According to a recent report by Vaping 360, on July 31st, a panel of three judges from the United States Fifth Circuit Court of Appeals cited their ruling in the Triton Distribution case as precedent, approving the review requests of five e-cigarette manufacturers and overturning the FDA's Market Denial Order (MDO).
The court has remanded the case back to the FDA for further review.
These five manufacturers can now continue to sell their products until the agency conducts a new scientific review of their pre-market tobacco product application (PMTA), or until the Supreme Court takes action.
The five companies are:
Cloud House, LLC, Paradigm Distribution, SWT Global Supply, Inc., Vaporized, Inc., and SV Packaging, LLC were all involved in a court ruling that stated: (1) the FDA did not provide fair notice to e-cigarette manufacturers about the long-term research requirements for PMTAs; (2) the FDA did not acknowledge or fully explain its changing position; (3) the FDA disregarded the manufacturers' reasonable and serious reliance interests as outlined in guidance prior to the market denial order (MDO).
In January of this year, the Fifth Circuit Court of Appeals ruled in favor of Triton Distribution (appearing in court documents under its legal name Wages and White Lion Investments) with a 10-6 decision in their appeal against the FDA Market Denial Order (MDO).
Two months later, the FDA applied to the Supreme Court for a review of the Fifth Circuit Court of Appeals' ruling, and last month the Supreme Court agreed to hear the FDA's appeal.
This case may be decided in the spring of next year, potentially reshaping the FDA's regulation practices regarding e-cigarette products.
The Fifth Circuit Court of Appeals believes that the issues raised in this week's ruling are similar to those in the Triton case.
In this case, the applicant produces flavored e-cigarette liquid containing nicotine. The applicant spent a significant amount of time and resources preparing their PMTA in accordance with FDA guidance, which stated they did not need to submit long-term clinical studies. However, the FDA used the same boilerplate language to reject their PMTA, just as they have done with Wages petitioners and thousands of other e-cigarette manufacturers. Therefore, for the reasons fully explained in the Wages case, we believe the FDA's actions in this case are also unlawful, as they rejected the applicant's PMTA on the basis of lack of long-term clinical studies.
These five companies submitted petitions to the court in October 2021, questioning the MDOs received in August and September of that year. These refusals were part of the early refusal letters issued one year after the September 2020 PMTA submission deadline. The court consolidated the five cases and granted all five petitioners a stay of execution in November 2021 for review.
In a recent progress report on the PMTA review process, the FDA stated that it has issued MDOs for 46,000 e-cigarette products. Dozens of e-cigarette manufacturers have challenged the refusal orders in federal court.
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