Last June a WLF Legal Pulse post argued that a federal court should hold that federal law preempts a consumer class action asserting that a moisturizing lotion is “illegal” under state law because the product is actually an unapproved drug. It seems that we were on to something, because as we learned from our friends at the Drug & Device Law Blog, on April 15 the Southern District of California court held the state-law claim preempted and ordered the case closed.

The plaintiff in Somers v. Beiersdorf alleged the defendant violated California’s Sherman Law when Beiersdorf failed to obtain approval from FDA of a New Drug Application (NDA) for its Nivea Skin Firming Hydration Body Lotion. On May 20, 2019, the court denied Beiersdorf’s motion to dismiss. The court stressed that its holding was “limited,” though, and suggested that the defendant pursue summary judgment. Beiersdorf filed such a motion, arguing that federal law preempted Somers’ claim.

The court acknowledged that the somewhat similar regulatory definitions of “drug” and “cosmetic” makes “the distinction between [them] a difficult one.” For that reason, “Congress gave FDA the sole authority to police violations of the [Food, Drug, and Cosmetic Act (FDCA)]” in Section 337(a). Federal court decisions, including the Buckman Co. Supreme Court ruling and the Ninth Circuit’s Perez v. Nidek Co., hold that plaintiffs seeking to essentially enforce the FDCA must “thread a ‘narrow gap’ to escape preemption.”

The court found that Somers could not traverse that gap. Somers claimed that Beiersdorf was violating California law, the court explained, because the company’s failure to seek an NDA violated the FDCA. Somers did not (and could not) reference any California drug-approval law or process that Beiersdorf allegedly failed to follow. But for the FDCA and its NDA requirement, Somers had no legal claim.

Somers tried to take refuge in the California and federal-court case law that endorses what WLF calls the Food Court three-step. Our previous post explained this maneuver:

First, find a labeling practice that appears to violate the FDCA. Second, invoke the California Sherman Food, Drug and Cosmetic Law (Sherman Law), which incorporates the FDCA’s labeling rules. Third (because the Sherman Law provides no private right of action), allege the Sherman Law violation as a predicate act in support of claims under another California law, such as the Unfair Competition Act (UCA). 

The court wasn’t buying Somers’ argument, though. Food labeling, the court noted, “is undoubtedly ‘within the states’ historic police powers,” while the drug-approval process is “uniquely federal.” Somers herself understood that only FDA can approve drugs—in the middle of her suit against Beiersdorf, she filed a Citizen Petition urging FDA to find that Nivea Skin Firming Hydration Body Lotion’s intended use was as a drug. FDA ultimately declined action.

Because we believe the court decisions sanctioning the Food Court three-step were wrongly decided, we regret that the Somers court endorsed those rulings’ rationale in the process of coming to the right decision. And while we’d like to believe that Somers will deter future “it’s a drug, not a cosmetic” lawsuits, we also know how low the risks, and costs, are for enterprising plaintiffs’ lawyers to try again in another federal district.

Also published by on WLF’s contributor page.