FDA, CRA/PCA Respond to CAA’s “Premium Cigar” Definition

After a few delays, various parties on both sides of the lawsuit over the FDA’s regulation of “premium cigars” responded to the latest saga in the nine-year-old litigation.

What is a premium cigar?

These responses are part of Cigar Association of America et al. v. United States Food and Drug Administration et al., a federal lawsuit that was filed in July 2016 by the Cigar Association of America (CAA), Cigar Rights of America (CRA) and Premium Cigar Association (PCA). After victories in 2022 and 2023 that found that the U.S. Food & Drug Administration (FDA) failed to follow the required rules when crafting its rules for regulating cigars, the debate has turned into what qualifies as a “premium cigar.”

In January, the U.S. Court of Appeals for the District of Columbia ruled 3-0 in favor of the cigar trade groups, but it added a twist. While it dismissed most of the FDA’s arguments as part of the appeal, the D.C. Circuit opted to send the case back to Judge Amit P. Mehta to have him determine the definition of a “premium cigar.”

That definition is crucial because cigars that meet the definition are not subject to the FDA’s regulations, which include product approval and testing requirements, bans on free samples and the payment of user fees.

The Working Definition

Since August 2020, the FDA has used a working definition of “premium cigar,” one that was introduced as a temporary solution that would allow the FDA to further study what a “premium cigar” is as part of this litigation. Since then, cigars that meet the definition have been largely exempt from FDA regulation as the court battle has played out. However, because the cigar industry won the court case, the working definition will be less temporary.

The working definition says that a cigar is considered a “premium cigar” if it meets all of the following conditions:

1. is wrapped in whole tobacco leaf;
2. contains a 100 percent leaf tobacco binder;
3. contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar);
4. is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling);
5. has no filter, nontobacco tip, or nontobacco mouthpiece;
6. does not have a characterizing flavor other than tobacco;
7. contains only tobacco, water, and vegetable gum with no other ingredients or additives;
8. and weighs more than 6 pounds per 1,000 units.

The D.C. Circuit found that because this definition was created by the FDA in a bizarre way and without much debate or scrutiny, the parties and Mehta should evaluate it more thoroughly.

It’s likely that amongst the three plaintiffs, the FDA and Mehta himself, only the CAA was interested in this.

Michael Edney—who represents the CRA and the PCA—tried to avoid this debate altogether. In March, he asked the D.C. Circuit to overturn its previous ruling because both of his clients and, apparently, the FDA itself were in favor of keeping the aforementioned working definition. The court rejected the request.

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The definition debate between the two sides is not about the unflavored handmade cigars. Assuming Mehta chooses between the two definitions, those cigars will be exempted from FDA regulation.

The debate is over whether more cigars should be exempted: flavored handmade cigars, cigars that are made mostly be machines, etc.

The CAA Definition

In June, the CAA presented its alternative definition of “premium cigar” to the court. A “premium cigar” is one that:

1. is wrapped in whole tobacco leaf;
2. contains a 100 percent leaf tobacco binder;
3. made by manually combining the wrapper, filler, and binder;
4. has no filter, tip, or non-tobacco mouthpiece and is capped by hand; and
5. weighs more than 6 pounds per 1,000 units.

To no one’s surprise, the CAA’s definition is far less restrictive. Most importantly, it would allow for flavored cigars to meet the definition of “premium.” In addition, it would remove the requirement that the cigar must be rolled by hand—instead, just capped by hand—and would no longer require the cigars to use at least 50 percent longfiller.

All of this makes sense. The CAA represents a wide range of cigar-related businesses from “premium cigar” companies like Perdomo, which doesn’t produce flavored cigars, to retailers like Cigars International and Famous Smoke Shop. However, the CAA’s members also include the companies that make and sell machine-made cigars like ITG and Swisher.

The CAA’s arguments can be categorized into two genres:

1. There Are (Potential) Holes in the Working Definition — The CAA claims that the working definition is, in parts, ambiguous, which might lead to the FDA regulating cigars that should be considered “premium” because they use vegetable gum or a company markets the cigar as having notes of “chocolate, leather and black pepper”
2. There’s No Difference in Consumption of the Products that the CAA’s Definition Might Allow — Data from an FDA-sponsored study shows that the consumption patterns of “premium cigars” and unflavored premium cigars are not any different

The FDA’s Response

As it turns out, the FDA would like to keep the current definition. Or perhaps more accurately, if forced to choose between the working definition and the CAA’s proposal, it would prefer the first one.

The FDA’s response is even more predictable than the CAA’s proposal.

