In major win for cosmetics industry, First Amendment bars new Proposition 65 lawsuits for titanium dioxide

Background

California Proposition 65 (Prop 65) prohibits businesses from exposing individuals to chemicals that are “known to the State” to cause cancer or reproductive harm without providing a clear and reasonable warning. In sharp contrast to the vast majority of American laws, Prop 65 places the burden of proof on the defendant business. To bring a Prop 65 action, the government enforcer—or deputized private citizen enforcers (also known as bounty hunters)—need only detect a listed chemical at any level, thereby requiring the business to show that the level is too low to require a warning. This unusual burden shifting mechanism—as well as the ability of private enforcers to collect attorneys’ fees—has fueled the well-documented abuse of the statute and a proliferation of warnings by businesses for whom settlements are much more cost effective than prolonged litigation.

The California Office of Environmental Health Hazard Assessment (OEHHA) added titanium dioxide (airborne, unbound particles of respirable size) (Listed Titanium Dioxide) to the Prop 65 list of carcinogens in 2011. OEHHA made no determination itself that this chemical causes cancer, instead relying on a 2010 determination by the International Agency for Research on Cancer that titanium dioxide is “possibly carcinogenic to humans” due to “sufficient evidence” of carcinogenicity in animals, based on two studies of titanium dioxide in rodents. IARC concluded at the time, however, that there was “inadequate evidence” of carcinogenicity in humans. The U.S. Food & Drug Administration, for its part, has concluded that titanium dioxide may be safely used as a color additive in many products and as a sunscreen. 

While Prop 65 bounty hunters wasted little time enforcing the warning requirement for Listed Titanium Dioxide when it became effective in 2012, the most recent, prolific enforcement activity began three years ago. From July 2021 to the present, Prop 65 bounty hunters have issued more than 550 notices of violation for alleged exposures to Listed Titanium Dioxide, aimed almost exclusively at cosmetics products ranging from blush to eyeshadow. More than 100 lawsuits have been filed on the basis of these notices, with bounty hunters showing little signs of slowing down. In 2023, they issued 347 notices of violation for the chemical. And just this year, bounty hunters have already issued 144 notices. 

Personal Care Products Council v. Bonta

In May 2023, the Personal Care Products Council (PCPC) filed a lawsuit against the California Attorney General in federal district court challenging the Prop 65 warning requirement for cancer as applied to Listed Titanium Dioxide. PCPC alleges that these compelled warnings are not “purely factual and uncontroversial” and thus run afoul of the First Amendment’s protections against government-compelled commercial speech. Personal Care Products Council v. Bonta, No 2:23-cv-01006-TLN-JDP.

In October 2023, PCPC sought a preliminary injunction prohibiting the attorney general and all Prop 65 bounty hunters from filing or prosecuting new lawsuits to enforce the warning requirement for cancer as applied to Listed Titanium Dioxide. Among other arguments, PCPC contended that under the U.S. Supreme Court’s decision in Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985), the government cannot compel commercial speakers to provide warnings that are not “purely factual and uncontroversial.” PCPC argued that a warning that Listed Titanium Dioxide is “known to the State” to cause cancer is not purely factual and uncontroversial because, among other reasons, no government or scientific agency has classified titanium dioxide as a “known” human carcinogen, the animal studies upon which IARC relied in listing the chemical have not been shown to have relevance in humans, and scientific studies have found no reliable evidence that exposures to titanium dioxide are associated with any risk of developing cancer in humans.  PCPC presented expert testimony from an epidemiologist and toxicologist, as well as a consumer survey expert.

Preliminary injunction granted

The Eastern District of California agreed that PCPC was likely to succeed on the merits, finding that the “Prop 65 warning requirements for Listed Titanium Dioxide are not purely factual because they tend to mislead the average consumer.” In so ruling, the court observed: “[I]t is reasonable for the average consumer to read the warning requirement and conclude that Listed Titanium Dioxide may cause them cancer or increase their chances of obtaining cancer. But such a conclusion is misleading, particularly where, as here, the organization that prompted Listed Titanium Dioxide’s inclusion on the Prop 65 list—IARC—specifically found that there is inadequate evidence for the carcinogenicity of titanium dioxide in humans.”

The court further concluded that PCPC’s members would suffer irreparable harm if new Prop 65 enforcement actions could be filed while PCPC’s lawsuit was pending, and that this harm outweighed the state’s and the public’s interest in those enforcement actions. The court reasoned: “Although the issuance of a preliminary injunction will necessarily impose some hardship on public and private enforcers, the balance of equities must tip in favor of those whose First Amendment rights are being violated.” 

Accordingly, the court granted PCPC’s motion and enjoined, “Defendant, his officers, employees, and agents, and all those acting in privity or concert with those individuals, including private citizen enforcers . . . from filing or prosecuting new lawsuits to enforce Prop 65’s warning requirement . . . for cancer as applied to Listed Titanium Dioxide (i.e., titanium dioxide that consists of airborne, unbound particles of respirable size) in cosmetic and personal care products.” The court explained, however, that its order does not alter any existing consent decrees, settlements, or other agreements related to Prop 65 warning requirements.

Impact

This case is the third as-applied First Amendment challenge to Prop 65 to prevail on preliminary injunction. In the first, the Eastern District of California struck down Prop 65’s warning requirement for glyphosate, a decision the Ninth Circuit upheld. Natl. Assoc. of Wheat Growers v. Bonta, 85 F.4th 1263 (9th Cir. 2023). In the second, the Eastern District of California issued a preliminary injunction against the filing or prosecution of new Prop 65 enforcement actions for alleged exposures to acrylamide, in a case that is still pending. Cal. Chamber of Comm. v. Bonta, 529 F. Supp. 3d 1099 (E.D. Cal. 2021). These victories, as well as evolving appellate precedent on compelled commercial speech, bode well for future challenges to Prop 65’s warning requirements for other chemicals where the science on risks to humans is controversial or, as for titanium dioxide, shows its safety. 

PCPC is represented by the authors, as well as Greg Sperla and Vanessa Adriance of DLA Piper LLP. Should you have any questions about the impact of the ruling, please reach out to the authors.

Authored by Trent Norris, David Barnes, and Alex Tablan.