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.
Takeaways from Listening Session on the Development of FDA’s Center for Tobacco Products Strategic Plan
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 previously blogged about CTP’s intent to issue a finalized five-year strategic plan by December 2023, including the agency’s five proposed strategic goals.
Oregon Imposes New “Equity Assessment” on Certain Manufacturers
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, applicable to tobacco product manufacturers that are nonparticipating manufacturers (NPMs) under the MSA, with an equity assessment.
FDA’s Center for Tobacco Products to Hold Public Meeting on PMTA Process
The Food and Drug Administration’s Center for Tobacco Products (“CTP”) will hold a two-day public meeting on the agency’s premarket tobacco product application (“PMTA”) process. The meeting will be held October 23-24 and can be attended in person in Silver Spring, Maryland, or online.
CTP’s press release indicates that staff
U.S. District Court Vacates FDA Deeming Rule With Respect To Premium Cigars
Yesterday, 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 rule that swept all tobacco products under the same set of regulations. In previous decisions, the District Court already had vacated the portions of the Deeming Rule that required premium cigars to display health warnings on packaging and advertising and to engage in the burdensome premarket authorization process.
FDA Touts “Significant Strides” in Addressing Reagan-Udall Report but Acknowledges More Work Remains
Our team has previously written about the Food and Drug Administration’s (FDA) response to the Reagan-Udall Foundation report on the Center for Tobacco Product’s operations. If you missed our prior posts, check them out at the links below:
Congress Urges FDA to Complete Its Review of E-Cigarette Applications
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 Applications (PMTAs) and its failure to remove unauthorized products from the market. The letter strongly urges “FDA to (1) expeditiously complete review of remaining e-cigarette PMTAs; (2) follow the science on the risks flavored [e-cigarettes] pose to youth and deny PMTAs for all non-tobacco flavored e-cigarettes, including menthol flavored products; and (3) increase enforcement actions against companies that make, distribute, and sell flavored products without a marketing order, especially products with a significant market share, or products that are most popular with youth.” The letter also requests that FDA respond to several questions by June 23, as summarized below (as of the date of this blog post, we are not aware of any FDA response).
Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Public Education Campaigns and Resources Task Forces
This is the fifth post in our multipart series evaluating the Food and Drug Administration’s (FDA’s) response to the Reagan-Udall Foundation report (the Report) on the operations of the Center for Tobacco Products (CTP). If you missed our prior posts on the Report and FDA’s response, check them out at the links below:
- Reagan-Udall Foundation Recommends Improvements to the FDA’s Center for Tobacco Products
- FDA Responds to Reagan-Udall Foundation Report
- Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Science and Application Review Task Force
- Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Cross-Cutting and Regulation and Guidance Task Forces
In this segment of our series evaluating FDA’s response to the Report, we review a subset of the Report’s recommendations and responses from two CTP Task Forces — “Public Education Campaigns” and “Resources.”
Troutman Tobacco + Nicotine Team to Participate in TMA Workshop on TPMP Proposed Rule
The Troutman Pepper Tobacco + Nicotine Team will attend a TMA workshop on FDA’s proposed rule on tobacco product manufacturing practices. Bryan Haynes will participate in a panel discussion of the legal implications of the proposed rule. The workshop is on Tuesday, June 13 at the Hyatt Regency at Reagan
Juul Labs, Inc. v. FDA: A FOIA Twist on the Challenge to FDA’s Marketing Denial Order
Published in Update on May 25, 2023. © Copyright 2023, Food and Drug Law Institute, publisher of Update. Reprinted here with permission.
Recent Freedom of Information Act (FOIA) litigation raises an interesting question: When federal agency action requires analyses under a holistic, multi-factor statutory standard, may the agency withhold from disclosure as “deliberative” records related to analyses that purportedly were not factored into the agency’s final decision? A federal court will address this question of public disclosure in litigation between Juul Labs, Inc. (JLI) and the U.S. Food and Drug Administration (FDA).