Esco Bar Maker Ends FDA Lawsuit Without a Ruling

Pastel Cartel LLC has voluntarily ended its federal lawsuit challenging the FDA’s refusal to accept premarket tobacco product applications (PMTA) for more than 100 Esco Bar products.

The dismissal leaves the central dispute unresolved. It also allows Pastel Cartel to bring the claims again because the case was dismissed without prejudice.

Pastel Cartel and the FDA filed a stipulation on July 7, and Senior U.S. District Judge David A. Ezra dismissed the case the next day. The one-page order did not decide whether the agency acted lawfully. It simply closed a case that had been pending since August 2023.

The company challenged refuse-to-accept (RTA) letters covering disposable vapes and bottled e-liquids sold under the Esco Bar name. Pastel Cartel argued that the FDA used technical filing defects to block applications before any scientific review could begin, according to the first report of the dismissal.

An RTA is not a marketing denial order (MDO). The FDA describes acceptance review as the first stage of the PMTA process. An application that passes moves toward filing and scientific review; an application that receives an RTA stops at the gate. The agency’s own PMTA review outline makes that sequence clear.

That distinction mattered because Pastel Cartel was not asking a court to overturn a scientific judgment about whether its products benefited public health. It was asking the court to review the agency’s refusal to consider the applications at all. The suit sought an injunction against the RTA letters while the challenge proceeded.

Pastel Cartel claimed the agency wrongly found that the required Tobacco Product Master File authorizations were missing. It also challenged the FDA’s reliance on revised application forms that appeared near the submission deadline. The amended complaint alleged violations of the Administrative Procedure Act and the Fifth Amendment’s Due Process Clause. A Justice Department summary of the case says the court denied Pastel Cartel’s preliminary injunction request without prejudice in December 2023.

The company’s withdrawal means the FDA never had to win those arguments on the merits.

Esco Bar had already become a major target in the agency’s disposable-vape enforcement campaign. In May 2023, the FDA announced warning letters and an import alert, saying Esco Bar products lacked marketing authorization. The agency later clarified its import policy, saying unauthorized imported e-cigarettes may be detained without physical examination, and a pending application creates no legal safe harbor.

For manufacturers, the result is familiar and unsatisfying. The FDA’s acceptance-stage gatekeeping survives this challenge not because a court approved it, but because the challenger walked away before the court ruled.