The FDA has issued an advance notice of proposed rulemaking in a move to lower nicotine in combustible cigarettes to minimal or non-addictive levels.
As part of the FDA’s comprehensive plan on tobacco and nicotine regulation, FDA Commissioner Scott Gottlieb, MD, has announced a move to lower nicotine in combustible cigarettes to minimal or non-addictive levels.
“We're at a crossroads when it comes to addressing nicotine addiction and smoking in this country—with important new tools to address this devastating public health burden,” he said in the statement.
With years of aggressive efforts put in place to tackle tobacco use, particularly cigarette smoking, rates of cigarette smoking among US adults have declined over the last decade, falling from 24.7% in 1997 to 14.1% in January to September 2017, according to a new CDC report. However, even with this decline in smoking rates, tobacco use kills more than 480,000 people every year in the United States and costs nearly $300 billion each year in direct healthcare costs and lost productivity, according to the FDA’s statement.
With the advance notice of proposed rulemaking, the FDA is asking the public to weigh in on critical questions, including: what potential maximum nicotine level would be appropriate for the protection of public health? Should a product standard be implemented all at once or gradually? What unintended consequences, such as the potential for illicit trade or for addicted smokers to compensate for lower nicotine by smoking more, might occur as a result?
A study published in the New England Journal of Medicine assessed the potential public health effects of enacting such a regulation in the United States using a simulation model with inputs derived from empirical evidence and expert opinion.
According to the analysis, with the implementation of the policy, 5 million additional adult smokers would quit smoking a year after the implementation, and that number would increase to a total of 13 million additional adult smokers quitting within 5 years. By 2100, the number of former smokers would increase to 33.1 million.
Looking at the number of tobacco-related deaths avoided and life-years gained because of the policy, the researchers determined that by 2060, an estimated 2.8 million tobacco-related deaths would be prevented; that number would rise to 8.5 million by 2100. The decline in deaths would result in 33.1 million life-years gained by 2060 and 134.4 million gained by 2100.