Products Liability Law Daily Wrap Up, WARNINGS ISSUES—FOOD AND BEVERAGES—E.D. Cal.: California Prop 65 dietary acrylamide warnings permanently enjoined and declared unconstitutional under First Amendment, (May 9, 2025)

By Justin Marcus Smith, J.D.

The district court held that permanent injunctive and declaratory relief was needed to correct a situation where California businesses had been “wrongly sued pursuant to an unconstitutional warning requirement and pressured into burdensome settlements.”

The California Chamber of Commerce (CalChamber) prevailed on the merits of its First Amendment claim against California Attorney General Ray Bonta in connection with dietary acrylamide Proposition 65 (Prop 65) display warnings, held the federal district court in Sacramento, California. The court granted summary judgment to CalChamber. The court found CalChamber showed the balance of equities and public interest favored an injunction and that CalChamber’s members were likely to suffer irreparable harm without an injunction. The court accordingly granted the Chamber’s request for injunctive and declaratory relief to permanently enjoin the Proposition 65 warning requirement as to acrylamide in food, as well as the companion California Health and Safety Code § 25249.6 requirement that any person in the course of doing business provide a clear and reasonable warning before exposing any individual to dietary acrylamide. The court further declared the Proposition 65 warning requirement unconstitutional as applied to dietary acrylamide (California Chamber of Commerce v. Bonta, No. 2:19-cv-02019-DJC-JDP (E.D. Cal. May 2, 2025)).

Prop 65 Background. California voters enacted Prop 65, also known as the Safe Drinking Water and Toxic Enforcement Act, by ballot initiative in 1986. Prop 65 requires the Governor of California to publish a list of known carcinogens and reproductive toxins at least annually. Businesses, in turn, must not knowingly or intentionally expose people to the listed chemicals without providing a “prior clear and reasonable warning.”

A few years after enactment of Prop 65, a California Court of Appeal interpreted California Health and Safety Code § 25249.8, Labor Code § 6382, and associated regulations as requiring the governor’s list of chemicals to include those known to cause cancer or reproductive harm only in animals. However, the requirement that businesses provide a warning involved a “no significant risk” safe harbor where a chemical poses no significant risk at specified exposure levels. To invoke the safe harbor, businesses could either rely on the safe exposure level published by the California Office of Environmental Health Hazard Assessment (OEHHA) or attempt to prove an alternate safe level through their own private experts. Failure to provide the required warning carried a civil penalty of up to $2,500 per day for each violation. The California Attorney General or private parties could attempt to enforce the warning requirement.

Procedural background. CalChamber questioned whether California could compel businesses to display Prop 65 warnings about dietary acrylamide, purportedly a carcinogen, without violating the First Amendment of the United States Constitution. Acrylamide had historical use in industrial plastics and grouting agents, but in 2002, researchers discovered high temperatures could inadvertently produce it during the cooking of various foods.

CalChamber filed the instant action in 2019 alleging that the state did not actually “know” that acrylamide in food causes cancer in humans, whereas the state-approved warning at the time said acrylamide was “known to the State of California to cause cancer.”

Defendant California Attorney General Rob Bonta (the state) argued that the Prop 65 warnings (i) passed constitutional muster inasmuch as there was no legitimate scientific debate that dietary acrylamide is a likely carcinogen and (ii) the required warnings communicated that stance accurately.

The court issued a preliminary injunction of the warnings in March 2021. The state did not appeal that ruling, but defendant-intervenor Council for Education and Research on Toxics appealed. The Ninth Circuit upheld the preliminary injunction as within district court discretion, and OEHHA issued a revised safe harbor warning specific to acrylamide in food calling it a “probable human carcinogen” that could be formed during the cooking of food at high temperatures.

The revised warning was in effect as of January 1, 2023, but in the wake of an indirectly related case about glyphosate, more commonly known as the weedkiller Roundup®, OEHHA revised the dietary acrylamide warning again with several optional word choices. At that point of revision, CalChamber sought declaratory relief and a permanent injunction barring all variants of the Prop 65 acrylamide warning, i.e., the original, revised (alternative), and second revised (new warning) warnings.

