The United States Court of Appeals for the Fourth Circuit and the United States District Courts for the District of Columbia and Maryland have agreed to extend the deadline for submitting Substantial Equivalence (SE) applications for cigar products from May 12, 2020, to September 9, 2020. The 120-day delay is the result of the impacts of the COVID-19 worldwide pandemic on the premium cigar industry.
A press release from the Premium Cigar Association indicated that since there was no guidance from the FDA as to what manufacturers were expected to submit, this delay should have been granted even in the absence of the ongoing crisis.
Scott Pearce, Executive Director of the PCA commented, “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.”
Under the FDA’s Deeming Rule, cigars introduced to the market before February 15, 2017, do not require FDA approval to remain on the market, but products introduced to the market between February 15, 2007, and August 8, 2016, require the costly Substantial Equivalence (SE) process.
When the Deeming Rule was announced in May 2016, the plan was that product approval, which includes SE, would be implemented beginning August 8, 2018. Shortly after U.S. President Donald Trump named Dr. Scott Gottlieb FDA Commissioner, Gottlieb announced a delay that pushed FDA approval out nearly three years to August 8, 2021.
This triggered a lawsuit filed by the American Academy of Pediatrics in the U.S. District Court of Maryland against the FDA claiming the FDA did not have the authority to delay the implementation. It created an interesting scenario where the Cigar Industry and FDA were on the same page as far as the 2021 deadline. In May 2019 Judge Paul Grimm of the Maryland Court ruled against the FDA, thus restoring the original August 8, 2018 deadline. Since that time had passed, Grimm implemented a new date of May 12, 2020. The ruling by the Maryland and Appeals court now pushies the deadline to September 9, 2020.
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 Judge Grimm’s court order, click here.