Despite greater attention paid to issues like obesity and alcohol abuse, cigarette smoking remains the leading cause of preventable death.
According to World Health Organization, over 1 billion people will die this century from tobacco-related diseases.
Each year, over 8 million people die because of combustible tobacco use.
Combustible cigarettes deliver nicotine through the burning of tobacco, which creates smoke, a complex mixture of particulates and gases. Cigarettes burn at temperatures ranging between 600-800°C to produce tobacco smoke, which contains more than 5,000 identified constituents, 93 of which have been identified by the FDA as harmful and potentially harmful constituents (HPHCs) linked to the five most serious health effects of tobacco use (cancer, cardiovascular disease, respiratory effects, reproductive problems, and addiction).
National Center for Biotechnology Information - Hazardous Compounds in Tobacco Smoke
Combustible cigarette use is directly responsible for approximately 90% of lung cancer deaths and approximately 80% of deaths caused by chronic respiratory disease, including chronic obstructive pulmonary diseases (COPD), emphysema, and chronic bronchitis.2
Harmful and potentially harmful constituents have been associated with common health complications resulting from tobacco use including cancer, heart disease, respiratory damage, reproductive issues, and nicotine addiction.3
Each year, as many as 1.2 million deaths are attributed to secondhand smoke worldwide.4 Tobacco smoke can expose both users and nonusers to thousands of chemicals, and presents serious health risks to the human body.
However, adult smokers who have not successfully quit should completely switch to potentially less harmful alternative nicotine products.
As a number of public health authorities observed, nicotine is not the primary cause of the harms associated with smoking combustible cigarettes — the only legal consumer product that, when used as intended, will kill half of all long-term users. It is the toxicants in combustible cigarette smoke that are responsible for the vast majority of smoking-related death and disease.
“Nicotine does not directly cause the estimated 480,000 deaths each year from smoking-related diseases. But nicotine is the astonishingly addictive hook that keeps people using toxic cigarettes and thus leads them to suffer long-term health consequences.”
- Mitch Zeller, Director of the FDA’s Center for Tobacco Products5
“While nicotine is what addicts and keeps people using tobacco products, it is not what makes tobacco use so deadly. Tobacco and tobacco smoke contain thousands of chemicals. This mix of chemicals — not nicotine — is what causes serious disease and death in tobacco users.”
- U.S. Food and Drug Administration6
Nicotine is, however, addictive and can be harmful. Inhalation of vapor products may aggravate pre-existing respiratory or heart conditions. Additionally, nicotine may cause other conditions, such as increasing heart rate and blood pressure, and causing dizziness, nausea, and stomach pain. No nicotine-containing product is safe for pregnant women to use.7
The most common way to consume nicotine is by smoking combustible cigarettes. Nicotine is also delivered via a number of other products, including electronic nicotine delivery systems (ENDS), smokeless tobacco products like snus, and FDA-approved nicotine replacement therapies like gums and patches.
The US FDA has established a comprehensive framework for tobacco and nicotine regulation which accepts that nicotine can be delivered on a continuum of risk, with combustible products on one end being the most dangerous and lethal, and nicotine replacement therapies such as gums and patches being the least harmful.
This framework contemplates that products which deliver nicotine without burning tobacco can pose much lower levels of individual risk than combustible cigarettes. The FDA’s approach is based on the belief that encouraging adult smokers to transition completely from combustible cigarettes to less harmful alternatives can yield a significant public health benefit.
“A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine – while highly addictive – is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.”
- Office of the Commissioner. “Press Announcements – FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of Tobacco-Related Disease, Death. U.S. Food and Drug Administration, 28 July 20178
“Nicotine, though not benign, is not responsible for the tobacco-caused cancer, lung disease, and heart disease that kills hundreds of thousands of Americans each year.”
- Scott Gottlieb, M.D., and Mitch Zeller, J.D., A Nicotine-Focused Framework for Public Health.9
Developing new technologies to deliver nicotine that reduce toxicant exposure is key to harm reduction. As a number of public health experts have observed: to transition adult smokers completely, ENDS must sufficiently appeal to smokers, provide a satisfying nicotine experience, and be lower in toxicity and harm.10
Many early ENDS products did not appeal to large numbers of current adult smokers because they failed to provide a nicotine experience in an amount and manner that is satisfactory.11 Products with nicotine delivery that more closely resemble the experience of smoking combustible cigarettes have helped make ENDS more satisfying for adult smokers and have facilitated complete switching.
Our pharmacokinetic studies demonstrate a nicotine absorption curve for the JUUL System that is competitive with, but lower, on average, than a combustible cigarette. See a representative pharmacokinetic curve.
Unlike combustible cigarettes, ENDS do not burn tobacco leaves, but instead use electronic heat sources to aerosolize a nicotine-containing liquid that is then inhaled by the user. This provides an experience similar to smoking a combustible cigarette, but avoids combustion, thus significantly minimizing exposure to the harmful chemicals found in tobacco smoke.
The JUUL Device incorporates robust firmware and temperature control to ensure consistent aerosol, limit thermal degradation of e-liquid constituents, and minimize the formation of toxicants while still delivering nicotine at levels to satisfy adult smokers and facilitate their transition from combustible cigarette use.