A federal judge in California filed an important OTC preemption decision earlier this month, and it’s important because it applied federal preemption to shut down (for now) one of the many recent benzene-related consumer class actions.  The case is Daugherty v. Padagis US LLC, No. 24-cv-02066, 2025 WL 2243622 (N.D. Cal. Aug. 6, 2025), and the products at issue are OTC benzoyl peroxide acne treatments. 

Pre-pubescents and gangly teens have been rubbing benzoyl peroxide creams on their faces to treat blemishes since the early 1960s, which we would call a pretty good sample size.  So what’s their beef now?  Well, it seems our friends at the “independent” lab Valisure got their hands on various benzoyl peroxide products and purportedly found that they “contain or systematically degrade” into benzene.  If the plaintiffs in Daughtery had known, they allegedly would have paid less for the products or would not have purchased them at all.  So give them their money back. 

We have seen this play before.  Moreover, as we reported here, the FDA tested “95 acne products containing benzoyl peroxide for possible benzene contamination,” and “more than 90% of tested products had undetectable or extremely low levels of benzene.”  FDA, Statement ¶1 (March 11, 2025). 

The plaintiffs in Daugherty sued anyway, and their lawsuit, like others, ran aground on federal preemption.  They had standing to sue, based on their allegation that they experienced some economic harm, i.e., injury in fact.  But with regard to OTC products, the FDCA expressly prohibits states from establishing “any requirement” that “is different from or in addition to, or that is otherwise not identical with” federal requirements.  That is express preemption, and the FDA’s Acne Monograph expressly permits the use of benzoyl peroxide as an active ingredient and imposes specific labeling and warning requirements.  Daugherty, at *3. 

To the extent the plaintiffs were seeking anything different, including different warnings about benzene, the FDCA expressly preempted their claims.  As the district court held, “This Court joins its sister courts in holding that the FDCA preempts Plaintiffs’ state law claims which challenge the omission of warnings on BPO products that are different from and not required by the FDCA . . . .”  Id. at *8. 

Many states, however, incorporate federal requirements—such as federal current Good Manufacturing Practices (“cGMP”) and federal adulteration standards—into state law, which allowed plaintiffs to claim that they were enforcing state requirements that echoed federal requirements.  In other words, federal law did not expressly preempt their claims because they were not “different from or in addition to” federal requirements.  They were the same.

The district court, however, was inclined to find those “parallel” claims impliedly preempted, too.  First, the plaintiffs’ state law claims appeared to require substantial interpretation of the FDCA and federal requirements.  Good Manufacturing Practices, for example, often call for “appropriate” determinations, or “satisfactory” conformance to specifications, or “thorough investigation” of nonconforming products.  Allowing courts from around the nation to interpret these provisions would (1) create an obstacle to the federal objective of national uniformity in OTC drug quality standards and (2) intrude on Congress’s delegation of exclusive enforcement of the FDCA to the FDA.  If the plaintiffs’ allegations required interpretation of federal requirements, implied preemption would apply. 

Second, the plaintiff failed to plead that the state laws they cited imposed requirements that are “parallel” to federal requirements.  The plaintiffs provided a “laundry list” of state statutes, but did not establish “that these state regulations actually impose requirements identical to federal ones.”  Daugherty at *12.  The plaintiffs alleged purported violations of cGMP, but they were not specific and did not elaborate.  They basically alleged that the defendants must have violated cGMP because they allegedly allowed benzene-contaminated products to reach consumers, sort of a res ipsa loquitur theory.  That, however, was not enough because “Plaintiffs do not assert how Defendants violated or deviated from specific cGMP standards and how such deviations led to the adulteration of [their] BPO products.”  Id.  In addition, to the extent the plaintiffs were alleging an omission-based theory of consumer fraud, their non-specific allegations failed to meet the standard under Rule 9(b). 

The court therefore was inclined to dismiss the plaintiffs’ claims, but allowed them leave to amend to allege, with specificity, the parallel state laws they are asserting and specific facts establishing that the defendants violated particular cGMPs.  Moreover, to avoid implied preemption, the asserted violations must be “limited to those which can be proven without interpretation” of federal requirements, which is a tall order.  Id. at *13.  The court could be throwing the plaintiffs a lifeline here, or it could be allowing them an opportunity to improve the record before it lowers the boom.  Given the court’s reasoning and its stated “inclination” to dismiss the case, we hope and expect the latter.