Last week, the U.S. Food & Drug Administration (FDA) opened a comment period seeking input on whether it should reevaluate its regulations on premium cigars. While that might be good news for the cigar industry, it might be great news for the cigar industry’s lawsuit against FDA.
In a court filing last week, attorneys for three cigar trade groups argued that FDA’s decision to issue Advanced Notice of Proposed Rulemaking (ANPRM) on reopening the idea of whether the agency should regulate premium cigars proves one of their fundamental arguments: FDA has planned on reevaluating cigar regulations and as such, certain requirements like warning labels should be delayed until after that reevaluation is completed.
If not, it means that regulations could go into effect only to be reversed later. With warning labels, that could mean the government’s indecision ends up costing the cigar industry millions of dollars.
As is pointed out in the brief, the judge overseeing the case—U.S. District Court Judge Amit P. Mehta—seems to agree that’s an issue. In a hearing last December, Mehta was skeptical of FDA’s position that it was planning on reevaluating the rule:
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.
Attorneys for the three cigar trade groups—Cigar Association of America, Cigar Rights of America and International Premium Cigar and Pipe Retailers Association (IPCPR)—are petitioning the court for a motion of partial summary judgment to delay the warning label requirements, which are currently scheduled to go into effect on Aug. 10, 2018, until after FDA finishes its reevaluation.
The ANPRM asks a number of questions, including what the definition of a premium cigar is as well as whether premium cigars have different health impacts from non-premium cigars and whether premium cigars have different use patterns from non-premium cigars.
It’s been a busy two weeks for the deeming regulations. In addition to the premium cigar ANPRM, FDA issued to other tobacco-related ANPRMs seeking input on whether it should establish a maximum level of nicotine for cigarettes and whether it should ban flavored tobacco.
In lawsuit news, attorneys for FDA asked the D.C. court to consolidate a separate lawsuit filed by a cigar retailer, manufacturer and trade group in Texas to the D.C. court for the aforementioned lawsuit. Separately, seven health groups and five pediatricians filed a lawsuit in Maryland pressuring FDA to not delay tobacco regulations anymore.