Esco Bars Manufacturer Files Suit to Challenge FDA
Credit: Pastel Cartel
Pastel Cartel, the manufacturer of Esco Bars vaping devices, has submitted a legal complaint to the U.S. Federal District Court in the Western District of Texas.
The dispute is in regards to a U.S. Food and Drug Administration decision to reject over one hundred documents that Pastel Cartel had included in their premarket tobacco product applications (PMTAs), according to court records.
In the lawsuit, Pastel Cartel accuses the FDA of acting negligently and carelessly by issuing refusing to accept (RTA) letters for the company’s PMTAs on technical grounds.
The company is seeking:
- A preliminary injunction staying the RTA orders until the case is decided;
- A judgment finding the RTAs violate the Administrative Procedure Act (APA) and the U.S. Constitution (the Due Process Clause of the Fifth Amendment);
- A final judgment setting aside the RTA orders and remanding the company’s PMTAs back to the FDA for further review.
Earlier this year, Shenzen Innokin Technology Co. Ltd., the producer of Esco Bars products, and Breeze Smoke, LLC who import and distribute Breeze products also received warning letters for manufacturing, distributing, and/or importing unauthorized tobacco products in the United States, according to the FDA.