Court Rejects Preemption, Asks FDA To Defend Pregnancy Label Warning For OTC Acetaminophen

Ruling on pre-trial motion in complaint against a Kenvue business in District Court for Southern New York is first in litigation alleging damages from using OTC monograph drug to find against federal preemption of state consumer protection laws and similar regulations.

The US Food and Drug Administration is challenged to prove the adequacy of the pregnancy label warning it requires for OTC acetaminophen by a judge who ruled federal preemption doesn’t preclude damages complaints against firms marketing drugs available under the agency’s monograph system.

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Doctors In The House: Sunscreen Innovation Diagnoses From Health Subcommittee

05 Apr 2025

• By Malcolm Spicer

Energy and Commerce Health Subcommittee members, including several health care professionals, make clear their concerns about the US sunscreen market during hearing on reauthorizing FDA’s OMUFA program.

Criticism Of US Progress On Sunscreen Ingredient Innovation Demands OMUFA Hearing Spotlight

05 Apr 2025

• By Malcolm Spicer

Discussion of introducing additional OTC sunscreen ingredients escaped a total eclipse criticism of Trump’s health agency layoffs caused. Comments and questions by Republican members joined by several Democrats and focused testimony and answers by witnesses representing the industry and public health groups spotlighted sunscreen.