Why Preemption Defense Worked In Recent Neutrogena Suits, But Not Others

Consumer suits seeking changes to, or disclosures in, J&J/Neutrogena sunscreen labeling claims – beyond what FDA requires – are preempted in accordance with the FDA Modernization Act, which Congress intended to promote national regulatory uniformity, a California appellate court has ruled. OTC drug and cosmetic firms, including J&J, have been less successful with preemption arguments in other cases.

A California appellate court ruling on disputed Neutrogena sunscreen claims highlights an important distinction in preemption arguments that may dictate their outcomes, namely whether proposed requirements for manufacturers under state law differ from or add to related federal requirements.

Compared with SPF claims, for example, which FDA has addressed with final and proposed rulemaking, "natural" claims have gone relatively untouched by the agency, making it more difficult for defendants...

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