The US Food and Drug Administration (FDA) on Wednesday announced [press release] major policy updates and enforcement efforts on electronic cigarettes such as JUUL and their distribution and sale to teens—what the statement called the “largest coordinated enforcement effort in the FDA’s history.”

The FDA announced the issuing of more than 1300 warning letters [materials] and civil penalties/fines to retailers for selling the e-cigarettes to minors after an investigation over the summer. In addition, the FDA sent letters [materials, PDF] to five top e-cigarette manufacturers—JUUL, Vuse, MarkTen XL, blu e-cigs, and Logic—compelling them to submit plans describing how each will address the problem of widespread youth access and use of their products within the next 60 days.

According to the FDA, more than 2 million middle and high school students were users of e-cigarettes in 2017, a level reaching epidemic proportions. The cigarettes have been particularly appealing to teenagers for their inconspicuous designs, and for coming in flavors like candy and creme brulee.

FDA Commissioner Scott Gottlieb spoke [transcript] upon the announcement:

I believe certain flavors are one of the principal drivers of the youth appeal of these products. While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids. We cannot allow a whole new generation to become addicted to nicotine.

Gottlieb said to address youth use, this may require brands to revise their sales and marketing practices, and to possibly “remove some or all of their flavored e-cig products from the market until they receive premarket authorization and otherwise meet applicable requirements.”

Other policy changes announced Wednesday include:

• Indefinitely stepping up FDA enforcement actions with a sustained campaign to monitor, penalize and prevent e-cigarette sales in convenience stores and other retail sites.
• Continued exploration of measures on flavors/designs that appeal to youth, child-resistant packaging and product labeling to prevent accidental child exposure to liquid nicotine.
• Continued public comment on the role that flavors in tobacco products play in attracting youth.