Health Law Daily Wrap Up, MISBRANDING (FOOD, DRUGS & MEDICAL DEVICES)—E.D. Cal.: Acne drug claims survive preemption challenge, (Aug 21, 2026)

By WK Editorial Staff

The district court denied a motion to dismiss claims alleging that benzoyl peroxide acne products were adulterated and misbranded, concluding that most of the asserted theories parallelled federal requirements and were not preempted.

A magistrate judge for the U.S. District Court for the Eastern District of California recommended granting in part and denying in part a motion to dismiss a putative consumer class action challenging benzoyl peroxide (BPO) acne treatment products. The district court concluded that most of the consumers’ theories, including claims based on adulteration, misbranding, and violations of current Good Manufacturing Practices (cGMPs), were sufficiently pleaded and were not preempted by federal law. The magistrate judge recommended that the suit proceed on the core allegations that the products allegedly contained or degraded into benzene, a known carcinogen, while dismissing a limited portion of the claims related to products the named consumers did not purchase and one specific labeling statement (Navarro v. Walgreens Boots Alliance, Inc., 1:24-cv-00290-JLT-SAB (E.D. Cal. Aug. 13, 2026)).

The court noted that the Food, Drug, and Cosmetic Act (FDC Act) required over-the-counter acne drugs to comply with applicable monographs and cGMP requirements. The applicable acne monograph authorized benzoyl peroxide as an active ingredient but also incorporated broader regulatory requirements through 21 C.F.R. § 330.1. The court emphasized that compliance with the monograph alone did not end the inquiry because the regulations also require compliance with general FDC Act provisions governing adulteration and misbranding.

Preemption. Walgreens argued that the FDA’s acne monograph exclusively governed labeling and safety requirements for BPO products and that any state-law claims imposing additional obligations would be preempted. The court disagreed and noted that the acne monograph expressly required compliance with the general conditions set forth in 21 C.F.R. § 330.1, which in turn incorporated Chapter V of the FDCA. Because Chapter V prohibited false or misleading labeling and addresses misbranding generally, the court concluded that claims paralleling those federal requirements were not categorically preempted.

Accepting the complaint’s allegations as true at the pleading stage, the court found that if benzene were present in the products and posed health risks as alleged, state-law claims premised on the failure to disclose that information could parallel federal misbranding requirements rather than impose new duties beyond federal law. According to the court, the consumers alleged a plausible theory that the products were falsely or misleadingly labeled because they did not disclose the alleged presence of benzene.

Adulteration. The court also addressed three separate adulteration theories. First, the consumers alleged adulteration under Section 351(a)(1) of the FDC ACT, arguing that the products contained a decomposed substance because benzoyl peroxide allegedly degrades into benzene. Second, they alleged adulteration under Section 351(b), relying on provisions of the United States Pharmacopeia (USP) that limit benzene levels. Third, they asserted adulteration under Section 351(a)(2)(B) based on alleged cGMP violations. The court concluded that none of these theories was categorically preempted.

With respect to the USP-based theory, the court focused on whether the USP's residual-solvent provisions could apply to benzene allegedly produced through degradation rather than being introduced as a manufacturing solvent. The court found enough ambiguity in the relevant USP provisions to support the plaintiffs’ interpretation at the motion-to-dismiss stage. The judge emphasized that, when viewed in the light most favorable to the plaintiffs, the cited USP provisions plausibly encompassed degradation products and therefore could support allegations that the products fell below applicable purity standards.

The court concluded that the cGMP allegations were sufficiently detailed to survive dismissal. The amended complaint identified specific categories of alleged violations, including failures to establish scientifically sound specifications, conduct appropriate testing, maintain suitable storage conditions, perform stability testing, support expiration dates with adequate data, and reject contaminated batches. The court found that the complaint moved beyond generalized references to cGMPs and provided sufficient detail explaining how the manufacturer allegedly failed to satisfy particular regulatory requirements.

The plausibility of the cGMP claims was strengthened by allegations concerning benzene testing. The complaint relied not only on testing described in a citizen petition submitted to the FDA but also on independent testing of a consumer’s unused product that allegedly detected benzene at levels well above a 2 parts-per-million threshold referenced in FDA guidance. Based on those allegations, the court determined that the plaintiffs plausibly alleged breakdowns in quality controls, testing procedures, and contamination-prevention measures. While recognizing that proof would ultimately be required through discovery and later proceedings, the court found the allegations sufficient to proceed.

The court also examined a series of challenged advertising statements. It concluded that statements asserting that Walgreens-branded products were authentic, tested, safe, manufactured under strict criteria, and tested by independent laboratories were specific and measurable representations rather than nonactionable puffery. According to the court, those representations could be evaluated through discovery and could be shown to be false if the products contained benzene as alleged. By contrast, the statement “Walgreens Pharmacist Recommended” was deemed nonactionable opinion and puffery because it conveyed a recommendation rather than a verifiable safety representation. The court therefore recommended dismissal of claims premised on that statement without leave to amend.

Primary jurisdiction doctrine. Walgreens urged the court to invoke the primary jurisdiction doctrine and defer to the FDA. The court declined to do so. Acknowledging the FDA’s expertise and comprehensive regulatory authority, the court concluded that the issues presented involved legal and factual questions that courts are capable of resolving. The court further found no indication that a stay would promote efficiency because there was no clear basis to expect the FDA to resolve the precise issues raised in the litigation within a meaningful timeframe.

The case is No. 1:24-cv-00290-JLT-SAB.

Judge: Boone, S.

Attorneys: Stephanie Brooks (Sherman Sherman Law, P.C.) for Grace Navarro, Chatham Mullins, Pamela Giarrizzo and Alexzander Hudson. Emerson B. Luke (Greenberg Traurig, P.A.) for Walgreens Boots Alliance, Inc.

Companies: Walgreens Boots Alliance, Inc.

Cases: CaseDecisions FDCActNews AdulterationNews CosmeticNews MisbrandingNews OTCNews PreemptionNews SafetyNews CaliforniaNews