E-Cigarette Companies Appeal FDA Decisions

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Logic Technology and JUUL Labs Respond to FDA Decisions

Logic E-Cigarette Appeal:  On Friday, Oct. 28, 2022, Logic Technology Development, LLC obtained a court order from the U.S. Circuit Court of Appeals for the Third Circuit temporarily staying the U.S. Food and Drug Administration’s Marketing Denial Order (MDO) issued on Oct. 26, 2022 regarding the company’s Logic Pro Menthol e-Liquid Package product and the Logic Power Menthol e-Liquid Package product.

The issuance of the Marketing Denial Order (MDO) by the FDA denied the pre-market tobacco applications filed with the agency by Logic Technology Development LLC for both the Logic Pro Menthol e-Liquid Package product and the Logic Power Menthol e-Liquid Package product.

However, the temporary stay issued by the circuit court means that both the Logic Pro Menthol e-Liquid Package product and the Logic Power Menthol e-Liquid Package product can be sold by retailers and wholesalers in the United States while the stay is in place and the Third Circuit Court of Appeals considers a further motion by Logic Technology Development LLC regarding the MDO. That is, the FDA is not allowed to take any action to enforce the MDO or require the Logic Technology Development LLC products to be removed from the marketplace until the court proceedings are finalized.

Below is a copy of the court order posted to the court’s electronic docket for this case:

ORDER (PORTER, Circuit Judge) The foregoing motion for a partial administrative stay is GRANTED as follows. The FDA’s marketing-denial order is TEMPORARILY STAYED as to the Logic Pro Menthol e-Liquid Package and the Logic Power Menthol e-Liquid Package products. Within seven days of this order, the petitioner must file its motion for a stay pending the petition. The FDA’s response must be filed within ten days thereafter. The panel considering the stay motion may decide it without waiting for a reply, see Fed. R. App. P. 27(a)(3)(A); 3d Cir. I.O.P. 10.2.3, so any reply must be filed as quickly as possible (and no later than three days after the response). The temporary administrative stay will remain in effect until a panel of this Court decides the forthcoming stay motion. If no timely stay motion is filed, the Clerk is authorized and directed to vacate this temporary administrative stay. Panel No.: ECO-005. Porter, Authoring Judge.

Juul E-Cigarette Appeal:  On June 23, 2022, the FDA issued a Marketing Denial Order for all of Juul Labs’ electronic cigarette products, which include the following:

  • JUUL Device
  • Virginia Tobacco Flavored Pod (5 percent nicotine concentration)
  • Virginia Tobacco Flavored Pod (3 percent nicotine concentration)
  • Menthol Flavored Pod (5 percent nicotine concentration)
  • Menthol Flavored Pod (3 percent nicotine concentration).

Then, on June 24, 2022, the U.S. Circuit Court of Appeals issued an order temporarily staying the FDA’s MDO issued on June 23, 2022.  According to that order, the Circuit Court stated that “[t]he purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion.”