Premium Cigar Association Expresses Concern for FDA Proposed Rule on Tobacco Product Establishment Registration and Product Listing
The Premium Cigar Association (PCA) acknowledges the release of the U.S. Food and Drug Administration’s (FDA) proposed rule titled Establishment Registration and Product Listing for Tobacco Products and will provide comment on behalf of its membership before the September 14, 2026, deadline.
As a result of the premium cigar industry’s successful litigation against the FDA’s Deeming Rule, this proposed regulation will not apply to establishments that manufacture only “premium cigars,” as defined by the court. The PCA and allied organizations fought and won on behalf of premium cigars, retailers, manufacturers, and consumers. That victory matters, and this new proposed regulation would hit every single premium cigar manufacturer if not for that important litigation, which provided clarity: that premium cigars are a distinct product category and should not be swept into regulatory schemes that were never designed for them.
While premium cigar manufacturers are protected by the court’s ruling, many products sold by the PCA’s 3,500 retail members may still be adversely impacted by this proposed regulation. Foreign pipe tobacco, pipe manufacturers, and cigar manufacturers of products not meeting the 8-part “premium cigar” definition would be subject to new registration, listing, recordkeeping, and foreign factory inspection requirements if the rule is finalized. These businesses must also be protected from costly and unnecessary regulatory burdens. Furthermore, mixed-use factories that produce both premium and non-premium cigars would be subject to this new regulation. This shifts the regulatory target from product type to producer.
In 2023, the PCA objected to the proposed rule on Requirements for Tobacco Products Manufacturing Practices. The Establishment Registration and Product Listing for Tobacco Products proposed rule contains provisions that, like the 2023 proposed rule, would have burdensome impacts on small businesses, and the PCA has similar concerns with this rule.
“Our stance on this proposed rule is consistent with all of our previous filings that pushed back against overregulation of the makers and sellers of premium tobacco products. Registration and inspection are usually the opening salvo of more regulations to come. When Big Tobacco and Anti-Tobacco Groups alike are celebrating an FDA proposed rule, you know there is a big problem for the overall marketplace,” says Joshua Habursky, Chief Executive Officer, Premium Cigar Association.
The PCA will oppose any regulation (or provisions thereof) that increases costs on the products our members sell, especially when those costs are passed directly to retailers and their consumer customers. The vast majority of PCA member stores sell products that would be affected by this proposal. Higher compliance costs for manufacturers do not stay with manufacturers. They move through the supply chain, raise prices at retail, reduce consumer choice, and make it harder for small businesses to compete.
PCA intends to fight against every unnecessary regulation affecting products sold by our membership and will weigh in on this regulation expressing our concern with specific provisions.ons.