The FDA has issued an advance notice of proposed rulemaking (ANPRM) to explore lowering nicotine levels in combustible cigarettes to non-addictive levels, FDA Commissioner Scott Gottlieb, MD, announced Thursday.
“This new regulatory step advances a comprehensive policy framework that we believe could help avoid millions of tobacco-related deaths across the country,” Gottlieb explained in a written press statement.
The proposal to reduce nicotine levels in cigarettes is the centerpiece of a comprehensive tobacco regulatory strategy announced by FDA officials last July.
The FDA will conduct a comprehensive review of the scientific evidence involving nicotine’s role in cigarette addiction and seek input from the public. At this time, however, no specific nicotine limit has been set.
“We’re interested in public input on critical questions such as: 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?” Gottlieb said in the statement.
He added that the FDA will soon issue two additional ANPRMs: one to seek data and comment on the role that flavors — including menthol — play in the initiation, use and cessation of tobacco products, and another to further explore the regulation of premium cigars.
The FDA commissioner also vowed to jump start efforts to speed development and regulation of novel nicotine replacement therapies to give smokers who want to quit more options to help them do so.
“When I returned to the U.S. Food and Drug Administration last year, it was immediately clear that tackling tobacco use — and cigarette smoking in particular — would be one of the most important actions I could take to advance public health,” the statement said.
“With that in mind, we’re taking a pivotal step today that could ultimately bring us closer to our vision of a world where combustible cigarettes would no longer create or sustain addiction — making it harder for future generations to become addicted in the first place and allowing more currently addicted smokers to quit or switch to potentially less harmful products.”
In an early afternoon press briefing, Gottlieb discussed finding from an analysis estimating the public health benefit of lowering nicotine in cigarettes to non-addictive levels, published Thursday in the New England Journal of Medicine in conjunction with the FDA announcement.
The analysis suggested that about 5 million additional adult smokers would kick the habit within a year of reducing nicotine in cigarettes to non-addictive levels. By the year 2100, according to the model, more than 33 million people — mostly youth and young adults — would have avoided becoming smokers and smoking rates would drop from the current 15% to 1.4%.
“All told, this framework could result in more than 8 million fewer tobacco-caused deaths through the end of the century,” Gottlieb said. “These estimates underscore the tremendous opportunity to save so many lives and forge a new path forward to combat the overwhelming disease and death caused by cigarettes.”
Roughly 40 million people in the U.S. smoke cigarettes, and tobacco use is estimated to contribute to more than 480,000 deaths each year.
FDA Center for Tobacco Products director Mitch Zeller, JD, said establishing a maximum nicotine level that would make cigarettes non-addictive has the potential to get adult smokers to quit and keep future generations of kids who experiment with cigarettes from becoming addicted.
A spokesman for tobacco giant R.J. Reynolds vowed to work with federal officials as they move forward.
“As this process gets underway, we look forward to working with FDA on its science-based review of nicotine levels in cigarettes and to build on the opportunity of establishing a regulatory framework that is based on tobacco harm reduction and recognizes the continuum of risk,” said R.J. Reynolds executive vice president James Figlar.
But Erika Sward of the American Lung Association said the FDA can expect challenges from tobacco companies.
“We can expect to see them put forward illegitimate and faulty studies during the fact-finding process,” she told MedPage Today. “An immense amount of political will will be needed to get this across the finish line.”
Sward called on the FDA to consider reducing nicotine levels to non-addictive levels in all combustible tobacco products.
This sentiment was echoed by Campaign for Tobacco Free Kids president Matthew Myers in a written statement.
“For this proposal to have maximum impact, the FDA should reduce nicotine levels in all combustible tobacco products and not just cigarettes, to prevent switching to other harmful products,” he said. “It is encouraging that the FDA recognizes this concern, noting in today’s regulatory notice that ‘if a standard were to apply to cigarettes only, it could be substantially less effective.’”
American Heart Association CEO Nancy Brown called the FDA action “a commendable move in the right direction.”
“We encourage the agency to not stop here but move forward quickly with a proposed rule on nicotine levels — not just for cigarettes, but for every combustible tobacco product on the market.”