Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton
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
On April 2, 2025, the Supreme Court unanimously held that the US Food and Drug Administration (FDA) lawfully denied marketing authorization for certain flavored e-liquids used in electronic nicotine delivery systems (ENDS),...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
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
On Monday, the Supreme Court heard oral arguments in a pivotal case that examines the Food and Drug Administration’s (FDA) authority to regulate flavored e-cigarettes. At the heart of the debate are the agency’s denials of...more
In October, the Oregon Court of Appeals ruled that a law restricting the packaging of e-cigarettes violates the state constitution’s free speech protections. The decision illustrates the utility of free speech arguments...more
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
We have previously reported on the proliferation of tobacco product flavor bans imposed by localities and subsequent legal challenges throughout the U.S. See Oregon Court Upholds Local Tobacco Product Flavor Ban; Troutman...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
As the age of tobacco-based nicotine products shrinks in the rearview mirror, it comes as no surprise that consumers, young and old, are increasingly being drawn to its modern equivalent: e-cigarettes, also known as vapes....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
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
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
Introduction The UAE has implemented laws and regulations to control and regulate the consumption of tobacco and tobacco-related products, including vaping, which refers to the use of electronic nicotine products. This...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
Manufacturers of e-cigarettes find themselves in a challenging regulatory environment to obtain U.S. Food and Drug Administration (FDA) marketing approval of flavored products. On October 12, 2023, the FDA denied premarket...more
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
FDA recently announced the issuance of warnings letters to 189 retailers found to be selling unauthorized tobacco products, specifically Elf Bars and Esco Bars....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
Minnesota Attorney General Keith Ellison recently announced the details of his Office’s settlement with JUUL and Altria for deceptively marketing e-cigarettes, which includes $60.5 million in combined payments by the two...more
While regular folks will count their pennies and fret about affording gifts for loved ones during an inflation-plagued holiday season, plutocrats have given the hoi polloi a rare glimpse of the major loot they see in the...more
Parents, educators, politicians, federal regulators, and advocates for Americans’ better health all should pause and consider the prime takeaways from a company’s willingness to strike a $439 million settlement with...more
The U.S. Food and Drug Administration (the FDA) issued marketing denial orders (MDOs) to JUUL Labs for all of its products currently marketed in the United States. As a result of this MDO, JUUL must stop selling and...more
On June 10, a bipartisan coalition of 31 state attorneys general, led by Idaho, Illinois, Nebraska, and Pennsylvania, sent a letter to Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf, asking the agency to...more
On October 12, 2021, the U.S. Food and Drug Administration (“FDA”) issued orders granting R.J. Reynolds (RJR) Vapor Company approval to market three of its electronic nicotine delivery system (ENDS) products – the Vuse Solo...more