Health Law Daily Wrap Up, TOBACCO—5th Cir.: No error in preliminary enjoinment of new tobacco warnings rule, (Aug 21, 2026)

By Sherri M. Schroeder, J.D.

The court upheld the lower court’s decision to grant a preliminary injunction and postpone the effective date of a new FDA rule adding new required warnings on cigarette packaging and advertising.

The U.S. Court of Appeals for the Fifth Circuit has upheld the interim relief granted by a Texas district court against claims made by the R J Reynolds Tobacco Co. and other defendants under the Administrative Procedure Act (APA) concerning a new final FDA rule. That final rule (the Rule) requires one of 11 warnings on cigarette packaging and advertising, rather than the Tobacco Control Act’s (TCA’s) requirement of one of nine. The majority of the FDA’s final rule was to go into effect 15 months after the required regulations were issued, but Reynolds Tobacco challenged the FDA’s authority to require a different number of warnings and the agency’s authority to depart from the Act’s warning text. The district court found that Congress did not grant the FDA authority to increase the number of required warnings and that Reynolds Tobacco had a substantial likelihood of success; the court also determined the proper remedy would be to postpone the rule’s effective date (see Court preliminarily enjoins enforcement of new tobacco warnings rule, Jan. 15, 2025). On appeal, the Fifth Circuit court concluded that the district court did not abuse its discretion and that the equities favored interim relief. Therefore, the court affirmed the district court’s postponement of the Rule effective date pending a final decision on the merits (R J Reynolds Tobacco Co. v. FDA, No. 25-40137 (5th Cir. Aug 18, 2026)).

The Fifth Circuit court framed the question before it narrowly—Did the district court abuse its discretion b concluding that Reynolds Tobacco was substantially likely to win on their claim that the FDA overstepped its statutory authority? The court concluded that because Reynolds Tobacco had made the requisite showing that the FDA likely lacked authority to increase the number of warning statements, the district court had not abused its discretion in finding the first interim-relief factor satisfied. TCA section 1333(a)(1) requires tobacco packages to bear “one of the following labels,” and then lists nine of them. Per the appeals court, this is an exclusive, “closed set of exactly those nine,” as there is no phrase like “including” or “such as.” The surrounding statutory structure reinforces this interpretation. “Throughout these provisions, Congress cross-references the warning already ‘specified’ in subsection (a)(1), confirming that the nine statements anchor the entire labeling regime,” stated the court.

FDA then argued that because section 1333(d)[2] authorizes it to “adjust the . . . text,” this authority implicitly includes the power to add new warnings or eliminate old ones. However, the court stated, “To adjust is to modify something that already exists—not to conjure something new.” Per the court, if Congress had intended to confer such authority, it would have done so expressly.

FDA then argued that the Federal Cigarette Labeling and Advertising Act’s preemption clause—section 1334—gives the agency broad power to change the number and content of the warnings. However, the court found the clause was not an independent grant of regulatory authority; rather, it presupposed valid authority conferred elsewhere but did not, itself, create authority. Reading it as the FDA suggested would “invert the statute’s structure and render § 1333(d)[2]’s limitations largely superfluous.” Additionally, the FDA’s authority to require “additional or different statements” remains bounded by section 133(d)[2]’s conditions and by the structure and text of section 1333(a), per the court. The court also found that the argument went against the “basic canon” that “no construction should render a neighboring provision inoperative.” If section 1334(a) is read as an independent license to require any number of warnings, then section 1333(d)[2]’s allowance that the FDA may adjust the labels only upon finding that a change would “promote greater public understanding” would collapse “into surplusage, a hoop the agency could sidestep at will.” Also, per the court, standard interpretive practice disfavors a reading that allows a general clause to swallow a specific one.

The court also found that the record adequately supported the conclusion that the remaining interim-relief factors weighed heavily in favor of interim relief. “Unrecoverable compliance costs imposed by allegedly unlawful agency action ordinarily qualify as irreparable harm,” per the court and Supreme Court precedent. The balance of equities also favored Reynolds Tobacco because the FDA identified no comparable hardship arising from a temporary postponement of the Rule’s effective date, while tobacco companies face “concrete, imminent, and unrecoverable” costs absent interim relief. The court also found that the district court had not abused its discretion in finding that interim relief was in the public’s interest. “The public is not served by a court enforcing a rule that may exceed an agency’s statutory authority,” stated the court. “Rather, the public has an interest in agencies acting within the bounds set by Congress and in avoiding regulatory disruption caused by rules later found unlawful.”

Finally, the court disagreed with the FDA that the district court should have confirmed the postponement to only the plaintiffs or severed the Rule’s invalid parts and let the rest take effect. According to the court, Congress framed the APA’s authority to authorize a reviewing court to postpone the effective date of an agency action “in action-centric rather than party-centric terms.” Therefore, a postponement or other interim stay of an agency rule affects persons in all judicial districts equally, just as vacatur does. Furthermore, Trump v. CASA, Inc. did not constrain the district court’s authority to grant rule-wide relief, as argued by the FDA, because the case addressed only the scope of equitable injunctions, not either of the APA’s remedies. Therefore, it did not foreclose the statutory relief granted in this case. Finally, the court found that the severability provision, by its own terms, did not yet apply because the Rule has yet to exist in a manner that would allow for any invalidation.

The case is No. 25-40137.

Judge: Willett, D.

Attorneys: Ryan Jeffrey Watson (Jones Day) for R. J. Reynolds Tobacco Co. Urja Mittal, U.S. Department of Justice, for the Food & Drug Administration.

Companies: R. J. Reynolds Tobacco Co.

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