USA – CALIFORNIA Trends and Developments Contributed by: Anne Marie Ellis, Marissa Alkhazov, Steven Di Saia and Christopher Van Gundy, Buchalter, LLP
against a recall or limit its scope. Food attorneys and scientists can help in this regard. State-level regulation Many states, like California, essentially defer much of their food safety enforcement to the FDA, but are beginning to take a more active role that may portend regulation to come. California’s Assembly Bill 899, for example, requires manufacturers of food products for children two and under to test regularly for these four metals and publish results on their websites, acces - sible also via a package QR code. The law sets no concentration standards, but makes this test data available to any consumer, federal regulator, or Prop 65 enforcer as a basis for future action. The federal–state disconnect on Prop 65 There is no direct indication that the FDA and Prop 65 enforcers regularly share information or co-ordinate regarding heavy metals. The Prop 65 “safe harbours” and FDA action levels, as well as each regime’s toxi - cological and exposure calculations, can differ sig - nificantly. Of course, the FDA’s publication of heavy metal testing results can influence the efforts of Prop 65 enforcers, and a Prop 65 lawsuit conceivably could bring an adulteration situation to FDA’s attention, in notable cases. Testing protocols and supply chain management: the foundation of any defence Regardless of differences between state and federal law, food companies can and should have in place a reliable, commercially reasonable testing protocol and supply chain management programme for these heavy metals. At concentrations measured in parts per billion, a reliable testing protocol at a minimum would involve use of reputable laboratories accredited for approved testing methodologies, with the ability to generate test results across production lots with appropriate margins of error. This type of testing pro - tocol may be more rigorous than routine checking of ingredient certificates of analysis, but can substan - tially minimise enforcement risk and strengthen legal defences. As discussed below, the same enforcement and testing challenges recur in cosmetics (talc, PFAS, fragrance allergens) and across consumer products
where trace contaminants drive both regulatory and litigation risk. The short-form warning is no longer short – and the implications are not simple Turning to Prop 65 across all categories of prod - ucts, enforcement volume remains high, with over 5,000 notices filed in 2025, but the targets often shift. Over the past several years, industry observers have watched the focus cycle through heavy metals, phtha - lates, PFAS, bisphenols, diethanolamine, and newer chemicals. Product categories rotate too ‒ foods, supplements, cosmetics, apparel, consumer goods with coatings or plastic components. As enforcement targets rotate, the tools companies have relied on to manage that risk are changing too. Warning strategies have also grown harder to man - age, and the reason is structural, not incremental. Effective 1 January 2025, the Office of Environmental Health Hazard Assessment (OEHHA) finalised amend - ments to the Prop 65 safe harbour regulations that fundamentally change what a short-form warning must say. The old short-form was two words and a website: “WARNING: CANCER ‒ www.P65Warnings. ca.gov.” No chemical name required. That brevity ‒ combined with the ability to comply without disclos - ing what chemical triggered the warning ‒ made the short-form warning the default choice for manufactur - ers, distributors, and retailers across virtually every product category. That is over. Under the amended regulations (Califor - nia Code of Regulations, Title 27, Section 25603 (b)), the short-form must now identify at least one listed chemical by name for each applicable endpoint ‒ can - cer, birth defects or reproductive harm. A carcinogen- only warning, for example, must now read: “WARN - ING: Cancer risk from exposure to [name of chemical]. See www.P65Warnings.ca.gov” or “WARNING: Can expose you to [name of chemical], a carcinogen. See www.P65Warnings.ca.gov.” Products triggering both endpoints must name a chemical for each. Business - es may also use “CA WARNING” or “CALIFORNIA WARNING” in place of “WARNING” ‒ a concession to companies selling nationally that want to signal the warning is California-specific.
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