The Premium Cigar Association (PCA) and Cigar Rights of America (CRA) filed a Joint Petition with several independent premium cigar manufacturers requesting that both the Secretary of Health and Human Services as well as the Commissioner of the FDA to enact a six month stay from the May 12th deadline for filing Substantial Equivalence Reports due to COVID-19.
These Substantial Equivalence Reports are required to continue to sell the thousands of premium cigars introduced to the markets between February 15, 2007 and August 8, 2016 and each report requires time, considerable cost, and effort.
The Secretary has the authority to stay any regulatory report in the public interest and the interests of justice and the Commissioner has independent authority to do the same for any Report required to be filed during a “public health emergency” and “as events reasonably require”. Given the hardship of completing these reports and the required closing of both Factories and Offices of the Premium Manufacturers, we asked both Secretary Azar and Commissioner Hahn to exercise their independent statutory authority to grant the delay.
Given the looming Substantial equivalence Report Submission Date, we advised both the Secretary and the Commissioner that absent such relief, that PCA and CRA would be amending our Complaint in the Federal District Court for the District of Columbia at the end of the week and requesting Judge Mehta grant the Premium Cigar Industry relief from the crushing burden and impossible schedule for these Reports caused by this unexpected Pandemic.
“Despite the challenges facing the industry and the new challenges presented by COVID-19, PCA will continue to advocate on our members behalf, provide timely and accurate information, and serve as the voice of the premium cigar industry in Washington, DC, State Capitols across the country, and before regulators and the courts on a consistent basis,” says Scott Pearce PCA Executive Director. We hope that everyone continues to stay safe and well during this crisis as we continue to protect the interests of Premium Cigars retailers, manufactures, and enthusiasts.
View the Petition for Stay Of Action here.
View the Exhibits to Petition here.