What if we could prevent over 8 million tobacco-related deaths in the United States by the end of the century? What if a federal regulation could help to create a future in which cigarettes were no longer responsible for lifetimes of addiction and disease?

FDA is working toward that future. In July 2017, Commissioner Dr. Scott Gottlieb announced a new comprehensive plan that places nicotine—and the issue of addiction—at the center of the agency’s tobacco regulation efforts. A key piece of the plan is the consideration of a product standard that would limit the level of nicotine in cigarettes, rendering them minimally addictive or nonaddictive.

On March 15, 2018, FDA issued an advance notice of proposed rulemaking (ANPRM) to seek comments on a potential nicotine product standard, encouraging the public to submit comments, research, and data on a number of related topics.

An FDA-funded study, “Potential Public Health Effects of Reducing Nicotine Levels in Cigarettes in the United States,” published in the March 2018 issue of New England Journal of Medicine, takes a closer look at the public health implications of one possible policy scenario for a nicotine product standard. The study uses statistical models and input from external experts to examine the potential public health impacts, over time, of rendering cigarettes minimally addictive through implementing such a product standard.  

Public Health Impacts

While no tobacco product is safe, the most harmful tobacco products are combustible ones—those that must be lit and burned to use them. Per the 2015 National Health Interview Survey (NHIS), over 87 percent of U.S. adult tobacco consumers use a combustible tobacco product, and 15 percent of all American adults smoke cigarettes. The cigarette is the deadliest of all combustible tobacco products given its combination of toxicity, addictiveness, prevalence, use patterns, and effects on nonusers. 

Cigarette smoking causes more deaths each year than AIDS, alcohol, illegal drug use, homicide, suicide, and motor vehicle crashes combined^1,2, and for adults 35 years of age and older, it is the primary cause each year of:

• 163,700 deaths from cancer;
• 160,600 deaths from cardiovascular and metabolic diseases, and;
• 113,100 deaths from pulmonary diseases.³

National survey data show 68 percent of current adult smokers in the United States want to quit, and although about 55 percent of adult smokers have attempted to quit in the past year, only 4 to 7 percent were successful.⁴ Why do quit attempts fail? Research shows that nicotine, a highly addictive chemical found in the tobacco plant, keeps people smoking even when they know it could shorten their lives and want to stop.

Modeling a Potential Nicotine Product Standard

The study authors created a model to estimate the impact of one possible policy scenario for a nicotine product standard, using data from scientific research studies and expert opinion. The model creates a baseline scenario in which the policy has not yet been enacted, using nationally representative data from the U.S. Census Bureau, NHIS, and the National Youth Tobacco Survey, among others. This baseline assumes that cigarette smoking would continue to decline based on recent trends in smoking initiation and cessation. The model compares this baseline scenario with a policy scenario in which a product standard is put in place in 2020 to lower levels of nicotine in cigarettes and other combustible tobacco products that are highly likely to serve as substitutes for traditional cigarettes (i.e., roll-your-own tobacco, pipe tobacco, non-premium cigars). The models take into account the following potential behaviors: completely quitting cigarettes; switching from combustible to non-combustible tobacco products; using two or more tobacco products; becoming a new smoker; and becoming a new user of non-combustible products instead of becoming a smoker. Both scenarios are projected through the end of the century.

More than 134 Million Years of Life Gained

According to this model, if the policy were put in place by 2020, approximately 5 million additional adult smokers would quit smoking within just one year after implementation, compared to the baseline scenario. In the years following, smoking rates would decline even more significantly. The study estimates that only about 1.4 percent of the U.S. adult population would smoke cigarettes by 2100, in part, because more than 33 million people would avoid becoming regular smokers. Since nearly nine out of 10 daily adult smokers begin before the age of 18,⁵ this means that millions of our nation’s youth would be protected from a lifetime of addiction, disease, and early death.

As the number of newly addicted smokers is projected to steadily drop because of the potential policy, life expectancy for those who avoid becoming smokers is expected to increase. According to the model’s estimates, as informed by expert input, the potential product standard would result in more than 134 million years of life gained among the U.S. population by the year 2100. This means that individuals who would have died far too early because of smoking would instead live longer lives.

Since the policy could enable Americans to live longer without addiction to combustible cigarettes, the incidence of otherwise preventable tobacco-related death and disease is projected to decrease over time (as long as the product standard remains in place). By the year 2100, more than 8 million premature deaths from tobacco could be avoided, per the authors’ model.

Ongoing Research

While the projected benefit to public health is very positive, FDA recognizes there are still questions to be answered about the possible unintended consequences of limiting nicotine levels in cigarettes. Some potentially unintended consequences FDA is seeking comment on include the potential for illicit trade and the potential for addicted smokers to increase the amount they smoke to compensate for lower levels of nicotine in cigarettes.

Lasting Effects

The projected, lasting effects of a potential product standard that lowers nicotine levels in cigarettes to minimally addictive levels include:

• tens of millions of U.S. youth who would never face the burden of addiction and preventable disease and death;⁶
• more time with loved ones for those whose lives could have otherwise been cut short due to smoking; and
• millions of premature deaths avoided.⁶

Find more information on FDA’s plan for nicotine and tobacco regulation on our website, and learn more about what FDA is doing to encourage current smokers to quit.