The Line Holds: Premium Cigars and FDA After the Remand

When FDA's deeming rule took effect in 2016, it brought every cigar, from a gas-station cigarillo to a hand-rolled Dominican corona, under the same federal tobacco regime. The industry sued that summer. A decade later, the result is a clear line between premium cigars and everything else. It is the most important change in the federal regulation of cigars since the deeming rule itself, and it deserves a careful reading.

How we got here

The Cigar Association of America and its co-plaintiffs filed suit in the District of Columbia in July 2016. In July 2022, Judge Amit Mehta held that FDA had acted arbitrarily and capriciously when it applied the deeming rule to premium cigars, because the agency had not adequately grappled with the record on how premium cigars are actually used. On August 9, 2023, he chose the remedy: the deeming rule was vacated as applied to premium cigars. If FDA wants to regulate them, it has to start over with a new rulemaking.

FDA appealed. On January 24, 2025, the D.C. Circuit affirmed the vacatur but sent one issue back: the definition of a premium cigar. After rehearing was granted in part, the court reissued its opinion in March 2025, affirming in part, reversing in part and remanding. The opinion treats the vacatur as prospective, a point that matters for the money discussed below.

The eight elements

On April 15, 2026, Judge Mehta resolved the remand. He kept the definition FDA had been using since 2020, which the agency itself supported. To be a premium cigar, a product must meet every one of these elements:

• It is wrapped in whole tobacco leaf.
• It has a binder made of 100% leaf tobacco.
• At least 50% of the filler, by weight, is long filler tobacco.
• It is handmade or hand rolled.
• It has no filter, nontobacco tip or nontobacco mouthpiece.
• It has no characterizing flavor other than tobacco.
• It contains only tobacco, water and vegetable gum.
• It weighs more than 6 pounds per 1,000 units.

A cigar that misses any one element is not a premium cigar for this purpose, however expensive or well made it is.

What the court declined to do

The Cigar Association of America asked for more, while its co-plaintiffs Cigar Rights of America and the Premium Cigar Association supported the existing definition. CAA's alternative would have reached flavored premium cigars and some made with machine assistance. The court said no, reasoning that any refinement of the definition should come through rulemaking rather than a judge's pen.

That is a significant result for the flavored segment and for factories that use machines for bunching or other steps. Those products remain fully deemed. They still need marketing authorization through substantial equivalence or a premarket application, still pay user fees and still sit within the registration and listing rules.

No notice of appeal of the April decision has been reported.

The money question

Premium manufacturers and importers paid FDA user fees for years under a rule that has now been vacated as to their products. Whether they get that money back is a separate fight.

FDA's position is stated in its own letters. For fiscal year 2026, the agency says it does not intend to assess user fees on premium cigars for the fiscal year and does not intend to refund payments for quarters before the August 2023 order. Its invoices are still calculated on total cigar volume, because the excise tax data FDA relies on does not separate premium from non-premium cigars. FDA has said companies may dispute an invoice within 45 days and may withhold the premium portion if they document it, and that it will use enforcement discretion on penalties for properly documented withholding.

Nine of the best-known premium manufacturers are testing the refund question in the Court of Federal Claims, in a suit reported in early July 2026 that seeks more than $10 million plus interest. How that court reads the D.C. Circuit's opinion will decide whether years of payments come back.

Why "court order, not statute" matters

The exemption is real, but it is a product of administrative law. FDA can open a new rulemaking aimed at premium cigars, with a fuller record, and try again. Nothing in the court's decisions forbids that.

Congress could settle the question permanently. S. 3922, introduced on February 25, 2026 by Senators Moody and Scott of Florida, would exempt "traditional large and premium cigars" by statute, using a definition broader than the court's, and would exclude them from user fees. It was referred to the Senate HELP Committee, and no further action has been reported.

Until one of those things happens, the burden of proof sits with the manufacturer. If FDA ever questions whether a product qualifies, the answer will come from records, not reputation.

What a manufacturer should keep on file

For each premium line, I would want a file that proves every element without anyone having to visit the factory:

• Wrapper and binder specifications showing whole-leaf wrapper and 100% leaf binder.
• Blend records that show long filler of at least 50% by weight, with the method used to measure it.
• A description of how the cigar is rolled, including any step where a machine is involved.
• An ingredient statement confirming tobacco, water and vegetable gum only, and no flavoring.
• Weight data supporting more than 6 pounds per 1,000 units for every vitola.
• Confirmation that no tip, filter or mouthpiece is used.

Factories that make both premium and non-premium lines have a second task. FDA proposed a registration and listing rule on June 29, 2026 that would extend those obligations to foreign establishments and require electronic submissions. Comments closed September 14, 2026, and FDA redesigned Form 3741 at the end of September. Premium products that meet the definition fall outside these obligations, but a Dominican or Nicaraguan factory that also produces machine-made or flavored cigars for the U.S. market should expect to be inside them.

What I am watching

Three things will decide whether this settlement lasts. The first is the Court of Federal Claims and its reading of the prospective vacatur. The second is any sign of a new FDA rulemaking on premium cigars, which would most likely appear first in the Unified Agenda. The third is S. 3922, which would turn a hard-won court victory into settled law.

For now, the line holds. The companies that benefit most will be the ones that can show, product by product, that they are on the right side of it.