USA – CALIFORNIA Trends and Developments Contributed by: Anne Marie Ellis, Marissa Alkhazov, Steven Di Saia and Christopher Van Gundy, Buchalter, LLP
When Compliance Collides: Lessons from the Front Lines Everything discussed in the preceding sections con - verges in the day-to-day experience of companies trying to sell regulated products in California and nationally. The common thread is that risks which used to be manageable in isolation now compound. PFAS detection in a cosmetic, a silica exposure claim against a stone manufacturer, an adverse event report filed under MoCRA or a Prop 65 notice about lead in a food product surfaces information that the FDA or a false advertising attorney may find worth pursuing particularly in the absence of clear, consistent regula - tory safe harbours. What works In practice, this means three things. First, treat chemi - cal compliance, advertising review, and Prop 65 strat - egy as one integrated function ‒ not three departments that meet after a complaint arrives. Second, track what the plaintiffs’ bar is filing, not just what regulators are publishing; enforcement trends forecast litigation theories, and the lag time between the two is shrink - ing. Third, pressure-test every consumer-facing claim against the only question that matters in California: not “Is this technically accurate?” but “What will a plaintiff argue a reasonable consumer understood this to mean?” The patterns across every topic in this article ‒ point in the same direction. Federal regulators are setting the table without filling in the menu. State enforcers and private plaintiffs are writing it for them. The compa - nies that recognise this early and build their compli - ance, marketing, and litigation strategies accordingly will spend far less time reacting, and far less money defending, than those that do not.
issues discussed above becomes concrete. The same PFAS that the FDA declined to regulate in cosmetics becomes the basis of a false advertising claim. The same heavy metal that falls below the FDA’s action level but above a Prop 65 safe harbour becomes the predicate for both a 60-day notice and a consumer class action. The regulatory gap is not just a compli - ance problem; it is the raw material for the complaint. Claim drift and consumer inference Medical devices and software as a medical device (SaMD) face a parallel risk through claim drift. Plaintiffs allege that marketing claims extend beyond cleared or approved indications for use, invoking FDA intended use principles under Title 21 of the Code of Federal Regulations, Section 201.128 (“21 C.F.R. § 201.128”). Plaintiffs argue that labels or marketing campaigns violate the intended use of the product and deceive the average consumer. The doctrinal shift is from what a company said to what a “reasonable” consumer allegedly understood. Portfolio-wide risk In practice, the consequence is that false advertising exposure is no longer about one product or one claim. Once a theory gains traction ‒ where a court allows a “non-toxic” challenge to survive a demurrer based on trace PFAS detection ‒ that theory is deployed against every brand making a similar claim. Companies must evaluate claims not only for technical compliance but also for how promotional content can be reframed in threatened litigation under the guise of alleged con - sumer deception.
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