A federal appeals court just told the FDA it went too far. The ruling was about cigarettes, but the legal theory — that the agency exceeded what Congress authorized — is the same one being used to challenge the FDA’s approach to nicotine pouches.

On 18 August 2026, the 5th U.S. Circuit Court of Appeals affirmed a lower-court injunction blocking an FDA rule that would have required 11 graphic health warnings on cigarette packages. The three-judge panel ruled that Congress authorized nine specific warnings under the 2009 Family Smoking Prevention and Tobacco Control Act and that the FDA could not add two more on its own.

“The FDA may require the nine warnings Congress prescribed — no more,” wrote Judge Don Willett for the panel. The FDA’s proposed images covered bladder cancer, head and neck cancers, fatal lung disease, impaired fetal growth, cataracts, and Type 2 diabetes. The court said the agency’s authority stops where Congress’s statute stops.

The case is R.J. Reynolds Tobacco Co. v. Food and Drug Administration, No. 25-40137. R.J. Reynolds, ITG Brands, and Liggett brought the challenge after the FDA revived the graphic-warning requirement in 2019.

Why it matters for nicotine pouches

The ruling is about cigarettes, not pouches. But the legal theory — that the FDA cannot exceed what Congress authorized — is the same theory being used to challenge the agency’s nicotine pouch enforcement approach in a separate federal lawsuit.

In May 2026, the FDA issued an enforcement guidance that allows certain e-cigarette and nicotine pouch products to stay on the market without completing the premarket tobacco product application (PMTA) review that the Tobacco Control Act requires. The agency said it would not use its enforcement discretion against products that meet certain criteria, effectively letting unauthorized pouches remain on shelves while their applications sit in review.

Three weeks later, a coalition including the Campaign for Tobacco-Free Kids and the American Heart Association sued. Their lawsuit, filed 14 July 2026 in the U.S. District Court for the District of Maryland, argues the guidance “permits potentially thousands of tobacco products to enter and remain on the market for an indefinite period of time without the [marketing granted order] required by” the Tobacco Control Act.

The argument is the same one the 5th Circuit just accepted: the FDA is doing something Congress did not authorize. The plaintiffs want the enforcement guidance set aside and the agency required to enforce the statute’s premarket review requirements as written.

If the Maryland court adopts the 5th Circuit’s reasoning — that the FDA’s authority is bounded by what Congress wrote — the pouch enforcement guidance could be struck down. That would mean manufacturers of unauthorized nicotine pouch products could face enforcement action, potentially requiring them to pull products from the market until they complete the full PMTA review process.

The broader pattern

The 5th Circuit ruling is the second time in two years that a federal court has pushed back on the FDA’s tobacco authority. The same circuit rejected a First Amendment challenge to the graphic-warning rule in 2024, but a Texas federal judge later blocked it on statutory grounds — the decision the 5th Circuit just affirmed.

For nicotine pouches, the stakes are concrete. The FDA has authorized 30 nicotine pouch products in 2026 — including 20 ZYN pouches with modified-risk claims and four new flavored on! pouches. But the enforcement guidance leaves a much larger number of unauthorized pouch products on the market under the agency’s discretion. A ruling that the guidance exceeds the FDA’s statutory authority would narrow that discretion significantly.

The FDA’s regulatory agenda for pouches — from enforcement guidance to modified-risk authorizations — now sits in a legal environment where courts are willing to say the agency went beyond what Congress allowed. The 5th Circuit just proved that argument can win.

What’s next

The Maryland lawsuit over the pouch enforcement guidance is in its early stages. The 5th Circuit ruling does not bind the Maryland court — different circuit, different case — but it provides a roadmap for how a court might approach the question of whether the FDA exceeded its authority. The tobacco companies that challenged the cigarette warning rule are not the same parties suing over pouch enforcement; the pouch case was brought by public health groups who want more regulation, not less. But the legal theory converges: the FDA’s power has limits, and courts are prepared to enforce them.

The FDA could appeal the 5th Circuit ruling, revise the cigarette warning rule to comply with the nine-warnings limit, or let the injunction stand. For pouches, the agency’s next move depends on whether it defends the enforcement guidance in court or revises it preemptively. Either way, the message from the judiciary is clear: the FDA gets the authority Congress gives it — not more.

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SOURCES:

• Bloomberg Law, "R.J. Reynolds Wins Fight to Keep FDA Graphic Warning Rule Halted." 18 Aug 2026. Judge Don Willett, 5th Circuit, No. 25-40137. FDA "likely overstepped its authority"; affirmed lower court injunction. Bloomberg Law
• Tobacco Reporter, "5th Circuit Blocks FDA’s 11 Graphic Cigarette Warnings." 19 Aug 2026. Congress authorized 9 warnings; FDA added 2 more; Willett wrote "no more." Case: R.J. Reynolds Tobacco Co. v. FDA, No. 25-40137. Tobacco Reporter
• Regulatory Oversight, "Fifth Circuit Affirms Postponement of FDA’s Cigarette Graphic Health Warning Rule." 20 Aug 2026. Legal analysis by Bryan Haynes, Agustin Rodriguez, Nick Ramos. Regulatory Oversight
• 5th Circuit opinion (PDF): R.J. Reynolds Tobacco Co. v. FDA, No. 25-40137. U.S. Court of Appeals for the Fifth Circuit
• PouchDaily, "Health groups sue the FDA as agency greenlights 30 nicotine pouch products." 19 Aug 2026. Campaign for Tobacco-Free Kids et al. v. FDA, D. Md., filed 14 Jul 2026. PouchDaily