The FDA rolled out a second major announcement at the same time: It is delaying for several years a key regulation affecting cigars and e-cigarettes, including flavored vaping products that studies show are especially enticing to youth. Specifically, it postponed the requirement that such products be approved by the agency.
FDA’s commissioner Scott Gottlieb said both actions are part of a comprehensive plan to eventually wean smokers off conventional cigarettes and steer them toward less harmful alternative forms of nicotine like vaping.
“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes — the only legal consumer product that, when used as intended, will kill half of all long-term users,” he said.
Some health proponents, however, expressed caution, pointing out that the nicotine-reduction proposal could take years to enact and could be derailed by major hurdles, including the significant lobbying power of tobacco industry.
“The only actual thing that is happening right away is the delay,” said Dave Dobbins, chief operating officer at the tobacco-control group Truth Initiative. Not only is FDA delaying the timetable for e-cigarettes, he noted, but also the one for cigars, cigarillos and hookah — currently sold in convenient stores in kid-friendly flavors like grape and tropical punch flavors. “There’s no excuse for not regulating those products as quickly as possible,” he said.
The reason FDA is delaying new regulations on e-cigarettes, Gottlieb said, is because it needs time to set the proper foundation for supervising such products, which he believes give smokers the nicotine they crave without many of the dangerous chemicals in cigarette smoke.
Some public health officials were enthusiastic. Josh Sharfstein, who was deputy FDA commissioner in the Obama administration and now is a professor at Johns Hopkins Bloomberg School of Public Health, said Gottlieb's announcement was an "exciting moment" because the FDA was signaling that it wanted to link its policies on e-cigarettes to those on cigarettes. "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 said.
The surprising plan to force tobacco companies to lower nicotine in their cigarettes could have serious ramifications for the industry, which has seen a steady drop in American smokers for decades.
Smoking in the United States is now at an all-time low, with just 15 percent of adults still lighting up. And tobacco use among youth has fallen to similarly historic lows, sparking hope among public health officials that a smoke-free generation may finally be within reach.
Even before Gottlieb’s announcement, the tobacco industry has been trying to find new ways of maintaining its hold on remaining smokers in the United States by getting into the vaping business or with new tobacco products that deliver nicotine without smoke.
For years, the public health world has been deeply divided over whether vaping and other alternative nicotine products are good for public health.
By tying the two issues — lowering nicotine in traditional cigarettes and regulating e-cigarettes — Gottlieb hoped to unite all sides who are opposed to conventional cigarettes while also allaying their fears on e-cigs.
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.
In his first agencywide speech, he told staffers that nothing they could accomplish in the next few years would be as important as reducing the smoking rate in America — and the 480,000 deaths every year it causes.
“I told them I wanted to do something to dramatically change that … I wanted to do something to bend the curve,” Gottlieb said.
The idea of reducing nicotine in cigarettes has existed for at least two decades, but the FDA did not have the authority to do so until a 2009 law gave it regulatory power over tobacco. Since then the FDA has slowly been laying the groundwork to wield that new authority.
Because it is such a drastic move, lowering the nicotine could have unintended consequences, a concern FDA officials acknowledged Friday and said they would be studying.
It could create a black market for higher nicotine cigarettes. Depending on how the plan is implemented, it could cause smokers to smoke more deeply or in greater amounts to compensate, warned some researchers. Others in the past have expressed concerns that the withdrawal it could imbalance smokers with mental illnesses — who make up a huge proportion of the people still smoking in the United States.
One of the most important decision for FDA will be whether it lowers nicotine gradually over several years or reduces it sharply to a much less addictive level, said Eric Donny, one of country’s foremost researchers on low-nicotine cigarettes. For the past six years at the University of Pittsburgh, Donny has run experiments — funded by the National Institutes of Health and the FDA — on low-nicotine cigarettes.
His studies have found that lower-nicotine cigarettes could indeed wean smokers of the habit and prompt them to quit. But dropping the nicotine level immediately is key, he said, because gradually lowering nicotine could lead to problems like causing smokers to smoke more. “It's a sound idea and if done the right way could have a huge effect,” he said.
In their Friday announcement, FDA officials said other rules affecting e-cigarettes, such as a ways to prevent sales to minors, will remain in place. And the delay won't affect future deadlines such as requirements that manufacturers provide FDA with lists of ingredients.
The announcement comes on the heels of furious lobbying by the e-cigarette industry to roll back hefty FDA regulations, issued last year, that would have affected e-cigarette products that came on market after Feb. 15, 2007. Nearly all the e-cig products sold today would be required to go through rigorous review, industry officials said.
Greg Conley, president of the pro-vaping American Vaping Association, said he was relieved by Gottlieb’s announcement, saying that without it, 99 percent of vaping products would have been banned.
Under the 2009 Tobacco Control Act, the FDA is permitted to consider reducing nicotine in cigarettes but may not ban it. The FDA, officials said, also will look at the impact of flavoring in e-cigarettes and cigars, both on children who might find flavors appealing and adults who might find them a useful tool to stop smoking. They also indicated they would consider exempting premium cigars from FDA regulations.
The product-approval requirement for e-cigarettes and cigars was part of the so-called “deeming rule,” in which the agency decided that e-cigarettes would be subject to the same rules as conventional cigarettes. The rule gave manufacturers about two years — until sometime in 2018 — to get FDA approval for their products or risk having them pulled off the market.
Under the revised timelines applications for products such as cigars, pipe tobacco and hookah tobacco, would need to be submitted by Aug. 8, 2021 and applications for noncombustible products such as e-cigarettes would need to be submitted by Aug, 8, 2022. Manufacturers would be permitted to continue to sell their products during the FDA reviews.