FDA Chief Outlines Case for Proposed E-Cig, Menthol Actions

Agency commissioner cites survey data, product attributes for proposed regulations
Photograph: Shutterstock

WASHINGTON – In an extended press release, the head of the U.S. Food and Drug Administration (FDA) laid out the core reasons for proposed actions that include restrictions on the sale of flavored electronic cigarettes and the potential banning of menthol cigarettes.

In the Nov. 15 announcement, Scott Gottlieb, commissioner of the FDA, elaborated on many personal concerns about a rise in teens using tobacco products, as well as the data source of his actions. That key resource was the 2018 National Youth Tobacco Survey, an annual sampling of young people that he was able to review earlier this fall.

From 2017 to 2018, the study reported a 78% increase in current e-cigarette use among high school students and a 48% increase among middle school students. The total number of middle and high school students currently using e-cigarettes rose to 3.6 million, a rise of 1.5 million more students than the previous year.

Additionally, more than a quarter (27.7%) of current high school e-cigarette users are vape regularly (on 20 or more days in the past month). More than two-thirds (67.8%) are using flavored e-cigarettes. Both these numbers have risen significantly since 2017, Gottlieb said.

“These increases must stop,” Gottlieb said. “And the bottom line is this: I will not allow a generation of children to become addicted to nicotine through e-cigarettes.”

These changes will not include mint- and menthol-flavored electronic nicotine-delivery systems (ENDS). “This reflects a careful balancing of public-health considerations,” he said. “Among all ENDS users, data suggests that mint- and menthol-flavored ENDS are more popular with adults than with kids.”

One nationally representative survey showed that, among ENDS users 12 to 17 years old, 20% used mint- and menthol-flavored ENDS; among adult ENDS users, 41% used mint- and menthol-flavored ENDS, Gottlieb said.

However, the commissioner said he was “deeply concerned” about the availability of menthol-flavored cigarettes. He said menthol-flavored products represent “one of the most common and pernicious routes by which kids initiate on combustible cigarettes. The menthol serves to mask some of the unattractive features of smoking that might otherwise discourage a child from smoking.”

As a result, Gottlieb said he would start the process of public review of many tobacco-related topics, including banning menthol cigarettes and imposing selling restrictions on flavored e-cigarettes.


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