Health Law Daily Wrap Up, COSMETICS—D. Minn.: Misbranding and false-advertising claims in benzene acne suit remain alive, (Jan 23, 2026)

By Martin A. Steinberg, J.D.

The court dismissed the plaintiffs’ claims for injunctive and declaratory relief for lack of standing, finding no plausible future purchasing risk.

The federal district court in St. Paul, Minnesota, largely denied Target Corporation’s motion to dismiss a putative consumer class action challenging its Up&Up benzoyl-peroxide (BPO) acne products, holding that plaintiffs plausibly alleged the products contained or degraded into benzene, a known carcinogen. The court concluded that damages claims may proceed, that misbranding and false-advertising theories are not preempted by federal law at the pleading stage, and that benzene-based adulteration claims were adequately alleged. However, the court dismissed requests for injunctive and declaratory relief for lack of Article III standing, rejected claims based on current good manufacturing practices (cGMPs) as conclusory, barred negligent-misrepresentation claims under state economic-loss doctrines, and declined to defer to the FDA under the primary-jurisdiction doctrine (In Re Target Corporation Bpo Sales and Marketing Litigation, No. 0:24-cv-01323-ECT-JFD (D. Minn. Jan. 20, 2026)).

Background. Benzene is widely recognized as a hazardous chemical associated with leukemia and other blood disorders. The FDA classifies benzene as a “Class 1” solvent that should be avoided in pharmaceutical manufacturing and permits no more than 2 parts per million (ppm) when unavoidable.

Valisure, an independent laboratory that tests consumer products, conducted a 2023 study of 66 benzoyl-peroxide acne products, including three Target Up&Up products. Using accelerated temperature testing intended to simulate real-world storage and consumer handling conditions, Valisure reported that all tested BPO products either contained benzene at baseline or generated benzene over time at levels exceeding FDA guidance thresholds. Valisure concluded that benzoyl-peroxide formulations are inherently unstable and prone to benzene formation and subsequently filed a citizen petition with the FDA requesting regulatory action, including potential recalls and suspension of BPO acne products.

The plaintiffs, four consumers from California, Nebraska, and Illinois, allege they purchased Target’s Up&Up benzoyl-peroxide acne products and relied on Target’s labeling and representations regarding safety and quality. They claim that had they known about the alleged benzene contamination, they would not have purchased the products or would have paid less.

Plaintiffs assert nine causes of action under state consumer-protection statutes, implied-warranty law, negligence theories, and unjust-enrichment doctrines. These include claims under California’s Unfair Competition Law, Consumers Legal Remedies Act, and False Advertising Law; multi-state deceptive-trade-practices statutes; Minnesota consumer-fraud and deceptive-trade-practices laws; breach of the implied warranty of merchantability; negligent misrepresentation and omission; and unjust enrichment. They seek damages and restitution, punitive damages, disgorgement, attorney fees, and declaratory and injunctive relief on behalf of a proposed nationwide class, with subclasses for California, Illinois, and Nebraska purchasers.

Substantively, all claims rest on three core liability theories. First, the plaintiffs alleged the products were misbranded because Target failed to disclose material benzene risks on product labels. Second, the plaintiffs allege that the products were adulterated due to benzene contamination resulting from the degradation of benzoyl peroxide. Third, they allege the products were adulterated because they were manufactured in violation of the FDA's current good manufacturing practice requirements.

Subject-matter jurisdiction and standing. The court found that it has subject-matter jurisdiction over the plaintiffs’ damage claims. Plaintiffs plausibly alleged that their purchased products contained benzene, establishing Article III injury, and satisfied CAFA’s jurisdictional requirements. However, the plaintiffs lacked standing to pursue injunctive or declaratory relief because they failed to allege any realistic likelihood of future harm.

Standing for damages claims. The primary jurisdictional dispute centered on whether the plaintiffs plausibly alleged that the products they purchased actually manifested the alleged defect. Under Eighth Circuit precedent governing defective-product litigation, a plaintiff must allege that the defect has occurred, rather than merely posing a risk of future failure.

At the motion-to-dismiss stage, the court concluded plaintiffs satisfied this requirement under two complementary theories. First, the plaintiffs alleged that any detectable benzene renders a BPO acne product defective. Valisure’s testing showed “native” benzene in all tested Up&Up products even before accelerated incubation. Because the plaintiffs also alleged that all Up&Up BPO products were manufactured in the same manner, the court held it was plausible to infer that the products they purchased likewise contained benzene at the time of sale.

Second, the plaintiffs alleged that benzene levels exceeding 2 ppm are particularly hazardous. Valisure’s accelerated testing showed that benzene levels in the tested products exceeded the threshold within days and continued to increase thereafter. The court emphasized that the testing methodology was designed to approximate real-world storage and handling conditions. When coupled with allegations of uniform manufacturing practices, the court found it plausible that the plaintiffs’ purchased products exhibited the same defect.

