Eight Cigar Companies & Two Cigar Trade Groups Seek Indefinite Delay of FDA Substantial Equivalence Due to Coronavirus

A new motion has been filed in one of the lawsuits related to the U.S. Food & Drug Administration’s (FDA) regulation of cigars, this time seeking an indefinite delay of a key regulatory deadline, set to go into effect next month.

Michael Edney, the attorney for the cigar industry in its two most notable lawsuits against FDA, filed a request for a preliminary injunction of the May 12 substantial equivalence deadline on behalf of  two of the cigar trade groups already suing the agency—Cigar Rights of America and the Premium Cigar Association—as well as eight cigar companies:

• Alec Bradley
• Arturo Fuente
• Ashton
• Crowned Heads
• Holt’s
• Oliva Cigar Co.
• Padrón
• Rocky Patel Premium Cigars

The Cigar Association of America—the third cigar trade group that is part of the original lawsuit—is not part of this motion. Of note, all of those companies except for Crowned Heads are represented on the board of Cigar Rights of America. “Holt Cigar Co.” does not appear to exist but likely refers to Holt’s, the Philadelphia-based retailer operated by the same family that owns Ashton.

Edney’s petition seeks to have the U.S. District Court for the District of Columbia delay the May 12, 2020 deadline for substantial equivalence until 90 days after the court rules on larger parts of the lawsuit. In it, Edney argues that the injunction is needed because these companies cannot meet the May 12, 2020 deadline due to the coronavirus COVID-19 pandemic.

If granted as requested, this petition would seemingly only apply to companies that are members of the two organizations—Cigar Rights of American and the Premium Cigar Association—something that would inevitably spark more lawsuits.

There are a number of things that would suggest this particular motion is a longshot.

Most notable is that there is already an indicative ruling in place following an agreement by FDA, public health/anti-tobacco groups and a Maryland-based federal court judge to delay the deadline for 120 days due to the coronavirus pandemic.

That agreement is currently waiting on another court—the U.S. Court of Appeals for the Fourth Circuit—to formally approve of the delay, something that was expected this past week but has not happened.

(The Maryland-based federal court is involved because FDA lost a lawsuit to the public health groups and doctors that moved up the original substantial equivalence deadline from August 2021 to May 2020.)

For those wondering about the delay in FDA cigar regulations, here’s what the government told a court yesterday. (Still waiting on the 4th Circuit Appeals Court to sign off on the 120-day delay.) pic.twitter.com/yJheck4ODa

— Charlie Minato (@charlieminato) April 16, 2020

If granted—which is expected by all of the aforementioned parties—that ruling would delay the deadline for substantial equivalence to Sept. 9, 2020 as well as delay certain regulations for e-cigarettes and vaping companies. Judge Paul Grimm of the Maryland-based federal court seemed to take extra precautions in issuing his indicative ruling, where he agreed that he would let the 120-delay happen but only after the Fourth Circuit approved it because he believed he did not have the authority to grant the delay without the appeals court’s approval.

Furthermore, Judge Amit P. Mehta—the D.C.-based federal judge who has ruled on the main lawsuit between the cigar and industry FDA—has previously declined to overrule the Maryland-based court’s decision once before.

Substantial equivalence is expected to be the main approval process for cigars once FDA’s regulations are fully in effect. In short, a manufacturer would argue that its product is substantially equivalent to an already approved or grandfathered product, and as such poses no additional health risks and does not market towards children.

Cigar manufacturers are required to either file for substantial equivalence or grandfather status by the deadline—still legally May 12, 2020—in order for their cigars to stay on the market. If they fail to do so, that product must be removed from sale in the U.S. and will not be able to be sold until FDA approves the report.

Complicating matters is that FDA has still not issued an update on its planned new procedures for substantial equivalence and also never issued guidelines from HPHC testing for cigars and other tobacco products. In January, FDA indicated that premium cigars were its lowest priority and that it would handle enforcement in a corresponding manner, though its unclear what that means.

Substantial equivalence was not scheduled to be due until next August, but last year FDA lost a court case in Maryland and Judge Grimm forced the agency to move up the deadline to this May due to concerns over vaping and e-cigarette use by minors.

While this particular legal matter is likely to reach its conclusion shortly, it won’t stop the appeals by various parties against Grimm’s initial ruling. The cigar industry, the vaping industry and FDA itself have all filed appeals against the ruling for a variety of reasons. Those lawsuits seek to move the date back to the August 2021 deadline.

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.