CRA, PCA Petition HHS/FDA to Delay May 2020 Substantial Equivalence Deadline

Two cigar trade groups have asked FDA to delay the May 2020 substantial equivalence submission deadline due to the coronavirus COVID-19 pandemic. If it doesn’t by the end of the week, the groups say they will ask a court to force the agency to do just that.

Cigar Rights of America (CRA) and the Premium Cigar Association (PCA), along with some cigar manufacturers, sent a joint letter to Dr. Stephen Hahn, the commissioner of the U.S. Food & Drug Administration (FDA), and Alex Azar, the secretary of Health Human & Services, asking for the delay.

The letter asks for a delay of six months from the current deadline of May 12, 2020.

The March 18 hearing was over the May 12, 2020 deadline for substantial equivalence, that date was moved up from August 2021 to May of this year by a federal court in Maryland last year. This hearing was part of the lawsuit from three cigar trade groups: Cigar Association of America (CAA), Cigar Rights of America (CRA) and the Premium Cigar Association (PCA).

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.

Cigar manufacturers are required to either file for substantial equivalence or grandfather status by May 12, 2020 in order for their cigars to stay on the market. If they fail to do so, that product must be removed from sale in the U.S. and will not be able to be sold until FDA approves the report.

Complicating matters is that FDA has still not issued an update on its planned new procedures for substantial equivalence and also never issued guidelines from HPHC testing for cigars and other tobacco products. In January, FDA indicated that premium cigars were its lowest priority and that it would handle enforcement in a corresponding manner, though its unclear what that means.

The two groups said that if the agencies didn’t act on their own by the end of the week, the groups would amend their lawsuit against FDA and request that Judge Amit P. Mehta of the U.S. District Court for the District of Columbia grant a stay due to coronavirus.

These groups, along with the CAA, are also fighting for a delay in the deadline in a federal appeals court, which heard arguments last week. In addition, FDA itself has asked a court to delay the May 12, 2020 deadline, which was supposed to be August 2021 until a Maryland-based federal court ruled against FDA in a lawsuit brought on by doctors and anti-tobacco groups.