FDA’s Tobacco Civil Money Penalty Authority, cont’d: Not Backing Down

A few months ago, we blogged about a Texas U.S. District Court’s Wulferic ruling that FDA’s civil monetary penalty (CMP) provision for tobacco products contained at 21 U.S.C. § 333(f)(9) is unconstitutional under the Seventh Amendment and SEC v. Jarkesy, 603 U.S. 109 (2024). Wulferic, LLC v. FDA, 793 F. Supp. 3d 830 (N.D. Tex. 2025).  (As a recap, the court, applying Jarkesy, ruled that the Seventh Amendment right to a jury trial applies to civil monetary penalties like those applied by the FD&C Act, and that the enforcement of these penalties by administrative law judges is unconstitutional.)  We also considered the potential implications of that ruling, and its place in the broader landscape of Jarkesy challenges to FDA’s tobacco CMPs.  Nearly four months on, the picture is coming into focus: the main action is now shifting to the D.C. Circuit and the Fifth Circuit, and with FDA going full steam ahead on pursuing tobacco CMPs and defending its position, the stakes remain high.

In September, FDA appealed the Wulferic decision and filed a brief in the Fifth Circuit case we were watching, Texas Tobacco Barn, forcefully defending the constitutionality of its tobacco CMP provisions.  The Fifth Circuit then decided to stay the Wulferic appeal pending the outcome of Texas Tobacco Barn, although the Wulferic petitioner (likely wanting to get a word in while it matters most) filed an amicus brief there.  See Wulferic, LLC v. FDA, No. 25-11112, Dkt. No. 18 (5th Cir. Oct. 10, 2025); Texas Tobacco Barn, LLC v. HHS, No. 25-60200, Dkt. Nos. 43, 44 (5th Cir. Aug. 3, 2025).  Texas Tobacco Barn is fully briefed, but no argument has yet been scheduled.

We were also keeping an eye out for a ruling in The Vaping Dragon, which presented a different judge in the Northern District of Texas with the same issues as Wulferic.  That judge has still not issued any ruling — although that case has not been formally stayed, it is possible that the judge too is keeping his pen dry until the outcome of the Fifth Circuit’s decision(s).

Over in the D.C. Circuit, things are moving a bit more speedily in the case we were watching there.  Much the same as in Texas Tobacco Barn, in D and A, FDA filed a brief forcefully defending its tobacco CMP provisions.  The D.C. Circuit has set oral argument for December 8, 2025 (we’ll be tuning in), offering the first chance for the Circuit courts to weigh in on this precise issue.  See D and A Business Invs., LLC v. FDA, No. 25-1074 (D.C. Cir. Sept. 12, 2025, Oct. 16, 2025).  While Texas Tobacco and D and A each present other challenges to the proceedings such that they theoretically could be resolved without reaching the Jarkesy question, in all likelihood, both Circuits will reach its merits.

As before, the stakes are high: a ruling from either court that FDA’s tobacco Civil Money Penalty proceedings are unlawful could significantly dismantle FDA’s arsenal of actions to enforce compliance with the FD&C Act’s tobacco provisions.  And even if such a ruling only purports to offer party-specific relief (as the district court Wulferic decision did), FDA would be much harder-pressed to continue business as usual given the broader precedent set by such a decision.  If the challengers lose either case, they will be highly motivated to seek review in the Supreme Court; and especially if the outcome of the two decisions results in a Circuit split, the Supreme Court will likely weigh in to resolve it (as it recently did in a series of challenges to FDA decisions on flavored e-cigarette tobacco marketing applications, see FDA v. Wages & White Lion Invs., 604 U.S. 542 (2025) (see our post here)).

At least so far, however, FDA’s CMP proceedings show every sign of proceeding apace even after the (limited) Wulferic loss: FDA records show that it has continued to file hundreds of new administrative CMP complaints in recent months, just as it did before. See FDA, Tobacco Compliance Check Outcomes.

We will continue to monitor the developments in these cases and any other major challenges that may arise; but for now, what goes on in the federal appeals courtrooms in the District of Columbia and then New Orleans will matter most.