• 1,610 notices of Proposition 65 lawsuits filed during the first half of 2020, including a peak of 348 notices filed in March at the start of the COVID-19 pandemic.

  • On April 1, new Proposition 65 warning requirements took effect

  • Hundreds of Proposition 65 lawsuits have targeted food products in recent years

  • Businesses must understand the requirements and their chemical risks

From manufacturing to retail, all food industry entities operating in California should know the chemical contaminants associated with their products and understand the Proposition 65 warning requirements. Any business marketing products in California should be aware of recent changes to the law that clarify the legal responsibility for warning requirements as well as the meaning of “actual knowledge” in terms of liability. 

Proposition 65 is a California law requiring “clear and reasonable” warning labels on products containing chemicals determined by the state to cause cancer, birth defects, or other reproductive harm. California’s Office of Environmental Health Hazard Assessment (OEHHA) manages the list of more than 1,000 naturally occurring and synthetic chemicals found in a broad range of products, including food and beverage products.

Beware of “bounty hunters”

For products sold in California, the enforcement of Proposition 65 is typically accomplished through lawsuits, and a plethora of lawsuits have been filed against companies by so-called “bounty hunter” attorneys or non-governmental organizations. In recent years, there has been an upward trend in lawsuits related to potential Proposition 65 violations, particularly lawsuits targeting food products. 

Under the law, a plaintiff must provide the state with a 60-day notice of its intent to file a lawsuit related to a Proposition 65 non-compliance or violation. If the state does not take action within 60 days, a lawsuit can be filed against a business. An upward trend in the annual number of 60-day notices associated with food products has persisted for several years. In fact, 330 notices were linked to food products in 2018, and more than 300 notices were filed by the first half of 2019. Overall, 1,610 notices of Proposition 65 lawsuits were filed during the first half of 2020, including a peak of 348 notices filed in March at the start of the COVID-19 pandemic.

In terms of food products, the majority of 60-day notices have been triggered by acrylamide and heavy metals. In recent years, attorneys have begun to target products not commonly named in Proposition 65 lawsuits, including seasoned seaweed, hamburger buns, and ice cream cones.

Acrylamide is a natural byproduct of the coffee roasting process and also forms during the high-temperature cooking of certain carbohydrate-rich foods, including potato-based foods and cereal foods (e.g. cookies, crackers, etc).  In 2019, acrylamide prompted more than 200 notices of potential lawsuits related to food products, including ice cream cones, waffles, bread, crackers, cookies, nuts and nut products, pretzels, snack chips, cocoa, olives, and prune juice.

Heavy metals are another leading reason for Proposition 65 lawsuit notices. Cadmium was named in 86 notices related to food products, and arsenic was identified as the reason for more than 40 notices last year.  Cadmium prompted dozens of notices related to seaweed products and dietary supplements.  Arsenic triggered 60-day notices due to its potential presence in seaweed products, dried shrimp, dietary supplements, bottled water, and various seasonings including ground oregano, sage, ginger, cinnamon, anise, and sumac.

Obligations and “Actual Knowledge”

Since 2018, California has required Proposition 65 warning statements to identify at least one chemical related to either cancer and/or reproductive toxicity. Several manufacturers have expressed concerns about the potential for increased litigation due to the mandate for identifying a specific chemical and health risk. The warning label requirements have been extended to food and alcoholic beverages sold online and within restaurants.       

Effective April 1, California amended its regulations to clarify the responsibilities of manufacturers, retailers, or other businesses in regard to consumer product exposure warnings.

A manufacturer was previously required to add a warning statement to the product label or to pass on their obligation for a warning statement by providing written notice to an authorized agent for a retail seller. Under the new amendments, the Proposition 65 warning obligation still begins with the manufacturer, but if the warning is not added to a label then the obligation should be communicated with each upstream entity. The manufacturer or distributor can provide notice to the authorized agent for the intermediary or the agent for a retailer, but it is mandatory to confirm receipt of the warning obligation. In effect, the importance of record keeping by retailers cannot be underestimated.

The definition of “actual knowledge” has been simplified for retailers. The final regulatory text states “actual knowledge” means the “the retailer seller…receives information from any reliable source that allows it to identify the specific product or products that cause the consumer product exposure.” The legal burden for providing a warning could fall on a retailer if the retailer has “actual knowledge” of potential consumer exposure to a Proposition 65 chemical.

Understanding the Risks

Mérieux NutriSciences recommends a stepwise process to determine the best course of action related to California Proposition 65 chemical risks in your food, ingredients, and, packaging. To begin, Mérieux NutriSciences can conduct a literature review on the ingredients, packaging, and finished food to determine the likelihood of these chemicals being present in the finished food.  

For a more detailed examination, Mérieux NutriSciences recommends analytical testing to determine the chemicals present in finished foods, ingredients, and packaging. Mérieux NutriSciences Board-certified Toxicologists can conduct a risk assessment to determine the risk of chemicals and the potential level of exposure to consumers in order to recommend warning label options. If a Proposition 65 chemical risk is determined our labeling professionals can review the toxicological risk assessment and the warning label for compliance to Proposition 65 requirements. Finally, Mérieux NutriSciences can provide litigation support through collaboration with external law firms.

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