PCA and the CRA Comment on Substantial Equivalence Extension

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FDA | Premium Cigar Regulation

The Premium Cigar Association (PCA) and Cigar Rights of America (CRA) are commending the decision made by the courts to extend the Substantial Equivalence (SE) deadline. The PCA and the CRA were among the organizations pushing for an extension for SE applications due to the disruption caused by the COVID-19 pandemic.

On behalf of the premium cigar industry, the PCA and the CRA filed a petition before the the FDA and litigation and motions before the United States Court of Appeals for the Fourth Circuit and the United States District Courts for the District of Columbia and Maryland to get this extension approved. It wasn’t until this week when that extension was finalized by court order.

“This is an appropriate action and a necessary step to seeking long term regulatory relief during this difficult time. We commend the efforts of our legal, advocacy, and lobbying teams that have produced results and will continue to push for a long term solution to the Substantial Equivalence Rule that will benefit the premium cigar industry and our collective memberships. This extension was a direct result of fighting the FDA in the courts, and we will continue that fight,” commented Scott Pearce, executive director of the PCA.

Glynn Loope, executive director of the CRA, added: “While we are pleased with this extension by the court, it should be noted that this action could have been granted by the Secretary of Health & Human Services and the FDA Commissioner without using the courts.” Loope continued, “We will use this time to continue our efforts to seek a more streamlined approach to this issue with the Trump Administration.”

Even with the extension, PCA and CRA are continuing to fight to overturn the substantial equivalence process imposed on the premium cigar industry. The U.S. District Court for the District of Columbia was scheduled to hear the case remotely on April 23, 2020, but now that case has been delayed due to COVID-19. It will now take place when the courthouse reopens.

The new extension pushes the deadline for substantial equivalence applications to Sept. 9, 2020. You can view the government’s letter to Judge Michael Grimm of the U.S. District Court for the District of Maryland here. You can also view the order by Judge Grimm by clicking here.

For all the latest news from the Premium Cigar Association, visit premiumcigars.org.