Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton
On May 14, Alabama Gov. Kay Ivey signed Alabama HB8 into law. Effective June 1, HB8 introduced sweeping changes that will reshape how nicotine products are sold, marketed, and regulated in Alabama. You heard that right,...more
We previously reported a decision by the U.S. Food and Drug Administration (FDA), denying the premarketing authorization of several flavored e-cigarette product. On April 2, 2025, the Supreme Court of the United States...more
Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Illinois AG’s and FTC’s Settlement Takes a $25 Million...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
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
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
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
The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more
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
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
On Oct. 13, Mississippi's highest court ruled that a South Korean company, LG Chem Ltd., which manufactured a battery that powered a vaping device, could be sued in Mississippi, despite that company having no physical...more
Last week, Mississippi’s highest court ruled that a South Korean company, LG Chem, which manufactured the battery that powered a “vaping device,” could be sued in Mississippi, despite that company having no physical presence...more
The State of Texas officially banned the manufacture and sale of smokable hemp products and hemp vapor cartridges. Effective August 2, 2020, the Texas Department of State Health Services (the “DSHS”) issued a final rule...more
2019 ushered in numerous changes and new initiatives at the U.S. Food and Drug Administration (FDA). From the increasing popularity of cannabis use to the rapidly evolving nature of artificial intelligence in medical devices,...more
Manufacturers, distributors, and suppliers of CBD products should embrace and participate in reform to address public health concerns, write Bilzin Sumberg attorneys. Consumer groups like the Arthritis Foundation are stepping...more
Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of...more