In the present day’s visitor put up is by Amy McVeigh and Jessica Farmer, who’re companions at Holland & Knight. They touch upon the demise of one other purported class motion towards a producer of hydrogen peroxide, which is an FDA-regulated over-the-counter (“OTC”) drug. As all the time our visitor posters deserve 100% of the credit score (and any blame) for for his or her work.

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In the present day’s put up dives into the fizz of authorized battles over the adequacy of labeling of over-the-counter (“OTC”) hydrogen peroxide.  You would possibly suppose hydrogen peroxide is only a humble brown bottle in your drugs cupboard, revered for its old-timey wound-cleaning prowess and its uncanny capacity to bleach your hair in moments of teenage revolt.  However what’s actually behind that label in your bottle of H₂O₂? And is it deceptive to say that it may be used to “deal with” minor cuts and abrasions?

The Western District of Michigan mentioned “No” to the latter query within the newest OTC preemption resolution involving a hydrogen peroxide product, Bridges v. Meijer, Inc.,2024 WL 1007883, at *3 (W.D. Mich. Feb. 20, 2024), report and advice 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 could recall a prior put up specializing in an identical resolution out of the Northern District of Illinois, Novotney v. Walgreen Co., — F. Supp. 3d —, 2023 WL 4698149 (N.D. Sick. July 20, 2023).  This newest casebuilds on Novotney and in addition will get it proper.

Hydrogen peroxide has lengthy been offered over-the-counter as a primary assist antiseptic.  Like different OTC merchandise, the FDA regulates hydrogen peroxide merchandise by means of a monograph course of.  A “monograph” is an in depth regulation describing the circumstances beneath which a category of medicine could be marketed with no prescription.  See 21 C.F.R. § 330.1; Nat. Res. Def. Council, Inc. v. U.S. Meals & Drug Admin., 710 F.3d 71, 75 (second Cir. 2013) (describing monograph course of).  It is sort of a “recipe” for that exact product which, amongst different issues, units out labeling necessities.  NRDC, 710 F.3d at 75.

In Bridges, the plaintiff asserted numerous state-law claims claiming that Meijer’s private-label hydrogen peroxide resolution was “misbranded” as a result of it was promoted “For Remedy of Minor Cuts and Abrasions.”  Like different latest hydrogen peroxide circumstances, plaintiff argued that the phrase “therapy” on the label was deceptive as a result of the phrase “deal with” means to “heal” or “treatment” and hydrogen peroxide couldn’t, really, heal or treatment cuts or abrasions.  She alleged that she paid a premium for the product—of a minimum of $1.29—based mostly on her understanding of the phrase “deal with” and sought to certify financial loss courses of Illinois, Michigan, Ohio, Indiana, Kentucky, and Wisconsin residents.

In fact, Weblog devotees and preemption fans know that with respect to OTC merchandise, Congress prohibited the states from establishing “any requirement … that’s totally different from or along with, or that’s in any other case not equivalent with, a requirement” imposed beneath federal regulation.  21. U.S.C. § 379r(a)(2).  Plaintiff argued that her state regulation claims weren’t preempted by this provision as a result of the FDA by no means endorsed the labeling of hydrogen peroxide for “therapy” functions and since “hydrogen peroxide doesn’t deal with minor cuts and abrasions as a result of no proof helps a connection between the variety of micro organism and discount in therapeutic time of a clear wound.”  However as Defendants identified, the FDA itself used the phrase “deal with” greater than 50 instances within the monograph, and used it to imply “give medical care to” or “apply topically.”  See Topical Antimicrobial Drug Merchandise for Over-the-Counter Human Use; Tentative Closing Monograph for First Help Antiseptic Drug Merchandise, 56 Fed. Reg. 33651; 33655, 1991 WL 303853 (Jul. 22, 1991).

In the end, relying closely on Novotney’s reasoning, the Courtroom held that the product’s labeling complied with FDA requirements, citing Novotney’s conclusion that “by claiming that another terminology is important to make sure that the label just isn’t deceptive, plaintiff impermissibly claims that state regulation imposes necessities which might be totally different from, extra to, or in any other case not equivalent with, the necessities 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. Sick. July 23, 2023)).  The Courtroom subsequently dismissed all of plaintiff’s state regulation claims as expressly preempted beneath 379(r).

Having disbursed with the state regulation claims, the Courtroom subsequent turned to the lone declare introduced beneath federal regulation:  violation of the Magnusson-Moss Guarantee Act (“MMWA”).  To state an MMWA declare, nonetheless, a plaintiff wants a viable, underlying state regulation breach of guarantee declare.  The Courtroom rightly held—like others earlier than it—that when the underlying breach of guarantee claims beneath state regulation are preempted, the MMWA declare should even be dismissed, stating “plaintiff’s MMWA declare fails as a result of she has no state regulation guarantee declare with respect to the Product or its label as a “therapy;” any such state regulation declare is preempted by federal regulation.”  2024 WL 1007883 at *3; see additionally In re Zantac (Ranitidine) Prod. Liab. Litig., 510 F. Supp. 3d 1141, 1172, (S.D. Fla. 2020).

In sum, it’s not deceptive to say that hydrogen peroxide can be utilized for therapy of minor cuts and abrasions.  However the everlasting query stays for an additional day: “who’s liable for my hair turning orange?”