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) marketing denial order (MDO) of petitioner’s premarket tobacco applications (PMTAs) violated the Administrative Procedure Act (APA).Continue Reading En Banc Fifth Circuit Solidifies Circuit Split on Flavored ENDS Product MDOs

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 bills would create a mechanism for states to bar the sale of products that are not FDA-authorized or subject to a pending premarket application. Like state cigarette directories implemented in connection with the tobacco Master Settlement Agreement, these directories would specify which vapor products are permitted to be sold in the state.Continue Reading Multiple States Consider Establishing Vapor Product Directories

The Troutman Pepper Tobacco + Nicotine Team will attend the Total Product Expo in Las Vegas, January 31 to February 2.  TPE is a business-to-business trade show that brings manufacturers, distributors and retailers together under one roof, providing an opportunity for companies to exhibit their products, connect with buyers, network with industry professionals, and obtain

The Food and Drug Administration’s Center for Tobacco Products (“CTP”) has released a strategic plan intended to guide the Center’s activity for the next five years. While the strategic plan highlights the laudable goals of regulatory clarity, stronger enforcement against non-compliant actors and more timely and transparent application review, the plan is problematic in that it promotes an agenda of burdensome new regulations and does not provide a clear emphasis on the promotion of less harmful alternatives in the tobacco and nicotine marketplace.  Continue Reading FDA’s Center for Tobacco Products Publishes Strategic Plan

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 notified the public that it was unable to complete the regulatory process within the required time period (i.e., one year of the date it was first noticed to the public), and that it instead intended to restart the process with a new regulatory proposal. OEHHA issued its Notice of Proposed Rulemaking Clear and reasonable Warnings: Short-form Warnings on October 27, 2023, and on November 30, 2023 issued a notice that it will hold a public hearing on December 13, 2023.  The public may submit comments until December 20, 2023.Continue Reading California Considers Modifying Prop 65 Warning Requirements (Again)

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 retailers.  The agency has been criticized for not doing enough to fight the sale of unauthorized vapor products, but these actions should at least remind manufacturers and retailers that the agency’s warning letters are not empty threats.Continue Reading FDA Continues ENDS Enforcement with New Injunction and Civil Money Penalty Proceedings

Bryan Haynes and Agustin Rodriguez of the Troutman Pepper Tobacco + Nicotine team will attend the Food and Drug Law Institute 2023 Enforcement Conference on Wednesday, December 6 in Washington D.C.

The conference will have two panels discussing hot topics in tobacco and nicotine enforcement and litigation matters.  Bryan Haynes will moderate a panel discussing

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 localities have prevailed. In this case, a group of retailers (the Retailers), sued Multnomah County, Oregon (the County) in January 2023 alleging that the County’s flavored tobacco product ban was unlawful. Earlier this month, consistent with the overall trend, the court ruled against the Retailers and upheld the County’s flavor ban.Continue Reading Oregon Court Upholds Local Tobacco Product Flavor Ban

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 those manufacturers (commonly referred to as “Participating Manufacturers”) acted in bad faith by disputing (and delaying the ultimate payment of) the amounts they owe to the state under the MSA. On August 22, 2023, Iowa compromised its past and future claims under the lawsuit and joined 37 other states that have settled similar disputes. Iowa Attorney General Brenna Bird announced that the state reached a settlement with the Participating Manufacturers that will result in the state receiving payments of more than $171 million over the next six years.  Continue Reading Iowa Reaches MSA Settlement with Tobacco Manufacturers, Ending 18-Year Legal Dispute