The commissioner of the U.S. Food and Drug Administration has a new plan to prevent smoking addiction by reducing the amount of nicotine in cigarettes.
Dr. Scott Gottlieb’s strategy to reduce nicotine to non-addictive levels is part of a new comprehensive plan for tobacco and nicotine regulation that will “serve as a multi-year road map to better protect kids and significantly reduce tobacco-related disease and death,” he said in a statement. The agency has made nicotine the focus of its tobacco regulation effort.
“The FDA is envisioning a world where cigarettes can no longer create a sustained addiction, and where adults who still need or want nicotine can get it from alternatives and less harmful sources,” Gottlieb told an audience at the Johns Hopkins Bloomberg School of Health in Baltimore, on October 19.
While nicotine hasn’t been shown to cause cancer and other fatal diseases, it is an extremely addictive drug that causes people to become addicted to cigarettes and other products that contain it. Nicotine products kill 480,000 people a year, according to the FDA.
The commissioner said the FDA plans to issue an Advance Notice of Proposed Rulemaking (ANPRM) to gather input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes.
The FDA wants to use the Family Smoking Prevention and Tobacco Control Act, passed by Congress and signed by President Barack Obama in 2009, to try to reduce the nicotine in cigarettes to nonaddictive levels. The legislation gives the agency the authority to regulate the manufacture, distribution, and marketing of tobacco products.
In an interview with The Washington Post, he said he told staff from the moment he took the job as FDA commissioner that he wanted to find a way to help smokers quit. He told staffers reducing the smoking rate in America and preventing about 480,000 deaths each year would be their biggest accomplishment.
“I told them I wanted to do something to dramatically change that … I wanted to do something to bend the curve,” Gottlieb said.
University of Pittsburgh Researcher Eric Donny, who has conducted FDA and National Institutes of Health-funded studies of low-nicotine cigarettes for the past six years, says his research indicates lowering nicotine could have the desired effect.
But, dropping the nicotine level immediately is key, he says, because gradually lowering nicotine could cause some smokers to smoke more, seeking the same effect. “It’s a sound idea and if done the right way could have a huge effect,” he told the Post.
During a panel discussion that followed Gottlieb’s speech, several participants warned that the nicotine reduction effort will face stiff opposition from the tobacco companies. “One of the things we know will happen is the industry will be lobbying incredibly hard with lots of money behind the scenes,” said Kenneth Warner, a professor of health management and policy at the University of Michigan School of Public Health.
This summer, the FDA also announced that it is delaying for several years a key regulation aimed at cigars and e-cigarettes. E-cigarettes are, in essence, electronic cigarettes with refillable cartridges which are surmised not to addict the person taking them. It has postponed a requirement that such products be approved by the agency.
The agency is delaying new regulations on e-cigarettes, Gottlieb told the Post, because it needs time to develop protocols for supervising such products, which he believes give smokers the nicotine they crave without many of the dangerous chemicals in cigarette smoke.
In their announcement, FDA officials said other rules affecting e-cigarettes, such as ways to prevent sales to minors, will remain in place. And the delay won’t change an FDA deadline for manufacturers to disclose product ingredients to the agency.
Josh Sharfstein, who was deputy FDA commissioner in the Obama administration and now is a professor at Johns Hopkins Bloomberg School of Public Health, called Gottlieb’s announcement an “exciting moment. The big picture here is that cigarettes as we know them could be phased out and e-cigarettes could be a bridge for people to not use cigarettes,” he told the Baltimore Sun.