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 ,
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
On December 17, 2024, Iowans for Alternatives to Smoking & Tobacco, Inc., Global Source Distribution, LLC, and others filed a complaint and motion for a preliminary injunction in federal district court against the Iowa...more
1/7/2025
/ E-Cigarettes ,
Equal Protection ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Preliminary Injunctions ,
Public Health ,
Public Safety ,
Regulatory Requirements ,
Retail Sales ,
Supremacy Clause ,
Tobacco ,
Tobacco Regulations ,
Vaping
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
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
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
Across states, lawmakers often embrace “medical” marijuana as a precursor to establishing a “recreational” marijuana market. Although marijuana remains illegal at the federal level — and would remain illegal even under the...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
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
The Food and Drug Administration’s Center for Tobacco Products (“CTP”) has released a strategic plan intended to guide the Center’s activity for the next five years. While the strategic plan highlights the laudable goals of...more
In December, the U.S. Food and Drug Administration (FDA) issued warning letters to online retailers for reportedly selling unauthorized e-cigarette products. Consistent with the Center for Tobacco Products’ (CTP) recent...more
Much attention has recently been placed on hemp-derived products marketed in packaging that mimics popular snack foods.
Originally published in Law360 - August 15, 2023....more
11/15/2023
/ Cannabis Products ,
Controlled Substances ,
Decriminalization of Marijuana ,
Food and Drug Administration (FDA) ,
Hemp ,
Marijuana ,
Marijuana-Infused Edibles ,
Plant Based Products ,
Product Packaging ,
Public Health ,
Recreational Use ,
THC
In September, the U.S. Food and Drug Administration (FDA) issued two new rounds of warning letters to online retailers, manufacturers, and distributors for reportedly selling or distributing unauthorized e-cigarette products....more
10/2/2023
/ Distributors ,
E-Cigarettes ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Public Health ,
Regulatory Agenda ,
Retail Market ,
Retailers ,
Tobacco Regulations ,
Warning Letters
It has been widely reported and confirmed publicly that, on August 29, the U.S. Department of Health and Human Services (HHS) sent a letter to the Drug Enforcement Administration (DEA) recommending that cannabis be moved from...more
9/5/2023
/ Biden Administration ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Dispensaries ,
Food and Drug Administration (FDA) ,
Marijuana ,
Medical Research ,
Recreational Use ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Reform ,
Research and Development ,
Schedule I Drugs
On August 22, 2023, the Troutman Pepper Tobacco + Nicotine Team attended the Food and Drug Administration’s Center for Tobacco Products (“CTP”) virtual listening session on the development of CTP’s strategic plan. We...more
The Food and Drug Administration’s Center for Tobacco Products (“CTP”) will hold a two-day public meeting on the agency’s premarket tobacco product application (“PMTA”) process. The meeting will be held October 23-24 and can...more