The Ninth Circuit recently issued a key Prop 65 decision that could have broader implications for businesses subjected to its regulatory regime. 

Enacted via a ballot initiative, Prop 65 requires a company to warn consumers when one of its products contains a chemical known to the state of California to be carcinogenic or harmful to reproductive health.  In 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) placed glyphosate on its list of chemicals requiring a warning after the International Agency for Research on Cancer (IARC) concluded that the herbicide was “probably carcinogenic.”  Shortly after, a group of agricultural and business groups sued to enjoin California from requiring glyphosate warnings, arguing that the requirement violated the First Amendment.  The Ninth Circuit agreed.  See Nat’l Ass’n of Wheat Growers v. Bonta,– F.4th–, 2023 WL 7314307, at *2 (9th Cir. Nov. 7, 2023).

The court grounded its analysis in compelled speech jurisprudence.  By default, courts apply intermediate scrutiny to compelled commercial speech issues.  But, under Zauderer, an exception to this general rule permits a lower level of scrutiny when the compelled speech provides “purely factual and uncontroversial information.”  Zauderer v. Off. of Disciplinary Couns. of Supreme Ct. of Ohio, 471 U.S. 626, 651 (1985).  This exception did not apply, however, because the warning options California offered suffered from the same fatal flaw: each “convey[ed] the overall message that glyphosate is unsafe which is, at best, disputed” and therefore not “purely factual.”  Id. at *15. 

The evidence suggested that, at a minimum, there was a robust debate about the safety of glyphosate. IARC is the only governmental or regulatory entity that has concluded that glyphosate is potentially carcinogenic.  By contrast, the EPA, foreign regulatory authorities, and even OEHHA itself have come to the “opposite conclusion.”  Id. at *6.  This disagreement makes any statement that leaves consumers with the impression that glyphosate causes cancer not “purely factual.”  The court also held that California’s proposed warning statements were controversial “because (1) of the unresolved scientific debate over glyphosate’s carcinogenicity, and (2) [the statements] still require[d] Plaintiffs to alter their desired message for the State’s preferred message that glyphosate presents a health risk.”  Id. at *15.

After dispensing with the Zauderer exception, the court easily concluded that the warning requirement failed intermediate scrutiny.  “Under that standard, the government may compel a disclosure of commercial speech only if (1) it directly advances a substantial governmental interest, and (2) the restriction is not more extensive than necessary to serve that interest.” Id. at *16.  Although the court recognized California’s substantial interest in its citizens’ health, the state could not meet the standard because compelling speech regarding an unconfirmed risk does not advance that interest.  Moreover, California had less-restrictive means of promoting its views on glyphosate, including ad campaigns and website updates.

The court’s decision is a welcome one for businesses who have long complained that Prop 65 leads to unnecessary warning.  The decision also opens the door for business to target other chemicals on the Prop 65 list where the scientific evidence of harm to consumers is either unsupported or subject to robust debate.

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Photo of James Holloway James Holloway

James Holloway advises companies and trade associations on FDA regulation of cosmetic, food, dietary supplement, drug, and medical device products as well as advertising and consumer protection law. With a focus on consumer products, James regularly counsels clients on how to minimize FDA…

James Holloway advises companies and trade associations on FDA regulation of cosmetic, food, dietary supplement, drug, and medical device products as well as advertising and consumer protection law. With a focus on consumer products, James regularly counsels clients on how to minimize FDA, FTC, state, and consumer class action risks while advancing their business objectives. His practice encompasses issues related to product labeling and marketing, favorable regulatory classifications, Proposition 65, mobile medical applications, strategic engagement with regulators and legislators, and FDA’s implementation of the Modernization of Cosmetics Regulation Act (MoCRA).

James also advises on a range of advertising and consumer protection issues including influencers, claim substantiation, and green claims. He also has experience representing clients before the NAD and in investigations conducted by the FTC regarding product marketing practices.