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|VAPOR TECHNOLOGY ASSOCIATION,
VAPOR STOCKROOM, LLC,
UNITED STATES FOOD AND DRUG ADMINISTRATION;
UNITED STATES DEPARTMENT OF HEALTH AND
HUMAN SERVICES; ALEX M. AZAR, II, Secretary of
Health and Human Services; STEPHEN HAHN, M.D.,
Commissioner of the Food and Drug Administration,
| No. 20-5199|
Appeal from the United States District Court
for the Eastern District of Kentucky at Lexington.
No. 5:19-cv-00330—Karen K. Caldwell, District Judge.
Argued: August 8, 2020
Decided and Filed: October 5, 2020
Before: ROGERS, KETHLEDGE, and NALBANDIAN, Circuit Judges.
PER CURIAM. Vapor Stockroom challenges the Food and Drug Administration’s
(FDA) current enforcement guidance timetable for when e-cigarette manufacturers must file
premarket tobacco applications to remain on the market. The challenged timetable was set by
the District Court for the District of Maryland in an injunction issued by that court in separate
litigation regarding the FDA’s 2017 enforcement guidance. Vapor Stockroom contends that the
FDA’s remedial brief and an attached declaration submitted by an FDA official to the Maryland
district court motivated that court to impose the challenged deadline for application submissions,
which significantly accelerated the original FDA deadline. The company alleges that the FDA’s
brief and declaration constituted a final agency action that violated the Administrative Procedure
Act (APA). However, the Maryland court’s injunction was independent from the FDA’s brief
and declaration. Vapor Stockroom therefore lacks Article III standing to obtain judicial review
of the remedial brief and attached declaration, because the alleged injury is the result of the
Maryland court’s independent action, not the challenged FDA filings. For similar reasons, the
company’s request for injunctive relief against enforcement proceedings is without merit because
the allegedly unauthorized court submissions do not form a plausible legal basis for an injunction
against subsequent, independently caused FDA enforcement proceedings.