Tag: Magellan

  • Second Circuit Appeals Court Rules in Favor of FDA

    Second Circuit Appeals Court Rules in Favor of FDA

    Credit: Brian Kinney

    A federal appeals court has ruled that the U.S. Food and Drug Administration didn’t change its position on admissible evidence and the agency’s failure to consider a marketing plan didn’t impact the outcome.

    The FDA acted reasonably in denying vapor maker Magellan Technology Inc.’s request for a marketing order for its flavored vaping products, the U.S. Court of Appeals for the Second Circuit ruled Friday.

    The court upheld the FDA’s finding that Magellan failed to show the product would provide a benefit to adult users that would outweigh the risks to youth.

    The agency found Magellan’s evidence—four non-clinical studies—was insufficient to establish that the flavored pods would be more effective than tobacco-flavored electronic nicotine delivery systems (ENDS) in helping smokers switch to e-cigarettes to stop smoking altogether, according to Bloomberglaw.

    The manufacturer of Hyde and Juno brand e-cigarettes sued the FDA and the U.S. Department of Health and Human Services claiming the agencies violated the Administrative Procedure Act.

    New York-based Magellan Technology accused the agencies of refusing to review the company’s premarket tobacco product applications (PMTAs) for 12 products, a process which cost the company $1 million. Magellan claims the FDA “arbitrarily” and “capriciously” rejected the applications.

    “Magellan had already spent over $1 million on the PMTAs at the time the RTA [refuse-to-accept] order [was] issued and plans to spend over $10 million on the PMTAs in total,” the suit states.

    Texas-based retailer Vapor Train 2 LLC is also a plaintiff in the suit. The companies asked a Texas federal court to temporarily stay the RTA order the FDA issued to Magellan, according to the lawsuit filed Thursday.

    “FDA acted arbitrarily, capriciously, and otherwise not in accordance with applicable law in issuing the [refuse-to-accept] order,” the lawsuit states. “The agency invoked regulations governing [premarket tobacco product applications] acceptance that do not apply to Magellan’s [applications] and failed to consider timely amendments containing required content that Magellan properly submitted.”

    The companies are expected to appeal the ruling. Magellan could now seek an en banc review of the case (a rehearing by the full Second Circuit) or could appeal to the Supreme Court of the United States. 

  • Hyde Maker Files Suit Against FDA for PMTA Denials

    Hyde Maker Files Suit Against FDA for PMTA Denials

    The manufacturer of Hyde and Juno brand e-cigarettes is suing the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services claiming the agencies violated the Administrative Procedure Act.

    New York-based Magellan Technology accuses the agencies of refusing to review company’s premarket tobacco product applications (PMTAs) for 12 products, a process which has cost the company $1 million. Magellan claims the FDA “arbitrarily” and “capriciously” rejected the applications, according to law360.

    “Magellan had already spent over $1 million on the PMTAs at the time the RTA [refuse-to-accept] order [was] issued and plans to spend over $10 million on the PMTAs in total,” the suit states.

    Texas-based retailer Vapor Train 2 LLC is also a plaintiff in the suit. The companies asked a Texas federal court to temporarily stay the RTA order the FDA issued to Magellan, according to the lawsuit filed Thursday.

    “FDA acted arbitrarily, capriciously, and otherwise not in accordance with applicable law in issuing the [refuse-to-accept] order,” the lawsuit states. “The agency invoked regulations governing [premarket tobacco product applications] acceptance that do not apply to Magellan’s [applications] and failed to consider timely amendments containing required content that Magellan properly submitted.”

    According to the suit, applications for Magellan’s products were submitted to the FDA on May 12 and 13 by a third-party company based in China, Skyte Testing Services Guangdong Co. Ltd., before the May 14 deadline.

    However leading up to the due date, the FDA made last-minute changes to what was required in an application, the suit claims. Specifically, on April 14, the agency used emergency powers to amend a document, Form 4057, which Magellan would need to include with its application.

    An amended version of this form wasn’t posted on the government’s website for almost two weeks, additionally, the FDA didn’t announce the change until May 16, two days after the applications were due.

    Magellan claims that at the time Skyte submitted the applications, the government’s website did not generate submission tracking numbers. Magellan claims didn’t learn those numbers until after the FDA issued its RTAs in October, according to the suit.

    Without the numbers, Magellan was not able to properly submit amendments to its application, specifically a new Form 4057. Skyte tried to submit updated documents on Aug. 18, explaining in the summary page that these documents were meant to be included with its May submissions, according to the suit.

