FDA Bans Juul’s E-Cigarettes from U.S. Market
The Food and Drug Administration (FDA) denied Juul’s premarket tobacco product applications. The FDA
cited safety concerns for the denial, specifically the agency said Juul’s applications
lacked “sufficient evidence regarding the toxicological profile of the products
to demonstrate that marketing of the products would be appropriate for the protection
of the public health”, according to the FDA-issued market denial orders (MDOs).
The
MDOs apply to tobacco- and menthol-flavored e-cigarette cartridges.
In 2020, Juul stopped the sales of sweet- and candy-flavored
e-cigarette cartridges in response to the FDA’s prohibition on that category
of e-cigarettes. While the FDA continued its review of the premarketing tobacco
product applications, Juul and other companies were permitted to continue selling
tobacco- and menthol-flavored cartridges.
The
MDOs effectively force the e-cigarette brand off the market. The orders are enforceable
only against the commercial distribution, importation and retail sales of Juul’s
products. The FDA made it clear that the MDOs were not enforceable against individual
consumer possession or use, thereby addressing concerns that the banning of menthol-flavored
tobacco products would result in an increase in arrests of minorities who are
the majority of menthol tobacco users.
Juul
will seek a stay of the FDA MDOs while appealing the agency’s decision.
