Are moisturizing lotions cosmetics or drugs? They say on TV that lotions “lift and moisturize,” but does that move them into the “Drug” column of the “Food Drug and Cosmetic” ledger? We will hazard a guess that lotions are usually cosmetics, but what if the manufacturer adds an SPF factor? We would then say that our moisturizing lotion is now a drug—regulated by FDA monographs that apply to sunscreens. How about shampoo—drug or cosmetic? Or the cleansing bar that is dissolving day by day in our shower? We would say those are cosmetics, too. But again, it can be complicated. What if the shampoo is medicated for dandruff, or our shrinking cleansing bar includes antibacterial agents or benzoyl peroxide for acne? That would probably make them drugs, or maybe both. What would you think about an ordinary bar of soap made from fat and alkali, such as lye? Drug or cosmetic? The answer is neither—soap is soap, and it is regulated by the Consumer Product Safety Commission, not the FDA. Go figure.
We’re having a little fun here, but the category into which a product falls makes a huge difference in how the product is regulated and how litigation over that product will play out. And much of that relates to the application of Bexis’ favorite section of the Food Drug and Cosmetic Act—Section 337(a), which gives the United States the sole authority to police violations of the FDCA. That is to say, there is no private right of action. See Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).
Take for example a consumer class action that recently met its demise in California, Somers v. Beiersdorf, Inc., No. 14-cv-2241, 2020 WL 1890575 (S.D. Cal. Apr. 15, 2020). In Somers, the plaintiff staked her claim on her characterization of moisturizing lotion as a “drug,” and she lived to regret it. That is because her self-styled “drug” case ran headlong into Section 337(a) and implied federal preemption.
Here is what happened. The plaintiff bought a particular brand of lotion on the Internet and sued the lotion manufacturer claiming that the sale was an “unlawful business practice or act” under California’s Unfair Competition Law. Id. at *1. Her basis was that the lotion was a “drug” sold without the approval of the FDA. The difference between a drug and a cosmetic depends on the intended use. Under the FDCA, “cosmetics” are “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Id. at *2 (citing 21 U.S.C. § 321(i)). On the other hand, “drugs” are articles “intended to affect the structure or any function of the body of man.” Id. (citing 21 U.S.C. § 321(g)(1)).
With these definitions in mind, the examples with which we started this post make more sense (although we will not attempt to explain why soap gets special treatment). For the defendant in Somers, it made sense to move for summary judgment on two bases—(1) that by alleging the sale was “unlawful” because it violated the FDCA, the plaintiff was privately enforcing the FDCA contrary to federal law (i.e., federal preemption); and (2) that the lotion was a cosmetic, not a drug. Id. at *1.
As much as we would like to debate whether this lotion was a cosmetic or a drug, the district court granted summary judgment on the first argument—federal preemption. The plaintiff had only one basis for her claim—that the lotion was a drug and that its sale therefore violated the FDCA. In other words, the plaintiff pleaded herself into a preemption corner:
Plaintiff’s Third Amended Complaint—which repeatedly references provisions of the FDCA—makes clear that she is suing [the defendant] because its decision to sell the . . . Lotion violated the FDCA. . . . She alleges, for example, that “Defendants engaged in illegal conduct by unlawfully making skin firming representations about its . . . Lotion that resulted in its being deemed a drug under FDA regulations, but did so without obtaining required FDA approval through the FDA NDA [New Drug Approval] process.” . . . There is no reasonable way to construe this allegation except as an attempt to privately enforce the FDCA, enforcement that has been committed by law to the FDA.
Id. at *3 (emphasis added). Because federal law allows only the FDA to enforce the FDCA, the plaintiff’s state-law claim purporting to do the same thing was preempted. Id.
None of the plaintiff’s arguments could avoid this result. First, the plaintiff argued that she was not enforcing FDCA, but was enforcing California’s Sherman Act, a state statute that prohibits the sale of “any new drug” unless the drug has “been approved . . . under . . . the federal act. Id. at *4 (citing Cal. Health & Safety Code § 111550). The district court rejected this argument as circular, observing that “a drug can only be unlawful under the California statute if it violates the FDCA.” Id.
Second, the plaintiff unsuccessfully drew comparisons to food labeling litigation, where some California plaintiffs have been allowed to pursue claims under state laws creating “parallel obligations.” Id. We are aware of those cases, and we have roundly criticized the California Supreme Court’s “food” jurisprudence here and here. This, alas, was not a food case. It was a “drug” case, and drug approval is firmly and uniquely within federal power. Id. Moreover, even the wrongly decided California food cases conclude that state food labeling laws are not preempted “to the extent they ‘do not seek to enforce the FDCA.’” Id. Here, the plaintiff was overtly purporting to enforce the FDCA, so her claim was preempted no matter what. Id. In coming to this conclusion, the district court relied on another recent lotion qua drug case that likewise found state-law claims preempted, Borchenko v. L’Oreal USA, Inc., 389 F. Supp. 3d 769 (C.D. Cal. 2019). You can read our take on Borchenko here.
Our takeaway is that the plaintiff’s attempt to “foodify” cosmetic litigation in California was a legal failure. The district court closed with this flair: “Because Congress has given the FDA a monopoly on FDCA enforcement in the New Drug Approval context, [the plaintiff’s] claims are preempted. As other courts have recognized, ‘the [FDCA’s] public enforcement mechanism is thwarted if savvy plaintiffs can label as arising under a state law for which there exists a private enforcement mechanism a claim that in substance seeks to enforce the FDCA.’” Id. at *5 (quoting Loreto v. Proctor & Gamble, 515 F. App’x 576, 579 (6th Cir. 2013)). A true and correct result.