In a landmark victory that could have wide-ranging implications for California Proposition 65 (Prop 65) lawsuits, the U.S. District Court for the Eastern District of California issued a preliminary injunction prohibiting the filing or prosecuting of new lawsuits to enforce Prop 65’s warning requirement as applied to List Titanium Dioxide (i.e., titanium dioxide in airborne, unbound particles of respirable size) in cosmetic and personal care products. In the June 12 order, the court agreed with the plaintiff (the Personal Care Products Council) that a Prop 65 warning for Titanium Dioxide as an alleged carcinogen violated the First Amendment's requirement that government-compelled speech be limited to that which is “purely factual."   

As background, Prop 65 prohibits businesses from exposing individuals to chemicals that are “known to the State” to cause cancer or reproductive harm the absence of providing a clear and reasonable warning on the product label. There are over 900 listed Prop 65 chemicals. Importantly, Prop 65 is generally enforced by private rights of action (lawsuits) with the potential for massive monetary penalties (i.e. fines accumulate per violation per day).  Since Titanium Dioxide was first added as a Prop 65 chemical in 2012, there have been more than 500 notices of violations against manufacturers and retailers for allegedly failing to include a Prop 65 warning, resulting in more than 100 lawsuits in the last three years. Most involve cosmetic products, particularly those in powder form (e.g. blush and eyeshadow).

In the wake of the slew of lawsuits, in May 2023, PCPC filed a constitutional challenge to the Prop 65 warning requirement as applied to Listed Titanium Dioxide. PCPC asserted that the warning was compelled speech that violated the First Amendment because it was not “purely factual and uncontroversial”, a standard articulated under the U.S. Supreme Court's 1985 decision in Zauderer v. Office of Disciplinary Counsel.  PCPC argued that (1) no government or scientific agency has classified titanium dioxide as a “known” human carcinogen, (2) studies upon which California relied in listing the chemical were done in animals and have not been shown to have relevance in humans, and (3) there is no clear evidence that Listed Titanium Dioxide exposure increases risk of cancer in humans.  The court agreed.

Applying the Zauderer test, Judge Nunley held that the waring was not “purely factual” because the science regarding the impact of titanium dioxide as a human carcinogen is unsettled.  Accordingly, the court found that a consumer could be misled by the Prop 65 warning into believing that exposure to the chemical in cosmetics and personal care products could increase their risk of cancer, which accordingly to the court, is not a ‘factual’ conclusion. Therefore, the court found that the warning requirement ran afoul of the First Amendment and granted PCPC's request for a preliminary injunction.

What This Means for Cosmetic Companies and All Business Impacted by Prop 65

The court's Order immediately halts hundreds of pending lawsuits against other cosmetic manufacturers and retailers and could spur future challenges to other Prop 65 chemicals. The Order does not, however, alter any existing consent decrees, settlements or agreements related to Prop 65 warning requirements.  Separately, and arguably, in response to the PCPC lawsuit (but prior to the order), California had proposed on May 10, 2024, issuing a ‘safe harbor' level for Titanium Dioxide. The safe harbor would not requiring a warning for daily average exposure level that falls below both of the following thresholds: (1) unbound, airborne particles with diameters of 10 micrometers or less: 440 micrograms per day; or (2) for unbound, airborne particles with diameters of 0.8 micrometers or less: 44 micrograms per day.  If challenges to titanium dioxide resume (including outside the cosmetic context) it is worth watching to see if California ultimately implements the proposed safe harbor level which could provide an additional layer of coverage to companies.