July 2023

The Premium Cigar Association (PCA) has filed a formal request for a meeting with the Ombudsman of the U.S. Food and Drug Administration’s (FDA’s) Center for Tobacco Products to discuss PCA’s significant concerns related to FDA’s March 10, 2023, Proposed Rule seeking to establish so-called tobacco product manufacturing practice (TPMP) requirements. The request references the July 2022 order by the United States District Court for the District of Columbia. It found that the FDA acted arbitrarily and capriciously in its 2016 action asserting regulatory authority over premium cigars. Yet, with the final remedy for that order still pending, the FDA has ploughed forward with multiple rules, including the TPMP proposal, that would potentially impact the premium cigar market. Notably, the TPMP proposal does not acknowledge the court’s order or the pending remedy ruling.

The final remedy ruling will address the practical consequences of the FDA’s violations of the Administrative Procedure Act. As PCA has advocated, it may vacate the FDA’s 2016 “Deeming Rule” applied to premium cigars. However, at minimum, it will require the FDA to consider the scientific evidence on premium cigar use in the administrative record that the court found the agency previously ignored.

“FDA is writing as many regulations as quickly as possible, knowing that the agency lost this court case,” said Joshua Habursky, PCA’s Head of Government Affairs. “These rules should not apply to premium cigars, and the FDA needs to acknowledge that explicitly given the backdrop of court victories by cigar trade groups.”

FDA’s regulatory agenda includes, for example, a final rule to establish a tobacco product standard for characterizing flavours in cigars that would chill speech used in the marketing of premium cigars; the above-mentioned proposed rule on TPMP requirements that seek to turn cigar factories into laboratory environments; and a yet to be released proposed rule seeking to establish “a maximum nicotine level in cigarettes and certain other [unidentified] finished tobacco products.”

“It’s a slap in the face of the judicial system. Hopefully, the Ombudsman will remind the political players at the FDA that their agenda is still subject to the law,” said Scott Pearce, PCA’s Executive Director.

The Office of the Ombudsman within FDA’s Center for Tobacco Products is a neutral resource that provides an independent review of complaints by regulated entities and other stakeholders, specifically for situations where there is no process for redress.

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