The Food and Drug Administration (FDA) announced Wednesday a new plan to curb the “epidemic” of teenage E-cigarette use that includes potentially taking products off the market if large manufacturers fail to deliver ideas for reversing the trend within 60 days.
FDA Commissioner Scott Gottlieb said he is revisiting the agency’s decision to allow e-cigarette manufacturers until 2022 to come into compliance with new regulations due to the “epidemic of youth use” that has been widely documented in recent media reports.
“Today, we asked five e-cigarette manufacturers to put forward plans to immediately and substantially reverse these trends, or face a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications,” Gottlieb said in a speech announcing the new approach.
E-cigarette makers such as the industry leader Juul have come under harsh criticism over the past few years as sales have soared. Critics cite the companies’ fruit-flavored products as evidence that their business model relies on addicting teen users, rather than helping adult cigarette smokers transition to an alternative, as their marketing materials claim.
Juul, which has recently modified its marketing materials and social media presence in response to concerns regarding teen use, expressed a desire to cooperate with the FDA in a statement provided to National Review.
“JUUL Labs will work proactively with FDA in response to its request. We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people,” a company spokesperson said. “Our mission is to improve the lives of adult smokers by providing them with a true alternative to combustible cigarettes. Appropriate flavors play an important role in helping adult smokers switch. By working together, we believe we can help adult smokers while preventing access to minors, and we will continue to engage with the FDA to fulfill our mission.”
Teen e-cigarette use skyrocketed 900 percent from 2011 to 2015 and the trend has continued unabated, according to the CDC.
In addition to requiring that manufacturers implement plans to curb teen use, the FDA conducted a massive “undercover blitz” this summer that led to 1,300 warning letters and fines imposed on retailers illegally selling the non-combustible nicotine products to minors.
The threat to e-cigarette makers comes after 17 companies were forced to stop advertising products with “kid-friendly” labels due to a warning letter from the FDA sent in May.