Agustin Rodriguez and Nicholas Ramos of the Troutman Pepper Tobacco Team will be attending the 2023 Federation of Tax Administration (FTA) Tobacco Section Annual Conference. This in-person event will be held in Tucson, Arizona from August 20-23, 2023, and presents a great opportunity for government and industry members to collaborate
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).
Stakeholders’ Input Welcome: Virginia ABC to Assess Options for Regulating Liquid Nicotine in the Commonwealth
The Virginia ABC will assess a regulatory scheme for liquid nicotine, with the consultation of stakeholders, and issue a report and recommendations.
On April 12, the Virginia General Assembly enacted House Bill 2296 and Senate Bill 1350, incorporating recommendations of Governor Glenn Youngkin to have the Virginia Alcoholic Beverage Control Authority (ABC) “assess” a potential licensing scheme for liquid nicotine manufacturers, distributors, and retail dealers, as well as administrative and enforcement matters relating to liquid nicotine licensing, age verification, product verification, and advertising restrictions. These bills effectively instruct the ABC to tell the Virginia General Assembly whether and how the Commonwealth should regulate liquid nicotine. The ABC’s report and recommendations are due by November 1, and will be informed by stakeholder input. The enactments specify that the ABC will conduct its assessment “in consultation with stakeholders, including public and community health organizations, retailers, tobacco and vaporized nicotine companies, and wholesalers.”
Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Cross-Cutting and Regulation and Guidance Task Forces
This is the third 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 here, here, and here.
In this segment of our series evaluating FDA’s response to the Report (which can be found here and here), we review a subset of the Report’s recommendations and responses from two CTP Task Forces—Cross Cutting and Regulation and Guidance.
Federal Government Ramping Up Vapor Enforcement
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.
The Food & Drug Administration (FDA) and Department of Justice (DOJ) are increasingly focusing enforcement efforts on electronic nicotine delivery systems (ENDS). Such enforcement priorities have been reflected in six DOJ complaints for injunctions and four FDA complaints for civil monetary penalties (CMP) against businesses dealing in ENDS without marketing authorization under the Food, Drug, and Cosmetic Act (FD&C Act). In addition, ENDS businesses have been receiving communications from DOJ’s Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) alleging violations of the PACT Act, and FDA has issued a substantial number of warning letters alleging ENDS businesses’ FD&C Act violations. Federal prioritization of ENDS enforcement has also been reflected in FDA statements in connection with its CMP complaints and the Reagan-Udall Foundation’s operational evaluation of FDA’s Center for Tobacco Products (CTP), which we have discussed here, here, and here.
Troutman Pepper Team to Attend TMA 2023
Bryan Haynes, Agustin Rodriguez and Nicholas Ramos of the Troutman Pepper Tobacco Team will be attending TMA’s 2023 Conference and Annual Meeting. This in-person event will be held in Leesburg, VA from April 17-19, 2023. Hot topics will include discussions surrounding nicotine policies; federal, state, and local enforcement initiatives
Troutman Pepper Tobacco Team Featured in Part Two of Podcast Discussing Significant Tobacco Industry Developments in 2022 and What to Expect in 2023
The Troutman Pepper Tobacco Team was featured in part two of a two-part podcast on recent developments in the tobacco industry and what to expect for the coming year. In this podcast, Bryan Haynes, Agustin Rodriguez and Nick Ramos discuss tobacco excise taxes; challenges to flavor bans; FDA’s regulation of
Troutman Pepper Tobacco Team Featured in Podcast Discussing Significant Tobacco Industry Developments in 2022 and What to Expect in 2023
The Troutman Pepper Tobacco Team was featured in part one of a two-part podcast on recent developments in the tobacco industry and what to expect for the coming year. In this podcast, Bryan Haynes, Agustin Rodriguez and Nick Ramos discuss developments at the federal level, including important happenings at FDA
Oregon Bill Proposes to Replace Escrow Deposit System With “Equity Assessment” for Certain Tobacco Product Manufacturers
The Oregon Legislature’s 2023 regular session kicked off with a bang for the tobacco industry when House Bill 2128 (HB2128) was introduced at the request of Attorney General Ellen Rosenblum who also happens to the be president-elect of the National Association of Attorneys General. If passed, HB2128 would replace Oregon’s escrow deposit system, applicable to tobacco product manufacturers that are nonparticipating manufacturers (NPMs) under the Master Settlement Agreement (MSA), with an equity assessment. While HB2128 was only recently introduced and has a number of hurdles to overcome before it becomes law, we are not aware of any other state that has made a similar proposal to retroactively change escrow deposit systems for NPMs. Thus, HB2128 is worth monitoring, not only for its potential impact to Oregon NPMs, but also to see whether similar legislation will be introduced in other states.
FDA Implements More Aggressive Approach to Enforcement of ENDS Premarket Requirements
In October 2022, the U.S. Food and Drug Administration (FDA) announced that the Department of Justice (DOJ), on its behalf, filed complaints against six electronic nicotine delivery system (ENDS) companies in federal district courts, seeking permanent injunctions. These cases are important because they mark the first time the FDA has litigated against companies to enforce the Federal Food, Drug, and Cosmetic Act’s premarket review requirements for new tobacco products.