Cigar Association of America Begins Appeal of FDA Substantial Equivalence Ruling

As expected, the Cigar Association of America (CAA) has formally begun the appeals process over last week’s ruling regarding the U.S. Food & Drug Administration’s (FDA) regulation of cigars. Only, this appeal isn’t the appeal many expected.

Last week, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia ruled that FDA did not have the ability to enforce premarket approval restrictions—a process for the cigar industry known as substantial equivalence—until after the agency went through a formal review process of whether it should create a streamlined process for “premium cigars.” In doing so, the court gave relief to the manufacturers behind most cigars sold in a humidor from having to apply for premarket approval by Sept. 9, 2020.

While the most impactful part of the ruling was in favor of the cigar industry, many of the individual rulings were actually in favor of FDA’s ability to regulate cigars. The court refused to invalidate any other part of the rule other than the Sept. 9 enforcement for “premium cigars” and even that could end up being just a temporary delay in enforcement.

The Cigar Association of America membership includes both premium and mass-market cigar manufacturers, though the latter are the group’s largest stakeholders. Given that all of the most popular mass-market cigars—products like Backwoods, Black & Mild, Phillies, Swisher and White Owl—would not qualify as a “premium cigar” per FDA’s newly established definition, many expected CAA to appeal the decision to try to get the deferment of enforcement to apply to all cigars.

An appeal would have likely happened regardless, but seems even more likely given the success CAA had earlier this year with the U.S. Court of Appeals for the District of Columbia. In February, Mehta ruled that FDA could not require warning labels for “premium cigars” and pipes. CAA appealed the ruling and got it overturned to include all cigars and pipes. Given that an appeal of last week’s ruling will once again go to the same courthouse, CAA has to like its odds of a similar result this time around.

As it turns out, the group is also going to appeal other parts of the decision.

In a filing yesterday, CAA requested an injunction of FDA’s enforcement of the Sept. 9 deadline while the group files an appeal over some of the counts of last week’s ruling. Per a notice filed with the court, this appeal will focus on four counts of Mehta’s decision:

• The FDA’s refusal to adjust the 2007 grandfather date for cigars and pipe tobacco products (Count I) was not arbitrary or capricious;
• The FDA’s imminent enforcement of the substantial equivalence process against cigars and pipe tobacco without finalizing implementing rules (Count XI) does not render the Final Deeming Rule arbitrary, capricious, or contrary to law;
• Plaintiffs have not shown that the 2016 Effective Date was premised on legal error (Count XIII);
• The FDA’s cost-benefit analysis (Count XV) was reasonable and reasonably explained to the extent it is reviewable;

Notably, the appeal does not cover Count XIV, which is the one that dealt with whether FDA acted properly when it considered comments over whether it should create a streamlined process for “premium cigars.”

Instead, CAA’s appeal focuses on the larger deeming regulations.

“The ruling therefore leaves these manufacturers in an untenable position as the deadline for filing substantial equivalence reports (“SE Reports”) approaches,” reads the filing. “The irreparable harm to such manufacturers is manifest, and the balance of equities and public interest all favor a stay so that the appeals court can consider the serious legal issues raised by this appeal.”

CAA says that Cigar Rights of America and Premium Cigar Association—the two other defendants in the D.C. lawsuit—do not oppose this appeal.

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.