1. Changing the Definition Now Would Cause Significant Problems — These range from user fee refunds—which would now need to be extended to significantly more products—to allowing products that were previously rejected a pathway onto the market. The second point is important because the FDA uses previous approval/denial decisions to guide future applications.
2. The FDA Has Public Health Concerns — This ranges from health/safety to youth usage concerns. Michele Mital, deputy director of the FDA’s Center for Tobacco Products, gave a declaration to the court that argued that adopting the CAA definition would short-circuit the FDA’s normal rulemaking process to allow for some flavored cigars to become essentially unregulated. This is especially controversial given that less than 18 months ago, the agency was preparing to ban the sale of all flavored cigars, though the Trump administration has halted that.
3. The CAA’s Position is Incompatible With Nearly a Decade of Court Proceedings — Attorneys for the agency argue that the CAA’s position is incompatible with the narrative about why “premium cigars” deserve the special status: that they are physically different from the more popular mass-market cigars, that they are consumed differently, and that the FDA failed to consider these differences when crafting the regulations.

It’s also clear that if CTP had its way, adopting the CAA definition would accelerate how quickly the FDA would do the “premium cigar” rulemaking, the process that would allow the agency to revise this definition, or more likely, regulate all cigars—premium or not—the same.

However, that is totally not how things will work. CTP is under the direction of the FDA, itself under the direction of the White House. And at least for the next 3 1/2 years, it seems very unlikely that would happen.

The CRA/PCA Response

Edney’s response on behalf of the other two trade groups is more aggressive than that of the government, though there’s significant overlap between the two briefs and Edney, at times, even argues the government’s position is the correct one, a position he has rarely taken in his roughly eight years on this case.

He argues that the CAA is advocating for its definition by the “fallacy of arguing by anecdote.” In short, he finds that the CAA’s arguments about the potential of the FDA regulating a “premium cigar” due to its use of vegetable glue as forgetting to shut the door. Rather than proposing to close the door, say modifying the definition to explicitly allow for vegetable glue, he thinks the CAA is wanting to take the door off the frame by allowing for chemicals to be added to cigars.

Edney points out that the vegetable glue and tasting note debates have been disproven by reality.

There are no reports of the FDA finding that a cigar does not meet the working definition due to vegetable glue or because it has notes of grapefruit and leather. It’s possible that some have, though presumably all three trade groups would have pointed that out to the court. Furthermore, it’s possible that once this litigation is over that the FDA gets more aggressive with disqualifying cigars that manufacturers argue are “premium cigars,” something that would likely produce more litigation.

Except for the amount of attention paid to Swisher, Edney’s arguments are mostly predictable. On one hand, it makes sense. Swisher, the privately held company behind Swisher Sweets and Drew Estate, is the largest producer of cigars in the world, mostly due to the billions of mass-market cigars it sells, most of which are flavored. But a lot of Edney’s response not only mentions Swisher by name but also includes images and even a video of the company’s products.

The core of his argument comes down to three points:

1. The CAA Missed Its Window to Debate About the Definition — While the CAA pointed out in footnotes and other briefs that it had issues with the definition, it had not made this type of argument before. It’s unclear when the group was supposed to make the argument that it had issues with the definition, though the CAA’s position that flavored cigars should get the same treatment as non-flavored handmade cigars is hardly new. Furthermore, the D.C. Circuit explicitly brought the definition debate back to the court. This is just the latest chapter in what has been the source of much consternation between the plaintiffs before they became co-plaintiffs in this case and it has led to intense arguments about how the millions of dollars in Edney’s fees should be paid.
2. More of the Same About Opening the Door — Edney reiterates and also adds some different arguments to the FDA’s position about expanding the definition. He argues that the CAA’s arguments about consumption patterns were incomplete because the study only examined one flavored cigar, ACID—a Drew Estate brand—and not the large swaths of cigars that might be able to meet the CAA’s proposed definition.
3. And Specific Examples of How More Cigars Could Meet CAA’s Definition With Minimal Modification — The aforementioned video to the court is meant to show how the manufacturing process of a mass-market cigar could easily be modified to meet the CAA’s definition. Furthermore, Edney’s brief—along with a supplement from the future coo of Oliva Cigar Co.—goes into detail about what they believe the minimal costs that would be required to change mass-market products to meet the definition by adding a few seconds of human labor. By contrast, they argue that the types of products that would meet the working definition are made in low volume by two workers—they suggest two workers can make about 200 cigars per day, which is common at factories though some will make more than double that—and that wrappers can cost $70 per pound, an outlandish number.

As for the next step, the CAA is set to respond to these briefs by Sept. 13, though many previous deadlines have been delayed.

Update — An earlier version of this article stated the Casa Carrillo was a member of the CAA. It is not.