E-Cigarette Companies Appeal FDA Decisions

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On July 5, 2022, the FDA administratively stayed the marketing denial order to allow time for the agency to conduct a further review of scientific issues related to the pre-market tobacco applications originally filed by Juul Labs. Subsequently, on July 29, 2022, Juul Labs filed what is known as a 10.75 Administrative Appeal with the FDA. This administrative appeal argues that the FDA’s issuance of the MDO for all of Juul Labs’ products was “substantively and procedurally flawed.” On its company website, Juul Labs states that “Through its 10.75 appeal, JLI [Juul Labs] requests that the MDO be rescinded and its PMTAs be placed back into substantive review so that FDA can complete a full and fair review to determine whether the JUUL System is appropriate for the protection of public health.”

While the administrative appeal is pending, Juul Labs electronic cigarette products can be sold in the marketplace.

Contributed by Thomas Briant, executive director of the National Association of Tobacco Outlets (NATO)