Over the past two years, at least 15 states have enacted laws requiring manufacturers of electronic nicotine delivery systems (ENDS) to certify the status of their federal premarket tobacco product applications (PMTAs) in...more
7/25/2025
/ Appeals ,
E-Cigarettes ,
Enforcement Actions ,
Equal Protection ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Litigation Strategies ,
Penalties ,
Preemption ,
Public Health ,
Regulatory Requirements ,
Retail Market ,
Retailers ,
State Legislatures ,
Tobacco Regulations
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
In the first major enforcement action involving the importation of illegal tobacco products by the new administration, and on the heels of the appointment of the new acting director of the U.S. Food and Drug Administration...more
5/30/2025
/ China ,
Customs and Border Protection ,
E-Cigarettes ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Imports ,
Intellectual Property Protection ,
Regulatory Requirements ,
Tobacco ,
Tobacco Regulations ,
Trademarks
In what appear to be the first restrictions of their kind, the state of California and the city and county of Denver have adopted bans on flavored tobacco products that cover not only products containing tobacco and nicotine,...more
2/13/2025
/ California ,
Consumer Protection Laws ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Local Ordinance ,
New Legislation ,
Public Health ,
Regulation ,
Regulatory Requirements ,
State and Local Government ,
Tobacco ,
Tobacco Regulations ,
Vaping
In late January, the U.S. Food and Drug Administration (FDA) withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. Although either proposal could be...more
2/12/2025
/ Comment Period ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Proposed Rules ,
Public Health ,
Regulation ,
Regulatory Agenda ,
Rulemaking Process ,
Tobacco ,
Tobacco Regulations ,
Trump Administration
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
On January 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would set a maximum nicotine level in combusted cigarettes and certain other combusted tobacco products....more
Bryan Haynes, a partner in Troutman Pepper Locke’s Tobacco + Nicotine Practice Group, was quoted in the January 10, 2025 Convenience Store News article, “Retailers Tap Into Pricing & Data to Boost Cigar Sales.”...more
1/14/2025
/ Data Collection ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Marketing ,
Pricing ,
Regulatory Agenda ,
Retail Market ,
Retail Sales ,
Retailers ,
Tobacco ,
Tobacco Regulations
Throughout 2024, the U.S. Food and Drug Administration (FDA) endeavored to curb sales of unauthorized electronic nicotine delivery systems (ENDS) in the U.S. In light of persistent demand for flavored ENDS — nearly all of...more
12/27/2024
/ E-Cigarettes ,
Enforcement Priorities ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Public Health ,
Public Safety ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Reform ,
Retail Sales ,
Tobacco ,
Tobacco Regulations ,
Trump Administration ,
Vaping
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
Earlier this month, 20 Democratic state attorneys general (AG) filed an amicus brief supporting the U.S. Food and Drug Administration’s (FDA) marketing denial orders (MDOs) of premarket tobacco applications (PMTAs) for...more
In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more
9/17/2024
/ Customs and Border Protection ,
E-Cigarettes ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Importers ,
Imports ,
Life Sciences ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Oversight ,
Tobacco ,
Tobacco Regulations ,
Tracking Systems
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 August 2, the U.S. Court of Appeals for the Eighth Circuit decided a case addressing Nebraska’s authority to require tribal cigarette manufacturers that are not parties to the Master Settlement Agreement (MSA) to comply...more
In late June, the U.S. District Court for the District of Montana held that federal law preempts the Montana Attorney General (AG) from removing the cigarette brands of Grand River Enterprises Six Nations, Ltd. (Grand River)...more
7/19/2024
/ E-Cigarettes ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Montana ,
Preemption ,
Regulatory Agenda ,
Retail Market ,
State Attorneys General ,
Tobacco ,
Tobacco Regulations ,
Vaping
In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more
7/5/2024
/ Civil Monetary Penalty ,
Department of Justice (DOJ) ,
E-Cigarettes ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Injunctions ,
Life Sciences ,
Manufacturers ,
Retail Market ,
Retailers ,
Tobacco ,
Tobacco Regulations ,
Vaping ,
Warning Letters
“Hi, we’re with the Bureau of Alcohol, Tobacco and Firearms, and we’d like to take a look at your tobacco product sales invoices, shipping records, and PACT Act reports.”...more
In August 2023, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia partially vacated a Food and Drug Administration (FDA) rule that had “deemed” premium cigars subject to the Federal Food, Drug, and...more
FDA recently announced the launch of a new searchable database containing almost 17,000 tobacco products that may be legally marketed in the U.S. The database provides information on each tobacco product including product...more
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
We recently reported that several state legislatures are considering bills to establish vapor product directories this year — namely Florida, Indiana, Missouri, and Virginia. Throughout January and early February, similar...more
2/8/2024
/ E-Cigarettes ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Marketing ,
Proposed Legislation ,
Public Health ,
Public Safety ,
Regulatory Agenda ,
Regulatory Reform ,
Retail Sales ,
Tobacco ,
Tobacco Regulations ,
Vaping
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
This year, several state legislatures will consider bills to establish vapor product directories. Amid heightened scrutiny of illicit vapor products by the U.S. Food and Drug Administration (FDA), these product directory...more
1/22/2024
/ E-Cigarettes ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Marketing ,
Proposed Legislation ,
Public Health ,
Public Safety ,
Regulatory Agenda ,
Regulatory Reform ,
Retail Sales ,
Tobacco ,
Tobacco Regulations ,
Vaping
We recently discussed the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products’ (CTP) strategic plan intended to guide CTP’s activity for the next five years. On the same day, CTP released its annual...more