That’s a point often lost in the current debate over teen use of these products: e-cigarettes were designed for smoking cessation, and that remains a goal that many of these advocacy groups still support, but there is barely any science on which to base a belief that e-cigarettes are more likely to result in a smoker quitting than a teenager moving on to traditional cigarettes.
Myers said government research shows that as many as one-quarter of all teens who use e-cigarettes may end up as smokers. The one study from the U.K. that has been cited most widely as proof that e-cigarettes do work as a smoking cessation device, including by the U.S. Congress, was deemed to be irrelevant to the U.S. marketplace by major medical groups, including the American Medical Association and American Academy of Pediatrics.
“The industry has been using the same argument since 2009 and 2010, and there is no more scientific evidence behind it, or only a little more behind it today,” Sward said, adding that “the Obama administration has a lot of responsibility for this laying at its feet as well.” In 2015, when a measure went to the White House to ban all new flavored e-cigarette products unless the manufacturers could provide a public health benefit, it was stripped out, a decision that Sward summed up as a complete “lack of political will” to take on corporations.
There is one belief that these groups do pin their hopes on, and it is not related to any of the concrete steps outlined by the FDA this month. It’s more personal. “I think the jury is out on whether this is just another delay, but I truly believe Gottlieb doesn’t want to be known as the person who allowed e-cigarettes to addict another generation of kids,” Myers said. “I don’t doubt that, but I’m not sure if he is prepared to take the actions needed. He hasn’t done it yet.”
In response to its critics, an FDA spokesman pointed to many of the steps outlined by the regulator and referred to Gottlieb’s statement that “the FDA won’t tolerate a whole generation of young people becoming addicted to nicotine.”
The FDA’s crackdown includes 1,300 warnings, letters and fines aimed at retailers illegally selling e-cigarettes to minors, “revisiting” its deadline for the compliance policy on premarket applications from flavored e-cigarette makers, stepping up enforcement actions, investigating unlawful marketing and sales of products on e-cigarette manufacturer websites and developing an “overall policy roadmap,” to address youth use.
Of the crackdown in retail sales, Myers was not hopeful, saying that it is “the smallest part of the problem. It’s easy to run stings.”
Gottlieb’s statement acknowledged FDA inaction. “I’ve spent a lot of time considering whether there were different choices we could have made last summer that would have lessened, or avoided, the epidemic of youth use that I believe is before us. … what if we hadn’t extended the compliance dates for filing applications for e-cigs on the market when the deeming rule went into effect?”
He concluded it would not have made a difference.
The FDA commissioner also implied that the advocacy groups may yet get their wish and see the FDA take significant regulatory action, and referenced the data on the increase in teen use already leaked to the press: “If as we expect, preliminary data that’s in our possession and will be finalized and released in the coming months confirm our present observations that the youth use of e-cigs is rising very sharply; we’ll swiftly change course.”
Critics aren’t hopeful that the plans submitted by the e-cigarette makers will do much good. “It is just naive,” Myers said. “To have not learned from history, to think we can count on the unregulated marketplace to prioritize public health.”