FDA Preemption Comment Could Sway California Against Prop 65 Warnings For Acetaminophen
Food and drug attorneys suggest it is unlikely California will require Prop 65 warnings on OTC acetaminophen products after FDA tells the state that warnings would violate federal regulations. FDA also says sciences doesn't support a conclusion acetaminophen can cause cancer and that the warnings would confuse consumers.
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Marketers of copies of national brand OTCs are required under FDA regulations to use the same labeling as the brand, a rule that in effect has limited complaints in California state court alleging Prop 65 violations with nonprescription drug labeling to targeting branded product marketers.
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.