Will FDA lower limit on nicotine in cigarettes? Health experts say the time is right

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Limiting nicotine in cigarettes and other tobacco products would be a major step in reducing addiction and the subsequent health effects of smoking, advocates said.

The U.S. Food and Drug Administration (FDA) could release a new rule that would require manufacturers to lower the amount of nicotine in cigarettes and other smoking products. It’s not an entirely new proposal. In 2018, during the first administration of President-elect Donald Trump, FDA scientists published a policy scenario with predictions about potential effects of reduced amounts of nicotine.

It was a good idea then and such a proposal deserves public support now, as it appears FDA could be open to considering restrictions on amounts of nicotine, said experts who convened online for a media briefing hosted by the Big Cities Health Coalition (BCHC).

“This will be an incredibly important moment for public health chronic disease prevention and really thinking about how to close disparities in disease and death,” said BCHC Executive Director Chrissie Juliano, MPP.

‘Tobacco use is not a choice’

“Tobacco remains the leading cause of preventable disease, disability and death in the United States, and tobacco companies do many things in their power to continue to hook new generations of tobacco users,” Juliano said.

That translates to 490,000 deaths a year and 16 million Americans living with chronic diseases caused by tobacco, said Erika Sward, assistant vice president of national advocacy for the American Lung Association.

Big Tobacco uses a one-two punch to keep their business going. First is aggressive marketing toward young people to get them to try flavored tobacco products, Sward said. The second is nicotine that keeps smokers coming back for decades, she said.

There is a limit to FDA’s power. The agency cannot eliminate an entire class of tobacco products, such as all cigarettes or all little cigars or all smokeless tobacco, and cannot reduce nicotine levels to zero. Those provisions are in the jurisdiction of Congress, Sward said.

But the Tobacco Control Act of 2009 does allow FDA to reduce nicotine levels to a nonaddictive level above zero, Sward said. That authority is clear, and so was a 2018 FDA advanced notice of proposed rulemaking about cutting nicotine levels to minimal levels.

“And that is really a key thing. We know that tobacco use is not a choice. It is an addiction,” Sward said. “It is not a habit. It is an addiction. And really the rule is significant.

“The proposed rule will be significant because when I mentioned the industry's one-two punch earlier, with nicotine being the factor that keeps users coming back, this would take away that second knockout punch from the industry,” she said. “(We) can imagine a scenario where kids who are lured by industry marketing, online influencers, and flavored tobacco products pick up a cigarette, but don't become regular users.”

As for current smokers, the U.S. Surgeon General has estimated 5 million adults would quit within a year if the lower nicotine policy went into effect, Sward said.

At the local level

While federal policy is crucial, Juliano acknowledged the state and local efforts in the fight against smoking. Those range from creating smoke-free air zones to higher tobacco taxes to minimum age requirements.

State and local health experts see the various effects, for good and bad. Cleveland, Ohio, has a 35% smoking rate, meaning 35% of all adults have smoked a cigarette in the last 30 days. That contributes to one of the highest rates of lung cancer death in the country, and neighborhoods with life expectancy in the mid-60s, compared with life expectancy up to the high 80s for residents of inner ring suburbs with lower smoking rates, said David Margolius, MD, director of public health for the City of Cleveland and a BCHC board member.

Cleveland has more than 600 tobacco retailers – one for every 600 residents – and those stores are near four out of five of the city’s public schools, Margolius said.

The city has tried to pass legislation to end the sale of flavored tobacco products. That leads to pushback with arguments about a law creating an illicit market, “as if there is a regulated market of cigarettes that we would be taking the cigarettes out of,” Margolius said.

The nation has laws around tobacco marketing and sales, Margolius said.

“But unlike alcohol, unlike meat, produce, other food products in our country, we have not had any kind of government regulation of the contents of our tobacco products,” he said. “And so this would be a huge deal to actually create a regulated market of cigarettes to at least have some control over what 35% of our residents, of my neighbors, are smoking on a consistent basis.”

Designed for addiction

In an awful way, cigarettes are exquisitely designed to addict users and maintain addiction, said Giridhar Mallya, MD, MSHP, senior policy officer for the Robert Wood Johnson Foundation. Mallya also is former director of policy and planning for the Philadelphia Department of Public Health.

Yet, when used as directed, half of regular users will die from tobacco-related diseases. “That’s unconscionable,” Mallya said, yet the tobacco industry opposes the regulation.

“In addition to strong science, one of the ways that you know a policy is going to be effective is the response of industry,” he said. “And they have been opposing a policy like this before it was even initially proposed by the federal government in 2018 because they know ultimately will impact their bottom line. And their bottom line is driven by getting kids, young people and adults addicted to these products.”

It is noteworthy that in the last 20 to 40 years, smoking rates have come down in amazing ways, Mallya said.

“But we see that smoking rates remain really high, disproportionately high in rural communities, for people with substance use disorder and mental health conditions, people with disabilities, and also among American Indian and Black folks in our country,” Mallya said. “So this policy will not only impact the and improve the health of our nation as a whole, but it will close gaps that we've seen the industry exploit for years and years.”