The surprise resignation of Federal Drug Administration chief Scott Gottlieb prompted a mix of celebration and trepidation among those pushing for the expansion of cigarette alternatives.
Gottlieb had spent the weeks leading up to his resignation speaking out critically about the e-cigarette and vaping industries and their threat to underage Americans. His rhetoric surprised those who had expected the Trump appointee to have an open mind toward smoking alternatives that utilize nicotine—either through turning it into water vapor or to deliver it through heat-not-burn technology—to wean smokers off of traditional cigarettes. In a 2017 policy statement Gottlieb said the agency is exploring the possibility of mandating lower nicotine levels in cigarettes to curb their addictiveness, while at the same time opening the door to alternative methods of cessation.
"I also hope that we can all see the potential benefits to addicted cigarette smokers, in a properly regulated marketplace, of products capable of delivering nicotine without having to set tobacco on fire," Gottlieb said. "The prospective benefit may be even greater for the subset of current cigarette smokers who find themselves unable or unwilling to quit."
Some in the vaping industry said he had failed to live up to his words, particularly with the agency's targeting of flavored electronic cigarettes that are currently available in the market today. Tony Abboud, executive director of Vapor Technology Association, said that the FDA's targeting of flavored electronic cigarette products is misguided. He urged the agency to refocus on "the dangers of combustible cigarettes" when evaluating the public health benefits of vaping alternatives.
"The Vapor Technology Association encourages the next Food & Drug Administration Commissioner to focus on the dangers of combustible cigarettes and maintaining an off-ramp for adult smokers to a safer alternative," he said in an email. "Taking flavored vapor products out of the hands of adults is the wrong approach. Previous proposals have run counter to science and will reduce access to vapor products that greatly improve public health."
Other companies seeking FDA approval for new tobacco alternatives had mixed feelings about Gottlieb's departure. Philip Morris International has spent $5 billion developing the heat-not-burn iQOS, which is already available in many countries, including the UK, and Japan. PMI is attempting to become the first company to receive permission from the FDA to market its product as a reduced risk alternative to cigarettes after presenting research showing dramatic reductions in toxins, carcinogens, and other cancer-causing chemicals. Company spokesman Corey Henry said Gottlieb's policy statement was a step in the right direction in smoking cessation debates.
"It was the first time a commissioner had been that clear about the need for alternatives and the possible benefits those alternatives have," Henry said. "I do think [Gottlieb's] type of messaging was very important for pushing the debate forward past entrenched positions. In the last couple of years debates over new technology—whether it's heat-not-burn or e-vaping—has evolved and needs to continue evolving in the right direction."
PMI's application is awaiting further agency review after it submitted additional lab studies for approval. Henry said the FDA's stamp of approval is necessary to allow the company to "present and communicate to current adult smokers to switch from cigarettes to alternatives if they're unwilling or unable to quit." He said Gottlieb's successor should continue to advance a reduced risk approach to the tobacco debate, rather than the all-or-nothing approach that limits smokers' options.
"What would be unfortunate is if there's movement backwards, if people begin to drift away from allowing consumers to get better information about alternatives," Henry said. "If we move backward it's basically denying those who continue to smoke the ability to switch."
Liz Mair of Vapers United cautioned those who welcomed Gottlieb's departure. She said there is no guarantee that his successor will agree to maintain an open mind toward tobacco alternatives. She said the group will monitor the potential nominees moving forward with a critical eye, but that the group is not "counting any chickens until they hatch."
"Vapers United recognizes that a lot of vapers, vapor companies and vapor advocates, including some of our own members, have privately and publicly expressed nothing short of pure joy that Commissioner Gottlieb will be resigning," she said in a statement. "However, as an organization, we take the view that no one should be cheering too loudly about Gottlieb’s departure because it is unclear who will ultimately take over from Gottlieb, and some contenders have records that should worry vapers, their family and friends."
Gottlieb is scheduled to leave the FDA by the end of the month.