Tag: Vapetasia

  • Court Rules FDA Sent Vapor Makers on ‘Wild Goose Chase’

    Court Rules FDA Sent Vapor Makers on ‘Wild Goose Chase’

    Image: BCFC

    Two e-liquid companies will be able to resubmit their marketing applications to the U.S. Food and Drug Administration following a court ruling, reports Bloomberg Law.

    On Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications (PMTA) of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.

    The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.

    The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.

    In a dissenting opinion, Judge Catharina Haynes stated that the agency “properly fulfilled its statutory mandate by considering the relevant portions of Petitioners’ PMTAs and coming to a reasonable conclusion that marketing Petitioners’ products is not appropriate for public health.”

    Oldham stated that the manufacturers dutifully spent untold millions “conforming their behavior and their applications to FDA’s say-so.”

    “Then, months after receiving hundreds of thousands of applications predicated on its instructions, FDA turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all one million flavored e-cigarette applications for failing to predict the agency’s volte face. Worse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the one million plans.”

    In an X post, Michael Siegel, a professor at Boston University School of Public Health, stated that the ruling “exposed” the FDA’s wrongful rejection of applications for flavored vapes, ultimately resulting in a “win for public health.”

    Eric Heyer, a lawyer for e-liquid makers Triton Distribution and Vapetasia LLC, said he was pleased with the ruling and hoped it would lead the FDA to make “a significant course correction by communicating with specificity” what companies must do to get approval.

    “No principle is more important when considering how the unelected administrators of the Fourth Branch of Government treat the American people,” Oldham wrote, apparently likening executive branch agencies such as the FDA to a separate branch of government. “And FDA’s regulatory switcheroos in this case bear no resemblance to square corners.”

    It is expected that the FDA will seek a review of the decision by the Supreme Court of the United States, however, the justice department hasn’t made an official announcement.

  • Court Denies Triton, Vapetasia Review of FDA Orders

    Court Denies Triton, Vapetasia Review of FDA Orders

    Fifth Circuit Court of Appeals

    Two e-liquid manufacturers may be forced to pull their products from store shelves after they lost their bid to force the U.S. Food and Drug Administration to allow them to market their vaping products.

    The U.S. Court of Appeals for the Fifth Circuit denied Wages and White Lion Investments LLC, doing business as Triton Distribution, and Vapetasia LLC’s requests Monday for review of the agency’s marketing denial orders (MDOs) in a 2-1 decision.

    The manufacturers didn’t show that the FDA acted arbitrarily or capriciously when it rejected their premarket tobacco product applications (PMTAs), the Fifth Circuit said.

    “In a mockery of ‘reasoned’ administrative decision-making,” Judge Edith Jones, a former chief judge of the Fifth Circuit who has served since the Reagan administration, wrote in her dissent. “FDA (1) changed the rules for private entities in the middle of their marketing application process, (2) failed to notify the public of the changes in time for compliance, and then (3) rubber-stamped the denial of their marketing applications because of the hitherto unknown requirements.”

    If the ruling holds, Triton and Vapetasia will not be able to sell their reduced-risk electronic nicotine-delivery system (ENDS) products.

    The companies had applied to market products with flavors like sour grape, pink lemonade, crème brulee and milk and cookies and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”

    Dozens of other smaller vape companies also have accused the regulatory agency of operating unfairly, and will likely be disheartened by this ruling, reports Alex Norcia for Filter.

    Todd Wages, a partner at Triton Distribution, told Filter he was “very disappointed” in the court. “We’re exploring our next steps. I will not stop fighting until I can’t any longer, until every door is closed,” he said.

    The FDA rejected applications to market 55,000 flavored e-cigarettes in August, 2021, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval.

    A Fifth Circuit panel in October then agreed with Triton’s claim that the new requirement for long-term studies differed from earlier FDA guidance and called the action a “surprise switcheroo” and the panel allowed Triton to keep selling its e-cigarettes until another panel could hear its appeal.

    Eric Heyer, the lawyer representing Triton Distribution, told Filter that the company “intends to file a petition for rehearing en banc by the entirety of the Fifth Circuit.”

    Most circuit court appeals are decided by a three-judge panel, however special circumstances could motivate the court to allow a majority of the active judges to vote to rehear the case “en banc.”

    Moving forward, Triton had asked the court in briefs to allow the company to “enjoin FDA from taking further adverse action on the Petitioners’ PMTAs for 18 months to allow Petitioners to conduct the necessary studies to prove comparative efficacy” if the panel ruled against Triton. The court denied that request.