The U.S. Court of Appeals for the Fourth Circuit has denied a motion by cigar trade groups to grant a stay on the May 12, 2020 deadline for substantial equivalence until after an appeals process is completed.
It did, however, grant a motion to expedite the next part of the process, wich a hearing scheduled for March 18, so that the court can make a ruling before May 12.
Substantial equivalence is expected to be the main approval process for cigars once FDA’s regulations are fully in effect. In short, a manufacturer would argue that its product is substantially equivalent to an already approved or grandfathered product, and as such poses no additional health risks and does not market towards children.
Applications were scheduled to be due next August, until last year, when Judge Paul W. Grimm, a federal judge in Maryland, ruled against FDA in the case, which was brought on by health groups and pediatricians in the state of Maryland.
Those groups argued that FDA’s approach to regulating other tobacco products, specifically vaping and e-cigarettes, was not legal and was causing both the groups and the public harm. Grimm ruled in favor of the plaintiffs, finding that FDA had arbitrarily created deadlines for various parts of the rule, most notably the deadlines for which tobacco products had to file submissions for product approval with FDA.
He then asked both sides to present alternative timelines for regulation. Ultimately, Grimm went with a timeline presented by FDA, which accelerated the regulatory process by about 450 days.
That has led to appeals by three cigar trade groups—the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the Premium Cigar Association (PCA)—as well as separate appeals from vapor groups and FDA itself.
The cigar groups sought to have the court issue a stay, indefinitely delaying the May 12, 2020 deadline until after the appeals process is completed. The court denied that motion but opted to expedite the hearing of the appeal so that a decision can be issued prior to May 12, 2020.