P&G's primary jurisdiction argument over tampon labels goes down like a lead balloon

Barton v. Procter & Gamble Co., 766 F.Supp.3d 1045 (S.D. Cal. 2025)

Plaintiffs alleged that P&G’s Tampax Pearl and Radiant tampons had dangerous levels of lead; the court allowed some of the usual California claims to proceed, including for injunctive relief.

There’s no safe level of lead exposure, and it’s “particularly harmful to young children and women of child-bearing age.” California’s Proposition 65 establishes a Maximum Allowable Dose Level of 0.5 micrograms of lead per day for reproductive toxicity. Based on “independent scientific testing and analysis,” the ordinary and expected use of the tampons would allegedly expose consumers to more than this MADL per day. Plaintiffs alleged that their independent laboratory testing of the super versions shows that Tampax Pearl Products contain .181 micrograms of lead per gram, and that Tampax Radiant Products contain .123 micrograms of lead per gram; extrapolating to light and regular, consumers would allegedly be exposed to lead in excess of the MADL regardless of which type they used.  Plaintiffs alleged that vaginal insertion allowed lead to be directly absorbed into the bloodstream, making this exposure particularly bad.

The package statements “#1 U.S. GYNECOLOGIST RECOMMENDED TAMPON BRAND”; “FREE OF PERFUME”; “FREE OF ELEMENTAL CHLORINE BLEACHING”; “TAMPON FREE OF DYES”; and “CLINICALLY TESTED GENTLE TO SKIN” allegedly mislead reasonable consumers to believe that the tampons are safe to use, including that “they are free from potentially harmful elements and ingredients.”

The court rejected the application of the primary jurisdiction doctrine. A 2024 study finding “measurable concentrations” of lead “in 30 tampons produced by 14 tampon brand manufacturers,” which concluded that “[f]uture research is necessary to replicate our findings and determine whether metals can leach out of tampons and cross the vaginal epithelium into systemic circulation.” “In response, on September 10, 2024, the FDA announced that it commissioned an independent literature review and initiated an internal bench laboratory study to determine if metals from tampons are released and if they are absorbed by the body.” The completed literature review “did not identify safety concerns associated with tampon use and contaminant exposure.” Despite the “limitations related to the methods used in the [reviewed] studies” and the fact that none of the studies actually addressed “how much, if any, of the contaminants identified are released from the tampon or absorbed through the vagina,” the FDA stated that it “continues to recommend FDA-cleared tampons as a safe option for use as a menstrual product.”

“Although the FDA has a history of regulating tampons, the primary jurisdiction doctrine does not ‘require[ ] that all claims within an agency’s purview ... be decided by the agency.’” “ The FDA’s literature review did not, and the FDA’s laboratory study will not, review affirmative representations such as those on the Product packaging and determine whether they were misleading when Defendant omitted the presence of lead in the tampons.” And, as to the fraudulent omission of an unreasonable safety risk allegations, the underlying questions of whether lead is released from tampons, enters the circulatory system, and creates an unreasonable safety risk are within the jurisdiction of the FDA, but there was no indication that the FDA was going to provide an opinion on any particular tampon, and staying the case would cause a delay. The FDA provided no timeline for releasing its findings after peer review. (And, honestly, even a functioning FDA takes years; does anyone believe that’s what we have?) “[P]rimary jurisdiction is not required when a referral to the agency would significantly postpone a ruling that a court is otherwise competent to make.”

However, the court found that the complaint lacked sufficient detail as to the laboratory that performed the testing or the form and date of testing. (I remain baffled by why this is important at the pleading stage.) Also, plaintiffs needed either to test the light and regular products or explain why extrapolation was appropriate, given that a different sub-brand of Tampax, pure cotton, didn’t have detectable levels of lead. (Maybe because it’s made differently?) Leave to amend was granted.

The court also denied P&G’s argument that the complaint was an impermissible attempt to bring a “back-door Proposition 65 claim.” Under Proposition 65, no person doing business shall “knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual” where the amount exceeds the “no significant risk level” established by the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment. Private parties can enforce Proposition 65, but only 60 days after they give “notice of an alleged violation” to the “alleged violator,” the California Attorney General, and local prosecutors. The notice must also include a “certificate of merit” that states that the “person executing the certificate has consulted with one or more persons with relevant and appropriate experience or expertise ... and that, based on that information, the person executing the certificate believes there is a reasonable and meritorious case for the private action.” Pre-filing notice is mandatory, and defective notice cannot be cured retroactively. A plaintiff cannot skirt these requirements by bringing claims – under consumer protection statutes – that would otherwise “be barred under Proposition 65.”

But the complaint here wasn’t entirely derivative of the unspoken Proposition 65 violation (failure-to-warn of lead). Plaintiffs alleged that P&G “has gone beyond the offenses of omission that Proposition 65 seeks to prevent and has affirmatively deceived its customers.”

Here, representations like “GYNECOLOGIST RECOMMENDED,” “FREE OF ELEMENTAL CHLORINE BLEACHING,” and “CLINICALLY TESTED GENTLE TO SKIN” were sufficiently “conceptually related” to the idea that the tampons are free from harmful substances, like lead. By contrast, statements on chocolate products such as “always small farmer grown” would not lead reasonable consumers to believe that the chocolate didn’t contain unsafe levels of toxins, because the connection between being locally grown and being free from toxins is attenuated. Here, safety- and additive- related representations more plausibly suggested the absence of lead.

However, material omission claims failed. Plaintiffs didn’t sufficiently allege that the presence of lead amounts to an unreasonable safety hazard. There was no allegation that the tampons even release lead, and the court thought that the allegations that they would “contradicted” the June 2024 study, although it looked to me like the study just said that it didn’t investigate that question itself, which is not a contradiction.  Even if the tampons released lead at the levels alleged, plaintiffs still failed to allege that the lead was “unreasonably hazardous at the particular levels in the specific Products.”

Equitable claims: Although plaintiffs could plead inadequate legal remedies in the alternative to seek disgorgement/restitution, they hadn’t done so (again, there was leave to amend). However, they had pled that legal remedies were inadequate as to prospective injunctive relief.  An injunction wouldn’t necessarily require P&G to change the product composition; it could require a disclosure. Plaintiffs properly alleged their inability to rely on the product label in the absence of an injunction.