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
We recently had the opportunity to attend, and present at, the industry portion of the 2024 Federation of Tax Administrators Tobacco Tax Annual Conference in Mobile, Alabama....more
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 June, the Bureau of Alcohol, Tobacco and Firearms (ATF) argued in federal court that the federal Prevent All Cigarette Trafficking (PACT) Act requires tribal retailers to obtain state licenses to sell cigarettes on their...more
8/6/2024
/ ATF ,
California ,
Native American Issues ,
PACT Act ,
Retail Sales ,
Tax Exemptions ,
Tax Liability ,
Tobacco ,
Tobacco Regulations ,
Tribal Governments ,
Tribal Lands ,
Tribal Treaty Rights
In May, the U.S. Department of Justice (DOJ) issued a notice of proposed rulemaking to transfer cannabis from Schedule I to Schedule III of the Controlled Substances Act (CSA), a change that could significantly affect current...more
7/25/2024
/ Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Controlled Substances ,
Controlled Substances Act ,
Department of Justice (DOJ) ,
Marijuana ,
Marijuana Related Businesses ,
Medical Marijuana ,
New Guidance ,
Notice of Proposed Rulemaking (NOPR) ,
Regulatory Agenda ,
Regulatory Reform ,
Schedule I Drugs ,
State and Local Government ,
THC
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 this post, we take a closer look at state tobacco and nicotine product licensing considerations. When approaching state licensing issues, it may be helpful to establish a checklist to help manufacturers, importers,...more
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
The landscape of tobacco product and cannabis flavor bans or restrictions varies significantly across the country. In both industries, some states restrict all or some flavors in all types of products, while other states...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
The Prevent All Cigarette Trafficking (PACT) Act, 15 U.S.C. § 375 et seq., is a federal law with two primary objectives: (1) to prevent federal and state tax evasion on tobacco products, and (2) to prevent sales of tobacco...more
4/16/2024
/ ATF ,
E-Cigarettes ,
E-Commerce ,
Internet Retailers ,
Interstate Commerce ,
Manufacturers ,
PACT Act ,
Regulatory Requirements ,
Reporting Requirements ,
Shipping Bans ,
Tax Evasion ,
Tobacco ,
Tobacco Regulations ,
Vaping
The principle of open government is foundational to a healthy democracy, and the availability of government records upon request from the public is one of its chief cornerstones.
Originally published in Law360 - January 5,...more
4/5/2024
/ Attorney-Client Privilege ,
Cannabis Products ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Decriminalization of Marijuana ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Discovery ,
Exemptions ,
FOIA ,
Interagency Guidance ,
Marijuana ,
Motion for Summary Judgment ,
Records Request ,
Redacted Documents
The Massachusetts Supreme Judicial Court (SJC) recently upheld, in a unanimous decision, the town of Brookline’s ordinance banning the sale of tobacco and e-cigarette products to anyone born after Jan. 1, 2000 (the Tobacco...more
3/26/2024
/ E-Cigarettes ,
Local Ordinance ,
MA Supreme Judicial Court ,
Preemption ,
Public Health ,
Regulatory Agenda ,
Retail Market ,
Retail Sales ,
Smoking Bans ,
Tobacco ,
Tobacco Litigation ,
Tobacco Regulations
On February 28, the Virginia General Assembly passed House Bill No. 698, which would legalize sales of recreational marijuana at retail in the Commonwealth. It now heads to the desk of Governor Glenn Youngkin, where its...more
3/5/2024
/ Agribusiness ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Decriminalization of Marijuana ,
Licenses ,
Licensing Rules ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Plant Based Products ,
Recreational Use ,
Regulatory Agenda ,
Regulatory Reform ,
State and Local Government ,
Virginia
A couple of years ago we posted an overview of state licensing and excise tax considerations for tobacco companies. In this post, we take a closer look at state excise tax considerations. When approaching state excise tax...more
Over the past decade, at least five states and hundreds of localities have passed, or attempted to pass, laws banning flavored tobacco products. To date, litigants have brought many challenges to these laws, often arguing...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
The Virginia Cannabis Control Authority (CCA), which assumed oversight of Virginia’s medical cannabis program from the Board of Pharmacy as of January 1, has promulgated regulations to govern medical cannabis operations in...more
1/24/2024
/ Dispensaries ,
Healthcare ,
License Applications ,
Marijuana ,
Medical Marijuana ,
New Regulations ,
Patient Access ,
Pharmaceutical Industry ,
Plant Based Products ,
Regulatory Oversight ,
Virginia
Recently enacted Pennsylvania Senate Bill 773 (SB773) introduces several amendments intended to expand opportunities and increase competition among existing cannabis licensees in Pennsylvania. The bill seeks to support...more
1/23/2024
/ Agribusiness ,
Business Licenses ,
Cannabis-Related Businesses (CRBs) ,
Competition ,
Dispensaries ,
Licensing Rules ,
Marijuana Related Businesses ,
Medical Marijuana ,
Monopolization ,
Multistate Corporations ,
Pennsylvania ,
Proposed Amendments ,
Regulatory Agenda ,
Regulatory Reform
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