Proposition 65 Titanium Dioxide Warning Lawsuits Halted by California Court Injunction

Background

The Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65 (Prop 65), requires California businesses to provide clear and reasonable warnings to consumers before knowingly and intentionally exposing them to chemicals listed by the state as the cause of cancer, birth defects, or other reproductive harm. The Prop 65 list, first published in 1987 and updated at least once a year, now includes around 900 chemicals.

Titanium dioxide, a common ingredient in cosmetic products, was added to the Prop 65 list on September 2, 2011. This inclusion has led to over 500 violation notices and many lawsuits against manufacturers and retailers. Most cases involve cosmetic and personal care products.

(The basic information of titanium dioxide listed on Prop 65)

Legal Challenge

On May 26, 2023, the Personal Care Products Council (PCPC), an American trade association representing global cosmetics and personal care industry, filed a constitutional challenge against the Prop 65 warning requirements for titanium dioxide, arguing that the required cancer warning violated the First Amendment to the United States Constitution as it did not meet the "purely factual and uncontroversial" standard from the U.S. Supreme Court's 1985 decision in Zauderer v. Office of Disciplinary Counsel. PCPC subsequently filed a motion seeking a preliminary injunction on October 6, 2023.

On June 12, 2024, the U.S. District Court for the Eastern District of California issued a preliminary injunction prohibiting new lawsuits to enforce the Prop 65 warnings for titanium dioxide in cosmetic and personal care products. The court agreed with PCPC, finding that the warning was not "purely factual and uncontroversial" due to unsettled science on titanium dioxide's carcinogenicity, which could mislead consumers. ¹

Proposed Regulatory Changes

In response to the PCPC lawsuit in 2023, California's Office of Environmental Health Hazard Assessment (OEHHA) proposed amending the state regulations to adopt a Prop 65 safe harbor for titanium dioxide (airborne, unbound particles of respirable size). ² The proposed safe harbor, known as the No Significant Risk Level (NSRL), would set daily average exposure limits below both of the following thresholds:

• For airborne, unbound particles with diameters of 10 micrometers (µm) or less: 440 micrograms (µg) per day;

• For airborne, unbound particles with diameters of 0.8 micrometers (µm) or less: 44 micrograms (µg) per day.

The public comment period for this proposal was initially open from May 10, 2024, to June 24, 2024, and was extended until July 1, 2024.