Key Takeaways
Brower reinforces two strong early defenses against class actions targeting OTC product labeling and marketing. First, plaintiffs alleging product contamination must plead product-specific testing linked to their own purchases; generalized testing or studies will not suffice. Second, omission-based claims are expressly preempted where the FDA’s governing monograph does not require the disclosure plaintiffs seek.
Brower extends to heavy metals claims against Colgate toothpastes the same reasoning we previously wrote about in PFAS consumer class actions, and pairs it with an express preemption ruling rejecting omission-based claims. Brower v. Colgate-Palmolive Co., 2026 WL 1831253 (S.D.N.Y. June 25, 2026). The decision provides additional authority for early dismissal of similar claims targeting FDA-regulated over-the-counter (“OTC”) products.
The court’s standing analysis tracks decisions dismissing contamination-based claims where plaintiffs relied on generalized testing untethered to their own purchases. Plaintiffs alleged they overpaid for toothpaste that purportedly contained lead and mercury. To establish standing, the court required each named plaintiff to plead facts making it plausible that the toothpaste they bought contained the alleged contaminants. Id. at *6–7. Several plaintiffs failed because they did not “meaningfully link” the cited testing to “their own purchases.” Id. at *7. The court similarly rejected plaintiffs’ reliance on testing that “fail[ed] to allege the date of testing, where the testing took place, what entity performed the testing, or how many units were tested.” Id. The court held that “[a]bsent allegations connecting that testing to the products they themselves purchased, these plaintiffs fail to plead a concrete, particularized injury fairly traceable to Colgate’s product.” Id. And plaintiffs whose own toothpastes tested below detectable mercury levels failed to plead “an injury-in-fact as to mercury.” Id. at *8.
On preemption, the court dismissed claims premised on Colgate’s alleged failure “to disclose the presence of heavy metal contamination” on its labels. Id. at *5. The Food, Drug, and Cosmetic Act (“FDCA”) “preempts any state-law requirement that is ‘different from’ or ‘in addition to’ federal requirements.” Id. (quoting 21 U.S.C. § 379r(a)). Because the FDA’s “comprehensive and granular” monograph for toothpastes does not require “heavy metal disclosures,” the court held that “[t]o allow state omission claims to supplement [the FDA’s] comprehensive scheme would be to substitute judicial judgment for agency judgment in precisely the domain Congress assigned to the FDA.” Id.
By contrast, the court held that affirmative misrepresentation claims based on marketing statements like “Whole Mouth Health” and “Responsibly Made” were not expressly preempted because they “ask[] the Court to police the accuracy of voluntary statements already appearing on the label.” Id. at *6.
The decision also cited the U.S. Supreme Court’s preemption ruling issued the same day in Monsanto Co. v. Durnell, 609 U.S. __ (2026). See Brower, 2026 WL 1831253, at *3. As we discussed in a recent OnPoint, Durnell held that a similar express preemption provision in the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) barred state-law failure-to-warn claims that would have required a cancer warning on an EPA-approved pesticide label.
Contributors
The authors would like to thank Samantha Suchsland for her contributions to this article.