On June 20, the Supreme Court concluded that marketing denial orders (MDOs) issued by the Food and Drug Administration (FDA) can be challenged not only by the applicants (typically, the manufacturer or importer of the...more
7/11/2025
/ Administrative Procedure Act ,
Appeals ,
E-Cigarettes ,
Food and Drug Administration (FDA) ,
Food and Drug Administration v RJ Reynolds Vapor Co ,
Judicial Review ,
Manufacturers ,
Marketing ,
Regulatory Requirements ,
Retailers ,
SCOTUS ,
Tobacco
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
2/4/2025
/ Administrative Procedure Act ,
Appeals ,
Arbitrary and Capricious ,
Constitutional Challenges ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Marketing ,
Popular ,
Regulatory Requirements ,
Retail Sales ,
RJ Reynolds ,
SCOTUS ,
Tobacco ,
Tobacco Control Act (TCA) ,
Tobacco Regulations ,
Vaping ,
Venue
Yet again, the premium cigar industry has prevailed in federal court against the U.S. Food and Drug Administration (FDA). FDA appealed a federal district court decision vacating its rule (the Deeming Rule) subjecting premium...more
1/30/2025
/ Administrative Procedure Act ,
Arbitrary and Capricious ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Final Rules ,
Food and Drug Administration (FDA) ,
Public Health ,
Regulatory Requirements ,
Rulemaking Process ,
Tobacco ,
Tobacco Litigation ,
Tobacco Regulations
In September, the U.S. Food and Drug Administration (FDA) told industry that it would begin enforcing the agency’s cigarette graphic warning rule in December 2025 in an enforcement policy outlined in a short guidance...more
9/30/2024
/ Administrative Procedure Act ,
Failure To Warn ,
FDA Approval ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Public Health ,
Tobacco ,
Tobacco Regulations ,
Warning Labels
In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more
8/28/2024
/ Administrative Procedure Act ,
Advertising ,
FDA Warning Letters ,
First Amendment ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Marketing ,
Petition for Writ of Certiorari ,
Product Labels ,
Public Health ,
Regulatory Authority ,
RJ Reynolds ,
SCOTUS ,
Tobacco ,
Tobacco Regulations ,
Warning Labels ,
Zauderer
On April 2, three advocacy organizations filed a complaint in the U.S. District Court for the Northern District of California seeking an order directing the U.S. Food and Drug Administration (“FDA”) to promulgate its...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
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
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