We’ve blogged a lot recently about preemption and the dismissal of complaints alleging that certain over the counter products, including acne medications, sunscreens, antiperspirants, expectorants, and shampoos contain benzene.  Almost a year ago we blogged about the dismissal of an OTC case involving medicated shampoo that allowed plaintiff leave to amend. Today’s decision, Pineda v. Lake Consumer Products, Inc., 2025 WL 2698991 (E.D. Pa. Sept. 22, 2025), is a mixed bag that addresses plaintiff’s amended complaint. It’s about coal-tar shampoos, which are known to include benzene and are subject to an FDA monograph that recognizes the naturally occurring presence of benzene in coal tar. Yet, shockingly, plaintiff filed a class action claiming she would not have purchased the shampoos had she known they contained benzene.

Plaintiff claimed that she purchased certain of the defendant’s dandruff and psoriasis shampoos that contained coal tar and discovered that they contained benzene. She brought a class action claiming that “there should not be any benzene in [defendant’s products,] that the contamination was avoidable,” and that she would not have purchased the products if she had known they contain benzene. Id. at *1.   In its motion to dismiss, the defendant pointed out that the FDA knew that coal tar contained benzene, emphasizing the following:

• In its notice of proposed rulemaking, an FDA panel concluded that “coal tar preparations are safe and effective for OTC use as shampoos for controlling dandruff and seborrheic dermatitis and psoriasis of the scalp.” Defendant’s Brief in Support of Motion to Dismiss, p. 3, No. 5:24-cv-01074 (E.D. Pa. Jan. 17, 2025), ECF No. 37 (quoting 47 Fed. Reg. 54,646 (Dec. 3, 1982)) (hereafter “Defendant’s Motion to Dismiss”).
• The FDA panel recognized that “coal tar consists generally of 2 to 8 percent light oils (benzene, toluene, and xylene),” and other mid to heavy oils. Id.
• In its tentative final monograph for coal tar containing shampoos, the FDA concluded that “the risks associated with coal tar use are less than the risks associated with alternative forms of psoriasis therapy.” Defendant’s Motion to Dismiss, pp. 3-4 (quoting 51 Fed. Reg. 27,346, 27,349 (July 30, 1986)).

The defendant also included a Prop 65 warning on all of its coal tar shampoo products, wherever sold, that provided:

WARNING: This product can expose you to chemicals including Coal Tar, which is known to the State of California to cause cancer. For more information go to: www.P65Warnings.ca.gov.

Defendant’s Motion to Dismiss, p. 1. (January 17, 2025) (emphasis in original).

The defendant argued that plaintiff’s claims were preempted since the relevant FDA monograph listed coal tar as a permitted active ingredient and did not require the disclosure of benzene on the label. As a result, plaintiff’s claims that (i) benzene should have been identified on the label, and (ii) that the shampoos should not have contained any benzene, sought to impose requirements that were “different from and in addition to those required by the FDCA.”  Id. at *6. 

The court began its preemption analysis by noting that the FDA regulates the defendant’s OTC products and issued a monograph for coal tar for treatment of certain scalp conditions. The monograph expressly permitted coal tar as an active ingredient, and it specified the indications for use, warnings, directions and other mandatory labeling requirements. Id. at *5.  The court held that plaintiff’s claim that the defendant should have warned about the presence of benzene would impose requirements different from and in addition to those imposed by the FDA:

No matter how [plaintiff] attempts to frame her claims, her Amended Complaint seeks to impose liability on [defendant] through a finding that it should have labeled the Products differently – not as required by the FDCA – to warn consumers of the presence of benzene. That is precisely the type of claim that is expressly preempted by the FDCA, and therefore, [plaintiff’s] labeling claims are stricken from her amended complaint.

Id. at *6.

That took care of failure to warn claims, but the court declined to dismiss plaintiff’s claims that the defendant failed to comply with current good manufacturing practices, or “cGMPs.” The court relied on In re Chantix, 735 F. supp. 3d 352, 388-89 (S.D.N.Y. May 28, 2024) for the proposition that allegations “based on specific cGMPs, as incorporated by parallel state regulatory frameworks, may survive preemption at the motion to dismiss stage.” Pineda, 2025 WL 2698991 at *7 (internal citations omitted).  Since plaintiff’s amended complaint identified “several cGMPs that were allegedly violated in connection with the manufacture of the Coal Tar Shampoo product,” the court found the allegations sufficient to survive preemption at the motion to dismiss stage. Id.

The court did not explain the conflict between its ruling that the claims could survive preemption and the fact that plaintiff’s relief—for a coal tar shampoo that did not contain benzene—was squarely at odds with the FDA’s monograph for the shampoos.  If the FDA monograph permitted the presence of benzene in coal tar shampoos, how can a claim that the conformance to cGMPs would have eliminated benzene not impose a requirement different from or in addition to that imposed by the FDA?

On October 2, 2025, the defendant filed a Motion to Certify Order for Interlocutory Appeal, No. 24-cv-1074 (E.D. Pa. Oct. 2, 2025), ECF No. 49. In support of its motion seeking interlocutory relief, the defendant argued that the court missed the preemption analysis in response to plaintiffs’ claims that it failed to comply with cGMP:

Plaintiff’s cGMP-based claims, which are all the claims remaining in this case, ‘are not parallel to the FDCA’s bar on the sale of adulterated or misbranded drugs because the relief [Plaintiff] seeks—the removal of benzene—is fundamentally at odds with the FDA’s monograph. Eisman, 2025 WL 241024, at *5 (quotation omitted). Because the FDA approved the sale of coal tar shampoo as generally safe and effective with full knowledge that it contains benzene, Plaintiff’s contention that cGMPs require the removal of benzene seeks to impose a requirement that ‘is different from or in addition to, or that is otherwise not identical with, a requirement under [the FDCA].’ 21 U.S.C. §379r(a).

Id. at 3 (alterations in original). Despite the effort, on October 31 the court denied defendant’s motion seeking interlocutory relief. Although it seems unlikely that any of the remaining claims could survive summary judgment, the defendant now has to incur the costs of getting to that point.