Judge Mehta Issues Ruling To Delay FDA Final Deeming Rule

Judge Mehta of US District Court of Washington has issued a ruling that provides a temporary win for the cigar industry. In his 38 page ruling, Judge Mehta ruled, “The court therefore remands the Final Deeming Rule to the FDA to consider developing a streamlined substantial equivalence process for premium cigars. The court further enjoins the FDA from enforcing the premarket review requirements against premium cigars, as those products are defined in the August 2020 Notice, until the agency has completed its review. No later than August 31, 2020, the parties shall submit a Joint Status Report proposing a schedule for further proceedings in this matter, if necessary.

How long the delay will last remains to be seen. Judge Mehta writes, “Accordingly, the court remands the Final Deeming Rule for the limited purpose of considering whether a streamlined substantial equivalence process is appropriate for premium cigars. The court further finds that additional equitable relief is warranted and necessary to grant Plaintiffs a complete remedy.

FDA Ruling 819 on Scribd