Earlier this morning, attorneys for three cigar trade groups and the Department of Justice delivered oral arguments to a federal judge in Washington, D.C. over the agency’s regulations for premium cigars.

Michael Edney, who represents the plaintiffs—Cigar Association of America (CAA), Cigar Rights of America (CRA) and Premium Cigar Association (PCA)—spoke for the majority of the two-hour hearing, answering questions from a joke-telling Judge Amit P. Mehta, the U.S. District Court Judge who has overseen the six years of litigation in Cigar Association of America et al. v. United States Food and Drug Administration et al. 

At one point, Edney quipped about a decision in the case last year by the U.S. Court of Appeals for the District of Columbia saying that while he lost that decision, he didn’t lose all of the cases he argued in front of the appeals court. A quick-witted Judge Mehta responded, “happens to the best of us,” inevitably referencing cases when the appeals court overruled his decisions, something that happened in this case in 2020.

While there were jokes—mainly related to how long this case has gone on and how well the parties have gotten to know one another and their lines of thinking—there was actual business before the court, specifically, a motion for summary judgement and permanent injunctive relief, filed in February 2021. That motion—which you can read more about here—focused on four basic arguments:

  1. Whether FDA properly concluded that the use of premium cigars poses a health risk that warrants regulation.
  2. Whether FDA has evidence that underage users smoke premium cigars.
  3. Whether FDA improperly moved the goal posts regarding the health risks questions.
  4. Whether FDA performed a proper cost benefit analysis regarding the financial impacts of the regulations.

In the most simple of terms, the cigar industry is asking the court to prevent FDA from enforcing the 2016 deeming regulations for “premium cigars.” It should be noted, many parts of the deeming regulation have been invalidated by various court rulings including warning labels and packaging change restrictions and substantial equivalence—the main part of the product approval process—is not currently enforceable for “premium cigars” due to a separate court order from Mehta.

The topic that received the most attention from both Edney and Garrett Coyle, the Department of Justice attorney representing FDA, was in regards to how FDA responded to comments submitted about how people smoke premium cigars and the effectiveness of regulations because of how these products are used.

In 2014, FDA outlined its plan of future tobacco regulation, including its first set of regulations for cigars. At the time, FDA not only talked about what it was planning to do, but—because it is required by law—gave the public and industry the opportunity to comment and ask questions about those plans. It also took the peculiar step of asking whether it should consider regulating some cigars—premium cigars—differently than other cigars. That led to two potential pathways: Option 1, where the agency would regulate all cigars the same; Option 2, where the agency would consider regulating premium cigars differently. Ultimately, it chose Option 1 in May 2016.

When the final rule was published, the agency responded to some of these comments. The plaintiffs argue that while FDA asked for comments and data about usage patterns for premium cigars would warrant a different way to regulate premium cigars, whether the different regulations for premium cigars could address the claimed health risks associated and questions over youth usage of premium cigars.

Edney repeatedly cited two different pieces of evidence, both studies produced by government agencies: Monograph 9, a 1998 report from the National Cancer Institute which studied the health effects of certain types of cigar smoking; and a 2014 article published by Catherine Corey of the Centers for Disease Control that studied cigar usage patterns. Monograph 9 indicates that there is very little detectable increase in mortality rates for people that smoke 1-2 large cigars per day that do not inhale. The Corey study indicates that just 3.3 percent of people who smoke premium cigars say that smoke them every day. Combined, Edney argues that premium cigars posed very little health risk and that regulating them would provide very little public health good.

Within this debate was some nuance regarding inhalation and types of cigar. Much of the data that FDA references about the harms of cigar smoking does not differentiate between types of cigars, let alone evidence that is specific to “premium cigars.” Because this lawsuit only deals with “premium cigars” it oftentimes creates debate over how relevant the evidence is. Furthermore, part of FDA’s argument is that all tobacco smoke is harmful and that even if cigar smokers say they don’t inhale, there’s no way to guarantee that no premium cigar isn’t inhaled.

But the real issue was that FDA responded to those comments by saying, “there were no data provided to support the premise that there are different patterns of use of premium cigars and that these patterns result in lower health risks.”

The problem according to Edney is that the “patterns of use” only addresses how the smoke was being consumed, i.e. the debate about inhalation, and not the fact that most people who smoke premium cigars do not do it very often.

This line of questioning led to one of the unresolved questions of today’s hearing: is there a necessary amount of people who might be positively affected by the rule?

