Respondents previously submitted Premarket Tobacco Applications (PMTA) to the Food and Drug Administration (FDA or Agency) for various open system (as opposed to closed cartridge-based systems such as JUUL and Vuse) flavored e-cigarettes products. 

FDA issued denial orders and found respondents’ PMTA for such products did not provide the Agency with sufficient scientific evidence to demonstrate the marketing of those products would be appropriate for the protection of public health (APPH). Namely, FDA concluded respondents did not provide evidence from a randomized controlled trial or longitudinal cohort study which demonstrated flavored products e-cigarettes did in fact have benefits over tobacco-flavored products. 

Respondents petitioned for judicial review of the FDA’s denial orders. An en banc panel of the Fifth Circuit concluded FDA acted arbitrarily and capriciously in denying the PMTA due to the changes in the FDA’s PMTA requirements between the time the revised Agency guidance was issued and FDA’s denials of the respondents’ PMTA. The Fifth Circuit granted the petitions for review and remanded to the FDA.

The US Supreme Court, in its ruling, found the FDA’s denial of the respondent’s PMTA for flavored e-cigarette products did not violate the change-in-position doctrine and that the Fifth Circuit had erred in its application of the Court's harmless-error precedents.

The Supreme Court vacated and remanded the case to the Fifth Circuit to reconsider its decision in light of the Supreme Court’s clarification of the harmless-error standard.

We will continue to monitor this case and keep you updated on its future impact to the e-cigarette/nicotine vaping category particularly in light of President Trump’s campaign promises to save the vaping industry, the Trump administration’s reorganization of FDA and departure of many key leaders within the FDA’s Center for Tobacco Products, including director Dr. Brian King.