Top Takeaways:

• Court Ruling Vacates FDA’s Deeming Rule for Premium Cigars: A federal appeals court upheld a decision to vacate the FDA’s regulation of premium cigars, citing the agency’s failure to consider relevant health data.
• Definition of “Premium Cigar” Under Review: The court remanded the case to the district court to establish a clear definition of “premium cigar,” which will determine the scope of FDA’s regulatory authority.
• Industry Disagreement on Definition: The Cigar Association of America (CAA) has proposed a broader definition that includes flavored cigars, while the Cigar Rights of America (CRA) and Premium Cigar Association (PCA) advocate for a more restrictive definition.

The ongoing legal battle over the U.S. Food and Drug Administration’s regulation of premium cigars has intensified as responses from the regulatory agency, Cigar Rights of America (CRA) and Premium Cigar Association (PCA) to the Cigar Association of America’s (CAA) proposed definition of “premium cigar” are presented to the court.

In June 2025, the CAA presented an alternative definition of a “premium cigar” to the court, which would expand the criteria to include flavored cigars and allow for machine-made products. Under the CAA’s definition, cigars would need to be wrapped in whole tobacco leaf, contain a 100% leaf tobacco binder, and weigh more than 6 pounds per 1,000 units but would no longer need to be entirely hand-rolled.

This broader definition has garnered support from the CAA’s wide membership, which includes both traditional premium cigar manufacturers and companies that produce machine-made cigars.

In response, the FDA and the two other trade groups, CRA and PCA, have expressed opposition to the CAA’s proposal. The FDA, which has consistently argued for maintaining a more restrictive definition, warned that adopting the CAA’s changes would complicate the regulatory process and undermine public health efforts.

FDA officials have raised concerns that the CAA’s definition could pave the way for more flavored cigars to be marketed without regulation, despite the agency’s previous efforts to ban flavored products.

Legal representatives for the CRA and PCA echoed the FDA’s concerns, stressing that expanding the definition could disrupt the regulatory framework established by the court. Michael Edney, who represents both groups, stated that the CAA’s arguments about allowing flavored cigars are an attempt to “open the door” to products that do not align with the characteristics of traditional premium cigars.

He noted that the CRA and PCA’s position was in line with the earlier court decisions, which focused on maintaining strict definitions to preserve public health protections.

The dispute centers on the issue of whether flavored cigars, machine-made cigars, and other variants should qualify for exemption from FDA regulations, which include product approval, testing, and user fees. The current working definition, established by the FDA in 2020, has allowed cigars meeting specific conditions—such as being handmade, containing at least 50% long filler tobacco, and having no additives—to be exempt from regulation while the case plays out.

While the debate continues, the court has decided to remand the case to Judge Amit P. Mehta, who will now determine the final definition of “premium cigar.” This decision is critical for both the cigar industry and public health, as the chosen definition will ultimately dictate which products are subject to FDA oversight and which are exempt.

The cigar industry has long argued that premium cigars differ significantly from mass-market products, both in terms of production and consumption. Supporters of the CAA’s broader definition contend that it would better reflect these differences, while critics, including the FDA, argue that it could lead to a loophole that weakens regulatory oversight.

As the legal proceedings unfold, industry groups are preparing for additional legal challenges and lobbying efforts to shape the final definition. With the case expected to continue into the fall, the outcome will likely have far-reaching implications for both the regulatory landscape and the future of the premium cigar market.