CRA Issues Statement As FDA Files Appeal to Postpone Substantial Equivalence
Cigar Rights of America is pleased to report that the FDA has appealed the decision of Judge Grimm of the United States District Court for the District of Maryland which dissolved the Guidance issued by the Food and Drug Administration delaying the filing date of Substantial Equivalence Reports for all newly deemed tobacco products, including Premium Cigars. The Government’s appeal of Judge Grimm’s ruling indicates that they believe that the FDA Guidance postponing enforcement of the filing date requirement for SE Reports was incorrect and should be overturned on appeal.
The original Guidance was issued during our litigation against the agency and allowed Premium Cigar manufacturers to hold off the expansive and outrageous requirements of preparation, fining and prosecution of SE Reports. While Judge Mehta denied our Motion to overrule Judge Grimm’s Order with respect to CRA, PCA and CAA Members on strictly procedural grounds, we are proceeding to vigorously contest the application of the SE Rules to Premium Cigars and towards that end, endorsed and filed an Amended Complaint this week with Judge Mehta including new and clarified claims with respect to SE Reports.
The CRA believes that it is inappropriate for the Premium Cigar industry to have to undertake the extraordinary cost and expense of these reports before any final guidance on SE contents in issued, the Agency acts on the ANPRM with respect to Premium Cigars and until the Court has the opportunity to review the merits of our claims with respect to SE Reports as outlined in the Amended Complaint.
The CRA applauds the Government’s action in appealing Judge Grimm’s sweeping decision which will have a material and adverse impact on Premium Cigar Manufacturers, Distributors, Retailers and Consumers.