USA – CALIFORNIA Trends and Developments Contributed by: Anne Marie Ellis, Marissa Alkhazov, Steven Di Saia and Christopher Van Gundy, Buchalter, LLP
Product Liability in 2026: Regulatory Ambiguity, Enforcement Expansion, and the California Proving Ground Introduction There is a pattern running through nearly every con - sumer product liability matter the firm handles right now: governmental agencies are erecting regulatory frameworks faster than they are filling them with sci - ence. The United States Food and Drug Administra - tion (FDA) has new authority over cosmetics, but no finalised test method for asbestos in talc. It has action levels for lead and arsenic in food for infants and small children only, but nothing yet for cadmium or mercury for the same age group or for these four heavy met - als in the general population. It acknowledges per- and polyfluoroalkyl substances (PFAS) in cosmetics but declines to set limits. The Occupational Safety and Health Administration (OSHA) has a permissible exposure limit (PEL) for respirable crystalline silica, but according to the plaintiffs’ bar, no meaningful enforce - ment infrastructure behind it. Into every one of these gaps steps consumer counsel willing to define the standard through litigation ‒ typi - cally in California, and typically under legal standards that rely heavily on vague and changeable under - standings as to what a “reasonable consumer” alleg - edly understands. To mitigate risk effectively, companies should pro - actively manage regulatory compliance, marketing/ labelling review, and litigation defence as a whole with the following principles in mind. Heavy Metals in Food: The FDA and California Trends, and Overlap with Proposition 65 Four heavy metals ‒ lead, arsenic, cadmium, and mer - cury ‒ are very much on the menu recently for federal and state regulators, particularly in foods consumed by infants and young children. These metals are ubiq - uitous in the food supply, coming from the air, soil, and water. Depending on the applicable law, they are sometimes considered toxic at concentrations so low ‒ parts per billion ‒ that some laboratories cannot quantify them reliably due to issues of cross-contam - ination and testing limits.
All four heavy metals are California Proposition 65 (“Prop 65”) listed substances and are frequently the subject of 60-day notices of violation for foods con - sumed by all ages. In terms of the science, standards, and enforcement actions, however, FDA regulation of these metals operates independently of Prop 65 enforcers, namely, the California Attorney General and private enforcers claiming to act in the public interest. A food company thus can be compliant with one regu - latory regime and exposed to liability under the other ‒ a dynamic that recurs, as discussed below, across cosmetics, consumer goods, and virtually every prod - uct category where trace chemicals are at issue. FDA’s “Closer to Zero” initiative Under this initiative, the FDA is developing science- based “action levels” ‒ the concentration of a metal at which the agency may treat a food as adulterated ‒ for these heavy metals in foods for infants and young chil - dren. In this regard, the FDA has finalised action lev - els for lead in fruits, yoghurts, vegetables, meats, and dry infant cereal, in addition to existing levels for the general population of these heavy metals for example in bottled drinking water. The FDA also has estab - lished “toxicity reference values” representing a safe upper limit for certain food categories, which values do not necessarily involve the enforcement priority of an action level. The initiative’s focus on infants and young children understates its reach because the FDA defines the foods broadly to include yoghurt, certain snack chips, fruit, and vegetable products that adults may also con - sume. Also, even without an action level, the agency can establish a “case-by-case” corrective level for a food consumed by the general population based on toxicological and consumption data it may have con - sidered under the initiative. Such enforcement inquir - ies can arise through biannual food facility audits, the FDA’s own testing, or reports to the FDA, with enforce - ment ranging from warning letters to potential recall investigations. The FDA has acknowledged enforcement flexibility by taking into account “unintended consequences,” such as eliminating from the marketplace foods that have significant nutritional benefits. This policy is an opportunity for a well-prepared company to advocate
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