Tag: Moose Jooce

  • 2 Cases Ask SCOTUS to Take Away FDA’s Vapor Rules

    2 Cases Ask SCOTUS to Take Away FDA’s Vapor Rules

    The litigants in two lawsuits challenging the constitutionality of the the U.S. Food and Drug Administration’s (FDA) Deeming Rule for vapor products have asked the Supreme Court of the United States (SCOTUS) to take up the cases.

    The cases are Big Time Vapes, Inc., et al. v. FDA, and Moose Jooce, et al. v. FDA.

    Attorneys for the plaintiffs in the Moose Jooce case filed a petition for writ of certiorari, a request to have the U.S. Supreme Court consider the case. On February 26, 2021, the Moose Jooce challengers filed their petition asking the Supreme Court to take up questions related to their challenge to the Deeming Rule under the “Appointments Clause” in Article II, § 2 of the Constitution.

    The plaintiffs claim that FDA acted improperly because the person that issued the deeming regulations was not qualified to do so per the Appointments Clause. In this case, the rule was issued by Leslie Kux, the associate commissioner for policy, and not the commissioner himself, according to an attorney for Troutman Pepper.

    FDA has argued that the commissioner—in both 2016 and 2019—ratified the regulations. Both the U.S. District Court for the District of Columbia and the U.S. Court of Appeals for the District of Columbia have ruled against plaintiffs in the Moose Jooce case. The district court and court of appeals held that these circumstances did not render the Deeming Rule invalid. The plaintiffs are represented by the Pacific Legal Foundation.

    In the Big Time Vapes case, the challengers petitioned the Supreme Court for a writ of certiorari on December 18, 2020. The case involves the claim that the statute purportedly authorizing the Deeming Rule is an unconstitutional delegation of Congress’ legislative power.

    The challengers in the Big Time suit initiated their case in the U.S. District Court for the Southern District of Mississippi. The court granted the FDA’s motion to dismiss and denied the challengers’ motion for preliminary injunction and the Fifth Circuit affirmed the decision.

    There is no guarantee that the Supreme Court will take up these cases. According to the Administrative Office of the U.S. Courts, the court accepts 100-150 of the more than 7,000 requests it receives each year.

    The FDA will have the opportunity to respond to the challengers’ petitions before the Supreme Court acts on them. Review “is not a matter of right, but of judicial discretion,” and the petitions “will be granted only for compelling reasons.”

    Currently, vapor businesses are still subject to the Deeming Rule.

  • Court Upholds FDA Right to Regulate Vapor as Tobacco

    Court Upholds FDA Right to Regulate Vapor as Tobacco

    The U.S. Food and Drug Administration’s (FDA) decision to regulate e-cigarettes as tobacco products has been upheld in a federal court. The ruling rejects challenges from the e-cigarette industry claiming the agency had violated the U.S. Constitution’s Appointments Clause.

    Two justice scales colliding
    Photo: Skypixel | Dreamstime.com

    A unanimous panel of the D.C. Circuit U.S. Court of Appeals ruled Thursday that the regulation did not run afoul of the Appointments Clause because the FDA official who promulgated it was not appointed by the president and confirmed by the Senate, according to Westlaw Today.

    Jonathan Wood of the Pacific Legal Foundation, a lawyer for the plaintiffs, said he and his clients were “disappointed” and considering next steps. “The Appointments Clause is an essential constitutional protection for democratic oversight and accountability,” he said. “Yet the court’s decision all but assures that agencies will suffer no consequences when they violate this clause.”A spokeswoman for the FDA did not immediately respond to a request for comment.

    The appeal came from a group of vape shops including Michigan-based Moose Jooce and manufacturers of the liquid used in e-cigarettes, all represented by the Pacific Legal Foundation, a conservative legal group.

    They argued that the FDA’s then-associate commissioner for policy Leslie Kux, who issued the 2016 rule deeming e-cigarettes to be tobacco products, lacked the authority to do so because she was a career employee, not a principal officer appointed by the president.

    The FDA countered that the authority had been delegated to Kux by the agency’s commissioner. Furthermore, it said, her authority did not matter because the rule was ultimately ratified by two different FDA commissioners, most recently FDA Commissioner Scott Gottlieb in April 2019.

    U.S. District Judge Christopher Cooper in Washington, D.C. agreed that the ratification overcame any Appointments Clause issues, and the plaintiffs appealed. Circuit Judge Judith Rogers, writing for a unanimous panel Tuesday, agreed, rejecting the plaintiffs’ arguments that Gottlieb was required to conduct a new review before ratifying the rule, and noting there was no evidence in the record that he had not.

    “Commissioner Gottlieb’s ratification, for the reasons discussed, cured any potential Appointments Clause defect arising from Associate Commissioner for Policy Kux’s issuance of the Deeming Rule,” she wrote.

    Circuit Judge Cornelia Pillard and Senior Circuit Judge David Sentelle joined in the opinion.
    E-cigarettes are handheld electronic devices that vaporize a fluid that often contains the addictive substance nicotine. The devices have been grabbing market share from traditional tobacco companies.