April 23, 2020, Washington, DC — Today, the Premium Cigar Association (PCA) and Cigar Rights of America (CRA) jointly commended the extension of the deadline to September 9, 2020 for the submission of the substantial equivalence reports for premium cigar manufacturers. The PCA and CRA filed a petition before 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 secure this important extension. The extension was finalized today by court order.
This requirement by FDA already presented a cumbersome and expensive burden to the industry that was made exponentially worse by the ongoing COVID-19 pandemic.
With no guidance available from FDA as to what manufacturers were expected to submit, this delay should have been granted even in the absence of the ongoing crisis. The PCA and CRA are continuing their fight to overturn the unfair and illegal application of the substantial equivalence process to premium cigars. The U.S. District Court for the District of Columbia was scheduled to hear that case remotely today to address these important issues before the May 12 deadline, but now will do so as soon as the courthouse reopens in light of the extension.
Scott Pearce, Executive Director of the PCA, stated that “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.”
Glynn Loope, Executive Director of 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.”
The PCA and CRA will continue to provide ongoing updates regarding the court challenge to the issue of substantial equivalence submission.
The PCA and CRA will continue to provide ongoing updates as it relates to the court challenge of substantial equivalence reporting.
To view the government’s letter to Judge Paul Grimm of the U.S. District Court for the District of Maryland, click here.
To view the order by Judge Paul Grimm, click here.
CONTACT
Scott Pearce, Executive Director
Premium Cigar Association
[email protected]