Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton
On January 21, the Supreme Court heard arguments in a case addressing who may challenge Food and Drug Administration (FDA) marketing denial orders for new tobacco products....more
We recently reported that several state legislatures are considering bills to establish vapor product directories this year — namely Florida, Indiana, Missouri, and Virginia. Throughout January and early February, similar...more
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
This year, several state legislatures will consider bills to establish vapor product directories. Amid heightened scrutiny of illicit vapor products by the U.S. Food and Drug Administration (FDA), these product directory...more
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
The U.S. Food and Drug Administration (the FDA) issued marketing denial orders (MDOs) to JUUL Labs for all of its products currently marketed in the United States. As a result of this MDO, JUUL must stop selling and...more