Proposition 65 (Prop 65) is a controversial California health law enacted in 1986 as the Safe Drinking Water and Toxic Enforcement Act. The law—which purports to protect consumers from exposure to substances known to the State of California to cause cancer, birth defects, or reproductive harm—mandates the placement of consumer warnings on products containing any of nearly a thousand different chemicals. In turn, Prop 65 is administered by the Office of Environmental Health Hazard Assessment (OEHHA), part of the California Environmental Protection Agency.
The confusion surrounding compliance with Prop 65 is pervasive and persistent. For starters, neither the regulators, businesses, plaintiff lawyers, or the courts can seem to agree on what products are affected and what warnings are required. In a recent high-profile case involving the sale of coffee, the court ruled that ready-to-drink and ready-to-prepare coffee products must be accompanied by a warning because coffee contains high levels of acrylamide, a chemical known to the state of California to cause cancer and reproductive harm. Following the ruling, OEHHA proposed new coffee regulations that would exempt coffee products from the warning requirements. Meanwhile, after plaintiff lawyers successfully argued that cereal products required warnings because of the presence of acrylamide, a California appeals court overturned the ruling.
In addition to the confusion being sown by the regulators and courts, the federal government is threatening to become involved as well. Recently introduced federal legislation, the Accurate Labels Act (ALA), would demand any food product warning requirements (i.e., those mandated by Prop 65) be subjected to rigorous evidence-based review supported by the best available science. More importantly, ALA would shift the burden of proof from the defendant to the party (government or private plaintiff) bringing any enforcement action.
Revised Warning Requirements
Recent changes to the Prop 65 regulations have also arguably increased the levels of confusion surrounding Prop 65 compliance. Historically, Prop 65 warnings were merely required to notify consumers if a chemical capable of causing cancer or reproductive harm might be present. That began to change in 2016, when OEHHA significantly revised the warning requirements. After a two-year phase-in, the new OEHHA warning revisions went into effect on Aug. 30, 2018. Even though the revisions do not substantively change the purpose of Prop 65, they have nonetheless generated significant confusion regarding how to best comply and are widely expected to lead to an increase in litigation.
Among other things, the new regulations require that any products needing a warning must now identify the specific chemical that may be present in a product. The regulatory changes shift responsibility for warnings further upstream in the supply chain, giving manufacturers the primary responsibility for providing Prop 65 warnings. Manufacturers can either affix warning labels to their products, or provide written notice to retailers that a product requires a warning, provide the warning materials, and obtain confirmation retailers received the notice.
The revisions also substantially modify the guidance relating to the form and content of the warnings. It should be noted that the precise format of the warnings is not mandated by the law. Rather, the warnings must simply be “clear and reasonable.”
The definition of what it means to be “clear and reasonable,” however, can and does vary greatly between, for instance, a commercial business and a plaintiff’s lawyer. To address this issue, the law gives manufacturers the option to use a form-template “safe harbor warning.” Warnings that meet the safe harbor warning requirements are deemed to be clear and reasonable.
To meet the safe harbor requirements, Prop 65 warnings for food products must: 1) contain the word “WARNING” in all capital letters and in bold print; 2) state whether the product contains a carcinogen, reproductive toxicant, or both; and, 3) reference the Prop 65 warning food website. If the warning is placed on the product label, it must be set off from other surrounding information and enclosed in a box. If the warning is in a language other than English, the warning must be in that language as well. Here is an example of the new warning: