By Timothy S. Donahue

Top Takeaways:

• One-day dispute: FDA says Flumizer missed the statutory filing deadline by one day.
• Company challenges notice: Flumizer argues the agency’s email and phone call did not constitute proper service.
• Judges skeptical: The panel repeatedly questioned whether equitable tolling should apply.

A vaping company’s challenge to a U.S. Food and Drug Administration marketing denial order may hinge on a single day.

During oral arguments before the U.S. Court of Appeals for the Ninth Circuit on June 11, judges examined whether Flumizer LLC missed the deadline to appeal its marketing denial order by one day — and whether that timing dispute should bar the company from pursuing its case against the FDA.

Unlike other vaping cases argued before the court that day, which focused on the FDA’s review standards for flavored products, the Flumizer appeal centers on a procedural question: when did the clock start running?

Flumizer attorney Georgia Latham argued that the company did not receive proper notice when the FDA sent an email described as a “courtesy copy” of the marketing denial order and later followed up with a phone call.

“The email … clearly states that it’s a courtesy copy, it’s not an actual service,” Latham told the panel.

According to Flumizer, the company’s filing deadline should not have been triggered by an email that explicitly labeled the document as a courtesy copy rather than formal service.

FDA sees the matter differently.

Agency attorney Jack Starcher argued that the denial order was issued on July 22 and that the statutory deadline for seeking judicial review began on that date. “The marketing denial order … is dated July 22,” Starcher told the court.

According to the FDA’s calculation, the filing deadline was Aug. 21. Flumizer filed its petition on Aug. 22. Judges repeatedly returned to the timing issue and pressed both sides on whether equitable tolling — a legal doctrine that can excuse missed deadlines — should apply.

Judges on the panel questioned whether the circumstances surrounding the FDA’s communications created sufficient confusion to justify an exception and whether Congress intended the filing deadline to be strictly enforced.

The dispute could prove significant because the court may never reach the merits of Flumizer’s challenge if it finds the appeal untimely. As a result, the case serves as a reminder that for tobacco and nicotine manufacturers, procedural deadlines can be as important as the substantive scientific and regulatory issues underlying FDA review decisions.

The panel took the case under submission and did not indicate when it would rule.