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Premarket Approval Applications Administrative Procedure Act Marketing

Troutman Pepper Locke

FDA Sued Over Years-Long Internal Review of Flavored ENDS MDO

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On August 21, 2025, NJOY, LLC (NJOY), a subsidiary of Altria Group, Inc., sued the U.S. Food and Drug Administration (FDA), alleging that the agency has unlawfully delayed rendering a decision on supervisory review of its...more

Troutman Pepper Locke

En Banc Fifth Circuit Solidifies Circuit Split on Flavored ENDS Product MDOs

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In early January, the U.S. Court of Appeals for the Fifth Circuit, sitting en banc in Wages & White Lion Investments, L.L.C. v. U.S. Food & Drug Administration, held that the U.S. Food and Drug Administration’s (FDA)...more

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