Our leadership
Learn more
We held off blogging about Navarro v. Walgreens Boots Alliance, Inc., 2026 WL 2355975 (Mag. E.D. Cal. Aug. 13, 2026) (“Navarro I”), in the hope that this absurd magistrate decision would be reversed by the district court. That didn’t happen – see Navarro v. Walgreens Boots Alliance, Inc., 2026 WL 2924631 (E.D. Cal. Sept. 29, 2026) (“Navarro II”). So, let’s dive into this ridiculous and atextual result.
This litigation is another example of the out-of-control OTC drug consumer class action environment enabled by an obsolete “zombie” presumption against preemption decision from the Ninth Circuit, Astiana v. Hain Celestial Group, Inc., 783 F.3d 753 (9th Cir. 2015), abrogated on other grounds, Hartford Casualty Insurance Co. v. J.R. Marketing, LLC, 353 P.3d 319 (Cal. 2015). We discussed this aspect of Astiana in our general OTC preemption post, here.
The Navarro I magistrate decision expressly relied on Astiana in holding that the plaintiff could ignore the express preemption clause directly governing OTC drugs, 21 U.S.C. §379r(a), in reliance on general FDCA “misbranding” language, so that plaintiffs could pursue warning claims directly contrary to what the FDA’s preemptive monograph allowed:
Chapter V of the FDCA generally prohibits the misbranding of drugs. 21 U.S.C. §352. A drug is misbranded if its labeling is false or misleading in any particular. Id. The Ninth Circuit has made clear that state causes of action alleging that a label is “false or misleading in any particular” are not generally preempted by the FDCA even if there is not a specific FDA regulation prohibiting the statement. See Astiana v. Hain Celestial Grp., Inc., 783 F.3d 753, 758-59 (9th Cir. 2015) (in context of cosmetics). . . . That is, OTC acne medications, among other requirements, must not contain labeling that is false or misleading in any particular.
Navarro I, 2026 WL 2355975, at *22.
But as we discussed in our prior post, the 2015 Astiana decision explicitly relied on a presumption against preemption in narrowly construing identical express preemption language in §379s (concerning cosmetics), to allow generalized “misbranding” claims to survive preemption:
In analyzing express preemption, we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress. The FDCA proscribes any . . . labeling that is false or misleading in any particular.
783 F.3d at 757.
That presumption no longer exists in cases such as Navarro that involve express preemption. One year after Astiana, the Supreme Court outright abolished any purported presumption against preemption in express preemption cases:
The plain text of the [preemption clause] begins and ends our analysis. . . . And because the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.
Puerto Rico v. Franklin California Tax-Free Trust, 579 U.S. 115, 125 (2016) (citations omitted).
Since PR v. Franklin, the Ninth Circuit has repeatedly rejected attempts to rely on any presumption against preemption in express preemption cases. In Hollins v. Walmart, Inc., 67 F.4th 1011 (9th Cir. 2023), an FDCA case, the court held – directly contrary to Astiana:
[A] state-law misbranding claim that would allow a state to impose requirements different from those permitted under the FDCA is preempted. “[W]e do not invoke any presumption against pre-emption” where, as here, “the statute contains an express pre-emption clause.”
