By Timothy S. Donahue

Top Takeaways:

• Case dismissed: The manufacturer behind Esco Bar has agreed to voluntarily dismiss its lawsuit challenging the FDA’s refusal to accept more than 100 PMTAs.
• No ruling: The case was dismissed without prejudice, leaving the underlying dispute unresolved and allowing the company to refile in the future.
• Regulatory backdrop: The lawsuit challenged the FDA’s “refuse-to-accept” process, which blocked Esco Bar’s applications from proceeding to scientific review.

The company behind the Esco Bar disposable vape brand has dropped its legal challenge to the U.S. Food and Drug Administration’s rejection of its premarket tobacco product applications (PMTAs).

A federal judge in the U.S. District Court for the Western District of Texas has dismissed, without prejudice, a lawsuit filed by Pastel Cartel LLC, the manufacturer of Esco Bar, after the company and the FDA jointly agreed to end the case.

The lawsuit, originally filed in 2023, challenged the FDA’s Refuse-to-Accept (RTA) determinations for more than 100 Esco Bar disposable vaping products and bottled e-liquids.

Unlike a marketing denial order, an RTA determination ends the review process before the FDA conducts a scientific evaluation, concluding that an application is incomplete or fails to meet threshold filing requirements.

Pastel Cartel argued that the FDA acted arbitrarily and capriciously by refusing to accept its applications for review. The company alleged that the agency improperly concluded that required Tobacco Product Master File authorizations were missing and relied on updated application forms that became available only shortly before or after the statutory submission deadline. The complaint also asserted violations of the Administrative Procedure Act and the Fifth Amendment’s Due Process Clause.

The dismissal does not resolve those claims on the merits. Instead, the parties stipulated to dismiss the action without prejudice, meaning the case ends without a judicial determination of whether the FDA acted lawfully and preserves the possibility of bringing the claims again.

Esco Bar has remained a focal point of the FDA’s enforcement against unauthorized disposable vaping products. In 2023, the agency placed Esco Bar products on import alert and issued warning letters to firms responsible for manufacturing and distributing the brand, stating that the products lacked FDA marketing authorization and therefore could not be legally marketed in the United States.

At the time, then-Center for Tobacco Products Director Brian King said, “The science clearly shows that a majority of youth who use e-cigarettes report that the products they are using are disposable and flavored,” and added that Esco Bar products were a priority for FDA compliance and enforcement efforts. The FDA has authorized Glas flavored vapes under now CTP Acting Director Brett Koplow.

The dismissal concludes one of several lawsuits challenging the FDA’s handling of PMTAs for disposable vaping products. Although the case is closed, the broader legal debate over the agency’s review process for electronic nicotine products continues across multiple federal courts.

The case is Pastel Cartel LLC v. U.S. Food and Drug Administration, U.S. District Court for the Western District of Texas.