Earlier this year, California’s Proposition 65 (California’s Safe Drinking Water and Toxic Enforcement Act of 1986) made national news because of litigation over whether your morning cup of coffee needed to come with a warning about cancer and reproductive harm. The litigation centered on the failure of coffee purveyors to warn of these risks because coffee contains acrylamide, a naturally occurring byproduct chemical of the coffee roasting process. The plaintiffs argued that because acrylamide is regulated under Proposition 65, businesses like Starbucks were violating the Safe Water and Toxic Enforcement Act that Proposition 65 enacted.
What Foods Contain Acrylamide?
Acrylamide was originally listed as a Proposition 65 carcinogen in 1990, and a safe harbor (No Significant Risk Level) of 0.2 micrograms/day was established for it. The chemical was subsequently listed as a Prop 65 reproductive toxicant. Initially the substance’s listings provoked little interest among Prop. 65 litigants, because the only known exposure to the chemical was in limited industrial settings.
However, in 2002 Swedish researchers discovered that acrylamide is generated when carbohydrate-rich foods are subjected to high heat levels during baking, roasting, frying, or similar processes. The levels of the chemical in these products were considerably higher than the 0.2 micrograms safe harbor level. It was primarily the Swedish study that sparked the lawsuit against the coffee industry, as acrylamide is allegedly a by-product when heat is applied to coffee beans.
Does Acrylamide Cause Cancer?
According to the Food & Drug Administration (FDA), acrylamide has caused cancer in animal studies at very high doses. The FDA has also previously reported that the amount of acrylamide found in brewed coffee is generally less than 12 parts per billion. It also warned OEHHA against establishing any alternative level requiring warnings for acrylamide in foods, as it was actively engaged in research on the impact of acrylamide consumption in foods in coordination with the World Health Organization. In 2016, the FDA issued its Guidance for Industry, Acrylamide in Foods, in which it outlined ways for food manufacturers to reduce acrylamide content in their products.
What Is The Post Foods Decision?
Enter Post Foods, LLC v. Superior Court of Los Angeles County (Sowinski). In the underlying case, Dr. Richard Sowinski sued the likes of Post Foods, Kellogg, and General Mills, alleging that the breakfast cereal manufacturers had failed to display the cancer and reproductive harm warnings required by Proposition 65 because the cereals contained acrylamide.
Long before Sowinski filed his case, the FDA had corresponded with California health agencies regarding acrylamide and Proposition 65 because a cancer warning would likely cause confusion among consumers who were being encouraged by the FDA to eat more whole grains. The dialog between the FDA and California agencies over acrylamide warnings for food spanned more than a decade and was noted to be ongoing in statements from the FDA, and the California agency responsible for Proposition 65’s implementation, OEHAA, even as the plaintiff filed his lawsuit.
The cereal companies pursued summary judgment on two grounds, both rooted in federalism and preemption: express preemption and conflict preemption. The trial court denied the motion for summary judgment. On the express preemption front, the trial court noted the FDA’s active interest in Proposition 65, acrylamide, and cereals, but found that this guidance did not create a federal “requirement” regarding acrylamide warnings on cereal products one way or the other. “[T]he fact that the FDA itself has recognized that research is ongoing reveals that no current federal standard is in place.”
Regarding conflict preemption, the trial court found that it was not “impossible” for the cereal makers to comply with both state and federal requirements. While the evidence showed “an important national policy of increasing consumers’ intake of whole grains (which would include breakfast cereal),” Proposition 65 does not make it “impossible” for the cereal makers to comply with state law “and [with] the federal policies encouraging consumption of whole grains.”
On appeal, the cereal makers challenged only the trial court’s ruling on conflict preemption, arguing that that the trial court only evaluated the impossibility test for conflict preemption when they were attempting to argue the obstacle preemption test. “Whether state law poses an obstacle to accomplishing the purposes of federal law ‘is a matter of judgment,’ ‘informed by examining the federal statute as a whole and identifying its purpose and intended effects.’” “When evaluating conflict preemption, courts have recognized that administrative agencies possess ‘a unique understanding of the statutes they administer and an attendant ability to make informed determinations about how state requirements may pose an “obstacle to the accomplishment and execution of the full purposes and objectives of Congress.”’” Following an analysis of both United State Supreme Court precedent (e.g., Crosby v. National Foreign Trade Council (2000) 530 U.S. 363 and Wyeth v. Levine (2009) 555 U.S. 555) and California Supreme Court precedent (e.g., Dowhal v. SmithKline Beecham Consumer Healthcare (2004) 32 Cal.4th 910), the California Court of Appeal found that the trial court failed to given adequate weight to the FDA’s letters regarding cereals and “that a Proposition 65 warning for acrylamide on breakfast cereals would pose an obstacle to the federal scheme and therefore is preempted by federal law.”
In October 2018, the California Supreme Court upheld the Post Foods decision. However, a number of interested parties requested depublication, including environmental groups, the California Attorney General, and OEHHA. The Supreme Court decertified the case for publication. Post Foods can no longer be cited as authoritative precedent.
CMBG3 Law LLC has represented clients in products liability matters, especially with respect to warning label issues, for many years. Our attorneys in California are well-versed on Prop 65 issues and requirements. We provide the most current legal advice to our clients by staying on top of developments in science, medicine, and regulations regarding a wide variety of substances and products used by consumers every day. If you have any questions or would like more information, please contact Gilliam Stewart (email him or 415-957-2322) or John Gardella (email him or 617-279-8225).