Id. at 1016 (quoting PR v. Franklin; other citations and quotation marks omitted). Numerous other Ninth Circuit decisions likewise recognize the demise of any presumption against express preemption. See KalshiEX, LLC v. Assad, 190 F.4th 1098, 1110 (9th Cir. 2026) (“we decline to apply any presumption against preemption and instead focus on the plain wording of [the statutory preemption clause]”) (citation and quotation marks omitted); American Apparel & Footwear Ass’n, Inc. v. Baden, 107 F.4th 934, 939 (9th Cir. 2024) (“the plain wording of the express preemption clause ‘necessarily contains the best evidence of Congress’[s] preemptive intent’”) (quoting PR v. Franklin); Assurance Wireless USA, L.P. v. Reynolds, 100 F.4th 1024, 1032 & n.4 (9th Cir. 2024) (“When a statute contains an express preemption clause, we look only to the text ‘without any presumptive thumb on the scale for or against preemption.’”; “[t]he presumption against preemption does not apply when there is an express preemption clause”) (quoting California Restaurant); California Restaurant Assn. v. City of Berkeley, 89 F.4th 1101, 1050 (9th Cir. 2024) (“we apply [statutory] textual analysis without any presumptive thumb on the scale”) (citation and quotation marks omitted); National Railroad Passenger Corp. v. Su, 41 F.4th 1147, 1153 n.1 (9th Cir. 2022) (“because the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption”) (quoting PR v. Franklin); Nacarino v. Kashi Co., 77 F.4th 1201, 1204 (9th Cir. 2023) (“[w]hen, as here, ‘the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause”) (quoting PR v. Franklin); R.J. Reynolds Tobacco Co. v. County of Los Angeles, 29 F.4th 542, 553 n.6 (9th Cir. 2022) (quoted in California Restaurant); Webb v. Trader Joe’s Co., 999 F.3d 1196, 1202 (9th Cir. 2021) (“[w]here the intent of a statutory provision that speaks expressly to the question of preemption is at issue, we do not invoke any presumption against pre-emption”) (citation and quotation marks omitted); Connell v. Lima Corp., 988 F.3d 1089, 1097 (9th Cir. 2021) (quoting PR v. Franklin); International Brotherhood of Teamsters, Local 2785 v. Federal Motor Carrier Safety Administration, 986 F.3d 841, 853 (9th Cir. 2021) (same as Nacarino); Atay v. County of Maui, 842 F.3d 688, 699 (9th Cir. 2016) (quoted in Webb).
Thus, the Ninth Circuit, following controlling Supreme Court precedent, has massively repudiated the presumption against preemption reasoning that led to the Astiana court’s creation of a “misbranding” exception to §379r(a)’s express language that all state tort claims that are “different from or in addition to, or that [are] otherwise not identical with” the FDA’s OTC drug requirements are preempted and thus of no effect. Nonetheless, Navarro I went down the Astiana road and reached an absurd result.
The Navarro class action plaintiffs brought state-law claims for unfair competition, false advertising, consumer protection violations, breach of express and implied warranties, and unjust enrichment. Nobody was hurt; they sought recovery only of purported economic harms. Navarro I, 2026 WL 2355975, at *4-5. The liability allegations are familiar – the defendant allegedly sold an OTC products (acne treatment) that purportedly “contain and/or degrade into dangerously high levels of benzene” which plaintiffs claim, in this context, is an “impurity, and illegal adulterant.” Id. at *1.
The trouble is, as many other courts – particularly outside the Ninth Circuit − have found, is that the FDA issued a “drug monograph” for these products that allowed use of the ingredient in question (benzol peroxide (“BPO”)) as an active ingredient in these medications and did not require any warnings about that ingredient decomposing into benzene. Id. at *8 (“The Acne Monograph expressly permits BPO to be an active ingredient in these products in an amount from 2.5 to 10 percent.”). Plaintiffs claim that this can happen, if one literally cooks the product at “122 degrees Fahrenheit for 18 days” as the plaintiff-friendly Valisure litigation lab did. Id. at *3. That’s a hotter stretch than Death Valley in the summertime.
To avoid preemptive effect of §379r(a)’s preemptive prohibition of state labeling requirement “different from or in addition to, or that [are] otherwise not identical with”, the magistrate in Navarro I jerry rigged a legal contraption that began with a sentence in the monograph that this type of product “is not misbranded if it meets each of the conditions in this subpart and each general condition established in §330.1 of this chapter.“ 2026 WL 2355975, at *9 (emphasis original). But §330.1 provides only that a nonconforming product is “liable to regulatory action.” Id. Nothing in that section says anything about preemption or state law. The magistrate then concluded that, because the monograph “in turn incorporates Chapter V labeling requirements,” id. at *10, it can use the adulteration/misbranding dodge to avoid the express terms of §379r(a). “[A] theory of misbranding, pursuant to state-law, may sufficiently parallel the FDCA’s requirements under Chapter V.” Id.
