No. 23-799
Magellan Technology, Inc. v. Food and Drug Administration
Tags: administrative-procedure-act agency-rulemaking arbitrary-and-capricious circuit-split comparative-efficacy electronic-nicotine-delivery-systems ends-products fda-regulation marketing-authorization reliance-interests youth-access
Latest Conference:
2025-04-17
(distributed 4 times)
Question Presented (from Petition)
Whether FDA's denial of Petitioner's marketing applications for flavored ENDS was arbitrary and capricious where FDA based the denial solely on a previously unannounced requirement for certain types of studies and where FDA ignored other evidence in the applications that FDA previously said was "critical" for marketing authorization.
Question Presented (AI Summary)
Whether FDA's denial of Petitioner's marketing applications for flavored ENDS was arbitrary and capricious
Docket Entries
2025-04-21
Petition DENIED.
2025-04-14
DISTRIBUTED for Conference of 4/17/2025.
2024-06-28
DISTRIBUTED for Conference of 7/1/2024.
2024-06-04
DISTRIBUTED for Conference of 6/20/2024.
2024-04-16
Rescheduled.
2024-04-10
DISTRIBUTED for Conference of 4/26/2024.
2024-03-25
Brief of respondent United States Food and Drug Administration in opposition filed.
2024-02-23
Brief amici curiae of E-Cigarette Businesses and Trade Associations filed.
2024-01-26
Motion to extend the time to file a response is granted and the time is extended to and including March 25, 2024
2024-01-25
Motion to extend the time to file a response from February 23, 2024 to March 25, 2024, submitted to The Clerk.
2024-01-22
Petition for a writ of certiorari filed. (Response due February 23, 2024)
2023-11-17
Application (23A421) granted by Justice Sotomayor extending the time to file until January 22, 2024.
2023-11-13
Application (23A421) to extend the time to file a petition for a writ of certiorari from November 23, 2023 to January 22, 2024, submitted to Justice Sotomayor.
Attorneys
E-Cigarette Businesses and Trade Associations
Eric Philip Gotting — Keller and Heckman LLP, Amicus
Magellan Technology, Inc.
Eric N. Heyer — Thompson Hine LLP, Petitioner
United States Food and Drug Administration
D. John Sauer — Solicitor General, Respondent
Elizabeth B. Prelogar — Respondent
Sarah M. Harris — Acting Solicitor General, Respondent