© Mirrorstudio stock.adobe.com
A federal court in New York has dismissed multi-district litigation (MDL) alleging that certain benzoyl peroxide (BPO) acne products produced by L’Oréal contained unsafe levels of the carcinogen benzene.
The judge ruled that the plaintiffs' state-law claims alleging the products were mislabelled and adulterated were preempted by the federal Food, Drug and Cosmetic Act (FDCA). Because L’Oréal’s acne products complied with the FDA’s monograph for over-the-counter (OTC) acne drug products, they met federal manufacturing and labelling requirements, the court found.
The 15 September ruling may offer guidance to companies defending against similar benzene-related product liability claims, which have become more common in recent years.
According to Kelly Jones Howell, an attorney at Harris Beach Murtha, the court’s reliance upon the FDA’s acne monograph reflects a growing willingness to defer to regulatory materials in such cases.
"Courts are increasingly recognising that an FDA monograph is more than a regulatory checklist," said Howell, who was not involved in the MDL.
"When the FDA spends decades evaluating a product category and omits a warning from a detailed monograph, courts are becoming more willing to view that omission as a deliberate regulatory judgment rather than a gap for state-law litigation to fill," she said.
Case history
The case dates back to 2024, when consumers from several states sued L’Oréal after independent laboratory Valisure found benzene in certain BPO acne products purchased by the plaintiffs.
The FDA later conducted its own tests and confirmed the presence of benzene in some of the accused products, but at lower levels than Valisure had found.
Plaintiffs sued under various state laws, alleging that L’Oréal failed to warn consumers that its products contained benzene or could degrade to form it. Several of the cases were consolidated into the current MDL action.
Preemption
The court found that plaintiffs’ claims were preempted by the FDCA because L’Oréal’s products met the requirements of the FDA’s acne monograph, which specifies allowable ingredients and details labelling requirements specific to acne drugs and cosmetics.
Under the FDA's framework, products that comply with the relevant monograph and general OTC drug requirements do not require pre-market approval.
In the court’s reading, the FDA’s acne monograph "explicitly allows BPO" and "imposes no requirement" that BPO product labels "warn consumers about the presence or potential presence of benzene".
Plaintiffs argued that other FDA requirements obligating OTC drugs to list all active and inactive ingredients and prohibiting false or misleading statements nonetheless required L’Oréal to warn consumers about benzene.
But the court refused to give what it called the OTC drug regulations' "general language" greater weight than the monograph's "carefully crafted" guidance specific to BPO.
That guidance, the court wrote, "was the product of the FDA’s decades of research and consideration of public comment" and created a strong "inference that the agency made a considered judgment about label content".
Howell said the dismissal of the case against L’Oréal could send a message to future plaintiffs "that a courtroom is not a second FDA".
"If the agency studied the issue and chose not to require a warning, that choice carries significant preemptive force," she said.
The case is In re L’Oréal USA Benzoyl Peroxide Products Litigation.