The Food and Drug Administration plans to try to lower the amount of nicotine in cigarettes to make them less addictive — an unprecedented move by the agency.
FDA Commissioner Dr. Scott Gottlieb said Thursday the agency would propose the rule, opening a long bureaucratic process.
It’s the boldest move yet against cigarette makers by the FDA, which only got permission to regulate tobacco products in 2009.
"Today’s milestone places us on the road to achieving of one of the biggest public heath victories by saving millions of lives," Gottlieb told reporters. He also said he wanted input about potentially unforeseen consequences of such a rule.
“As part of our comprehensive plan on tobacco and nicotine regulation announced last summer, we’re issuing an advance notice of proposed rulemaking to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels,” Gottlieb said in a statement.
“This new regulatory step advances a comprehensive policy framework that we believe could help avoid millions of tobacco-related deaths across the country.”
The FDA does not have the authority to ban tobacco-based products, but since it was given some powers by Congress in 2009, it has moved gradually to impose some limits of tobacco sales and marketing.
"We believe the public health benefits and the potential to save millions of lives, both in the near and long term, support this effort," Gottlieb said.
The New England Journal of Medicine rushed out a study Thursday from FDA's Center for Tobacco Products that projected the effects of lowering nicotine to "minimally addictive levels".
"We estimate that a nicotine product standard for cigarettes in the United States cold save millions of lives and tens of millions of life-years over the next several decades," they wrote.
The move would be a big blow to Big Tobacco, which has successfully fought off attempts to regulate how cigarettes are formulated.
But tobacco makers were forced to admit to deliberately making cigarettes more addictive in an ad campaign that is currently running.
"It is critical that the FDA move as quickly as possible to turn this plan into reality."
It has not been enough, said Gottlieb. According to the Centers for Disease Control and Prevention, 15 percent of U.S. adults still smoke.
“Despite years of aggressive efforts to tackle the leading cause of preventable disease and death in the United States, tobacco use – largely cigarette smoking – still kills more than 480,000 Americans every single year,” he said.
“Tobacco use also costs nearly $300 billion a year in direct health care and lost productivity. In fact, cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users.”
Cigarette smoke can also kill people who don't even smoke themselves, Gottlieb noted.
The long rulemaking process is designed to let people comment.
“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?” Gottlieb said.
“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?”
Health groups urged the FDA to set a deadline and move fast.
"It is critical that the FDA move as quickly as possible to turn this plan into reality," said Matthew Myers, president of the Campaign for Tobacco-Free Kids.
"There is no other single action our country can take that would prevent more young people from smoking or save more lives."
American Heart Association CEO Nancy Brown said FDA could do even more. “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," Brown said.
Gottlieb said the FDA does not want to make nicotine products harder to get.
“We must make it possible for current adult smokers who still seek nicotine to get it from alternative and less harmful sources,” he said.
“To that end, the agency’s regulation of both novel nicotine delivery products such as e-cigarettes and traditional tobacco products will encourage the innovation of less harmful products while still ensuring that all tobacco products are put through an appropriate series of regulatory gates to maximize any public health benefits and minimize their harms.”
Gottlieb said the FDA would also be seeking comment on more potential rules, including one on the effects of putting menthol in cigarettes. Anti-smoking groups have lobbied FDA for years to forbid the use of menthol, which they say makes cigarettes more appealing and that may also make the body absorb more of their toxins.
A second rulemaking process will look at regulating premium cigars, Gottlieb said.
Tobacco companies were chewing over the proposal.
“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 Dr. James Figlar, and executive vice president of research and development for R.J. Reynolds Tobacco Company.