By Timothy S. Donahue

Top Takeaways:

• The Cigar Association of America (CAA) has proposed a new, broader definition of “premium cigars” that would allow some flavored products to qualify—departing from FDA’s existing working standard.
• The U.S. District Court must now define what qualifies as a “premium cigar” after a higher court remanded part of a nearly decade-long lawsuit challenging the FDA’s regulation of cigars.
• A split has emerged between the CAA and its co-plaintiffs, the Premium Cigar Association (PCA) and Cigar Rights of America (CRA), over whether flavored cigars should be included in the exempted category.

Nearly nine years into a high-profile lawsuit challenging the U.S. Food and Drug Administration’s oversight of cigars, the case has reached a pivotal stage: defining what exactly constitutes a “premium cigar.”

Last week, the Cigar Association of America (CAA), one of three trade groups that brought the original lawsuit in 2016, filed a new brief asking a federal court to adopt a revised, more inclusive definition that would allow certain flavored cigars to be considered “premium.”

This marks a departure from the FDA’s longstanding, though unofficial, criteria and has exposed a rift between the CAA and its co-plaintiffs, the Premium Cigar Association (PCA) and Cigar Rights of America (CRA).

The case, Cigar Association of America et al. v. U.S. Food and Drug Administration, was remanded earlier this year by the U.S. Court of Appeals for the D.C. Circuit.

While the appeals court largely upheld previous rulings that the FDA acted improperly in crafting its rules, it sent the case back to U.S. District Judge Amit P. Mehta to establish a final legal definition for “premium cigar”—a category exempt from many FDA requirements, including premarket review and user fees.

Competing Definitions

The FDA’s current working definition—which Judge Mehta has used since 2020—includes eight criteria. These include that the cigar be wrapped in whole tobacco leaf, hand-rolled, contain at least 50% long-filler tobacco, weigh more than six pounds per 1,000 units, and notably, have no characterizing flavor other than tobacco.

In contrast, the CAA’s newly proposed five-point standard would drop the flavor restriction entirely, thereby opening the door for products like ACID, Deadwood, JAVA, and Tatiana to be classified as premium cigars. It also proposes changing the requirement that cigars be “handmade” to “made manually,” which could include cigars rolled with the assistance of vintage hand-operated machines.

“The government has never clearly defined what a ‘characterizing flavor’ actually is,” the CAA argued in its filing. The group added that many so-called premium cigars are marketed with flavor notes such as cream or chocolate, whether or not any additives are used.

The filing cites data from NERA Economic Consulting and Consilium Sciences to support the claim that youth usage of flavored premium cigars is virtually nonexistent, regardless of flavor.

Industry Divide

The PCA and CRA, however, have attempted to avoid the flavor debate altogether, preferring to stick with the FDA’s more restrictive framework in hopes of maintaining broad judicial and political support for regulatory relief.

Earlier this year, the two groups—along with the FDA—requested that the court accept the working definition as final. The CAA objected, and the appeals court ultimately sided with continuing the process before Judge Mehta.

Although the three trade groups initially filed the lawsuit together, tensions over the inclusion of flavored cigars predate the legal action. The CAA’s membership includes companies such as Swisher and Drew Estate, which produce a range of flavored cigars, while the CRA and PCA generally represent manufacturers and retailers of traditional, unflavored handmade cigars.

What’s at Stake

Premium cigars that fall within the final definition could remain exempt from a host of FDA rules, including warning label requirements, flavor bans, and costly premarket tobacco product applications (PMTAs). A broader definition could benefit a wider group of manufacturers but may reignite public health criticism over flavored tobacco products.

Federal regulators and the two co-plaintiff groups must respond to the CAA’s proposal by July 7. Judge Mehta is expected to issue a final ruling after reviewing all arguments.

In parallel, congressional efforts continue to advance legislation that would exempt premium cigars from FDA oversight entirely. The outcome of the current court proceedings may either strengthen or undercut those legislative moves.

For now, the future of premium cigar regulation—and whether flavored versions will qualify—hangs in the balance.