FDA considers regulatory action as vaping among US teens jumps 78% in a yearBMJ 2019; 364 doi: https://doi.org/10.1136/bmj.l741 (Published 14 February 2019) Cite this as: BMJ 2019;364:l741
Scott Gottlieb, commissioner of the US Food and Drug Administration, has said that his agency’s plan to wean US adults off combustible tobacco is threatened by an “exploding epidemic” of vaping among young people that could force the agency to restrict access to non-combustible products.
Data from the National Youth Tobacco Survey1 showed that overall use of tobacco products (including non-combustible products) increased by 38.3% among US high school students in 2018. About 4.9 million middle and high school students had used some type of tobacco product in the past 30 days, up from 3.6 million in 2017. This increase was driven entirely by e-cigarette use, as use of other tobacco products actually fell slightly.
Current e-cigarette use (in the past 30 days) increased from 6.6% to 10.4% among eighth grade students (ages 13-14) and from 16.6% to 26.7% among final year high school students.
The same survey showed that US teen vaping rates fell in 2016 and held steady in 2017. The 2018 spike, said Gottlieb, “is likely due to the recent popularity of certain types of e-cigarettes, such as Juul.”
The FDA has frequently singled out Juul as a manufacturer whose products are especially appealing to minors. It has also highlighted flavoured products as a particular risk to young people.
Gottlieb, a physician and cancer survivor, declared anti-tobacco efforts an FDA priority when he became commissioner in May 2017, but he has shown much greater tolerance towards non-combustible products, which he has frequently described as an “off-ramp” (an exit) for adults trying to quit cigarettes.
Under him the agency developed an ambitious plan to turn older US smokers into vapers, using its regulatory powers to force manufacturers to reduce nicotine in cigarettes to levels that smokers find unsatisfying. The FDA planned to simultaneously facilitate approval for makers of non-combustible nicotine delivery systems, potentially pushing millions of US smokers towards the less harmful alternative.
But that plan is now threatened by the “mounting public health crisis” of youth vaping, said Gottlieb, citing a study published last week in JAMA Network Open,2 which he said reinforced the FDA’s fears that vaping, for young people, is in fact an “on-ramp” (an entry) to smoking.
A nationally representative study of adolescents aged 12-15 found that prior e-cigarette use was associated with over four times the odds of ever using cigarettes (odds ratio 4.09 (95% confidence interval 2.97 to 5.63)) and nearly three times the odds of current cigarette use (2.75 (1.60 to 4.73)) when compared with no prior tobacco use.
Gottlieb said that the agency was already moving to limit the marketing of flavours other than mint, menthol, and tobacco and would be “revisiting our compliance policy that has resulted in certain e-cigarettes, including flavoured e-cigarettes, remaining on the market until 2022 while their manufacturers submit applications for premarket authorisation.”
The FDA, he said, was stepping up enforcement and inspections of retailers suspected of selling to minors in person or online, and he was requesting meetings with the leadership of the manufacturers Juul and Altria Group, who “don’t seem fully committed to their written promises about the steps they’d take to stop youth use of their products.”
Gottlieb said, “If these youth use trends continue, we’ll be forced to consider regulatory steps that could constrain or even foreclose the opportunities for currently addicted adult smokers to have the same level of access to these products that they now enjoy,” adding that the early signs in 2019 were “not encouraging.”
“I recognise that such a move could come with significant impacts to adult smokers,” he said. “E-cigarettes may have promise as a tool for helping currently addicted adult smokers quit smoking. But, with the staggering data on youth trends, we’re struggling to preserve these opportunities for adults while addressing the youth epidemic.
“I simply won’t allow their sale to come at the expense of addicting a generation of kids to nicotine.”