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
Over the last several months, FDA and DOJ enforcement efforts have increasingly focused on manufacturers and distributors of vapor products covered by the Food, Drug, & Cosmetic Act and the PACT Act....more
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
California voters have approved Senate Bill 793, which prohibits tobacco retailers from selling flavored tobacco products or tobacco product flavor enhancers. A lawsuit has been filed in federal court claiming that it is...more
Over the past few years, at least five states and several hundred localities have passed, or attempted to pass, laws banning flavored tobacco products. There have been a number of challenges to those laws—few of which have...more
FDA reports that the progress of its review of popular vapor products’ pending PMTAs remains in line with its first report....more
Status report concerns FDA’s review of 240 PMTAs submitted on or before September 9, 2020, for vapor products with larger market shares. FDA estimates that it will resolve most of these in the periods before July 2022 and...more
The U.S. Court of Appeals for the Ninth Circuit has denied the Plaintiffs’/Appellants’ petition for a rehearing en banc following a divided panel’s holding that the Family Smoking Prevention and Tobacco Control Act neither...more
Under Judge Grimm’s Revised Remedial Order, FDA must submit quarterly status reports regarding its review of pending PMTAs for certain popular vapor products....more
The U.S. District Court for the Eastern District of Pennsylvania entered a permanent injunction against Philadelphia’s enforcement of an ordinance banning the sale of certain flavored tobacco products, after the U.S. Court of...more
The vapor industry has been dealing with the FDA’s Deeming Tobacco Products to Be Subject to the Federal Food, Drug, & Cosmetic Act, 81 Fed. Reg. 28,973 (May 10, 2016) (the “Deeming Rule”) for some time now. Is it...more
On December 22, 2020, we blogged about the omnibus 2021 Consolidated Appropriations Act passed by Congress, which included legislation extending the applicability of the Prevent All Cigarette Trafficking (“PACT”) Act to...more
The U.S. Court of Appeals for the Third Circuit will review a preliminary injunction against Philadelphia’s enforcement of an ordinance banning the sale of certain flavored tobacco products....more