FDCA mostly preempts claims against ineffective decongestant

Yousefzadeh v. Johnson & Johnson Consumer Inc., --- F.4th ----, 2026 WL 2192415, Nos. 24-3296 (L), 25-119 (CON) (2d Cir. Jul. 30, 2026)

Oral phenylephrine (oral PE), used in popular products as Nyquil Severe Cold & Flu, Advil Sinus Congestion & Pain, and Mucinex Sinus Max, was long considered an effective nasal decongestant. In 1994, the FDA published a final monograph determining that oral PE was generally recognized as safe and effective as a nasal decongestant.

Starting in 2007, however, scientific studies began casting doubt on that finding. Indeed, in 2016, some studies concluded that oral PE “[was] no more effective than [a] placebo” as a decongestant. Yet, the FDA has continued to require manufacturers to adhere to its existing labeling requirements denoting oral PE as effective.

In September 2023, the FDA convened an expert panel that concluded, by a unanimous vote of 16-0, that oral PE products were ineffective as nasal decongestants, and in 2024 it proposed an administrative order to remove oral PE from the nasal decongestant monograph. Until the administrative order becomes final, however, the FDA stated that, “[f]or now, companies may continue to market OTC monograph drug products containing [oral PE] as a nasal decongestant.”

What does this mean for this consumer protection lawsuit alleging that, in the past decade, drug manufacturers have sold some $12 billion’s worth of ineffective nasal decongestants? This consolidated complaint alleged NY GBL and common-law claims as well as RICO claims (which will not be further discussed because they are RICO claims).

The district court found FDCA preemption and also rejected a Lanham Act claim in a related case. The court of appeals found that the FDCA expressly preempted the majority of the consumer plaintiffs’ state law claims. “Defendant Manufacturers followed the FDA’s prescribed labeling requirements by designating their decongestants’ purpose as decongestion. Defendant Manufacturers cannot now be sued for complying with those FDA specifications.” Loper Bright didn’t change things because it didn’t “subvert agencies’ authority to promulgate preemptive regulations pursuant to the authority vested in them by statute -- authority the FDCA vests in the FDA here. Indeed, the Supreme Court has given preemptive effect to federal regulations since before Chevron.”

The discussion is extensive, but a couple of points: There was no duty to update the labeling merely because the ingredient didn’t work; “a monograph drug could be considered misbranded if it has a dangerous effect on the user, even when the drug’s label conforms to the monograph requirements, thus allowing a manufacturer to add a safety disclaimer to the product’s label.” But it’s not automatically misbranded if it is simply “ineffective when used as recommended or suggested in the label.” Thus, the FDA had declined to impose additional labeling requirements for ineffectiveness as opposed to safety risks. “Because monograph drug manufacturers cannot utilize [a specifically provided-for] process to unilaterally change their labels’ efficacy information, … their obligation is to conform to the applicable monograph, not to update their labels to reflect new scientific evidence.” To require additional disclosures would be to impose a requirement other than that imposed by the FDCA, and “any such compulsory language would not be permissible if it was inconsistent with the statements required by the FDA.”

What about failure to disclose in marketing and advertising, as distinct from labeling? The statute’s express preemption “voids state law marketing and advertising claims, not only labeling claims,” by specifying that its preemptive effect extends to “any requirement relating to public information or any other form of public communication relating to a warning of any kind for a drug.” Allowing failure-to-disclose claims would create an end run around federal labeling rules.

Not preempted: Allegations that using “Maximum Strength” or “Max Strength” on certain products constituted a false statement that the products work better than other oral nasal decongestants, such as pseudoephedrine. No FDCA provision or regulation addresses phrases such as “Maximum Strength” or claims of comparative strength. “Defendant Manufacturers therefore voluntarily and on their own accord placed these Maximum Strength statements on their products; they were not obligated to do so. Consequently, these additional statements are subject to the misbranding provision’s requirements and cannot be rescued by the monograph or approved NDAs.”

In addition, manufacturers who obtained FDA approval through the NDA (new drug application) process could have an independent duty to update their drugs’ labels through the prescribed process to reflect newly acquired information bearing on a drug’s efficacy. While that process is unavailable for monograph drugs, it is available for brand-name NDA drugs, so the court remanded for consideration of this theory as well.

What about the related Lanham Act claim, not brought by consumer plaintiffs?  The district court didn’t abuse its discretion in dismissing the claim because the competitor-plaintiff neglected many opportunities to preserve or raise the claim. Given the fact that there’s no preemption of federal claims, this seems like a serious error on its part.