In 2009, Congress enacted legislation giving the Federal Food and Drug Administration authority to regulate tobacco products including the manufacture, marketing, distribution, and product standards of cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco products. The agency later extended its authority to all tobacco products, including electronic cigarettes. Included in the FDA’s tobacco product standards authority is the regulation of nicotine content.
The FDA recently issued notice of its intent of proposed rulemaking to obtain information for consideration in developing a maximum nicotine-product standard. The idea is to reduce the level of nicotine in cigarettes to either minimally addictive or non-addictive levels. The federal law did not give the FDA the power to mandate a nicotine level of zero.
The FDA has been slow to issue tobacco regulations due to political pressures, a slow-moving federal bureaucracy and legal challenges from the tobacco industry. So it is rather surprising that the FDA has moved so soon to regulate the nicotine content of cigarettes — a bold and radical move I thought would not take place for many years.
Nicotine, at levels commonly encountered in tobacco products, is not particularly toxic. It’s the other 7,000 chemicals found in tobacco, 70 of which are carcinogenic, that cause the smoking-related diseases that kill nearly a half-million people in the U.S. every year. It’s the addictive nicotine component that sustains tobacco use and thus perpetuates the resultant diseases.
Nicotine is a highly addictive drug, and cessation is extremely difficult, as everyone knows. More than half of smokers attempt to quit each year, but only about 4 to 5 percent are successful. There are still 40 million Americans addicted to tobacco, many of them hopelessly. Children who initiate smoking can become regular smokers after smoking just 100 cigarettes. And like any addictive drug, tolerance to the effects of nicotine develops rapidly.
The FDA believes reducing nicotine to minimally addictive or non-addictive levels has the potential to reduce the number of youth progressing from tobacco experimentation to regular use, improve adult cessation success, and reduce relapse rates. Moreover, the decision to smoke would be a decision of free will rather than being largely pre-empted by one’s addiction. It has been estimated that by reducing nicotine to minimal levels, 5 million adult smokers would quit within the first year of implementation, and 33 million would avoid becoming regular smokers by 2100. This would reduce adult smoking prevalence from today’s 15 percent to an astonishing 1.4 percent.
There are many research questions to answer. What is the optimal maximum concentration of nicotine that would not sustain a tobacco addiction? Should nicotine content be regulated just for cigarettes or for all combustible tobacco products? People could migrate to other tobacco products to sustain their habits. Should the nicotine be reduced gradually or all at once? There is some evidence that a one-time optimal reduction might be more effective in reducing smoking, although I suspect not politically acceptable. Would smokers faced with low-nicotine cigarettes just smoke more to achieve their desired nicotine intake? Surprisingly, some evidence suggests that this does not generally occur. And would an illicit market for conventional nicotine-dosed cigarettes be created?
Regulating the addictive nicotine in tobacco has the potential to enormously improve the nation’s health. The FDA’s primary goal is to reduce combustible tobacco use, by far the most harmful, even if it results the increased use of less toxic non-combusted tobacco products including e-cigarettes.
This would be a game-changer.