UPDATE: On June 12, 2024, the U.S. District Court for the Eastern District of California entered a preliminary injunction in The Personal Care Products Council v. Bonta.
The order provides, in pertinent part, "Defendant, his officers, employees, and agents, and all those acting in privity or concert with those individuals, including private citizen enforcers under California Health & Safety Code § 25249.7(d), are hereby ENJOINED from filing or prosecuting new lawsuits to enforce Prop 65's warning requirement, California Health & Safety Code § 25249.6, 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. This Order does not alter any existing consent decrees, settlements, or agreements related to Prop 65 warning requirements. The amount of the security bond for this order shall be $0. The preliminary injunction shall remain in place until further Order of this Court."
Posted: June 11, 2024
Titanium dioxide was added to the California Proposition 65 ("Prop. 65") list in 2011 due to its classification as a cancer-causing agent, when present as "airborne, unbound particles of respirable size." Nevertheless, titanium dioxide has continued to serve as a key ingredient in many consumer products, including powdered cosmetics products. In particular, titanium dioxide is renowned for its ability to enhance color brightness through light absorption and scattering properties.
In recent years, Prop. 65 plaintiffs have unleashed a blitz on the cosmetics industry, targeting titanium dioxide in makeup without warnings and demanding substantial attorneys' fees under laws that permit plaintiffs to recover such costs. Cosmetics companies, regardless of size, have been targeted. Since 2020, more than 600 Prop. 65 Notices of Violation for alleged titanium dioxide in cosmetics have been issued to cosmetics companies ranging from small, family-run companies to international companies.
Cosmetics firms have struggled to defend themselves in these actions due to the absence of a set "safe harbor" threshold for titanium dioxide, leaving uncertainty about when a warning is necessary. Accordingly, plaintiffs assert that even a molecule can cause harm despite any science to back that up. As a result, cosmetics companies are heavily investing in ingredient alternatives, aiming to reformulate their products to avoid titanium dioxide altogether.
But there has been pushback. Last year, the Personal Care Products Council ("PCPC"), a national trade association representing cosmetics and personal care products companies, sued the State of California in a lawsuit filed May 26, 2023 (E.D. Cal. Case No. 2:23-CV-01006-TLN-JDP) alleging that requiring a warning for titanium dioxide is unconstitutional given the lack of identified evidence suggesting a causal relationship between listed titanium dioxide and cancer risk. More recently, PCPC filed a Motion for a Preliminary Injunction, which is presently pending before the court, which would enjoin the State Attorney General and private enforcers from enforcing a warning requirement for cancer as to titanium dioxide in cosmetic and personal care products. If issued, such an injunction could upend the hundreds of lawsuits currently pending in the California courts.
The State of California is evaluating the issue. Perhaps in response, on May 10, 2024, the Office of Environmental Health Hazard Assessment ("OEHHA") proposed to adopt a Prop. 65 safe harbor (No Significant Risk Level ("NSRL")) for titanium dioxide (airborne, unbound particles of respirable size). The NSRL proposed by OEHHA is expressed as a daily average exposure level that falls below both of the following thresholds:
- For unbound, airborne particles with diameters of 10 micrometers or less: 440 micrograms per day ;
- For unbound, airborne particles with diameters of 0.8 micrometers or less: 44 micrograms per day.
OEHHA is taking public comments on the NSRL through June 24, 2024, and comments can be submitted here. Whether or not the NSRL and/or PCPC case will moot the various pending lawsuits against cosmetic companies remains to be seen. In any event, it appears that at least some amount of titanium dioxide may be permitted in cosmetics in the future without a Prop. 65 warning.
If you are a cosmetics company facing a potential Prop. 65 lawsuit based on titanium dioxide, we encourage you to consult with counsel to assess how these legal and regulatory changes may impact your case.
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