Photo credit: Luiscarlosrubino (Copyright information)
What distinguishes a “cosmetic” from a “drug” under the Federal Food, Drug, and Cosmetic Act (FDCA)? The FDA has struggled to offer clear guidance on the distinction, but the classification as one or the other (or both) carries significant legal and regulatory consequences for manufacturers: a product that is a “drug” needs pre-market approval from the FDA, while a “cosmetic” does not. A cosmetic product that has not received this approval may not represent that, like a drug, it is “intended to affect the structure or any function of the body of man.” 21 U.S.C. § 321(g)(1). Thus, a product that claims to be capable of changing how part of the body works (e.g., “reduces cellulite” or “regenerates cells”), but has not been subjected to this pre-approval process, is considered mislabeled under the FDCA.
The potential consequence of such mislabeling is not just limited to agency action. In the past few years, plaintiffs have tried to package “cosmetics improperly marketed as drugs” as a basis for consumer false advertising class actions. As we have previously written, to skirt the statutory prohibition on private enforcement of the FDCA, see 21 U.S.C. § 337(a), these plaintiffs have alleged that, by violating the FDCA, the defendant also violated one or more state consumer protection laws that expressly adopt or incorporate the FDCA’s provisions. Those claims have been met with mixed success. A recent decision out of California federal district court, Somers v. Beiersdorf, Inc., 2020 WL 1890575 (S.D. Cal. Apr. 15, 2020), offers a blueprint for defending against such challenges—and suggests some momentum in favor of courts finding such claims preempted.
Case Background
The plaintiff in Somers brought a putative class action against Beiersdorf, Inc., the manufacturer of Nivea CoQ10 Lotion. Id. at *1. The plaintiff alleged that certain claims made on the lotion’s label—including, for example, its purported ability “to firm and tighten [the] skin’s surface in as little as two weeks,” id.—demonstrated that the product was “intended to affect the structure . . . of the body,” and thus, was really intended as a drug, not a cosmetic.
Consequently, the plaintiff asserted, the lotion had been improperly marketed without the FDA preapproval necessary for new drugs. Id. at *4. Rather than sue directly under the FDCA—which would have ensured prompt dismissal for lack of a private right of action—the plaintiff sued under California’s Sherman Law, which (like the FDCA itself) requires drug manufacturers to obtain approval from the FDA before selling “any new drug.” Id. (quoting Cal. Health & Safety Code § 111550).
Photo credit: Somers, No. 14-cv-2241 (S.D. Cal.), DE 1-1 at 4.
Beiersdorf moved for summary judgment, arguing both that the lotion was a cosmetic, not a drug, and that in any event, the plaintiff’s claims were preempted by the FDCA. Id. at *1.
The Somers Court’s Decision
In its April 2020 decision, the court agreed with Beiersdorf that the FDCA preempted the plaintiff’s claims. The court first recognized that “the distinction between drugs and cosmetics is a difficult one,” which was one reason why “Congress gave FDA the sole authority to police violations of the FDCA.” Id. at *2. The court then cited Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013), in which the Ninth Circuit stated that plaintiffs must navigate a “narrow gap” if they wish “to escape preemption by the FDCA: The plaintiff must be suing for conduct that violates the FDCA,” or else the claim will impermissibly conflict with federal law—“but the plaintiff must not be suing because the conduct violates the FDCA,” or else the claim will be tantamount to impermissible private enforcement of the statute. Id. at 1120 (citation omitted).
The court in Somers found that the plaintiff’s claims could “not thread that narrow gap.” 2020 WL 1890575 at *3. Instead, the court reasoned that Somers’ complaint—which “repeatedly reference[d]” the FDCA’s provisions—made “clear that,” regardless of her choice to sue under state law, rather than directly under the FDCA, “she [was] suing Beiersdorf because its decision to sell the Nivea CoQ10 Lotion violated the FDCA.” Id. The plaintiff had not, for example, cited “any separate or distinct state law drug [approval] process that should have been followed.” Id. (Nor does any such California-specific drug approval process exist.) Thus, the court could find “no reasonable way to construe [the plaintiff’s liability theory] except as an attempt to privately enforce the FDCA”—a right that Congress has expressly “committed by law to the FDA.” Id. The court also found it relevant that the plaintiff had previously sought relief from the FDA by asking it to send Beiersdorf a warning letter, which the agency declined to do. Id.
