Author: Connor Jaccard

FDA Regulation of Underage ENDS Use and the Incidence of Fatal Lung Disease.

The Food and Drug Administration (FDA) has tightened its regulation
of e-cigarettes and other electronic nicotine delivery systems (ENDS) since it
promulgated a rule extending existing tobacco regulations to ENDS in August of 2016.
Many of these regulatory developments occurred under former FDA Commissioner
Scott Gottlieb with the objective of curbing widespread underage use of ENDS and
continue even after Gottlieb has resigned his post as commissioner.

In September 2019, the Trump administration asked the FDA to
ban flavored e-liquids amid a surge in underage use of ENDS, and as hundreds of
cases of life-threatening or sometimes fatal ENDS-related lung illnesses occurred.
Studies have indicated a strong likelihood that flavored e-liquids draw teenagers
to ENDS use, so this ban could be an important step in lowering underage ENDS
use in those who already use the devices, and in deterring other minors from
experimenting with nicotine use in the first place.

However, the FDA’s previous attempts to restrict the
availability of a wide array of e-liquid flavor options were unsuccessful.
Underage use of ENDS has been a problem for several years, but support for this
regulatory measure has only grown substantially in the months leading up to
September 2019. The difference in support appears to be related to the numerous
instances of illnesses and deaths caused by ENDS-related lung disease in recent
months which is a separate problem from the ongoing issue of ENDS use by

Where instances of teen use of ENDS are often linked to lax online sales policies and the appeal of flavored e-liquid, investigations by the CDC and FDA have linked many of the recent instances of lung illness to the use of illegally tampered with vaping products. Because of the differences in the causes of these problems, they might not both be solved by a ban on most of the currently available e-liquid flavoring options. Many of the products associated with serious lung injury and death have been bought illegally online and have been adulterated by third parties. The adulterated ENDS components frequently contain compounds, such as cannabidiol and tetrahydrocannabinol, found in marijuana. Therefore, the new flavor regulations promulgated by the FDA do not directly address the increase in ENDS-related lung illnesses.

Banning many flavors in e-liquids and other ENDS components,
can have a positive impact by addressing problems with underage use of these
products. However, many supporters of the new rules expect a decline in the
instance of life-threatening ENDS-related lung illness to occur as a result of
the restrictions of e-liquid flavors. Such a decline might not occur until the
devices causing lung illness are removed from the stream of commerce. Therefore,
more restrictions on the availability of illegal ENDS products online could
help to address this issue going forward.