Cigar Rights of America and PCA Request Substantial Equivalence Delay

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Cigar Rights of America and PCA Request Substantial Equivalence Delay

Cigar Rights of America (CRA) and the Premium Cigar Association (PCA), along with several premium cigar manufacturers, filed a joint petition requesting a six month delay in Substantial Equivalence (SE) due dates.

Glynn Loope, executive director of CRA stated, “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.”

Scott Pearce, executive director of the PCA, added: ‚ÄúDespite 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. 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.”

Substantial Equivalence has been a contentious part of the U.S. Food and Drug Administration’s (FDA) regulation of tobacco products. Last year, health organizations filed a lawsuit accusing the FDA of not doing its part to regulate tobacco products by requiring companies to file Substantial Equivalent reports. These reports are a requirement and part of the Deeming Rule and though the FDA had pushed out the date, a ruling on the lawsuit filed by health groups moved the date for Substantial Equivalence filings up to May 12, 2020 [read more here].

CRA and PCA announced the filing of the petition to delay this filing date in a joint press release on March 24, 2020. The petition was sent to the Secretary of Health and Human Services and the FDA Commissioner, requesting that they enact a six month stay in the due date for the substantial equivalence reports that are due May 12, 2020. The trade organizations and manufacturers are calling for a delay in Substantial Equivalence due to the impact of COVID-19, which they will cause premium cigar manufacturers to be unable to meet the deadline imposed by the Maryland federal district court. The press release points out that Secretary Alex Azar has the authority to stay any regulatory report in the public interest and Dr. Stephen Hahn, commissioner of the FDA, has independent authority to do the same for any report required to be filed during a “public health emergency” or “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,” the trade organizations state in the press release.

Should the request to delay the Substantial Equivalence go ignored, the CRA and PCA announced that they would be amending their complaint in the federal district court for the District of Columbia at the end of the week. This would involve a request to Judge Amit Mehta that he grant relief to the premium cigar industry from the burdens imposed by the Substantial Equivalence deadline and the unexpected challenges brought on by COVID-19.

You can view the Petition for Stay of Action here. The Exhibits to Petition can be viewed here.