The court acknowledged that some prior cases had held that mislabeling claims brought under California’s Sherman Law were not preempted by the FDCA because the Sherman Law imposes “parallel obligations” that are substantively identical to, yet separate from, the FDCA. See id. at *4. In Farm Raised Salmon Cases, for example, the California Supreme Court held that a private plaintiff’s challenge to a company’s use of undisclosed artificial colors in salmon was not preempted by the FDCA because the allegations were “predicated on violations of obligations imposed by the Sherman Law”—even though the FDCA required that any such state law impose “obligations identical to those imposed by the FDCA.” 42 Cal. 4th 1077, 1181 (2008). But the court in Somers distinguished Farm Raised Salmon and similar cases on the ground that they arose “from the food labeling context.” 2020 WL 1890575 at *4. The court suggested that, while food labeling is “undoubtedly ‘within the state’s historic police powers,’ the same cannot be said for a new drug approval, a process that is uniquely federal.” Id. (citation omitted). Indeed, unlike in Farm Raised Salmon and similar food mislabeling cases, the plaintiff’s liability theory in Somers expressly faulted Beiersdorf for not approaching and obtaining approval from a federal agency—the FDA. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 347 (2001) (noting that a company’s “dealings with the FDA,” a federal agency, are “inherently federal in character”); PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2578 (2011) (observing that the FDCA “preempt[s] a state-law tort claim based on failure to properly communicate with the FDA”).
Notably, Somers tried unsuccessfully to distinguish her case from Borchenko v. L’Oreal USA, Inc., 389 F. Supp. 3d 769 (C.D. Cal. 2019), in which the court had found similar claims regarding skin-care products preempted, on the ground that she sought monetary rather than injunctive relief. The Somers court held that “nothing in the Borchenko opinion . . . suggest[ed] that the presence of injunctive relief was determinative” of whether a claim was preempted by the FDCA. Somers, 2020 WL 1890575 at *4. This was the correct conclusion: after all, in Buckman, the Supreme Court’s seminal case finding preemption of claims involving “dealings with the FDA,” the plaintiffs likewise sought money damages, rather than injunctive relief. See 531 U.S. at 343 (noting that “plaintiffs sought damages from petitioner under state tort law” (emphasis added)).
Key Takeaways
Somers reflects California federal courts’ growing skepticism—first articulated in Perez and more recently reaffirmed in Borchenko—toward recognizing an indirect private right to enforce the FDCA using California’s Sherman Law as a vehicle. As the Somers court sensibly emphasized, Congress saw fit to make the FDA the sole arbiter of whether a product complies with the FDCA’s provisions—especially in light of the often hazy distinction between drugs and cosmetics. That decision reflects the reasoned judgment of Congress that only the FDA has the knowledge, experience, and expertise necessary to make discretionary choices about when and how to enforce the statute. See Sigma-Tau Pharms. v. Schwetz, 288 F.3d 141, 146-47 (4th Cir. 2002) (noting that the determination of an article’s proper classification under the FDCA “entail[s] the exercise of judgment grounded in policy concerns”). By permitting private plaintiffs to bring state-law claims that depend entirely on the proper interpretation of the FDCA’s requirements—claims which would penalize businesses for not “properly” engaging with the FDA—courts would risk disrupting the FDA’s carefully defined role in enforcing these provisions. See Somers, 2020 WL 1890575 at *2–4.
Somers also reflects a growing consensus that the correct approach to preemption in cases like these turns not on the superficial “form” of the plaintiff’s claim, but on its “real-world consequences.” Northwest, Inc. v. Ginsberg, 134 S. Ct. 1422, 1430 (2014). No court would permit a private plaintiff to bring a claim like the one in Somers if it were expressly couched as a claim for violating the FDCA. But merely reframing that claim as one for violating state laws that incorporate the FDCA does not change the “real-world consequences” of the claim one iota. If the former claim would improperly usurp the FDA’s authority and “exert an extraneous pull on the scheme established by Congress,” Buckman, 531 U.S. at 353, the latter claim necessarily would as well, since it penalizes the exact same conduct. As another federal court recently explained, “[i]t would not mean much for Congress to foreclose private enforcement of the FDA if this meant that any plaintiff could end-run this restriction by suing to enforce the FDCA under the guise of a state law claim for relief.” Patane v. Nestlé Waters N. Am., Inc., 314 F. Supp. 3d 375, 385 (D. Conn. 2018).
We commend the Somers court for blocking another attempted “end-run” around the FDCA’s private enforcement ban. Hopefully, other courts will follow the same playbook.