Navarro I also had avoid the Supreme Court’s recent Durnell reaffirmation of the preemptive effect of similar preemption language. It did so with a bootstrap argument relying on the same rationale it had just cobbled together:
The Court has reviewed the case and finds that it is not apposite to the case at bar. Critically, Durnell did not involve the interplay between a monograph and preemption statute. Rather, in Durnell − a case involving pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act − the issue before the Court involved only a preemption statute.
Id. at 10 (citation omitted). That is an excuse rather than a reason.
As the Supreme Court recognized, the language of FIFRA and the FDCA is quite similar. Durnell held that “different from” and “in addition to” preemption language (part of §379r(a) as well) mean just that
In sum, federal law requires [defendant] to sell [its product] with the label that EPA approved . . . − that is, the label without a cancer warning. [Plaintiff]’s state tort claim, by contrast, would require [defendant] to add a cancer warning to its labels. That [state]-law requirement is “in addition to” and “different from” [defendant]’s federal-law labeling obligations.
Monsanto Co. v. Durnell, 609 U.S. 371, 385 (2026). No “interplay” is necessary under Durnell. The language state law purportedly demanded was “different from” and “in addition to” what the responsible regulatory agency required. Therefore, it was preempted. Nor could “general” misbranding allegations overcome the “specific requirements” applicable to the particular product at issue:
[T]hat argument operates at far too high a level of generality and disregards the central and comprehensive role that [agency] performs in making labeling determinations under [the statute’s] registration provisions. Looking at only {the statute’s] general standard for misbranding rather than the specific requirements imposed under federal law would nullify [the statute’s] preemption clause and the uniformity that Congress sought for safety warnings on pesticide labels.
Id. at 388. Durnell thus does not admit of Navarro I-style sophistry. “If FDA’s premarket approval . . . preempted additional state-law requirements, so too must EPA’s registration.” Id. at 387.
To allow plaintiffs’ adulteration claim, Navarro I engaged in similarly makeshift analysis that invoked a general FDCA provision (21 U.S.C. §351(b)) and something from out in left field – the United States Pharmacopœia. Rather than make this post even longer by explaining this ourselves, we instead offer the analysis in a more recent decision in the same litigation that thoroughly debunks this contrived argument:
The pathway from the FDCA to the USP standards is found at 21 U.S.C §351(b), which states that a drug is adulterated “[i]f it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium.” Plaintiffs then claim that “[u]nder USP General Chapter 467, benzene is limited to 2 ppm in pharmaceuticals.”
The problem is that the USP General Chapter 467 limit applies to benzene when used as a “Residual Solvent.” Chapter 467 defines residual solvents in pharmaceuticals “as organic volatile chemicals that are used or produced in the manufacture of drug substances . . ., or in the preparation of drug products” and that “are not completely removed by practical manufacturing techniques.”. . . .
Plaintiffs’ allegation . . . is that BPO, through a multi-step process, “decompose[s]” into benzene. . . . In Plaintiffs’ words, benzene is not directly “produced” in the manufacturing process and, therefore, does not fall under USP Chapter 467’s definition of a residual solvent.
Lastly, the Court makes a final observation on the repeated use of the word “should” throughout USP Chapter 467, which causes its statements to be read as recommendations not binding requirements. . . . Even if benzene somehow met USP Chapter 467’s definition of a “residual solvent,” the Court would find that USP Chapter 467 . . . is non-binding guidance.
