In one of his last acts as head of the Food and Drug Administration (FDA), outgoing Commissioner Dr. Scott Gottlieb released new plans for restricting the sale of certain flavored e-cigarettes, in an effort to combat teen vaping.
The draft guidance, which will remain open for public comment for 30 days before being finalized, crystallizes some of the agency’s prior plans for regulating flavored e-cigarettes, which have become so popular among teenagers that many doctors fear they could contribute to widespread nicotine addiction among young people. Vaping among high school students rose by 78% (from almost 12% to almost 21% of students) between 2017 and 2018, according to federal data.
If finalized, the policy would restrict sales of all but tobacco-, mint- and menthol-flavored e-cigarettes; crack down on products that are expressly appealing to minors; and move up the date by which e-cigarette companies have to apply for FDA review. Some flavored e-cigarettes could be pulled from the market all together, according to an FDA statement.
“Under the new policy announced today, we’re putting all manufacturers and retailers on notice,” Gottlieb said in the statement.
The FDA is focusing on e-cigarettes in flavors such as fruit and candy because they have been shown to be especially appealing to kids, whereas mint and menthol flavors — which are also used in other tobacco products — may be used by adult smokers to help them transition off of combustible cigarettes, Gottlieb said. In line with a November announcement from Gottlieb, the FDA plans to limit the sale of these flavored products to websites and stores with age-verification practices in place, since e-cigarettes are not legally available to anyone under 18 in the U.S. Shops with customers of all ages, such as gas stations and convenience stores, must maintain a designated, age-controlled area for e-cigarette sales.
The FDA will also stop the sale of products clearly targeted to minors, such as those made to look like juice boxes or candy, the draft guidance says.
The guidance also moves up by a year the date by which e-cigarette companies must apply for FDA review. The FDA gained the authority to regulate e-cigarettes in 2016, and at that time stopped new products from entering the market and required those already being sold to apply for agency clearance by 2018. That deadline was later extended to 2022, but the new guidance moves it up to Aug. 8, 2021, citing “uncertainty created by extended availability of these new tobacco products without scientific review and evaluation under the public health standard.” After that date, the FDA will have greater power to crack down on companies that fail to apply for or secure clearance.
The draft guidance also moves to limit the sale of many flavored cigars, including mint and menthol products. Unlike mint and menthol e-cigarettes, which may help some adult smokers quit combustible cigarettes, “there is no similar potential public health benefit to new mint- and menthol-flavored cigars remaining on the market,” the document says.
Limiting youth access to e-cigarettes has been a priority for Gottlieb during his time at the FDA, especially as teen use soars. By 2018, almost 40% of high school seniors said they had vaped during the prior year.
Gottlieb’s sudden resignation, which is set to take effect in early April, called into question whether many of the agency’s proposed regulations would take effect. But the release of the draft guidance suggests that e-cigarette regulations will continue, as does the appointment of Dr. Ned Sharpless, the director of the National Cancer Institute, as acting commissioner. Sharpless has supported Gottlieb’s crackdown on e-cigarettes.
“There will be no let up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes,” said Alex Azar, Department of Health and Human Services Secretary, while announcing Sharpless’ appointment.
Jamie Ducharme at jamie.ducharme.