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
We previously wrote about this case last January, when Iowans for Alternatives to Smoking & Tobacco, Inc., Global Source Distribution, LLC, and others filed a complaint and motion for a preliminary injunction in federal...more
5/12/2025
/ Constitutional Challenges ,
E-Cigarettes ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
New Legislation ,
Preemption ,
Preliminary Injunctions ,
Regulatory Authority ,
State and Local Government ,
Tobacco ,
Vaping
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 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
On September 14, Virginia’s Attorney General (AG) Jason Miyares issued a letter to the registered agent of the Good Vibes Shop, a Radford, VA store, for selling tetrahydrocannabinol (THC) products without proper labeling and...more
10/4/2024
/ Cannabis Products ,
Decriminalization of Marijuana ,
Distributors ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Hemp ,
Legalization ,
Licenses ,
Manufacturers ,
Marijuana ,
Marijuana Related Businesses ,
Product Labels ,
Recreational Use ,
Regulatory Requirements ,
Retailers ,
THC ,
Virginia
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
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
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
As we previously reported, the Treasury Department released a 2022 report on Competition in the Markets for Beer, Wine, and Spirits (the Competition Report) recommending, in part, that the Alcohol and Tobacco Tax and Trade...more
2/8/2024
/ Food and Drug Administration (FDA) ,
Labeling ,
Manufacturers ,
Nutrition Facts Labels ,
Product Labels ,
Public Comment ,
Public Health ,
Regulatory Oversight ,
Retail Market ,
TTB ,
Virtual Meetings ,
Wine & Alcohol
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
On June 8, more than 50 members of Congress signed a letter addressed to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf, expressing concerns over FDA’s delays in reviewing pending Premarket Tobacco Product...more
In this segment of our series evaluating FDA’s response to the Report, we review a subset of the Report’s recommendations and responses from two CTP Task Forces—Cross Cutting and Regulation and Guidance....more
Over the last several months, FDA and DOJ enforcement efforts have increasingly focused on manufacturers and distributors of vapor products covered by the Food, Drug, & Cosmetic Act and the PACT Act....more
In this second of a two-part series, Stephen Piepgrass continues his discussion with colleagues Bryan Haynes, Agustin Rodriguez and Nick Ramos about significant developments in the tobacco industry during the past year, and...more
The U.S. tobacco industry is subject to a variety of regulators at the federal and state level. In this first of a two-part series focused on significant regulatory developments in the tobacco industry, Stephen Piepgrass is...more
In October 2022, the U.S. Food and Drug Administration (FDA) announced that the Department of Justice (DOJ), on its behalf, filed complaints against six electronic nicotine delivery system (ENDS) companies in federal district...more
The Senate recently passed the Medical Marijuana and Cannabidiol Research Expansion Act (the Act) by a voice vote after the House of Representatives passed the bill with strong bipartisan support (325-95) last July. The Act...more
In a prior update, we discussed the ongoing legal challenges to the U.S. Food and Drug Administration’s (FDA) March 2020 rule on a graphic-warning requirement for cigarettes. Initially slated to take effect June 18, 2021, the...more
The rapid evolution of the cannabis industry in the United States poses many unique questions, the most interesting of which is what cannabis regulation will look like under federal legalization. Although (legal) cannabis is...more
The US Food and Drug Administration (FDA) recently announced plans to publish a proposed rule that would establish a maximum nicotine level in cigarettes and certain “other combusted tobacco products.” At the moment, it is...more
Governor Gavin Newsome recently signed California Assembly Bill 45 (AB 45) into law, which, among other things, allows hemp-derived cannabidiol (CBD) to be included in any food, beverages, and dietary supplements sold in...more
The term tetrahydrocannabinol (THC) is most often associated with the delta-9 THC cannabinoid, which is one of over 100 cannabinoids found in both high-THC marijuana and low-THC hemp. Delta-9 THC is also the cannabinoid most...more
A number of U.S. Representatives on both sides of the aisle recently cosponsored a proposed bill that would limit the U.S. Food & Drug Administration’s (FDA’s) ability to regulate premium cigars. Although the text of the...more
On June 11, 2021, the U.S. Food and Drug Administration (FDA) withdrew an advanced notice of proposed rulemaking (ANPRM) for premium cigars issued in March 2018 as part of the Spring 2021 Unified Agenda of Regulatory and...more
On April 29, the U.S. Food & Drug Administration (FDA) announced that it will issue proposed tobacco product standards within the next year that will effectively ban menthol cigarettes and characterizing flavors in cigars....more