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

 
• By Malcolm Spicer

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.

• Source: Shutterstock

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.

The ruling on a pre-trial motion by attorneys for Johnson & Johnson Consumer Inc., a Kenvue Inc. subsidiary, in...

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