Tag: Prohibition Juice

  • Court Confirms FDA’s Authority Over Vaping Products

    Court Confirms FDA’s Authority Over Vaping Products

    Photo: Mikhail Reshetnikov

    A U.S. appeals court endorsed the Food and Drug Administration’s  authority over vaping products in a case challenging a marketing denial order (MDO), reports ECigIntelligence.  

    New York-based Prohibition Juice had disputed an MDO, asserting that the agency lacked the statutory authority to consider a product’s “relative effectiveness at promoting cessation of combustible cigarette use versus another product with an otherwise similar health risk profile and labeling.”

    However, the U.S. Court of Appeals for the District of Columbia Circuit ruled that the FDA is entitled under the Tobacco Control Act to determine whether a product is appropriate for the protection of public health, and that meant an applicant must supply all information concerning investigations that have been made on the health risks of a product as well as whether a product presents less risk than others.

  • D.C. Court Rejects Prohibition Juice Co. Appeal of MDO

    D.C. Court Rejects Prohibition Juice Co. Appeal of MDO

    On July 26, the United States Court of Appeals for the District of Columbia rejected an appeal by four e-liquid manufacturers that challenged the FDA’s denial of their premarket tobacco product applications (PMTAs), ruling that the agency acted within Congress’ authorization, and its decisions were supported by evidence.

    Prohibition Juice Co., Cool Breeze Vapor, ECig Charleston, and Jay Shore Liquids argued that the FDA lacked statutory authority to require that the manufacturers establish that their flavored liquids carry greater public health benefits than unflavored liquids.

    According to the motion, the companies also challenged the PMTA denials as arbitrary and capricious, asserting that the FDA: (1) departed from an earlier guidance document, changing both the types of evidence the agency would accept and the substantive showing it expected parties to make; (2) underscored the potential importance of marketing plans including measures to limit youth access to their products but then failed to consider the plans petitioners submitted; and (3) overlooked various other aspects of the problem.

    “We deny the petitions for review. The FDA plainly had statutory authority under the Tobacco Control Act to regulate as it did. As to the arbitrary and capricious challenges, we hold that the FDA did not change the evidentiary or substantive standard from its 2019 Guidance,” the court wrote in its motion. “We also hold that any error in the FDA’s failure to consider the marketing plans was harmless because the manufacturers failed to identify how individualized review of the plans they submitted could have made any difference.

    “Finally, the FDA did not otherwise fail to consider important aspects of the problem. We accordingly deny the petitions for review.”

    The D.C. Circuit has not stayed the enforcement of any MDO.