Tag: Breeze Smoke

  • 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.

  • Appeals Court Rejects Breeze Smoke’s Plea for MDO Stay

    Appeals Court Rejects Breeze Smoke’s Plea for MDO Stay

    A divided panel of the U.S. Court of Appeals for the Sixth Circuit rejected Breeze Smoke LLC’s application of a stay of the U.S. Food and Drug Administration’s order Friday, denying the company’s premarket tobacco product application (PMTA) for some of its vaping products.

    In Breeze Smoke LLC v. FDA, the Sixth Circuit rejected the Fifth Circuit’s conclusion that the FDA had orchestrated a “surprise switcheroo” in the PMTA review process. This creates an interesting circuit split that might attract Supreme Court interest, according to Reason’s Jonathan Hadler.

    The Sixth Circuit’s order, on behalf of Judges Moore and Gilman, concluded that the FDA had never committed itself to accepting PMTA applications for flavored vaping products that lacked long-term studies. Rather, the FDA had merely indicated that “it might accept evidence other than long-term studies, if that evidence had sufficient scientific underpinnings to meet the [Tobacco Control Act’s] statutory mandate of demonstrating that flavored ENDS devices are appropriate for the protection of public health” (emphasis in original).

    Thus the court concluded that Breeze Smoke had failed to demonstrate the strong likelihood of success on the merits necessary to support a stay. Judge Kethledge dissented, noting his agreement with the Fifth Circuit’s decision in Wages and White Lion Investments LLC v USFDA.

    While rejecting Breeze Smoke’s stay request, the Sixth Circuit panel did note some concern with the FDA’s handling of the company’s application, particularly its “formulaic consideration” of Breeze Smoke’s plans to prevent marketing to youth. This failing, and the impact of a PMTA denial on Breeze Smoke’s business were still not enough to convince a majority of the panel to enter a stay however.