June 11, 2025
Recent California Court Cites “Misleading Message” as Part of Ruling Prohibiting Proposition 65 Warnings for Acrylamide in Food
A recent California court ruling prohibiting Proposition 65 warning labels for acrylamide in food provides a notable change in labeling requirements, and states cancer classifications can be misleading.
As part of California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or Prop 65), the state publishes a list of chemicals that are “known to the State of California to cause cancer or reproductive toxicity.” A substance can be added to this list as a carcinogen if an “authoritative body” concludes the substance can cause cancer in humans or laboratory animals. Several organizations* are considered to be authoritative bodies by the State of California, and a substance can require labeling based on the conclusions of any particular body. This approach can lead to questions and controversy about how the process addresses substances when there is no scientific consensus – either between scientific disciplines (i.e., human and animal evidence) or across scientific bodies (e.g., the International Agency for Research on Cancer [IARC] and US Food and Drug Administration [US FDA]). The latest California court ruling illustrates the issues related to the labeling process.
On May 2, 2025, the US District Court for the Eastern District of California issued a ruling in California Chamber of Commerce v. Bonta, Case No. 2:19-cv-02019, prohibiting Proposition 65 warnings for acrylamide in food. The basis of the warning was the conclusion by authoritative bodies, including IARC, that used a hazard-based approach to classify acrylamide as a “probable carcinogen” based on animal studies. This conclusion was used over the conclusion of other authoritative bodies, such as US FDA, that take a risk-based approach and have not concluded that dietary exposure to acrylamide can cause cancer. Of note in this case, the court acknowledged that the authoritative bodies’ findings were not in alignment on the cancer risk of acrylamide in food. Further, the court concluded that the classification of an agent, such as acrylamide, as a probable carcinogen is misleading because it implies a cancer risk from food consumption without scientific consensus. Importantly, the court noted that the term “probable” is itself misleading, as it implies a substance is probably carcinogenic even though this is not always the case.
The court’s ruling could indicate future contests to Proposition 65 labeling requirements, particularly when the specific language used in the classification of an agent could be misleading and scientific consensus is lacking.
*Organizations designated as authoritative bodies by the State of California under Proposition 65: US Environmental Protection Agency, US FDA, National Institute for Occupational Safety and Health (NIOSH), National Toxicology Program (NTP) of the US Department of Health and Human Services, and IARC.
Contact:
Denali Boon, Ph.D., M.P.H.
Senior Epidemiologist
Julie E. Goodman, Ph.D., DABT, FACE, ATS
Principal