In re L’Oreal USA Benzoyl Peroxide Products Litigation, ___ F. Supp.3d ___, 2026 WL 2719653, at *10 (S.D.N.Y. Sept. 15, 2026) (citations omitted) (emphasis added). Plaintiffs’ allegations in this litigation about where benzene supposedly comes from are identical. E.g., Navarro I, 2026 WL 2355975, at *2 (“Plaintiffs allege that the BPO in products made and sold by [defendant] degrades over time to directly form benzene.”). The USP aspect of the opinion is another slipshod excuse to avoid preemption.
The result is facially absurd. The controlling FDA monograph has consistently allowed the active ingredient BPO as an active ingredient in the subject product. The same monograph does not mandate any labeling concerning “benzene” in any form. Congress’ express preemption language flatly precludes any purportedly state-law claim that is “different from or in addition to, or that is otherwise not identical with” the FDA’s requirements. Nonetheless, by relying on general “adulteration”/”misbranding” provisions, Navarro I allowed exactly that – state law claims demanding “benzene” labeling – in short “parallel” claims that are in no way parallel to what the legally binding FDA monograph requires.
We were inclined to dismiss Navarro I as the misguided work of a pro-plaintiff magistrate, but we were wrong. In a three-page order, Navarro II, 2026 WL 2924631, adopted Navarro I in full. It refused to follow either Durnell, Yousefzadeh v. Johnson & Johnson Consumer Inc., 184 F.4th 130 (2d Cir. July 30, 2026), or L’Oreal USA Benzoyl Peroxide, 2026 WL 2719653. As we recently discussed, Yousefzadeh, specifically rejected the presumption-based preemption analysis in Astiana that allowed “misbranding” claims contrary to the FDA’s product-specific requirements. In a single sentence, Navarro II declared Durnell “unavailing” without coming to grips with the Supreme Court’s specific rejection of misbranding/adulteration claims that negate product-specific agency requirements. 2026 WL 2924631, at *2. It dispensed with Yousefzadeh in another single sentence, based on the unelaborated “facts and circumstances of this case.” Id. Finally, it flatly rejected the holdings of the MDL court in L’Oreal USA Benzoyl Peroxide:
Finally, defendant’s post-objection supplemental authority, In re L’Oréal USA Benzoyl Peroxide Products Litigation, 2026 WL 2719653 . . ., is non-binding and in any event, is not a basis to depart from the instant findings and recommendations. L’Oréal’s determination that the FDA considered and resolved BPO related benzene risk through the monograph and GRASE findings is belied by the FDA’s subsequent benzene alerts and warnings, the independent [Valisure Death Valley Days] testing. . . . Also, the L’Oréal Court’s rejection of the theory that benzene is a residual solvent for purposes of USP Chapter (467) did not consider BPO degradation as a potential solvent source, a matter discussed in detail by the magistrate judge.
2026 WL 2924631, at *2. As our block quote from L’Oréal two paragraphs previous demonstrates, Navarro II’s last critique about failure to “consider” product “degradation” in connection with the plaintiffs’ “USP” argument is simply wrong. L’Oréal, considered that claim in depth and found that degradation allegations inherently precluded reliance on the USP (which lacked force of law in any event).
We’ve already discussed in our prior post about Yousefzadeh that there is now an express circuit split between the Second and Ninth Circuits on the fundamental issue in Navarro, which is the use of generalized misbranding/adulteration allegations in OTC preemption cases to assert claims at odds with FDA product-specific requirements. The Ninth Circuit’s Astiana-based approach is undercut by the Supreme Court’s subsequent abolition of presumptions against express preemption, while the Second Circuit’s view is bolstered by Durnell’s recent rejection of such claims in the FIFRA context. Now it looks like the same circuit split has also arisen specifically in the BPO litigation – with Navarro rejecting the MDL decision in L’Oréal.
If ever a decision warranted interlocutory appeal to resolve controlling and fundamental judicial conflicts, the Navarro litigation is it.