FDA takes new steps to address epidemic of youth e-cigarette use

FDA announced on Wednesday a series of "critical and historic" enforcement actions associated with the sale and marketing of e-cigarettes to children.

FDA announced on Wednesday a series of "critical and historic" enforcement actions associated with the sale and marketing of e-cigarettes to children. The agency has issued more than 1,300 warning letters and fines to retailers who illegally sold JUUL and other e-cigarette devices to minors during a nationwide, undercover operation targeting brick-and-mortar and online stores over the summer. FDA Commissioner Scott Gottlieb, MD, said: "We're committed to the comprehensive approach to address addiction to nicotine that we announced last year. But at the same time, we see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger. This starts with the actions we're taking today to crack down on retail sales of e-cigarettes to minors." Gottlieb said the agency will "also revisit our compliance policy that extended the dates for manufacturers of certain flavored e-cigarettes to submit applications for premarket authorization." According to him, FDA has asked five e-cigarette manufacturers, including JUUL, to develop plans within 60 days to immediately mitigate youth sales, or face a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications. "If they fail to do so, or if the plans do not appropriately address this issue, the FDA will consider whether it would be appropriate to revisit the current policy that results in these products remaining on the market without a marketing order from the agency," FDA said. Gottlieb also noted, "In enabling a path for e-cigarettes to offer a potentially lower risk alternative for adult smokers, we won't allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products."