On July 29, JLI submitted an appeal to FDA, which explains the company’s position, based on science and evidence, that the marketing denial order (MDO) for its premarket tobacco product applications (PMTAs) was substantively and procedurally flawed.
In the appeal, JLI requests that the MDO be rescinded and its PMTAs be placed back into substantive review so that FDA can complete a full and fair review to determine whether the JUUL System is appropriate for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 – as required by law.
This appeal, referred to as a 10.75 appeal, is currently under review by FDA.
We made the decision to publish our 10.75 appeal and related review materials in an effort to provide transparency on the process and educate stakeholders on the science supporting our PMTAs, as well as the bases for FDA’s decision. We are also publishing FDA’s Marketing Denial Order and Technical Project Lead memorandum to provide additional context for our decision.
By necessity, the 10.75 appeal contains information and statements about the relative health risks of the JUUL System compared to combustible cigarettes, as well as other tobacco products. The information and statements in the 10.75 appeal are neither intended for nor directed to consumers and should not be relied upon as health claims, as they have not been authorized by the FDA.
Juul Labs Science – 2022-10-24.
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