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
Effective July 1, Mississippi will require all cigarette and ENDS manufacturers to provide annual certifications and have their products listed on a state directory in order for their products to be sold in the state. The...more
In the ninth episode of our 12 Days of Regulatory Insights podcast series, Michael Jordan, a member of the firm's Tobacco + Nicotine practice, is joined by colleagues Bryan Haynes and Agustin Rodriguez to delve into the...more
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
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
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
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
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
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
In 2021 we wrote about the California Office of Environmental Health Hazard Assessment’s (OEHHA) plans to amend regulations governing Proposition 65 (Prop 65) short-form warning labels. On May 20, 2022, however, OEHHA...more
12/13/2023
/ Advertising ,
Amended Regulation ,
California ,
Manufacturers ,
OEHHA ,
Proposition 65 ,
Public Health ,
Public Hearing ,
Retailers ,
Safe Harbors ,
Suppliers ,
Toxic Chemicals ,
Toxic Exposure ,
Warning Labels
On October 30, Virginia’s hemp industry suffered an early defeat in its effort to overturn Virginia SB 903, a law that imposed stricter limitations on hemp products than what is currently required under federal law....more
11/15/2023
/ Commerce Clause ,
Dormant Commerce Clause ,
Farm Bill ,
Hemp ,
Hemp Cultivation ,
Hemp Related Businesses ,
Manufacturers ,
Preemption ,
Regulatory Oversight ,
THC ,
Virginia
Recently, NJOY LLC filed a complaint in the U.S. District Court for the Central District of California against more than 30 foreign and domestic defendants that manufacture, market, distribute, and sell tobacco products in an...more
10/31/2023
/ E-Cigarettes ,
False Advertising ,
Imports ,
International Trade Commission (ITC) ,
Lanham Act ,
Manufacturers ,
PACT Act ,
Public Health ,
Public Safety ,
Regulatory Oversight ,
Regulatory Requirements ,
RJ Reynolds ,
Tariff Act of 1930 ,
Tobacco ,
Tobacco Litigation ,
Tobacco Regulations ,
Unfair Competition Law (UCL) ,
Vaping
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
Over the last decade, hundreds of localities have passed ordinances restricting or prohibiting the sale of some or all types of tobacco products. Some of these ordinances have been challenged in court, but, in most cases, the...more
Last summer, we wrote about the Iowa Attorney General’s $133 million suit against the tobacco manufacturers that are signatories to the Master Settlement Agreement (MSA). Brought in Iowa state court, this suit alleged that...more
Oregon has enacted a new “equity assessment” upon non-signatories to the tobacco Master Settlement Agreement (MSA). We previously blogged about the bill’s introduction. The law replaces Oregon’s escrow deposit system,...more
On August 9, 2023, Judge Amit P. Mehta of the US District Court for the District of Columbia issued his decision vacating the decision of the Food and Drug Administration (“FDA”) to “deem” premium cigars covered by FDA’s 2016...more
Virginia’s new hemp-derived products statutes (Va. Code § 3.2-5145.1 et seq.) went into effect as of July 1, standing to drastically alter the availability of hemp-derived products in Virginia. ...more
The Virginia ABC will assess a regulatory scheme for liquid nicotine, with the consultation of stakeholders, and issue a report and recommendations.
On April 12, the Virginia General Assembly enacted House Bill 2296 and...more
In late November, the New Mexico attorney general announced a lawsuit in the Santa Fe County First Judicial District Court against Philip Morris USA Inc., R.J. Reynolds and other signatories to the tobacco master settlement...more
On March 8, the Food and Drug Administration announced that it is proposing a long-awaited rule on so-called “tobacco product manufacturing practices.” Here are some preliminary thoughts on the proposed rule...more
On July 28, the Iowa attorney general’s office filed suit against Philip Morris, USA, R.J. Reynolds Tobacco Co., and 16 other tobacco companies, accusing them of defrauding Iowa of over $133 million by allegedly engaging in...more