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Food and Drug Administration (FDA) › Administrative Procedure Act › Public Health

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FDA Says Agency Will Enforce the Cigarette Graphic Warning Rule in December 2025, But Pending Litigation Could Still Derail Those...

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In September, the U.S. Food and Drug Administration (FDA) told industry that it would begin enforcing the agency’s cigarette graphic warning rule in December 2025 in an enforcement policy outlined in a short guidance...more

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Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings

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In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more

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Juul Labs, Inc. v. FDA: A FOIA Twist on the Challenge to FDA's Marketing Denial Order

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Recent Freedom of Information Act (FOIA) litigation raises an interesting question: When federal agency action requires analyses under a holistic, multi-factor statutory standard, may the agency withhold from disclosure as...more

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Hidden FDA Report Raises Questions About Its Approach to Public Records and Premarket Tobacco Review

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FDA’s approach to a premarket tobacco product application (PMTA) raises new questions about whether its marketing denial order was arbitrary and capricious and whether the deliberative-process exemption justifies its...more

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