In the latest round of the cigar industry’s lawsuit against the U.S. Food and Drug Administration (FDA), the three plaintiffs have motioned the court to throw out the current Warning Label requirements that are a part of the Deeming Regulations. The move comes a little over a week after the FDA issued an Advanced Noticed of Proposed Rule Making (ANPRM) that essentially re-evaluates the current industry rules regarding premium cigars.
The motion states, “The warnings requirement cannot be allowed to go into effect on August 10, 2018, while the agency reconsiders a decision with tremendous constitutional and financial stakes.”
The motion referenced the following dialogue that took place between Judge Amit Mehta (The Court) and the FDA’s attorney Eric Beckenhauer back when oral arguments were made in December. At the time, this was before the ANPRM was issued and the judge made his concerns known about implementing regulations that could potentially change.
THE COURT: So what then is the FDA studying? I mean, when it says it is studying patterns of use and resulting public-health impacts of premium cigars, what is it studying? What will it be studying?
MR. BECKENHAUER: So I think essentially it’s agreed that going forward, it will take another look at this issue. But it did, during the deeming rule, take a full look at this issue and —
THE COURT: So hold on. You mean to tell me that the FDA is now saying, we’ll take a harder look at the labeling issue with respect to premium cigars?
MR. BECKENHAUER: It’s not looking at labeling in and of itself. It’s agreed to look at two things: One, of course, is the use of flavors in tobacco products. And the second is patterns of use of premium cigars and potentially resulting health —
THE COURT: So isn’t that relevant to the warnings issue? Why is it — just say hypothetically — and let’s say hypothetically your study reveals the following, which is that premium cigars, 95 percent of consumers of premium cigars are adults. Furthermore, of that population, 90 percent of them, you know what, smoking has risks, I understand that, I got it. Warning labels aren’t going to make a whit of difference; I’m still going to buy cigars. Is the government’s interest the same in that circumstance for having warning labels on premium cigars?
MR. BECKENHAUER: Your Honor, I want to be careful not to get ahead of where the agency is on this —
THE COURT: But then you’re asking me to get ahead of it when the agency doesn’t have all the evidence, it sounds like.
MR. BECKENHAUER: No, Your Honor. I’m asking you to consider the evidence that was on the record at the time that the deeming rule was proposed and adopted.
THE COURT: But if the agency has now said, now communicated that we are going to reconsider the evidence or we’re going to take a harder look at the evidence — that’s what it said, right?
MR. BECKENHAUER: I think what the agency has said is we will open a rule-making for the submission of additional evidence on this point.
THE COURT: I guess the question is ultimately, if what the Supreme Court says is and the Circuit says that, look, the government essentially has to have all its ducks in a row first, right? In other words, it’s got to do its study and then it imposes the requirements. I just — I don’t understand — and I mean you’ve said earlier that they’re asking for a special carve-out, but isn’t the agency, at least at the present moment, leaving open the possibility of a carve-out by continuing to study the issue with respect to premium cigars?
MR. BECKENHAUER: Your Honor, it’s certainly — it’s opened up a rule-making to take more evidence on the issue. But the evidence currently before the agency, or at least before the agency at the time, was that there wasn’t sufficient evidence to conclude that premium cigars are special; that they present different health risks than other cigars.
THE COURT: So is it a possibility, in your mind, that the premium cigar industry is going to spend millions of dollars updating these boxes and putting labels on them, only to be told later on, didn’t have to do it?
MR. BECKENHAUER: Your Honor, again, I want to be cautious not to get ahead of the agency if the agency decides to take a different course. But what I would emphasize is —
THE COURT: I guess I just have a real problem, it seems to me, with a government agency telling an entire industry, spend millions of dollars to satisfy a regulation that we’re not sure is going to be on the books a year from now or two years from now.
While the Trade Associations wanted the Warning Labels thrown out back in December, the latest motion brings the ANPRM into the forefront of the lawsuit. Judge Mehta still has to make a decision from the oral arguments made in December on both Warning Labels and User Fees.