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Volume XI, Number 133

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The Perilous Seas of Prop 65: Safe Harbors Should Not Be Controversial

Should companies be forced to label their products as containing chemicals “known” to cause cancer despite controversial scientific information?  A federal court in California doesn’t think so. On March 29, the U.S. District Court for the Eastern District of California granted a preliminary injunction to the California Chamber of Commerce (“the Chamber”), halting new lawsuits by both the State of California as well as private parties seeking to enforce Proposition 65 (“Prop 65”) warning requirements for the chemical acrylamide in food and beverages.

Acrylamide forms in some food during high-temperature cooking processes, such as frying, roasting, and baking, from a reaction between sugars and an amino acid that are naturally present. Acrylamide is found in coffee, French fries, potato chips, roasted nuts, and many foods made from grains (such as breakfast cereals, cookies, and toast).

California’s Prop 65 requires businesses to provide a “clear and reasonable warning” before knowingly exposing any individual to chemicals “known” to the State of California to cause cancer and/or reproductive harm.  However, as we have reported previously, the criteria used by California can result in warning requirements for substances for which there is little or conflicting evidence of human carcinogenicity or reproductive harm.

Under the standard established for government-compelled commercial speech by the U.S. Supreme Court in Zauderer v. Office of Disciplinary Council, 471 U.S. 626 (1985) and further interpreted in Am. Beverage Ass’n v. City & Cty. of San Francisco, 916 F.3d 749, 756 (9th Cir. 2019) (en banc), the state has the burden to show that the compelled warning:

  1. requires the disclosure of purely factual and uncontroversial information only,

  2. is justified and not unduly burdensome, and

  3. is reasonably related to a substantial government interest.

The court found that the safe harbor warning for acrylamide was not “purely factual” because “the warning implies incorrectly that acrylamide is an additive,” and because consumers are unlikely to understand the assumptions underlying the warning language.  The court further concluded that the warning was not “uncontroversial” because “it elevates one side of a legitimately unresolved scientific debate about whether eating foods and drinks containing acrylamide increases the risk of cancer.”

Although the State argued that other warnings are permissible under Proposition 65, the court agreed with the Chamber that “only the safe harbor warning is actually useable in practice.”  The court opined that “If 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.”

The court’s opinion in this preliminary injunction may bode well for other businesses struggling to accommodate Prop 65 warnings.  If ultimately successful, the arguments presented by the Chamber and validation by a court that “purely factual and uncontroversial information” does not always underpin the listing of Prop 65 chemicals may open the door for additional similar challenges.

While this action is pending and until a further order of the court, no new lawsuits may be filed to enforce the Prop 65 warning requirement for acrylamide in food and beverages. However, the order does not affect previous consent decrees or settlements and may not impact pending litigation.  Businesses that manufacture, distribute, or sell products into California should continue to warn consumers about acrylamide in their products unless a favorable final decision is obtained.

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Copyright © 2021 Womble Bond Dickinson (US) LLP All Rights Reserved.National Law Review, Volume XI, Number 105
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About this Author

Mark J. Vaders FDA Litigation Attorney Womble Bond Dickinson Winston-Salem, NC
Associate

Mark Vaders provides cost-effective scientific and legal solutions to clients whose branded products are regulated by the FDA and state agencies. He has assisted in drafting many submissions to FDA’s Center for Tobacco Products, and serves as an in-house resource on vapor product science. His practice also focuses on developing legal- and science-based defenses to product liability lawsuits. Mark has provided counsel to RJ Reynolds Tobacco Company, RJ Reynolds Vapor Company, a leading national supplier of scientific and medical equipment, a global reinsurance provider, and other clients....

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