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 (Alex Azar) as well as the Commissioner (Dr. Stephen Hahn) of the U.S. Food and Drug Administration (FDA) to enact a six month stay from the May 12th deadline for filing Substantial Equivalence (SE) Reports due to COVID-19.
Under the 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 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 restoring the original August 8, 2018 deadline. Since that time had passed, Grimm implemented a new date of May 12, 2020.
With the May 12th date fast approaching, CRA and PCA advised the Secretary and the Commissioner that absent such relief, CRA and PCA would be amending their complaint in the federal district court for the District of Columbia at the end of the week, requesting that Judge Amit Mehta grant the premium cigar industry relief by implementing a new date.
According to a statement by the CRA:
The basis for this request is the impact of the COVID-19 Pandemic on the ability of premium cigar manufacturers to prepare and file these reports by the accelerated deadline imposed recently by the federal district court in Maryland. Secretary Alex Azar has the authority to stay any regulatory report in the public interest, and FDA Commissioner Dr. Stephen Hahn 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 closure of factories and offices of premium cigar manufacturers, CRA and PCA asked Secretary Azar and Commissioner Hahn to exercise their independent statutory authority to grant the delay, given the looming substantial equivalence report submission date.
“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 in a press release. “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.”
Glynn Loope, executive director of CRA added, “Even during these complex and trying times, it is important to note that the wheels of the unelected bureaucracy continue to churn and threaten the premium cigar industry. Although the government is rightfully consumed with addressing the COVID-19 crisis, CRA and PCA continue to work the appropriate channels to convey the message of regulatory relief with Congress, the courts, and the Trump administration.”