Neither Edney nor Coyle gave a specific number. Edney’s position is that FDA needed to, at the very least, accurately determine how many people might be impacted by the rule before enacting it. All three people who spoke during the hearing—Coyle, Edney and Mehta—acknowledged that Monograph 9 did show a difference in all-cause mortality between premium cigar smokers and non-smokers, but that the differences were very minimal. At one point, Coyle conceded that the number was not statistically significant, but did not propose a standard about how much more dangerous it needed to be to justify action. He also argued that the Administrative Procedures Act (APA)—a federal law that regulates executive agencies like FDA—does not require FDA to answer every question. Mehta suggested that if the agency wasn’t going to respond to comments like this—one submitted by CRA, an industry trade group—than what comments would warrant a response.

At one point, Mehta pushed the argument even further, asking Coyle if no amount of smoking is safe, then why did FDA ask between Option 1 and Option 2 in 2014. For his part, Coyle replied that it was his thinking that FDA wanted to see if there was better evidence and not to debate whether smoking was good or bad.

A surprising amount of time was dealt with the question of youth access to premium cigars. Coyle argued that if the court ruled in the cigar industry’s favor, it would mean that all of the deeming regulations requirements, which included a new at the time federal law that created a minimum age of 18-years-old to purchase tobacco products. While that is true, this case would not affect whether 18-year-olds could purchase premium cigars. As was pointed out later during the hearing, in December 2019, President Donald Trump signed a bill that introduced a new federal law requiring the minimum age to purchase tobacco products to be 21-years-old.

This led to another discussion about numerical thresholds for regulation and their potential impacts. Edney argued that FDA mischaracterized the prevalence of youth smoking premium cigars, which he said was .114 percent and not 3.8 percent. Edney’s point regarding youth access seemed to be that FDA couldn’t prove why this rule would change the behavior of the limited number of people that fall into the .114 percent of underage Americans who say the smoke premium cigars.

Throughout these lines of questioning, Mehta showed a keen understanding of the nuances and facts regarding this case, a clear sign that he is well-versed on the topic. At the end of the hearing, he joked how it was great to start a Monday morning off with arguments about an APA case, an interesting comment from a judge who is most often in the news for hearing cases over alleged crimes committed during the storming of the Capitol on Jan. 6, 2021.

There was some discussion about the potential conclusion Mehta might reach, specifically, if the court were to rule in the cigar industry’s favor. Edney argued that the D.C. Circuit decided a case that was similar to this one: County of Los Angeles, et al. v. Shalala. That case revolved around whether Department of Health and Human Services (HHS) properly calculated the payments that hospitals should be paid for Medicare. More specifically, it dealt with questions about why HHS chose to use an older set of data instead of a newer set data to formulate these payments. Edney’s position is that the decision in that case was that HHS should have looked at the newer set of data but didn’t and therefore erred in how it determined the payments made to the hospitals. The U.S. Court of Appeals for the District of Columbia ultimately found that HHS failed to provide a reasonable explanation about why it used the older data and instructed the agency to redo its payment structure taking into account the new data.

Edney did not argue that FDA should be told to look at the evidence again, instead, concluding that the precedent established in County of Los Angeles, et al. v. Shalala indicates the deeming rule should be vacated in regards to premium cigar. If Edney’s request is granted, this would mean that the deeming regulations—everything laid out in the 499-page document from 2016 and the updates since then—would not apply to whatever the court defines a “premium cigar.” That said, it would not mean that FDA could never regulate “premium cigars,” rather, FDA would have to start the process over again from scratch—announcing proposed regulations, a comment period, etc.—to enact the regulation for premium cigars.

To this point, Mehta seemed aware of the uniqueness of this case, even apologizing for how long this particular hearing came to fruition. Perhaps that is why he pushed Edney repeatedly to answer if there were any ongoing regulations from the proverbial “phone book of regulations” that Edney likes to mention so often that premium cigar makers face in the status quo that could prove to be a harm. While Edney provided examples of regulations, Mehta seemed to dismiss those as adequately answering the questions because most of them were one-time costs, some of which are likely to have already been incurred.

There is a scenario where Mehta could rule in the industry’s favor but not fully vacating the rule on this particular matter, though those options were not discussed today.

Illuminating just how large and drawn out this case has gotten, Mehta asked Coyle what FDA’s current thinking was in light of the recently-published NASEM report on premium cigar marketing and usage, something that came about due to an August 2021 ruling made by Mehta on a different part of this case. For his part, Coyle said he was unaware of FDA’s current thinking on the NASEM report.

As to when that conclusion could come, it won’t be for some months and likely not until the end of this year. Even then, whichever side loses will almost certainly appeal and if FDA were to win this particular matter, it would not be the end of everything in front of Mehta in this case.

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Charlie Minato

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I have written about the cigar industry for more than a decade, covering everything from product launches to regulation to M&A. In addition, I handle a lot of the behind-the-scenes stuff here at halfwheel. I enjoy playing tennis, watching boxing, falling asleep to the Le Mans 24, wearing sweatshirts year-round and eating gyros. echte liebe.