Target argued that the plaintiffs failed to test the specific units they purchased and pointed to allegations suggesting benzene contamination was not inevitable. The court rejected these arguments, explaining that the plaintiffs alleged Target’s manufacturing and storage practices resulted in contamination, even if alternative practices might, in theory, avoid the problem. Although the court acknowledged some complaint language could be read as alleging only a risk of degradation, it concluded that the plaintiffs’ primary theory was that contamination actually occurred. That was sufficient to establish Article III injury for damages claims at the pleading stage.

Standing to seek injunctive and declaratory relief. The court dismissed the plaintiffs’ requests for injunctive and declaratory relief for lack of Article III standing. It held that plaintiffs alleged only past purchases and failed to plead any realistic likelihood of future interaction with Target’s acne products. Without a plausible threat of future harm, the court concluded that forward-looking relief was constitutionally unavailable.

CAFA jurisdiction. Although neither party contested subject-matter jurisdiction under the Class Action Fairness Act (CAFA), the court independently evaluated whether the statutory requirements were satisfied. The court found that minimal diversity was adequately pleaded because the plaintiffs were citizens of California, Nebraska, and Illinois, while Target is headquartered and incorporated in Minnesota. The court also found that numerosity was plausibly alleged based on claims that hundreds of thousands of consumers nationwide purchased Up&Up products.

The court’s principal concern was the $5 million amount-in-controversy requirement. Plaintiffs did not allege specific product prices or aggregate damages figures; instead, they pleaded only the statutory threshold. While acknowledging this deficiency, the court concluded that the requirement was plausibly met based on the size of the proposed class, the nationwide scope of the claims, and the plaintiffs’ requests for punitive damages and attorneys’ fees. The absence of any challenge from Target further supported this conclusion.

FDCA Preemption. The court rejected Target's argument that the plaintiffs’ misbranding and false-advertising theories were preempted by the FDCA’s express preemption provision governing over-the-counter drugs. State-law claims may survive preemption if they parallel federal requirements rather than impose additional or inconsistent obligations. Although FDA acne monographs specify permitted active ingredients and mandatory labeling content, OTC products must also comply with broader FDCA provisions prohibiting false or misleading labeling.

Plaintiffs alleged that Target failed to disclose the presence of benzene and related health risks. The court held that if benzene was present and posed material safety concerns, federal law itself could require disclosure. Accordingly, plaintiffs’ misbranding theory plausibly paralleled FDCA requirements rather than adding new labeling obligations.

The court acknowledged decisions holding that warnings not expressly required by the acne monograph are preempted but distinguished those cases on the ground that they did not fully address the FDCA’s general prohibition on misleading labeling. The court also rejected Target’s argument that any deviation from monograph labeling automatically renders a product misbranded. Instead, it held that manufacturers must comply with both monograph-specific requirements and the FDCA’s general misbranding provisions.

Adulteration theory. The court allowed the plaintiffs’ benzene-contamination adulteration theory to proceed, finding it plausible that Target’s products contained benzene and therefore qualified as “decomposed” substances under the FDCA. Laboratory testing and allegations of uniform manufacturing practices supported a reasonable inference that the purchased products were affected.

The court dismissed the separate cGMP-based adulteration theory as conclusory. Plaintiffs cited more than twenty regulatory provisions but failed to allege specific facts showing how Target’s manufacturing processes deviated from FDA standards. The court held that regulatory quotations and “information and belief” allegations are insufficient under federal pleading rules.

Primary jurisdiction doctrine. Target argued that the court should dismiss or stay the case under the primary-jurisdiction doctrine due to the FDA’s ongoing review of Valisure’s citizen petition. The court declined to do so. It concluded that FDA action would not resolve the legal and factual issues underlying plaintiffs’ damages claims. The court also emphasized that the plaintiffs were no longer seeking market-wide injunctive relief and that the issues presented fell within the conventional competence of courts and juries. Invoking primary jurisdiction, the court held, would unnecessarily delay the litigation without meaningful benefit.

Negligent misrepresentation and economic-loss doctrine. Finally, the court dismissed the plaintiffs’ negligent misrepresentation and negligent omission claims under California, Illinois, and Nebraska law. Plaintiffs sought only economic losses arising from the purchase of allegedly defective products and did not allege personal injury or property damage beyond the products themselves. Under controlling state law, such purely economic losses are barred by the economic-loss doctrine in negligence-based product cases. Plaintiffs’ attempt to characterize the claims as involving intentional misconduct did not alter the analysis. As a result, the negligence-based claims were dismissed.

The Case is No. 0:24-cv-01323-ECT-JFD.

Judge: Tostrud, E.

Attorneys: Christopher Devivo (Levi & Korsinsky, LLP) for Bria Miller. Rick Lynn Shackelford (Greenberg Traurig, P.A.) for Target Corp.

Companies: Target Corp.

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