Many in the food industry are still unaware that in addition to following extensive federal labeling laws, they must also be attentive to a unique California public disclosure law known as Proposition 65 or “Prop 65.” Formally known as the Safe Drinking Water and Toxic Enforcement Act, Prop 65 is behind that sign seen throughout California warning you that some thing or place may expose you to chemicals known to the state to cause cancer or reproductive harm.

Prop 65 requires businesses to provide a warning before exposing a person in California to a chemical on the State’s Prop 65 list. Failing to do so leaves a company vulnerable to costly enforcement action, most of which occurs at the hands of an aggressive citizen contingent rather than by the state or an agency. With a heavy burden of proof, most defendants settle these cases, paying tens to hundreds of thousand of dollars in penalties and attorneys fees (including the plaintiff’s).

In 2018, a court decision in a high-profile case ruled a Prop 65 warning is required on coffee for exposure to acrylamide. Because it is generated by cooking or roasting, Acrylamide is among the more difficult chemicals to control in food. It is found in coffee, bread, crackers, cookies, nuts, fried potatoes and veggie snacks, among other things.

More than 400 new Prop 65 enforcement actions were initiated in 2018, alleging failure to warn on a range of food and food supplement products. Nearly 60 claims targeted nuts and nut butters for the presence of acrylamide, lead or cadmium, and more than 30 claims were made against spices for arsenic and/or lead. Acrylamide continued to spur claims against cookies, crackers, and veggie snacks, while lead and cadmium gave rise to claims against chocolate, cocoa, seaweed, and a range of other products.

Every food manufacturer should investigate their products to determine whether any listed chemicals are present in a quantity that would constitute an exposure that triggers the warning requirement. While there are a wide range of chemicals to consider (well over 900 appear on the state’s list), as is evident in recent claims, the more common chemicals found in food products are relatively few: primarily lead, cadmium, arsenic, and acrylamide.

The mere presence of a listed chemical does not necessarily mean a warning is required. Safe harbor exposure levels have been established for many listed chemicals. Translating those levels to an allowable concentration in food, however, is not always a straight-forward exercise. Given the risk assessment challenges, many in the non-food world simply add a warning to their products. To food producers, however, placing a cancer warning on packaging alongside claims of health and nutritional benefits is not an attractive option. Consequently, many are looking carefully at ingredient sourcing, formulation, and alternative production techniques, as well as statutory exemptions, before seriously considering a Prop 65 warning.

No warning is required if chemical exposure is below safe harbor levels. Additionally, chemicals that are naturally occurring in a product (not from anthropogenic sources) do not contribute to the exposure calculation and can exempt a product from warning requirements. Additionally, chemicals present in food that are produced by cooking necessary to render the food palatable or to avoid microbiological contamination are also exempt

When a warning is necessary, the regulations establish requirements to meet the statutory standard of “clear and reasonable.” Unfortunately, many who have examined their products and added a Prop 65 warning are not aware that the warning regulations have recently changed. Among the more significant changes is the requirement to identify at least one listed chemical for each endpoint (cancer or reproductive toxicity, as applicable). In addition to specific wording, the regulations include parameters for the appearance of, or “method of communicating” the warning. Food warnings, for example, need to be outlined by a box, while non-food warnings require a yellow triangle symbol enclosing an exclamation point.

Retailers, distributors and suppliers also need to be engaged, as every party in the chain of commerce is potentially liable. Notification and indemnification agreements to ensure Prop 65 warnings are passed down to consumers and to allocate legal and financial liability have become common strategies to limit exposure to enforcement.

The process of identifying potential chemicals, evaluating exposure and crafting a compliant warning can be a challenging and nuanced exercise. Those who have experienced the sting of enforcement, however, feel that careful consideration of these issues is worth the effort.