With a related appeal pending in the U.S. Court of Appeals for the D.C. Circuit, what will become of pending trial litigation in Cigar Association of America, et al. v. U.S. Food & Drug Administration, et al., No. 1:16-cv-01460 (D.D.C.) (“Cigar Association”), and En Fuego Tobacco Shop LLC, et al. v. U.S. Food & Drug Admin., et al., No. 1:18-cv-1797 (D.D.C.) (“En Fuego”)?

It seems that the appeal will take the larger focus for now.

Judgment and Appeal in Cigar Association

In the challenge to the Deeming Regulations filed in Cigar Association, on May 15 Judge Amit P. Mehta awarded the FDA summary judgment on Counts II and III (challenging the user fee rule), Counts VI and VII (challenging the health warning requirements), and Count IX (challenging the FDA’s designation of pipes as tobacco product “components”).

The challengers, however, won summary judgment on Count VIII. Judge Mehta found that the FDA violated the Administrative Procedure Act, 5 U.S.C. § 500, et seq., in its manner of designating certain retailers – who engage in-store, pipe-tobacco blending – as manufacturers subject to annual registration requirements. This issue was remanded to the FDA.

Issues under Counts I (challenging the premarket review process), IV (challenging the cost-benefit analysis), and V (challenging the decision to regulate premium cigars) had been held off, pending further regulatory action expected from the FDA.

On June 27, Judge Mehta entered a final judgment on Counts VI and VII, on an unopposed motion to facilitate an appeal. That same day, the challengers noticed their appeal.

The appeal is Cigar Association of America, et al. v. U.S. Food & Drug Admin., et al., No. 18-5195 (D.C. Cir.). It is focused on Counts VI and VII, specifically, the challenges against the large health warnings required by the FDA, see 21 C.F.R. §§ 1143.3 and .5, as violating the First Amendment to the U.S. Constitution, the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C. § 387, et seq., and the Administrative Procedure Act, 5 U.S.C. § 500, et seq.

Meanwhile, Judge Mehta has enjoined the cigar and pipe tobacco warning requirements pending the appeal.

En Fuego Transferred

After some back and forth over whether it would be transferred, En Fuego has come to the District of Columbia and is assigned to Judge Mehta. The case was originally filed in the U.S. District Court for the Eastern District of Texas.

As previously discussed by this blog, on May 22 the FDA’s motion to transfer had at first been denied by U.S. Magistrate Judge Kimberly C. Priest Johnson.

On July 2, Judge Priest Johnson withdrew that decision and granted the FDA’s motion to transfer. Procedural developments in Cigar Association had since made clear that “the crux of [En Fuego]—the FDA’s failure to treat premium cigars differently from other cigars and to exempt premium cigars from the warning requirement—is squarely before the court in Cigar Association.”

The challengers appealed the transfer order to Judge Amos L. Mazzant, who affirmed and ordered the case transferred to the U.S. District Court for the District Columbia.

It had been anticipated that En Fuego might be consolidated with Cigar Association upon such a transfer; however, it appears that no action has been taken toward such a consolidation.

What to Do with Cigar Association and En Fuego at the Trial Level?

 Yesterday, Judge Mehta held status conferences with counsel in Cigar Association and En Fuego. Judge Mehta had advised the parties to be prepared to address their respective positions as to “how they wish to proceed” with the two cases.

Thereafter, Judge Mehta ordered the parties to submit a Joint Status Report by November 1.


It remains to be seen how the cases will proceed or what will be the results, but a uniformity in the decisions seems likely. As the crux of both cases has been seen as largely the same, Judge Mehta will presumably approach the two in a similar manner (all the more so if the cases are consolidated), and any appellate proceedings will be funneled through the D.C. Circuit. Thus, the transfer has dashed any hopes that the En Fuego plaintiffs might have had in obtaining a more favorable decision in a different circuit.

With the November 1 Joint Status Report a way off in the trial proceedings, further appellate proceedings will apparently take the focus for the time being.

We will continue to monitor for further updates.