Analysis. The court had previously found the Prop 65 warnings were “misleading and controversial” in light of “vigorous scientific debate” surrounding dietary acrylamide. The court said it explained its findings about the scientific debate in “thorough detail.” Among other things, it noted that the United Nations World Health Organization’s International Agency for Research on Cancer (IARC) and the United States Environmental Protection Agency (EPA) had issued somewhat varying statements about acrylamide carcinogenicity over the years.

The court distinguished between hazard assessments and risk assessments. It said IARC, EPA, and the National Toxicology Program (NTP) had based their acrylamide “hazard” determinations primarily on animal studies and “mechanistic” data, but the implications for cancer “risk” were “uncertain,” and the epidemiological studies were “inconclusive.” The court continued that the Food and Drug Administration (FDA) had also been “reticent to advise consumers against consuming foods containing acrylamide in recognition of the health benefits these [primarily plant -based] foods may offer.” The court reviewed these and its other similar findings at considerable length.

Standing. The court held that CalChamber satisfactorily demonstrated that its members had standing to challenge the Prop 65 compelled speech requirements about dietary acrylamide. The court said it disagreed with the state’s argument that CalChamber failed to show that the state required any of its members to warn about dietary acrylamide in their products. The state contended there was no legal obligation to warn if a business could satisfy the “no significant risk” safe harbor. The state also faulted CalChamber for not providing evidence about its members’ food products in support of the CalChamber motion for summary judgment.

The court analyzed that the Prop 65 warning was a “presumptive burden” unless businesses could affirmatively invoke the “no significant risk” safe harbor. The court said invoking the safe harbor would be a costly endeavor with “no guarantee” that businesses would “then be free from litigation challenging their compliance with Prop 65’s warning requirements.” The court noted other courts had already deemed the Prop 65 enforcement scheme a “constant, credible” private enforcement threat because private enforcers need only credibly allege that a given product contains acrylamide, rather than a harmful amount of it, making lawsuits “almost absurdly easy” to pursue at the pleading and pretrial stages.

The court concluded here that businesses had no effective “reprieve” from facing enforcement actions even if they could prove that their products were not a cancer risk. CalChamber also provided evidence of a history of enforcement actions that included more than 90 lawsuits. The court said these circumstances were enough to perfect CalChamber standing.

Unconstitutionality. The court found the Prop 65 warnings for dietary acrylamide failed to satisfy either of the Supreme Court’s tests for determining the constitutionality of government restraints on commercial speech.

First, under the less strict Zauderer standard, the court found the Prop 65 acrylamide warnings were “neither uncontroversial nor purely factual” because they espoused a “one-sided view that dietary acrylamide poses a human cancer risk despite a lack of scientific consensus on that point.” See Zauderer v. Office of Disc. Counsel, 471 U.S. 626 (1985). The court acknowledged that each sentence of the new warning may be factual in a strict sense, but Ninth Circuit precedent did not take such a “narrow view.” The court said it must look to the meaning of the warning in context, and the context clearly communicated the message that dietary acrylamide poses a risk of cancer.

Second, under the stricter Central Hudson standard, the court found that “misleading statements” about acrylamide carcinogenicity did not advance state public health interests where the state had less burdensome alternatives for achieving its goals. See Central Hudson Gas & Electric Corp. v. Public Service Commission of New York, 447 U.S. 557 (1980). Accordingly, the court held that the Prop 65 warning requirement, “as applied” to dietary acrylamide, violated the First Amendment. The court granted summary judgment in favor of CalChamber.

Recent developments. The court confirmed that there had been no developments in the evidentiary record after the entry of the preliminary injunction calling for a finding other than the original finding that the Prop 65 warning requirement for dietary acrylamide was “misleading” and not “purely factual and controversial” in light of scientific debate. Purely factual information was “not enough to qualify for the Zauderer exception.” Again, the overall context mattered, and Zauderer also required commercial speech to be “uncontroversial” to pass constitutional scrutiny.

