Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton
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
A group of 20 Democratic AGs, led by Massachusetts AG Andrea Campbell, has filed an amicus brief before the U.S. Supreme Court in Food and Drug Administration v. Wages and White Lion Investments, LLC., dba Triton...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
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
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
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
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
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
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
On May 11, RJ Reynolds Tobacco Company, along with two convenience stores and the American Petroleum and Convenience Store Association, sued the California attorney general and district attorney for Fresno County in their...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
This is the second post in our multipart series evaluating the Food and Drug Administration’s response to the Regan-Udall Foundation report on the operations of the Center for Tobacco Products. If you missed our first post,...more
California voters have approved Senate Bill 793, which prohibits tobacco retailers from selling flavored tobacco products or tobacco product flavor enhancers. A lawsuit has been filed in federal court claiming that it is...more
Over the past few years, at least five states and several hundred localities have passed, or attempted to pass, laws banning flavored tobacco products. There have been a number of challenges to those laws—few of which have...more
House Representatives Morgan Griffith (R-VA) and Brett Guthrie (R-KY) recently sent a letter to FDA Commissioner Robert Califf expressing “continued concerns involving systemic problems within the” Center for Tobacco Products...more
FDA reports that the progress of its review of popular vapor products’ pending PMTAs remains in line with its first report....more