November 15, 2018
When Commissioner Gottlieb announced FDA's Comprehensive Plan for Tobacco and Nicotine Regulation in 2017, the deadlines for certain deemed products were extended, in part, to allow for the potential benefits of innovative new products to be studied more thoroughly. This deadline was extended under the condition that the youth e-cigarette use numbers would not change for the worse. At the time, FDA was seeing change in the right direction as high school current e-cigarette use had decreased from its peak of 16.0 percent in 2015 to 11.3 percent in 2016 and held steady in 2017.
Unfortunately, the situation has changed drastically in the last year. According to new findings from the 2018 National Youth Tobacco Survey (NYTS) released today, there has been a dramatic increase in youth use of e-cigarettes and other electronic nicotine delivery systems (ENDS): From 2017 to 2018, there was a 78 percent increase in current e-cigarette use among high school students and a 48 percent increase among middle school students. This startling surge we're seeing in youth e-cigarette use is beyond troubling and FDA will not sit idly by while we face the threat of a whole generation getting addicted to these products.
Therefore, today FDA is outlining a new policy framework to address what appear to be the central problems—youth appeal and youth access to flavored tobacco products. FDA will be taking steps on the following product categories:
- Flavored ENDS products (other than tobacco, mint, and menthol flavors or non-flavored products) that are not sold in an age-restricted, in-person location;
- Flavored ENDS products (other than tobacco, mint, and menthol flavors or non-flavored products) that are sold online without heightened age verification processes;
- Flavored cigars;
- ENDS products that are marketed to kids; and
- Menthol in combustible tobacco products, including cigarettes and cigars.
FDA intends to issue guidance shortly that provides additional details, including what the agency might consider an "age-restricted" location, what it might consider "heightened" age-verification online, and timelines for when FDA intends to implement these policies. Commissioner Gottlieb has stated that he hopes that in the next 90 days, manufacturers will choose to remove flavored ENDS products from stores where kids can access them and from online sites that do not have sufficient age-verification procedures.
FDA also intends to move forward with proposed rulemaking to ban menthol in cigarettes and all flavors, including menthol, in cigars, on an expedited timeline.
The framework being announced today reflects FDA's aim of providing the right balance between closing the on ramp for kids to become addicted to nicotine while maintaining access to potentially less harmful forms of nicotine delivery for adult smokers seeking to transition away from combustible tobacco products.
This policy framework is an important step toward reversing the epidemic that is underway. FDA will continue to base its actions on the best available science and will continue to take aggressive actions to protect our youth through a wide range of prevention and enforcement actions.
For more information on these new actions, please read FDA Commissioner Dr. Scott Gottlieb's statement and HHS Secretary Alex M. Azar's statement in support of today's announcement.