In opposition to CalChamber’s contention that none of the dietary acrylamide safe harbor warnings were “purely factual and uncontroversial,” the state effectively conceded that the original and revised warnings were unconstitutional. The state focused instead on its contention that every required sentence of the second revised warning was purely factual. That warning included: (i) a statement that consuming the product can expose you to acrylamide; and, (ii) a statement concerning the findings of an authoritative scientific agency on acrylamide’s carcinogenicity which recites the agency’s findings verbatim. The state also argued the second revised warning was not misleading because only foods that will expose consumers to a risk of cancer were subject to the warning requirement. Last, the state argued the second revised warning was uncontroversial because there is scientific consensus that acrylamide is a probable or likely carcinogen.

The court said the state’s summary judgment evidence failed to change the court’s conclusion that the warnings remained controversial. The businesses certainly subjectively considered them controversial, and while the science was clear in the contexts of mice and rats exposed to large doses, the battling experts strongly disagreed on whether those animal results could be extrapolated to humans. The court again distinguished between “hazard” and “risk.” The court said the Ninth Circuit had already explained that the point of Prop 65 was to inform consumers about risks, not mere hazards. There was also a sub-debate about industrial versus dietary acrylamide exposure.

The court acknowledged that, at this point, the state provided stronger evidence that dietary acrylamide is a human carcinogen, but the court said it did not find the evidence strong enough to overcome judgment for CalChamber. The existence of scientific debate about dietary acrylamide, specifically, meant the required labeling was controversial. In the court’s view, the state’s argument that the second revised warning was factually true also ignored the reality that it conveyed a “core message” that consuming food containing acrylamide posed a risk of cancer, a message that remains “unsettled’ in the scientific community. Moreover, the state could not have it “both ways by focusing myopically on the individual words in the New Warning and also justifying the regulation by the importance of warning consumers about cancer risk.”

Zauderer relaxed scrutiny did not apply. The Prop 65 warning had to satisfy intermediate scrutiny under Central Hudson, but no Prop 65 safe harbor satisfied it. The second revised warning did not directly advance the asserted government interest because it was “misleading” and the state had alternatives, like advertising campaigns or posting information on the internet, that would not burden businesses. The court confirmed that the court would grant summary judgment in favor of CalChamber despite the revisions to the Prop 65 warning since entry of the preliminary injunction.

Permanent injunction. The court said its analysis of the permanent injunction factors was largely the same as in its order granting preliminary injunctive relief. The loss of First Amendment freedoms, even for brief periods, unquestionably involved irreparable injury. CalChamber convinced the court that its members were likely to suffer irreparable harm without an injunction against the Prop 65 warning requirement for acrylamide in food. The balance of equities and public interest factors merged because the government was a party. The state had an interest in promoting public health, but First Amendment principles were also important here, whereas the state had no interest in enforcing an unconstitutional law where misleading or false labels would undermine the state’s interest in public health. The court weighed the balance in favor of CalChamber’s requested injunction.

The court also found declaratory relief warranted for essentially the same reasons. The court declared the Prop 65 warning requirement for dietary acrylamide violated the First Amendment because existing consent judgments continued to force businesses either to “disparage” their products with “alarmist warnings” or to “needlessly reformulate their products.” Declaratory relief was necessary to relieve businesses “wrongly sued pursuant to an unconstitutional warning requirement and pressured into burdensome settlements.”

The case is No. 2:19-cv-02019-DJC-JDP.

Judge: Calabretta, D.

Attorneys: Trenton H. Norris (Hogan Lovells US LLP) and Samuel Zachary Fayne (Arnold & Porter Kaye Scholer LLP) for California Chamber of Commerce. Elizabeth Song, Office of the Attorney General, and Laura Zuckerman, State of California Department of Justice, for Rob Bonta.

Companies: California Chamber of Commerce

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