[Author note: this post was written by Wendel Rosen attorney Wendy Manley.]
Just weeks after a court determined that a Proposition 65 (Prop 65) warning is required for acrylamide in coffee, a California appellate court ruled a warning is NOT required for acrylamide in breakfast cereals. Acrylamide is listed as a carcinogen by the State of California and, consequently, a warning must be provided before exposing California consumers to acrylamide.
Warning exemption pending for acrylamide in coffee
Not surprisingly, the coffee decision created a high degree of confusion and disbelief among dedicated coffee drinkers who, just months earlier, embraced the good news that coffee may protect against certain cancers. In June, the International Agency for Research on Cancer (IARC) released a monograph that reviewed more than 1,000 studies of coffee and cancer. IRAC concluded that coffee is associated with a reduced risk of liver and uterine cancer and there is inadequate evidence that coffee causes cancer. In other words, the scientific studies show that while acrylamide causes cancer, coffee — which contains acrylamide — does not.
Recognizing that the Prop 65 warning requirement cannot be reconciled with the science, OEHHA (the Office of Environmental Health Hazard Assessment) immediately proposed a new (and still pending) regulation exempting coffee from Prop 65 warning requirements with respect to acrylamide and certain other chemicals. The proposed rule states: “Exposures to listed chemicals in coffee created by and inherent in the processes of roasting coffee beans or brewing coffee do not pose a significant risk of cancer.” In its Initial Statement of Reasons supporting the rule, OEHHA identifies other Prop 65 chemicals formed in the brewing of coffee that would be encompassed by the exemption, including acetaldehyde, furfuryl alcohol, formaldehyde, naphthalene, and several chemicals with polysyllabic, tongue-twisting names.
The coffee research highlights a gap in Prop 65’s science: the mere presence of a chemical known to cause cancer (even at levels above what is believed to be safe), does not necessarily equate to a risk of cancer from exposure to an item that contains that chemical. Most products, unlike coffee, have not been exhaustively studied for cancer risk, and few manufacturers either have or are willing to expend the resources necessary to undertake a comprehensive risk assessment to determine whether a product containing a Prop 65 chemical in fact presents a risk of cancer or reproductive toxicity under Prop 65. As a result, many warnings are not supported by science, and some may not be supportable were the research performed. To add further uncertainty, OEHHA has not established “safe harbor” levels for most of the more than 900 chemicals listed under Prop 65, making it even more difficult for manufacturers to complete a risk assessment.
OEHHA will hold a hearing on the proposed coffee warning exemption on August 16, 2018, and will accept comments through August 30, 2018. Follow developments on the OEHHA website.
Warning requirement for acrylamide in breakfast cereal preempted
In another recent decision, a court determined that Prop 65 warnings are NOT required for breakfast cereal. The basis for the decision was the principle of federal preemption: states cannot implement laws that conflict with federal laws. The court found that Prop 65 poses an obstacle to the accomplishment and execution of a policy under federal law in which the Food and Drug Administration (FDA) promotes whole grain foods in the American diet. When there is no express preemption provision in federal law, the court examines the entire scheme of a federal statute for implied preemption, and if the court determines that its purpose and operation are frustrated by the state law, then the state law is preempted. In Post Foods v. Superior Court, the court found Prop 65 is an obstacle to the accomplishment and execution of the FDA policy of promoting whole grain foods in the American diet.
Although most cereals contain acrylamide at a level that would require a Prop 65 warning, whole grains are a significant source of important vitamins, minerals and fiber. Based on research demonstrating the health benefits of whole grains, the FDA established a policy to promote the consumption of whole grains.
FDA described its policy in two letters to OEHHA and the Attorney General in 2003 and 2006 advising against acrylamide warnings on food. FDA was concerned that labeling foods with warnings about dangerous levels of acrylamide would confuse and potentially mislead consumers, both because the labeling would be so broad as to be meaningless and because the risk of consumption of acrylamide in food is not yet clear. FDA also worried the warning would dilute its messaging about healthy eating, mislead consumers into thinking acrylamide is only a hazard in store-bought foods, and ultimately cause consumers to avoid grains (specifically breads and cereals), potentially increasing their risks of disease from less fiber and other beneficial nutrients in their diets. FDA concluded that Prop 65 warnings on foods would “conflict with FDA’s ongoing efforts to provide consumers with effective scientifically based risk communication to prevent disease and promote health.” FDA’s advised that Prop 65 warnings for acrylamide should not be placed on foods, including breakfast cereals, unless and until the science supports such a warning. FDA noted that even if acrylamide warnings became warranted, FDA may require manufacturers (as it does with trans fats) to identify foods containing acrylamide and the amount based on quantities consumed.
The Second District Court of Appeal found FDA’s letters thorough, consistent, and containing persuasive reasoning why Prop 65 acrylamide warnings on whole grain cereals would mislead consumers and lead to health detriments. Prop 65 warnings, it concluded, conflict with a clear federal program to encourage healthy eating by consumers, and so is preempted.
Under the Post Foods case, breakfast cereals are now exempt from Prop 65 warnings (pending any potential appeal). The exemption should extend to other grain products such as bread and granola bars, and arguably to other foods encompassed by FDA’s letters, but it is not generally felt that the decision will discourage all Prop 65 food claims based on acrylamide. The decision may also invigorate other defendants to pursue federal preemption arguments, given appropriate supportive facts.