Tobacco Harm Reduction

Our Goals
Develop tobacco products that may offer lower risk for adult tobacco consumers and engage the FDA constructively about them.

Support programs that help reduce underage tobacco use.

Provide access to expert quitting information for those who have decided to quit.
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Our Goals
Develop tobacco products that may offer lower risk for adult tobacco consumers and engage the FDA constructively about them.

Support programs that help reduce underage tobacco use.

Provide access to expert quitting information for those who have decided to quit.
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  Blue Right
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​Public health authorities increasingly recognize that – with the right regulatory oversight – lower-risk products have a genuine role to play in reducing tobacco-related harm​. 
Despite efforts to persuade people never to start or to quit once they do, millions of adults will continue using tobacco products. For these consumers, lower-risk products offer a promising opportunity to reduce the harm associated with tobacco use, particularly cigarette smoking. Making reduced-harm products available to these consumers is a critical part of our broader Tobacco Harm Reduction strategy – which also includes supporting cessation​ and preventing underage tobacco use​​​.

This "Tobacco Harm Reduction" approach to public health has gained momentum in recent years.
 
A strong public health consensus has formed that not all tobacco products present the same risk. In fact, public health authorities agree that there is a broad continuum of risk among tobacco products, with conventional, combustible cigarettes at the highest end of that spectrum. 
“There is a very pronounced continuum of risk depending upon how toxicants and nicotine, the major addictive substance in tobacco, are delivered. Cigarette smoking is undoubtedly a more hazardous nicotine delivery system than various forms of noncombustible tobacco products for those who continue to use tobacco, which in turn are more hazardous than pharmaceutical nicotine products.”   – Strategic Dialogue, 2009
​​"The health risks of smokeless tobacco are considerably lower than those associated with combustible tobacco as it is largely the combustion process that makes tobacco use so deadly."   – Royal College of Physicians, "Harm Reduction in Nicotine Addiction: Helping People Who Can’t Quit," 2007​
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In addition, there is now a comprehensive federal regulatory framework around all tobacco products in the U.S. This regulatory system empowers the Food and Drug Administration (FDA) to evaluate potentially reduced-harm tobacco products and determine what reduced-risk information should be communicated to consumers. The FDA can advance this goal either by evaluating manufacturers’ requests to communicate reduced harm information about specific products, or by directly communicating reduced harm information to consumers.
With this regulatory system in place, many scientists and public health officials are advocating for broader communication of reduced harm information to enable consumers to make more informed decisions.  
​​"There is potential for an ever-wider range of consumer-acceptable alternatives to the cigarette for smokers who will not otherwise cease their dependence on nicotine."  ​– Strategic Dialogue, 2009​
Developing Lower-risk Products​​
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Our companies are committed to helping reduce the health effects of tobacco use and have invested billions of dollars over the years in developing products with lower risk.  We’ve learned a lot from this work, and we will continue to going forward. 
Our role in a regulated Tobacco Harm Reduction environment is to understand adult tobacco consumer preferences, develop the products that meet them, and seek appropriate regulatory authorizations. In short, our companies focus on consumer insights, innovation and science.​
Understanding Consumer Preferences​​
 
​Adult tobacco consumers must be willing to try and like a lower-risk product in order for that product to succeed at reducing harm. Our research shows that tobacco consumers consider many features when trying new products, including taste, performance, and value.​
Making sure that a potentially reduced-harm product is satisfying to adult tobacco consumers is important if harm reduction is going to work. That’s why our companies' product development efforts start with their expectations in mind. 
Authorized reduced-harm products that meet adult tobacco consumers’ expectations have the greatest opportunity to improve public health.
Innovation & Product Development​
 
Our companies use consumer insights to help develop products that adult consumers want. Adult tobacco consumers today have a variety of preferences, which is why we focus on commercializing multiple innovative products for them. Failing to satisfy consumers' expectations, especially when it comes to newer technologies, will adversely affect the product’s chance of reducing harm.​
Our companies' efforts today span multiple product types, including:​​
​​​Smokeless Tobacco Products
 
Smokeless tobacco products​​​
​​​E-vapor and other Tobacco-Derived nicotine products​​
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E-vapor and other tobacco-derived nicotine products​​
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Heated tobacco products​​
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Other innovative products​​
​Over the next several years, our companies intend to pursue FDA authorization of superior branded products that offer reduced risk alternatives to adult tobacco consumers.​
For example, we're supporting Philip Morris International's (PMI) efforts to submit FDA applications on an electronically-heated tobacco product. We have entered an agreement with PMI that gives Philip Morris USA the exclusive rights to market and distribute this product in the U.S. if the FDA grants PMI’s Modified Risk Tobacco Product application, which is now pending with the agency.​
Advancing the Science​
 
Science and evidence are the foundation for developing potentially reduced-harm products. As regulated companies, we're required by law to demonstrate to the FDA that a product is less harmful to individual consumers as well as to the population as a whole before making any reduced-risk statements.​
To support this effort, we established a rigorous scientific framework based on FDA's guidance to evaluate potentially reduced-harm tobacco products.​



This framework helps us generate important data, like clinical research, perception and behavior studies to support reduced risk product applications by​:​
  • measuring harmful and potentially harmful compounds;​
  • evaluating the product's health effects;
  • researching how adult tobacco consumers use the product and their understanding of its risk; and
  • substantiating that the product is unlikely to appeal to unintended audiences.​
Sharing Our Research​
 
It's important to contribute to the scientific understanding of tobacco harm reduction.​
We share the results of our scientific studies with the FDA and others through peer-reviewed journals, conference presentations and one-on-one meetings. Since 2009, our scientists have published more than 100 peer-reviewed articles related to harm reduction in numerous scientific journals.​
Our research is also available on a website intended for scientists and the public health and regulatory communities. This website offers information to help these stakeholders l​earn more about our approach and provide their perspective on the work we do.​
E-Vapor​
 
There is growing evidence that e-vapor products may be less risky than traditional combustible cigarettes for smokers who switch entirely from cigarettes to e-vapor. Unlike traditional cigarettes, which involve burning tobacco and inhaling smoke, e-vapor products create an aerosol from a nicotine solution that is heated. This difference has led many in public health to note the reduced-risk potential for individual consumers:​
"Although it is not possible to estimate the long-term health risk associated with e-cigarettes precisely, the available data suggest that they are unlikely to exceed 5% of those associated with smoked tobacco products, and may well be substantially lower than this figure."  – Royal College of Physicians, "Nicotine without the smoke: tobacco harm reduction," April 2016
To date, however, the FDA has not reached any conclusions as to e-vapor products generally as a category of product, nor has it ruled on any application from an e-vapor manufacturer seeking authorization for a claim.
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