Health Law Daily Wrap Up, LABELING AND PACKAGING (FOOD, DRUGS & MEDICAL DEVICES)—2d Cir.: Second Circuit affirms dismissal of Tylenol 'Rapid Release' suit on preemption grounds, (Aug 8, 2025)

By Elena Eyber, J.D.

The Second Circuit upheld the dismissal of a class action against Johnson & Johnson, ruling that marketing and pricing claims over Tylenol Rapid Release Gelcaps are preempted by federal over-the-counter drug labeling laws.

The Court of Appeals for the Second Circuit affirmed a Southern District of New York decision dismissing a proposed class action against Johnson & Johnson over the marketing and pricing of Tylenol Extra Strength Rapid Release Gelcaps. The Second Circuit held that the marketing and pricing claims were preempted by the federal Food, Drug, and Cosmetic Act (FDC Act) because success on those claims would require adding disclaimers or altering federally approved labeling and marketing language. The Second Circuit found that allowing these claims to proceed would impose additional requirements beyond federal standards, which the FDC Act expressly prohibits (Collaza v. Johnson & Johnson Consumer, Inc., No. 24-2568-cv (2d Cir. Aug. 6, 2025)).

The Second Circuit explained that the FDC Act grants the FDA authority to regulate labeling and marketing of over-the-counter drugs, including acetaminophen products. Under 21 U.S.C. § 379r(a), states cannot impose requirements “different from or in addition to” federal standards. The FDA regulations and guidance set dissolution standards for acetaminophen tablets labeled “immediate release” or “rapid release,” and it was undisputed that the Gelcaps met those standards. The Second Circuit also noted that multiple prior cases have found similar “rapid release” challenges preempted because they would impose additional labeling requirements beyond federal rules.

The Second Circuit determined that the marketing and pricing claims effectively sought to compel Johnson & Johnson to add disclaimers or modify federally approved language. Prevailing on these claims would require statements that “rapid release” Gelcaps are not faster than other Tylenol products, which would constitute additional labeling obligations barred by the FDC Act’s express preemption clause. The Second Circuit emphasized that allowing these claims to proceed would create an impermissible end-run around federal regulation.

The Second Circuit rejected arguments that the allegations concerned only advertising and pricing, as there were no separate claims of false statements unrelated to the FDA-approved terminology. Because success on these claims would require altering federally sanctioned labeling and marketing language, the Second Circuit held they were preempted and affirmed the judgment of the district court in full.

The case is No. 24-2568-cv.

Attorneys: Jason Owen Barnes (Simmons Hanly Conroy LLC) for Evie Collaza. Mark Alan Neubauer (Carlton Fields, LLP) for Johnson & Johnson Consumer Inc.

Companies: Johnson & Johnson Consumer Inc.

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