In January 2025, the U.S. Court of Appeals for the District of Columbia delivered a landmark decision that exempts premium cigars from FDA regulation, marking a significant victory for the Cigar Association of America (CAA) and the broader premium cigar industry in the U.S. To better understand the impact of this ruling, we spoke with Javier Estades, CEO of Tabacalera USA and Chairman of the Cigar Association of America. Here’s what we learned.

A Long-Awaited Victory

The legal battle against the Deeming Rule began in 2016, when the FDA extended its regulatory authority over all tobacco products, including premium cigars. Javier Estades shared the process of challenging the FDA’s regulation of premium cigars – a collaborative effort between the Cigar Rights of America, the Premium Cigar Association and the CAA.

Their efforts included legal briefings, coordinated advocacy, and direct engagement with lawmakers in Washington to emphasize the distinct nature of premium cigars. By uniting industry stakeholders and presenting strong evidence, they effectively positioned the case for success in the legal system. Estades, in his role at the CAA, is very proud to have led as the named plaintiff in this case and to have worked alongside other industry partners for this outcome.

After years of legal battles, the ultimate goal was achieved: the court ruled premium cigars exempt from FDA regulation and that the FDA had acted arbitrarily and capriciously by failing to consider compelling evidence that premium cigars pose different risks and are consumed differently than other combustible tobacco products.  However, even before this most recent significant decision, the litigation had resulted in other important victories for the premium cigar industry in the U.S., including:

Other Key Industry Wins

• Labeling requirements reduced. The 2016 rule mandated large health warnings on cigar packaging and advertising, which no longer apply.
• Expensive standalone HPHC testing delayed.  Testing for Harmful and Potentially Harmful Constituents for all cigars delayed to an undetermined date.
• Premium cigars exempted from costly premarket approval requirements, eliminating time-consuming product testing and compliance measures.
• Financial relief: The ruling removes premium cigars from future FDA user fees, estimated to total approximately $20 million annually for the premium cigar industry in the U.S..

What Defines a Premium Cigar

What truly makes a cigar premium? According to industry leaders like Tabacalera USA, premium cigars are distinguished by their craftsmanship. They are handmade using whole tobacco leaves, without filters or tips, and are larger and typically used occasionally. Unlike mass-produced cigars, these are carefully rolled, following traditional methods that have been passed down for generations.

This definition carries significant weight for the premium cigar industry in the U.S. following the recent court ruling. The exemption from FDA regulation means that a clear legal classification of premium cigars is more important than ever. As discussions continue, manufacturers and industry advocates stress that recognizing premium cigars as a distinct category will help preserve the heritage and economic impact of the sector, particularly for local businesses and skilled artisans.

Moving Forward with Cautious Optimism

Although this ruling marks a significant victory, the legal battle is not entirely over. The industry must stay vigilant as the case will return to the district court, where the precise definition of a “premium cigar” will be determined. Furthermore, the FDA has 45 days (until March 10) to ask the DC Court of Appeals to reconsider the decision or escalate the case to the U.S. Supreme Court. Should additional legal proceedings ensue, the final resolution could be delayed until late 2026.

“We have adjusted our ways of working since 2016, and while this decision brings relief, we must stay prepared for potential regulatory shifts,” Estades cautioned. “There will be a transition period, and we must see how the district court defines premium cigars moving forward.”

The industry embraces this achievement with optimism, acknowledging that regulatory challenges may still emerge. As it progresses, this decision underscores the significance of evidence-based regulation and safeguards the distinct status of the premium cigar industry in the U.S. in the market.