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Today’s guest post is by Amy McVeigh and Jessica Farmer, who are partners at Holland & Knight. They comment on the demise of another purported class action against a manufacturer of hydrogen peroxide, which is an FDA-regulated over-the-counter (“OTC”) drug. As always our guest posters deserve 100% of the credit (and any blame) for for their work.


Today’s post dives into the fizz of legal battles over the adequacy of labeling of over-the-counter (“OTC”) hydrogen peroxide.  You might think hydrogen peroxide is just a humble brown bottle in your medicine cabinet, revered for its old-timey wound-cleaning prowess and its uncanny ability to bleach your hair in moments of teenage rebellion.  But what’s really behind that label on your bottle of H2O2? And is it misleading to say that it can be used to “treat” minor cuts and abrasions?

The Western District of Michigan said “No” to the latter question in the latest OTC preemption decision involving a hydrogen peroxide product, Bridges v. Meijer, Inc.,2024 WL 1007883, at *3 (W.D. Mich. Feb. 20, 2024), report and recommendation adopted sub nom. Lashan Bridges, Plaintiff, v. Meijer, Inc., Defendant, No. 1:22-CV-1112, 2024 WL 1141865 (W.D. Mich. Mar. 15, 2024).  Frequent readers may recall a prior post focusing on a similar decision out of the Northern District of Illinois, Novotney v. Walgreen Co., F. Supp. 3d —, 2023 WL 4698149 (N.D. Ill. July 20, 2023).  This latest casebuilds on Novotney and also gets it right.

Hydrogen peroxide has long been sold over-the-counter as a first aid antiseptic.  Like other OTC products, the FDA regulates hydrogen peroxide products through a monograph process.  A “monograph” is a detailed regulation describing the conditions under which a class of drugs can be marketed without a prescription.  See 21 C.F.R. § 330.1; Nat. Res. Def. Council, Inc. v. U.S. Food & Drug Admin., 710 F.3d 71, 75 (2d Cir. 2013) (describing monograph process).  It is like a “recipe” for that particular product which, among other things, sets out labeling requirements.  NRDC, 710 F.3d at 75.

In Bridges, the plaintiff asserted a number of state-law claims claiming that Meijer’s private-label hydrogen peroxide solution was “misbranded” because it was promoted “For Treatment of Minor Cuts and Abrasions.”  Like other recent hydrogen peroxide cases, plaintiff argued that the word “treatment” on the label was misleading because the word “treat” means to “heal” or “cure” and hydrogen peroxide could not, actually, heal or cure cuts or abrasions.  She alleged that she paid a premium for the product—of at least $1.29—based on her understanding of the word “treat” and sought to certify economic loss classes of Illinois, Michigan, Ohio, Indiana, Kentucky, and Wisconsin residents.

Of course, Blog devotees and preemption enthusiasts know that with respect to OTC products, Congress prohibited the states from establishing “any requirement … that is different from or in addition to, or that is otherwise not identical with, a requirement” imposed under federal law.  21. U.S.C. § 379r(a)(2).  Plaintiff argued that her state law claims were not preempted by this provision because the FDA never endorsed the labeling of hydrogen peroxide for “treatment” purposes and because “hydrogen peroxide does not treat minor cuts and abrasions because no evidence supports a connection between the number of bacteria and reduction in healing time of a clean wound.”  But as Defendants pointed out, the FDA itself used the word “treat” more than 50 times in the monograph, and used it to mean “give medical care to” or “apply topically.”  See Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for First Aid Antiseptic Drug Products, 56 Fed. Reg. 33651; 33655, 1991 WL 303853 (Jul. 22, 1991).

Ultimately, relying heavily on Novotney’s reasoning, the Court held that the product’s labeling complied with FDA standards, citing Novotney’s conclusion that “by claiming that some other terminology is necessary to ensure that the label is not misleading, plaintiff impermissibly claims that state law imposes requirements that are different from, additional to, or otherwise not identical with, the requirements of the FDCA. 2024 WL 1007883 at *3 (citing Novotney v. Walgreen Co., No. 22 C 3439, 2023 WL 4698149, — F. Supp. 3d — (N.D. Ill. July 23, 2023)).  The Court therefore dismissed all of plaintiff’s state law claims as expressly preempted under 379(r).

Having dispensed with the state law claims, the Court next turned to the lone claim brought under federal law:  violation of the Magnusson-Moss Warranty Act (“MMWA”).  To state an MMWA claim, however, a plaintiff needs a viable, underlying state law breach of warranty claim.  The Court rightly held—like others before it—that when the underlying breach of warranty claims under state law are preempted, the MMWA claim must also be dismissed, stating “plaintiff’s MMWA claim fails because she has no state law warranty claim with respect to the Product or its label as a “treatment;” any such state law claim is preempted by federal law.”  2024 WL 1007883 at *3; see also In re Zantac (Ranitidine) Prod. Liab. Litig., 510 F. Supp. 3d 1141, 1172, (S.D. Fla. 2020).

In sum, it is not misleading to say that hydrogen peroxide can be used for treatment of minor cuts and abrasions.  But the eternal question remains for another day: “who is responsible for my hair turning orange?”