The new initiative was launched as part of the government’s so-called “unified agenda”. Released twice a year, it is a set of planned federal regulatory actions.
The rule says that the effort to decrease the nicotine in tobacco products would reduce people’s addiction to smoking and give people a better chance to quit. Reducing the amount of nicotine in these products would likely also prevent people from starting to smoke.
“Nicotine is powerfully addictive,” said FDA Commissioner Dr. Robert Califf, in the statement. “Reducing nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people will become addicted to cigarettes and help more addicted smokers to quit.”
“If we could stop them from being addicted in the first place, that would be good and that has the potential to actually produce a dramatic change in tobacco use,” Robertson said.
The number of smokers has declined significantly over the past 15 years, but in 2020, still about 12.5% of US adults, or 30.8 million people, smoked cigarettes. More than 16 million are living with a smoking-related disease, according to the CDC.
“This is an important step for public health,” said Erika Sward, assistant vice president for national defense for the American Lung Association.
Even with low-nicotine products, not all smoking-related illnesses would go away. Low nicotine cigarettes still contain the harmful products that can cause illness.
“Much of the damage comes from inhaling the burnt smoke. Burnt smoke still exists in low-nicotine cigarettes,” Robertson said. “Because they’re low in nicotine doesn’t mean they’re low in anything else.”
So it would still take a public health effort to get people to give up, Robertson said. Reducing the nicotine content could certainly help with this.
Regulations will not happen overnight, experts say, and there is no guarantee that they will be enacted.
Then the FDA will have to issue a notice of proposed regulation by May 2023 and there will be time for public comment. This process can take at least a year. So it is “very likely”, experts say, that tobacco companies will sue to prevent the rule from taking effect.
Myers and other tobacco experts said they expected the FDA and the Biden administration to act quickly on this initiative.
“We’ve seen how things move slowly in many areas with tobacco and many impediments to action can arise,” Myers said. “We just have to make a compromise to make sure it gets done.”