By: Samantha Hong
In a consequential ruling, on March 29, 2021, an Eastern District of California federal judge preliminarily enjoined any person from filing or prosecuting new lawsuits seeking to enforce the California Proposition 65 cancer warning requirement as applied to acrylamide in food and beverage products.[1]
California’s Safe Drinking Water and Toxic Enforcement Act of 1986, more commonly known as Proposition 65, prohibits businesses from “knowingly and intentionally” exposing individuals to chemicals “known to the state to cause cancer or reproductive toxicity” without first providing “clear and reasonable warning.”[2] Violations of Proposition 65 are subject to civil penalties of up to $2,500 per day for each violation.[3] California law further permits private parties to bring Proposition 65 enforcement actions if certain requirements are met.[4]
Acrylamide—a chemical substance that can form during high-temperature cooking primarily in certain plant-based foods—was added to the Proposition 65 list in 1990, but was only first detected in foods in 2002.[5] While studies have shown that acrylamide can cause cancer in laboratory animals at high doses. However, as FDA has acknowledged, there is no consistent evidence confirming that acrylamide from food consumption can cause cancer in humans.
In the present case, the California Chamber of Commerce (“Chamber”) sued the State of California in 2019, alleging that the First Amendment prohibits California from compelling a Proposition 65 warning regarding acrylamide because, given the lack of scientific evidence, the warning is not “purely factual and uncontroversial” as is required for compelled commercial speech.[6] After the court denied California’s attempt to dismiss the litigation, the Chamber sought a preliminary injunction.
In view of the scientific uncertainty regarding acrylamide’s effects on humans, the court determined that the Chamber was likely to succeed on the merits of its First Amendment claims. In particular, California regulations provide a model warning that serves as a safe harbor against liability, which for acrylamide, would state that “Consuming this product can expose you to chemicals including acrylamide, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov/food.”[7] The court concluded that the Chamber was likely to show that the warning was not purely factual and uncontroversial because California does not “know” that acrylamide causes cancer. The court further concluded that the use of alternative warnings is not a practicable solution given the “heavy litigation burden” on businesses who may choose to do so at risk of private or State enforcement. It explained that “[i]f the seas beyond the safe harbor are so perilous that no one risks a voyage, then the State has either compelled speech that is not purely factual, or its regulations impose an undue burden.”
In granting the Chamber’s request, the court agreed that the recent increase in private enforcement actions regarding acrylamide in food demonstrated that the Chamber would face irreparable harm absent a preliminary injunction and noted that its injunction is narrowly limited to new lawsuits—private parties and the State can still take actions such as sending demand letters and violation notices, and pursuing public relations campaigns, research, and advertisements. This lawsuit is ongoing; the court’s final determinations on whether cancer warnings for acrylamide compelled by Proposition 65 are unconstitutional and whether the Chamber is entitled to a permanent injunction are still pending.
Whether this decision will result in additional successful challenges to Proposition 65 as it applies to other listed chemicals remains to be seen. Regardless, it has significant implications on the future of Proposition 65 enforcement and provides a helpful framework for future litigants seeking to chip away at Proposition 65’s reach. We will continue to monitor this and other Proposition 65 litigation closely.
[1] California Chamber of Commerce v. Becerra, No. 2:19-cv-02019-KJM-JDP (E.D. Cal. Mar. 29, 2021).
[2] Cal. Health & Safety Code § 24249.6.
[4] Id. § 25249.7(d).
[5] See FDA, Guidance for Industry Acrylamide in Foods, March 2016, available at https://www.fda.gov/media/87150/download.
[6] See Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985).
[7] Cal. Code Regs. tit. 27, § 25607.2(a)(2).