Products Liability Law Daily Wrap Up, PREEMPTION—CHEMICAL PRODUCTS—W.D. Mich.: FDCA precludes state law suit on alleged acne medicine benzene contamination, (Mar 10, 2026)

By Steven Melendez

The consumer’s claims were preempted by the FDCA because they would impose requirements in addition to those established by federal law.

A consumer has standing to bring state class action claims over alleged benzene contamination in benzoyl peroxide (BPO)-based acne medication, but his claims are preempted by the federal Food, Drug, and Cosmetic Act, a federal judge ruled, granting a motion to dismiss. The case is one of a series of class action lawsuits alleging that acne treatment products with BPO as an active ingredient may inadvertently contain benzene, a dangerous carcinogen (Kouyate v. L. Perrigo Co., No. 1:25-cv-01013-HYJ-RSK (W.D. Mich. Mar. 3, 2026)).

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Background. The consumer brought suit against Padigis US, LLC over Perrigo-branded acne treatments, alleging they can inadvertently contain benzene, a carcinogenic chemical. Padigis was part of L. Perrigo Company until splitting off in 2021, and Perrigo was itself dismissed from the case via stipulation.

When BPO is exposed to sufficient heat, it can transform into benzene, and this can potentially occur during hot conditions in shipping, according to the ruling in the case. Benzene can be absorbed through the skin, and Food and Drug Administration (FDA) studies have shown Benzene from skincare products can wind up in the bloodstream.

The consumer claimed BPO decays into benzene under conditions that regularly occur in distribution. He cited lab tests performed by Valisure, LLC, which monitors medicine and supplement safety and frequently submits petitions to the FDA, some of which have led to recalls.

In 2024, Valisure tested 99 products containing BPO and found 94 of them also contained benzene. Its results found “Perrigo 5% BPO acne treatment gel contained 14 parts per million (ppm)” before being exposed to additional heat. Studies suggest exposure to any amount of benzene can be harmful, and the FDA has said that if exposure to benzene is needed for a “significant therapeutic advance,” it should be limited to 2 ppm.

Valisure in 2024 submitted a petition to the FDA requesting recalls of the products where it found benzene, but the FDA conducted its own tests and only found elevated benzene levels in six of the products. Their manufacturers made voluntary recalls. Perrigo’s was not among the products found by the FDA to have elevated benzene levels, according to the ruling.

The consumer alleges he bought the Perrigo product, which he alleges is economically worthless because it is harmful, seeking to represent a nationwide class of people who bought the product as well as subclasses who bought it in New York or several other states with similar consumer fraud laws.

Standing. Padigis alleges the consumer lacks standing for failure to allege “actual or imminent” injury. It’s not warranted to assume that the product he bought must contain benzene because it was found in the sample Valisure tested, the company argued.

But the court found that, taking the consumer’s allegations as true, he established actual injury, since he alleges the BPO can degrade to benzene under ordinary handling conditions and points to Valisure testing finding benzene in almost every tested product. Padigis can dispute the factual claims, according to the ruling, but those wouldn’t be resolved on a motion to dismiss.

Other product contamination cases cited by Padigis are distinct, according to the ruling, because they didn’t allege widespread contamination the way the consumer did in pointing to the Valisure testing.

Padigis also argued the consumer lacks standing to sue on behalf of a nationwide class due to variations in state laws. But the court found that if that dispute falls under Rule 23 of the Federal Rules of Civil Procedure, it should be resolved at the class certification stage, and if it is a matter of fundamental Article III standing, “it is a small enough variation that

Article III is satisfied,” since the named consumer and “the proposed class members all suffered essentially the same alleged injury: they bought Perrigo products that were falsely marketed and worthless because they contained benzene.”

FDCA Preemption. Padigis also argued the claims were preempted by the federal Food, Drug, and Cosmetic Act (FDCA). The law, according to the ruling, has an explicit preemption provision with regard to nonprescription drugs saying that “no State or political subdivision of a State may establish or continue in effect any requirement... that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter…”

In other words, according to the ruling, a plaintiff cannot bring a state law suit against a defendant who has complied with the federal law, because that would impose requirements in addition to those of the FDCA. In short, to avoid preemption, a plaintiff must bring a claim that (1) would be cognizable under state law regardless of the existence of the FDCA, but (2) the claims are based on actions that violate the FDCA or its associated regulations.

Here, the consumer meets the first requirement, according to the ruling, since his claims fall under general state consumer protection laws, not the FDCA itself. But, the court found, the second requirement to avoid preemption is not met.

The consumer attempted to satisfy the second requirement by arguing that Padagis’s labeling and sale of the products at issue violated FDA regulations. The FDA has issued a “monograph” indicating that BPO is “generally recognized as safe and effective” in topical acne treatments, but the consumer argued that it in these products, it is “adulterated” by the presence of benzene. The term “adulterated” is defined in the FDCA to mean “it consists in whole or in part of any filthy, putrid, or decomposed substance” and the consumer argued that benzene is decomposed.

The court found that benzene isn’t a “decomposed substance” in the meaning of the law, finding that in context of “filthy” and “putrid,” the statute is referring specifically to organic decomposition and “rotted organic matter.”

The consumer also argued that the product is “misbranded” since it isn’t labeled to reflect the danger of benzene, but the FDA monograph indicates that compliant BPO acne products are not misbranded. “Because such a claim adds an additional requirement that the FDA has not imposed, it is preempted,” according to the ruling. And claims that BPO degrades to benzene under ordinary handling conditions “that the FDA would have anticipated when it crafted its rule” are disallowed, and the consumer failed to allege that specific unusual conditions created by Padigis caused the alleged benzene problem. Similarly, arguments that the company failed to meet rules around “good manufacturing processes” were barred by the determination that BPO is safe, the court found.

Additionally, the consumer argued that Padigis failed to list benzene as an inactive ingredient in violation of the law, but the court found that would only apply if benzene were intentionally added to the product.

The Case is No. 1:25-cv-01013-HYJ-RSK.

Judge: Jarbou, H.

Attorneys: Benjamin Yehuda Kaufman (Wolf Haldenstein Adler Freeman & Herz LLP) for Moussa Kouyate. Sean Leo Gugerty (Goodell Devries Leech & Dann, LLP) for L. Perrigo Co.

Companies: L. Perrigo Co.

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