Robert Claiborne Jr. on Food and Drug Administration (FDA)

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

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

5/25/2023 / Administrative Procedure Act , FOIA , Food and Drug Administration (FDA) , Marketing , Public Health , Tobacco , Tobacco Litigation , Vaping

Federal Government Ramping Up Vapor Enforcement

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

4/12/2023 / E-Cigarettes , Food and Drug Administration (FDA) , Tobacco , Tobacco Regulations , Vaping

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

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

3/15/2023 / Administrative Procedure Act , FOIA , Food and Drug Administration (FDA) , Internal Memorandum , Premarket Approval Applications , Public Health , Public Records , Tobacco , Vaping

Deeming Regulations Litigation Update – FDA Files Second Status Report on Pending Vapor Products PMTAs

FDA reports that the progress of its review of popular vapor products’ pending PMTAs remains in line with its first report....more

7/29/2022 / E-Cigarettes , Food and Drug Administration (FDA) , Tobacco , Tobacco Regulations , Vaping

Deeming Regulations Litigation Update – FDA Files Status Report on Pending PMTAs for Popular Vapor Products

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

6/14/2022 / E-Cigarettes , Food and Drug Administration (FDA) , Tobacco , Vaping

Deeming Regulations Litigation Update—Federal Court Exercises Even More Oversight over FDA’s PMTA Review

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

4/19/2022 / E-Cigarettes , Food and Drug Administration (FDA) , Tobacco Regulations , Vaping

Vapor Litigants Ask Supreme Court to Review Deeming Rule Cases

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

3/9/2021 / Constitutional Challenges , E-Cigarettes , Food and Drug Administration (FDA) , Vaping

THC, CBD and other Non-tobacco Vaping Product Sellers Should Take Note of New PACT Act Provisions

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

1/7/2021 / Cannabidiol (CBD) oil , Consolidated Appropriations Act (CAA) , E-Cigarettes , Food and Drug Administration (FDA) , Internet Retailers , Marijuana , Vaping

DC Circuit Decides Deeming Rule Doesn’t Violate Appointments Clause or First Amendment

Did the FDA violate the Constitution when it issued its rule Deeming Tobacco Products to Be Subject to the Federal Food, Drug, & Cosmetic Act, 81 Fed. Reg. 28,973 (May 10, 2016) (the “Deeming Rule”)? No, according to a recent...more

12/9/2020 / Appointments Clause , Constitutional Challenges , Department of Health and Human Services (HHS) , First Amendment , Food and Drug Administration (FDA)

Robert Claiborne Jr.

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