FDA head Gottlieb announces plans to regulate nicotine in cigarettes

Big Tobacco is getting an unprecedented challenge from the Trump administration.

For the first time, the Food and Drug Administration (FDA) has proposed slashing nicotine — you know, that highly addictive ingredient in cigarettes — to negligible, nearly non-addictive levels. FDA Commissioner Scott Gottlieb, whom President Trump nominated to the powerful post in 2017, announced on Thursday the start of regulatory actions he said would decrease smoking rates in the U.S. from 15 percent to 1.4 percent.

Gottlieb said previous efforts to curb smoking, though "aggressive," still result in 480,000 American deaths each year.

"In fact, cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users," Gottlieb said in a statement.

It's a move tobacco companies will almost certainly fight, but one that public health experts believe is far overdue.

"Cigarettes have no place in society any longer," said Desmond Jenson, a senior law attorney at the Public Law Health Center, in an interview.

"If cigarettes were invented today, no country in the world would allow them to be sold."

#FDA has taken 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. My statement on these important efforts: https://t.co/4kPZMsh9Tx pic.twitter.com/IJSZC81LpJ

— Scott Gottlieb, M.D. (@SGottliebFDA) March 15, 2018

The FDA, however, is still a ways away from actually ordering tobacco companies to dramatically lower nicotine levels in cigarettes. They've formally issued an "advance notice of proposed rulemaking," which is an initial effort in creating actual regulatory rules.

"It's the first step of a long process that will take years," said Jenson. "While it's important, the devil is in the details."

For instance, the final rules should include other "combustable products," said Jenson, like pipe tobacco and cigars.

"If the FDA only regulates cigarettes, the potential benefit of the rule would be diminished by some other people switching to other combustable products," he explained.

Following Gottlieb's announcement, the New England Journal of Medicinepromptly published a public health report estimating the future societal effects from cutting nicotine levels in cigarettes. If nicotine levels remained as they are, researchers estimated that by 2100 around eight percent of the adult U.S. population would still smoke cigarettes, as other intervention programs and educational efforts would gradually lower the number of projected smokers.

Special Report from @US_FDA: Potential #PublicHealth Effects of Reducing Nicotine Levels in Cigarettes in the United States.

— NEJM (@NEJM) March 15, 2018

But if the FDA nicotine rules were enacted, the researchers found smoking levels would drop to less than two percent, although they note inherent uncertainty with projecting novel smoking regulations.

"Our model indicates that enacting a regulation to lower the nicotine content of cigarettes to minimally addictive levels in the United States would lead to a substantial reduction in tobacco-related mortality, despite uncertainty about the precise magnitude of the effects on smoking behaviors," the authors wrote.

Tobacco companies will likely fight any nicotine regulation in court.

"I do not expect them to roll over and accept this regulation," said Jenson. "Obviously the industry is very huge and powerful. Their ability to fight FDA regulation has been largely successful."

For instance, in 2011 the FDA attempted to institute a graphic warning label on cigarette boxes, similar to the intentionally disgusting images of tar-coated lungs on packaging in Europe. But U.S. tobacco companies successfully fought this effort in court. They cited, broadly, that such graphics impeded their First Amendment rights to communicate with their customers, said Jenson.

In 2006, a U.S. District Court judge found that U.S. tobacco companies had executed "a massive 50-year scheme to defraud the public" about the health effects of cigarettes.

"It has known the truth and has lied for decades," said Jenson. "That is the industry we're dealing with."