The 'Maximum Strength' Loophole: Second Circuit Charts a Narrow Path Through FDA Preemption

The Second Circuit's recent decision in the nationwide decongestant false-advertising MDL offers something increasingly rare in consumer class action litigation: a roadmap for surviving preemption. In a ruling reported July 30, 2026, the court held that while the Federal Food, Drug, and Cosmetic Act preempts most state-law claims against drugmakers and retailers who followed FDA-approved labeling, plaintiffs can still pursue claims based on marketing language the FDA never required—specifically, the phrase "maximum strength."

The decision is a masterclass in express preemption analysis under 21 U.S.C. § 379r, the FDCA's preemption provision for over-the-counter drugs. But more importantly for practitioners, it demonstrates that even in the face of broad statutory preemption, creative pleading that isolates non-mandated marketing language can salvage viable claims from what might otherwise be complete dismissal.

The Preemption Wall—And Its Cracks

The FDCA's preemption clause is deliberately broad. Section 379r(a) preempts state requirements that are "different from or in addition to" FDA requirements for OTC drugs. For years, defense counsel have wielded this provision as a nearly complete shield against consumer fraud claims: if the label complied with FDA regulations, the argument goes, state law cannot second-guess it.

The Second Circuit accepted this framework for most of the plaintiffs' claims. Where defendants used FDA-approved labeling language—no more, no less—state-law challenges to that labeling are preempted. This holding aligns with the general principle articulated in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), that express preemption provisions mean what they say.

But the court drew a critical line. When defendants added "maximum strength" to their labels—language not mandated or approved by the FDA as part of the drug approval process—they stepped outside the preemption safe harbor. Claims challenging that specific enhancement survive, because they target voluntary marketing choices, not FDA-compelled disclosures.

The practical lesson: preemption protects compliance with federal mandates, not opportunistic puffery that goes beyond what regulators required.

Pleading Around Preemption: A Template Emerges

For plaintiffs' counsel in consumer product cases, this decision provides a clear drafting strategy. The complaint must isolate specific marketing language or design choices that exceed FDA requirements. Generic challenges to FDA-approved labeling will fail. But claims targeting:

• Voluntary descriptors ("maximum strength," "clinical strength," "doctor recommended")
• Marketing imagery or packaging elements not required by FDA monographs
• Comparative claims that go beyond approved indications

...may survive a preemption motion, provided plaintiffs can tie alleged consumer deception specifically to those non-mandated elements.

Defense counsel, meanwhile, should take note: the decision creates an incentive structure that may push manufacturers toward less voluntary marketing language, not more. Every word beyond the FDA-approved minimum is now a potential litigation target. Expect to see more conservative labeling in the OTC space as legal departments audit existing packaging for unnecessary exposure.

The RICO Standing Setback

The Second Circuit's other significant holding trims a different arrow from the plaintiffs' quiver. The court held that plaintiffs lacked Article III standing to bring civil RICO claims premised on a scheme to defraud both the public and the FDA itself.

This is a meaningful limitation on a tactic that has become increasingly common in consumer MDLs: stacking RICO claims on top of state consumer protection counts to access treble damages and federal jurisdiction. The court's reasoning suggests that where the alleged fraud operates through regulatory channels—defrauding the FDA as an intermediary—the causal chain to consumer injury may be too attenuated to satisfy RICO's proximate cause requirement, echoing concerns from Bridge v. Phoenix Bond & Indem. Co., 553 U.S. 639 (2008).

The practical impact: plaintiffs can no longer assume RICO will ride along with state-law fraud claims in cases involving FDA-regulated products. The standing analysis requires a direct line between the alleged RICO predicate acts and consumer injury—not merely a fraudulent scheme that happened to deceive regulators along the way.

What This Means for MDL Practice

The decision arrives at a moment when consumer product MDLs are proliferating, particularly in the pharmaceutical and supplement spaces. The Second Circuit's framework will likely influence how transferee judges structure these cases:

Bifurcation opportunities: Courts may increasingly separate preemption-vulnerable claims (those challenging FDA-required language) from preemption-surviving claims (those targeting voluntary marketing), potentially leading to partial early dismissals that reshape settlement leverage.

Discovery scoping: The surviving "maximum strength" claims will require discovery into marketing decisions, consumer perception studies, and internal communications about label design—discovery that might not have been relevant to preempted claims. This changes the economics of continued litigation.

Settlement dynamics: Defendants facing only the narrow slice of non-preempted claims may calculate settlement values differently than when facing the full panoply of state consumer protection theories. The Second Circuit has, in effect, created a two-tier system for evaluating exposure.

The Bottom Line

This is not a plaintiffs' victory in the traditional sense—most claims were preempted, and the RICO theory failed. But it is a strategic victory for the plaintiffs' bar, demonstrating that even robust statutory preemption leaves room for carefully targeted claims. The decision rewards precision in pleading and punishes overreach.

For defense counsel, the message is equally clear: FDA compliance is a shield, but only for what the FDA actually required. Marketing departments that embellish beyond regulatory minimums do so at their legal peril. The "maximum strength" that sells products may also be the phrase that keeps litigation alive.

Expect this decision to be cited extensively in preemption briefing across consumer product MDLs in the coming months. The Second Circuit has drawn a line that both sides will now litigate—repeatedly.