The Food and Drug Administration launched a historic effort Thursday to try to end cigarette addiction, proposing to slash the level of nicotine in smokes in an attempt to curb what remains a deadly public health issue.
FDA Commissioner Scott Gottlieb said the proposal is part of a broader effort to cut smoking rates from 15 percent of Americans to about 1 percent by the end of the century. The plan calls for encouraging future generations to use safer products and for legacy smokers to quit or seek less-risky alternatives such as nicotine patches or candy.
“We believe the public health benefits and the potential to save millions of lives, both in the near and long term, support this effort,” Dr. Gottlieb said.
The effort is being launched after years of progress. Smoking rates have dropped from more than 40 percent in the 1960s to 15 percent after years of public education, clean air rules and excise taxes on tobacco products.
Rates among high school students rose to 36 percent in the 1990s but sank to the midteens this decade.
Tobacco use remains the leading cause of preventable death in the U.S., killing 480,000 per year, the FDA said. That is far above the rate of opioid overdose deaths, which reached 42,000 in 2016, prompting an emergency response from Washington.
The agency’s push is based on rules Congress passed in 2009 giving the FDA explicit power to regulate the manufacture, distribution and marketing of tobacco products.
Under that law, the FDA forced changes to packaging and pushed retailers to move tobacco products behind checkout counters.
In this latest phase, regulators plan to examine the role flavors play in encouraging tobacco use and vowed to be vigilant about attempts to target children as future users.
The agency also gave notice that it will propose rules to govern how much nicotine should be allowable in cigarettes, with an eye toward protecting public health.
Cigarettes generally contain 1.1 to 1.7 milligrams of nicotine, the notice said. The FDA is considering cutting that to 0.3 to 0.5 milligrams.
The FDA also wants to consider the trade-offs of reducing nicotine content, such as whether smokers would turn to illicitly imported products or simply smoke more cigarettes.
It also must determine how nicotine levels should be reduced. Options include genetic engineering by tobacco growers and changes in manufacturing.
The agency estimates that its framework can result in 8 million fewer tobacco-related deaths by 2100.
“Cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users,” Dr. Gottlieb said. “Given their combination of toxicity, addictiveness, prevalence and effect on nonusers, it’s clear that to maximize the possible public health benefits of our regulation, we must focus our efforts on the death and disease caused by addiction to combustible cigarettes.”
The Campaign for Tobacco-Free Kids urged the FDA to act expeditiously and demanded enhanced, more graphic health warnings on cigarette packs.
“There is no other single action our country can take that would prevent more young people from smoking or save more lives,” campaign President Matthew L. Myers said. “This is truly a once-in-a-lifetime opportunity to greatly accelerate progress in reducing tobacco use — the nation’s No. 1 cause of preventable death — and bring us closer to eliminating the death and disease it causes.”
The American Lung Association hailed the move as an “important step forward.” Leading tobacco companies responded with restraint, saying they anticipated the move and would be a part of the discussion.
“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 James Figlar, executive vice president of research and development for R.J. Reynolds Tobacco Co.
Dr. Gottlieb said he hopes existing smokers shift from traditional cigarettes to less-dangerous products containing nicotine, though he stopped short of endorsing electronic cigarettes, which the FDA is still evaluating.
“The jury’s still out on the value of those products as alternatives to combustible tobacco,” Dr. Gottlieb said.
The agency said it does not know how long its nicotine-slashing effort will take but that it has no immediate effect on products in the pipeline or are sitting on shelves now.
Altria Group Inc., the parent company of Philip Morris USA, said it is pleased that the FDA noted the distinction between regular cigarettes and noncombustible products. It cited an FDA study that said more than half of the roughly 40 million adult smokers in the U.S. are interested in “satisfying, but less harmful, nicotine alternatives to cigarettes.”
“That’s why we invest in developing a compelling portfolio of noncombustible products, while conducting the necessary science to bring them to market,” spokesman David Sutton said. “A portfolio approach is important because we know that not all smokers are looking for the same experience.”