own products, that if tobacco is heated above 250 °C, similar amounts of nicotine as those found in cigarette smoke, can be released. At the same time, keeping the temperature low enough means the tobacco is not burned and the levels of harmful and potentially harmful constituents (HPHCs) generated and therefore inhaled are significantly reduced. Our studies have shown an average reduction of 90-95% in the levels of HPHCs measured in the aerosol of our tobacco heating system (THS) compared to those found in the smoke of a standard research reference cigarette (3R4F).

Learn more about heated tobacco products in general:

Our nicotine salt product (NSP) and our Mesh Vaping System (MVS) do not contain tobacco and provide nicotine in an alternative way. 

Scientifically substantiated smoke-free products for adult smokers who would otherwise continue to smoke could, indeed, complement existing tobacco control efforts, including smoking prevention and the encouragement of cessation. They could be part of an overall harm reduction strategy to benefit public health.  

While smoke-free products are not risk free and in general contain nicotine which is addictive, switching completely to a scientifically substantiated smoke-free alternative can be a better choice for adults who would otherwise continue to smoke. The risk reduction potential of each product must be scientifically verified on a product-by-product basis.