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
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).Continue Reading Juul Labs, Inc. v. FDA: A FOIA Twist on the Challenge to FDA’s Marketing Denial Order
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.”Continue Reading Stakeholders’ Input Welcome: Virginia ABC to Assess Options for Regulating Liquid Nicotine in the Commonwealth
RJ Reynolds Sues California AG Disputing Applicability of Flavor Ban
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
Troutman Pepper Tobacco + Nicotine Team to Present at FDLI Annual Conference
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
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.Continue Reading Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Cross-Cutting and Regulation and Guidance Task Forces
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.Continue Reading Federal Government Ramping Up Vapor Enforcement
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, FDA submission pathways, FDA tobacco
House Committee Investigates FDA’s Regulation of Tobacco and Nicotine Products
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
Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Science and Application Review Task Force
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, check it out here.
There is a common refrain that appears throughout the Reagan-Udall Foundation report on the Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA) — lack of transparency. The report found that stakeholders generally perceived premarket tobacco product applications (PMTAs) — required for all electronic nicotine delivery systems (ENDS) on the market — as “ineffective and problematic” due in part to a “lack of adequate guidance and transparency regarding CTP expectations,” as well as a “lack of clarity regarding review standards.”Continue Reading Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Science and Application Review Task Force