Published in Law360 on June 27, 2023. © Copyright 2023, Portfolio Media, Inc., publisher of Law360. Reprinted here with permission.

On May 11, R.J. Reynolds Tobacco Co. Inc. went on the offensive to keep its new line of nonmenthol cigarettes marketed with language like “crisp,” “smooth” and “mellow” on store shelves in California.[1]

This suit, R.J. Reynolds Tobacco Co. v. Bonta, seeks declaratory relief in the Superior Court of California, County of Fresno, that California’s attorney general misinterpreted and misapplied the state’s ban on flavored tobacco products, and incorrectly concluded that R.J. Reynolds’ new products violate this ban.Continue Reading What RJ Reynolds’ Calif. Suit Means for Tobacco Regulation

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:

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.”Continue Reading Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Public Education Campaigns and Resources Task Forces

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 National Airport. We hope you

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).Continue Reading Juul Labs, Inc. v. FDA: A FOIA Twist on the Challenge to FDA’s Marketing Denial Order

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 official capacities, seeking declaratory relief that these California officials misinterpreted and misapplied California’s ban on flavored tobacco products and incorrectly concluded that RJ Reynolds’ new products violate this ban.Continue Reading RJ Reynolds Sues California AG Disputing Applicability of Flavor Ban

Bryan Haynes of Troutman Pepper’s Tobacco + Nicotine team will be moderating the panel discussion, 2023 and Beyond — Tobacco Product Standards and Additional Needed Rulemaking, as part of FDLI’s Annual Conference on May 17-18 in Washington, DC.

The panel will discuss the FDA Center for Tobacco Products’ plans for product standards that would eliminate

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.Continue Reading Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Cross-Cutting and Regulation and Guidance Task Forces

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.Continue Reading Federal Government Ramping Up Vapor Enforcement

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, FDA submission pathways, FDA tobacco

Coming on the heels of the Reagan-Udall Foundation report on the Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA), the U.S. House of Representatives’ Committee on Oversight and Accountability has commenced an investigation into CTP’s regulation of tobacco and nicotine products.  In a letter to FDA Commissioner Robert Califf, the Committee notes that CTP has failed to effectively administer its tobacco and nicotine regulations, resulting in uncertainty by compliant stakeholders and a proliferation of unsafe and unregulated products in the marketplace.  The Committee has requested a variety of documents and a staff-level briefing regarding CTP’s activities.Continue Reading House Committee Investigates FDA’s Regulation of Tobacco and Nicotine Products