Review makes clear FDA’s thinking on safety acetaminophen use during pregnancy, but likely won’t sway federal judge from her conclusion that a warning about risks of in utero exposure could be added to drug containing the ingredient and available under an OTC monograph without violating FDA regulations.

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 Health Choices Coalition sent letters urging House and Senate members to support legislation that would strike the health care reform law requirement that consumers obtain a prescription in order to purchase OTCs with a pre-tax savings account.