A federal court in Manhattan has tallied another win for preemption in the high-stakes battle over cancer warnings, deciding the scientific work of the Food and Drug Administration preempts attempts to litigate under state law claims.
Moreover, U.S. District Judge Analisa Torres of the U.S. District Court for the Southern District of New York granted the defendant manufacturer’s motion to dismiss with prejudice, essentially ending the multi-district litigation, and, in doing so, struck and emphatic blow to many of the state-law labeling and adulteration theories used by plaintiffs in labeling claims.
The case — L’Oréal USA Benzoyl Peroxide Products Litigation, No. 24 Civ. 2735 (AT), 2026 WL 2719653 (S.D.N.Y. Sept. 15, 2026) — alleged L’Oréal USA failed to disclose that benzoyl peroxide (BPO) acne treatments contained, or could degrade to form, benzene, a known carcinogen. BPO is a common ingredient in products used to treat acne.
The decision is significant for manufacturers of OTC drugs and other FDA-regulated products because it treats an FDA monograph as a considered, comprehensive regulatory judgment that governs over-the-counter drugs.
“[W]here the FDA has constructed an elaborate labeling framework [in a monograph] specifying labeling requirements, and [a particular substance] appear[s] nowhere in that framework, the inference that the agency made a considered judgment about label content is substantially stronger than in cases where the regulatory scheme merely touches on the relevant product category,” Torres wrote.
Much like the U.S. Supreme Court’s Roundup decision we wrote about in July, the L’Oréal decision rejects the idea of adding warnings the federal agency does not require based on scientific work conducted over many years.
Background
The litigation concerned three topical acne treatments: CeraVe Acne Foam Cream Cleanser (4% BPO), CeraVe Acne Foaming Cream Wash (10% BPO) and La Roche-Posay Effaclar Duo Dual Acne Treatment (5.5% BPO). It grew from a 2024 request by independent laboratory Valisure, which asked the U.S. Food and Drug Administration to recall BPO products after Valisure’s testing suggested BPO could decompose into benzene, particularly at elevated temperatures.
The FDA, which had been studying benzene for years, subsequently tested 95 acne products and found more than 90% had undetectable or extremely low benzene levels and that fewer products showed contamination than those suggested by Valisure.
The FDA supported limited retail-level recalls, including one lot of La Roche-Posay Effaclar Duo and said that, even with daily use for decades, the risk of developing cancer from the benzene levels found in the recalled products was “very low.”
Plaintiffs claimed the L’Oréal products were adulterated and misbranded and claims of asserted deceptive-practices, implied-warranty, negligent-misrepresentation/omission and unjust-enrichment. The many lawsuits over the products from states throughout the country were eventually consolidated before Torres in the U.S. District Court for the Southern District of New York.
L’Oréal moved to dismiss the case, arguing the claims conflicted with the federal regulatory framework for nonprescription drugs.
The Court’s Decision
The court noted the FDA has examined BPO safety since the early 1980s and concluded in 1982 that BPO at monograph concentrations is safe and effective. When the FDA finalized the monograph in 2010 it declared the word “cancer” should not appear on BPO acne-product labeling – what the judge considered a regulatory judgment.
Judge Torres found no false or misleading labeling occurred because that would create a warning obligation the product-specific monograph did not impose. The Federal Food, Drug, and Cosmetic Act (FDCA) bars states from imposing over-the-counter drug labeling requirements that differ from or add to federal requirements.
The court also noted the benzene identified in the acne products was the result of degradation and not intentional inclusion in the manufacturing process, therefore, it was not an active ingredient in the product.
The plaintiffs separately alleged benzene above 2 parts per million rendered the products adulterated. The court found no such binding limit in the FDCA, FDA regulations or the Acne Monograph. A voluntary recall did not establish a federal violation, and the FDA’s recall notice did not characterize the product as adulterated. FDA guidance and warning letters stated it contains “nonbinding recommendations” and “does not establish any rights for any person and is not binding on FDA or the public.” The court also emphasized the FDA used the word “should,” which means suggests or recommends, while not using the word “shall” which means taking action is mandatory.
What Could the Decision Mean for Similar Litigation?
Several conclusions in this warning are worth highlighting for use in defending similar lawsuits. Those include:
- Monograph specificity strengthens preemption. When the FDA has prescribed ingredients, concentrations and warnings for an OTC category, courts are more likely to rule plaintiffs cannot use state consumer laws to supersede agency judgement.
- Permission is not obligation. While a manufacturer may have the ability to add additional warnings, that does not make it a requirement.
- Regulatory communications must be classified carefully. Citizen petitions, safety communications, warning letters, voluntary recalls are not automatically considered enforceable federal requirements.
- Manufacturer ingredients and byproducts of degradation are not equal. In this case, substance formed through degradation was not an intended active ingredient and, therefore, could not be considered in a claim that a product is mislabeled.
In addition to these defense strategies, the court’s decision shows the importance of manufacturers preserving a complete record of monograph compliance, labeling decisions, stability data, validated testing, storage controls and cGMP procedures. Companies should also continue to investigate quality signals and cooperate with FDA as appropriate.
In re L’Oréal reinforces an important boundary: state-law litigation generally cannot operate as a second regulatory process to impose warnings or contaminant limits the FDA considered but did not adopt.
Harris Beach Murtha’s Medical and Life Sciences Practice Group frequently handles such cases and our attorneys are analyzing this decision. If you need assistance with a case or have questions, please reach out to attorney Kelly Jones Howell at (212) 912-3652 and khowell@harrisbeachmurtha.com; or the Harris Beach Murtha attorney with whom you most frequently work.
This alert is not a substitute for advice of counsel on specific legal issues.
Harris Beach Murtha’s lawyers and consultants practice from offices throughout Connecticut in Bantam, Hartford, New Haven and Stamford; New York State in Albany, Binghamton, Buffalo, Ithaca, New York City, Niagara Falls, Rochester, Saratoga Springs, Syracuse, Long Island and White Plains; as well as in Boston, Massachusetts; Providence, Rhode Island; and Newark, New Jersey.