USA – CALIFORNIA Trends and Developments Contributed by: Anne Marie Ellis, Marissa Alkhazov, Steven Di Saia and Christopher Van Gundy, Buchalter, LLP
PFAS PFAS present the same structural problem. The FDA’s 2025 Report to Congress acknowledged PFAS in cer - tain cosmetics but concluded that toxicological and exposure data are insufficient to set safety thresholds or restrictions. The agency declined to establish limits, bans, or standardised testing methodologies, instead identifying significant gaps in toxicological and expo - sure data. This creates a familiar MoCRA dilemma: the statutory obligation to maintain “adequate substantia - tion of safety” is fully operative, yet there is no clear benchmark against which substantiation will be evalu - ated. In practice, companies must define their own testing thresholds and risk assessments ‒ decisions that are inherently vulnerable to second-guessing by regulators and plaintiffs. Meanwhile, states are not waiting: California, Washington, Oregon, and others have enacted their own bans or disclosure require - ments, creating a patchwork that companies must navigate alongside the federal vacuum. PFAS will reappear in the discussion of false advertis - ing below, as the absence of a federal standard has not prevented plaintiffs from arguing that consumers reasonably expect “clean” or “non-toxic” products to be PFAS-free. This regulatory gap does not insulate companies from litigation; it funds it. Fragrance allergens The same pattern extends to fragrance allergens, where MoCRA directs the FDA to mandate disclo - sure but the agency has yet to finalise a rule iden - tifying covered allergens, concentration thresholds, or testing expectations. Companies are left relying on supplier certifications, internal assessments, and EU standards while anticipating a rule that may ulti - mately align with, or diverge from, EU-style disclosure structures. Simultaneously, fragrance-related adverse events remain reportable, and the FDA retains author - ity to access substantiation data, exposing the irony that the obligation to report exists even though the framework for preventing the reportable event remains undefined. What this means in practice Collectively, these developments reflect a structural shift. MoCRA has created a model informed system without fixed scientific guardrails. Compliance is no
longer a static inquiry into defined requirements; it is a process of building substantiation frameworks capa - ble of withstanding scrutiny in an evolving regulatory environment where ambiguity is a source of risk. As a result, companies must build and revisit their compli - ance programmes to comply with the current regula - tory landscape, predict and solve for future implemen - tations, adhere to state legislatures filling gaps, and anticipate plaintiffs leveraging compliance ambiguities in their favour. False Advertising and the Litigation Machine The regulatory ambiguity running through each of the preceding sections does not just create compliance headaches. It creates litigation theories. And nowhere is that more apparent than in California false advertis - ing law. Claims under the CLRA, the Unfair Competition Law (UCL), and the False Advertising Law (FAL) have evolved well past the straightforward cases of a com - pany making an allegedly false or misleading claim on a label. The current wave of litigation is built on omission- and implication-based theories that reframe technically compliant conduct as misleading, trans - forming regulatory gaps into affirmative litigation shakedowns. The reverse-engineered complaint An emerging trend is the shift from express claims to implied representations. In food and beverage, terms such as “natural,” “healthy,” or flavour descriptors are challenged based on regulatory nuances. In dietary supplements, structure-function claims are attacked where surrounding marketing or testimonials sug - gest disease-related benefits. The inquiry has shifted from what is stated to what a reasonable consumer is alleged to infer from the totality of messaging. In cosmetics and personal care products, claims such as “clean,” “non-toxic,” “hypoallergenic,” and “clini - cally tested” are paired with omission theories tied to ingredient profiles, trace contaminants, or emerging chemicals of concern, including PFAS. In the absence of harmonised federal standards under MoCRA, plaintiffs are effectively defining what constitutes “a reasonable expectation of safety and disclosure” through litigation. This is where the overlap with the
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