Tag: Esco Bars

  • Esco Bars Manufacturer Files Suit to Challenge FDA

    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.

  • U.S. FDA Warns Retailers for Elf Bar, Esco Bar Sales

    U.S. FDA Warns Retailers for Elf Bar, Esco Bar Sales

    Credit: Pastel Cartel

    The U.S. Food and Drug Administration is continuing its crackdown on illegal disposable vape devices. The regulatory agency has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars brands. 

    “The FDA is prepared to use all of its authorities to ensure these, and other illegal and youth-appealing products, stay out of the hands of kids,” said FDA Commissioner Robert M. Califf. “We are committed to a multipronged approach using regulation, compliance and enforcement action and education to protect our nation’s youth.” 

    The warning letters are the result of a nationwide retailer inspection blitz over the past several weeks cracking down on the sale of these unauthorized e-cigarettes.

    The FDA continuously monitors the marketplace and took these actions as emerging marketplace data led to concerns over their appeal and risks to young people, according to an FDA release. More specifically, the agency’s ongoing surveillance efforts helped FDA identify Elf Bar and Esco Bars as being among the most popular brands in the United States and having high youth appeal.

    “All players in the supply chain—including retailers—have a role in keeping illegal e-cigarettes off the shelves,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “This latest blitz should be a wake-up call for retailers of Elf Bar and Esco Bars products nationwide. If they’re waiting for a personal invitation to comply with the law, they might just get it in the form of a warning letter or other action from the FDA.”

    Last month, the FDA issued import alerts for all products under both the Elf Bar and Esco Bars brands. An import alert places these tobacco products on the red list, which makes them subject to Detention Without Physical Examination and allows the FDA to detain a product without physically examining it at the time of entry.

    Elf Bar and Esco Bars products do not have the required marketing authorization from the FDA.

  • U.S. FDA Warns Vape Makers Esco Bars, Breeze Smoke

    U.S. FDA Warns Vape Makers Esco Bars, Breeze Smoke

    Credit: Pastel Cartel

    Two warning letters to firms that manufacture popular flavored, disposable e-cigarette products have received warning letters from the U.S. Food and Drug Administration.

    Shenzen Innokin Technology Co. Ltd., the producer of Esco Bars products, and Breeze Smoke, LLC who import and distribute Breeze products for manufacturing, distributing, and/or importing unauthorized tobacco products in the United States, according to the FDA.

    Esco Bars and Breeze are presently among the most commonly sold brands of disposable products in the United States.

    “Today’s actions underscore FDA’s commitment to protecting youth against illegal flavored, disposable e-cigarette products. On May 12, FDA also issued an import alert for Esco Bars products,” according to an FDA statement. “The import alert places these tobacco products on the red list, which allows FDA to refuse or detain the product at the time of entry and to prevent illegal products from being distributed in the U.S.”

    Credit: Breeze

    Brian King, the director of the FDA’s Center for Tobacco Products, 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 products. “Given their appeal to youth, these products are a priority for FDA compliance and enforcement action,” King said.

    FDA generally sends warning letters the first time an investigation or inspection reveals a violation. A majority of recipients of warning letters correct the stated violation.

    However, failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties.