According to the latest data from the Office of Smoking and Health of the U.S. Centers for Disease Control and Prevention, almost 90% of all adult smokers started smoking before the age of 18,  and each day in the U.S., nearly 2,500 young people smoke their first cigarette. 
The relative young age in which many smokers begin smoking is a great concern to health authorities, since the age at which people start smoking may greatly influence how much they smoke per day and how long they will smoke. This, in turn, influences the individual’s risks of tobacco-related disease and premature death.
Inhaling tobacco smoke, which may contain at least 250 chemicals known to be harmful to both smokers and nonsmokers, including hydrogen cyanide, carbon monoxide, and ammonia, is highly addictive. And while nicotine, the drug primarily responsible for addiction, is not a direct cause of tobacco and smoking related diseases, including cancer, cardiovascular disease and pulmonary diseases, it is the addiction to nicotine, similar to the addiction caused by illicit drugs such as heroin and cocaine, that is considered the proximate cause of these deadly diseases and premature death.
The simple reason is that nicotine addiction sustains smoking behavior, and, as a result, indirectly stimulates exposure to disease causing chemicals in cigarettes.
[This] bold proposal [will] substantially reduce the nicotine content of cigarettes, and possibly other combustible tobacco products… [and] save millions of lives that would otherwise be lost as result of tobacco-related cancers and other diseases…
Reduce the nicotine content of cigarettes
In 1994, Benowitz and Henningfield first proposed an idea to develop a federal regulation of the nicotine content of cigarettes designed to reduce the nicotine content of cigarettes wover time. Benowitz and Henningfield strongly believed that lowering the intake of nicotine would result in a lower level of nicotine dependence.
By lowering nicotine in cigarettes to a minimally or non-addictive level, regulators at the U.S. Food and Drug Administration believe that they could decrease the likelihood that future generations become addicted to cigarettes while creating an opportunity for currently addicted smokers to quit.
Although there has been a decade long, aggressive, effort to tackle the leading cause of preventable disease and premature death in the United States, tobacco use, largely based on cigarette smoking, still kills more than 480,000 Americans every single year.
These first, organized, efforts started in 1964 with a strong statement in the seminal Report of the Advisory Committee to the Surgeon General of the Public Health Service. The report stated ?Cigarette smoking is a health hazard of sufficient importance in the United States to warrant appropriate remedial action.? Since then, the Surgeon General has issued 28 more reports on tobacco and health, most recently in 2005.
Tobacco use, which is associated with 18 different types of cancers, costs nearly US $ 300 billion a year in direct health care expenses and lost productivity.
“Cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users. Given their combination of toxicity, addictiveness, prevalence and effect on non-users, it?s clear that to maximize the possible public health benefits of tobacco regulation, the U.S. Food and Drug Administration needs to focus its efforts on the death and disease caused by addiction to combustible cigarettes,” noted FDA Commissioner Scott Gottlieb, MD, earlier this month on a pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels.
In its advance notice of proposed rule-making or ANPRM, the FDA announced that it is seeking to develop a potential nicotine product standard for combustible cigarettes with nicotine levels at minimally or nonaddictive levels.
In a commentary, Dorothy K. Hatsukami, Ph.D, Associate Director of Cancer Prevention and Control at the University of Minnesota Masonic Cancer Center, said, in an announcement made in collaboration with the American Association of Cancer Research (AACR), that the FDA?s first step in the rule-making process is really encouraging.
?[This] bold proposal [will] substantially reduce the nicotine content of cigarettes, and possibly other combustible tobacco products… [and] save millions of lives that would otherwise be lost as result of tobacco-related cancers and other diseases,” Hatsukami noted.
The new FDA initiative includes an FDA-funded study, published in the March 2018 issue of New England Journal of Medicine, which 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.
The authors of the study published in the New England Journal of Medicine created a model designed to estimate the impact of a possible policy scenario for a nicotine product standard.
Using data from nationally representative sources, including the U.S. Census Bureau, NHIS, and the National Youth Tobacco Survey, the model the authors created included a baseline scenario in which a policy was not yet established. This baseline assumed that cigarette smoking would continue to decline based on recent trends in smoking initiation and cessation. Following, the model compared the baseline scenario with a policy scenario in which a product standard was put in place to lower levels of nicotine in cigarettes and other combustible tobacco products that are highly likely to serve as substitutes for traditional cigarettes.
In their article, the authors conclude that their model, despite uncertainty about the precise magnitude of the effects on smoking behaviors, indicates that enacting a regulation to lower the nicotine content of cigarettes to minimally addictive levels, may lead to a substantial reduction in tobacco-related mortality.
With the planned development nicotine product standard and other advance notice of proposed rule-making the FDA is attempting to reduce the use of cigarettes among youth and adults. Among the additional advance notice of proposed rule-making, the regulators are investigating the role that flavors, including menthol, play in initiation, use, and cessation of tobacco products. Another advance notice of proposed rule-making aims to regulation of premium cigars.
Earlier this year the FDA organized a public hearing on its approach to evaluating the safety and efficacy of nicotine replacement therapy (NRT) products, including how to promote innovation in these products and how they should be used and labeled.
Overall, it is very encouraging to see the ongoing commitment of regulators to make it harder for future generations to become addicted to tobacco products in the first place and to allow currently addicted smokers to quit or switch to potentially less harmful products.
Last Editorial Review: March 19, 2018
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