    But the FDA later rejected these forms for not including the submission tracking number, the lawsuit claims. The agency specifically noted that “although you submitted additional submissions which may have been intended to amend your applications, [the submissions] did not specify the [tracking number] assigned to the original submission within FDA Form 4057,” according to the suit.

    Magellan claims the omission was not its fault.

    The FDA did not act “in accordance with law by failing to consider Magellan’s timely amendments submitted on Aug. 18, 2022, on the grounds that the amendments did not include or reference the submission tracking numbers assigned … when FDA itself failed to assign the original bundled applications corresponding submission tracking numbers,” the suit states.

  • FDA Fails to First Inform Hyde of MDOs Before Public

    FDA Fails to First Inform Hyde of MDOs Before Public

    The U.S. Food and Drug Administration confirmed that Magellan Technology received marketing denial orders (MDOs) on Oct. 6 for 32 products. However, Magellan CEO Jon Glauser said the FDA acknowledged in writing that it had “erred in failing to inform the company” about the MDOs and only after the Oct. 6 announcement did Magellan receive the letters from the FDA.

    “Because the affected PMTAs had been pending with the agency for over two years, we can only surmise that what the FDA deemed an “inadvertent error” in failing to inform the company was caused by an apparent rush to include the MDO action with the Agency’s press release on the National Youth Tobacco Survey data, which shows youth vaping down 50% since 2019,” Glauser states in an email. “The MDOs covered only certain Hyde products containing tobacco-derived nicotine. No Hyde products containing non-tobacco nicotine are subject to an MDO.”

    In response to an inquiry by Vaping360, the FDA reiterated that it had served Magellan Technology with an MDO.

    “After reviewing premarket tobacco applications for 32 Hyde e-cigarettes, FDA issued marketing denial orders (MDOs) for these applications submitted by Magellan Technology, Inc. on Oct. 6,” the agency told Vaping360. “In addition to the MDOs issued on Oct. 6, as acknowledged by Magellan Technology, Inc. in their statement, FDA also issued a Refuse to Accept (RTA) Letter for other Hyde e-cigarette products.”

    Glauser states that the FDA did issue a Refuse to Accept (RTA) letter for certain of Magellan’s Hyde
    products containing non-tobacco nicotine, identifying two administrative requirements the regulatory agency claims the company’s premarket tobacco product applications (PMTAs) were lacking.

    “First, with respect to two of our bundled applications, the FDA stated that a signed statement as to the accuracy of certain translated documents was missing. However, the agency misunderstood the fact that the documents themselves are dual language documents that are maintained by our Chinese manufacturer in both English and Chinese. Because the relevant FDA regulation only requires a
    certification for documents that have been translated from another language into English, we believe that the cited regulation is inapplicable,” Glauser explains. “This is the only issue cited against one of our bundled applications and on October 12, 2022, we filed a petition for stay with FDA requesting that the agency immediately stay the RTA determination on this basis.”

    The second Item, Glauser wrote, relates to nine other applications that the FDA claims a certification statement verifying the PMTA submissions were “true and correct” was missing from those submissions. The FDA had preciously told Magellan that the company already had submitted amendments to its applications with the certification, but the agency could not determine to which applications the amendments needed to be applied.

    “To that end, the FDA noted that ‘although your submission(s) may include the required content for a PMTA,’ the absence of the form made it impossible for the FDA to review the applications. While it is unfortunate that these technical issues cropped up with respect to these applications which had to be filed under enormously short time constraints, it is not a reflection of the high quality of scientific work that Magellan has assembled and continues to generate as part of its commitment to the PMTA process, work which the FDA has not yet reviewed,” wrote Glauser. “Magellan’s counsel and consultants already are engaging with the FDA regarding these issues and are asking the Agency to reconsider its initial determination so that Magellan’s application review can progress forward. In the event that FDA refuses, Magellan intends to move promptly to seek judicial relief regarding the RTA letter.”

    In response to the FDA press statement announcing the order, Magellan Technology denied having received an MDO, saying the agency had refused to accept its premarket tobacco product application (PMTA) on a technicality without reviewing the PMTA on its merits.

    Magellan Technology demanded that FDA not only retract the press announcement but also issue a corrective statement making clear that FDA did not issue an MDO to Magellan and that it has not yet conducted a scientific review of Magellan’s products.