FDA Preemption Comment Could Sway California Against Prop 65 Warnings For Acetaminophen
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If acetaminophen is added to California's Prop 65 list, it would likely be a qualified listing, requiring OTC marketers only warn consumers under special circumstances, says a consumer products lawyer. Listing could spur argument between stakeholders and the state over FDA labeling pre-emption.
The FDA Modernization Act promotes regulatory uniformity and pre-empts litigation seeking changes to J&J/Neutrogena sunscreen labeling claims beyond FDA requirements, a California state appellate court says. OTC drug and cosmetic firms have been less successful with pre-emption arguments in other cases.