The court goes on to state that the only way it would be able to grant full relief from the premarket review process through vacate would be to vacate the FDA’s predicate decision to “deem” premium cigars as being subject to the TCA. This cannot be granted because the cigar groups request for vacatur is not possible because it’s the TCA, not the Final Deeming Rule, that is the source of the premarket review requirements.
“The FDA does have discretion to set the form and manner of the substantial equivalence process, and so the court ordered remand “for the limited purpose of considering whether a streamlined substantial equivalence process is appropriate for premium cigars …. The relief Plaintiffs not request–vacate–was not warranted or available. For the foregoing reasons, the court declines to ‘clarify’ or modify its Aug. 19, 2020 Order and denies Plaintiffs’ motion.”
Currently, the court enjoined the FDA from enforcing the TCA’s premarket review requirements against premium cigars until the agency has completed a review of the process.
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