12 Days of Regulatory Insights: Day 9 - Trends in the Tobacco Industry — Regulatory Oversight Podcast
2022 Significant Developments in the Tobacco Industry and What to Expect in 2023 (Part Two) - Regulatory Oversight Podcast
On August 21, 2025, NJOY, LLC (NJOY), a subsidiary of Altria Group, Inc., sued the U.S. Food and Drug Administration (FDA), alleging that the agency has unlawfully delayed rendering a decision on supervisory review of its...more
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)...more
Manufacturers of e-cigarettes find themselves in a challenging regulatory environment to obtain U.S. Food and Drug Administration (FDA) marketing approval of flavored products. On October 12, 2023, the FDA denied premarket...more
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...more
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...more
FDA’s approach to a premarket tobacco product application (PMTA) raises new questions about whether its marketing denial order was arbitrary and capricious and whether the deliberative-process exemption justifies its...more
The U.S. Food and Drug Administration (the FDA) issued marketing denial orders (MDOs) to JUUL Labs for all of its products currently marketed in the United States. As a result of this MDO, JUUL must stop selling and...more
The US Food and Drug Administration recently issued an order authorizing R.J. Reynolds Vapor Co. to market its Vuse Solo electronic nicotine delivery system and corresponding e-liquid pods. These authorizations mark the first...more
On Wednesday, August 19, 2020, the U.S. District Court for the District of Columbia issued an order enjoining FDA from enforcing the premarket review requirement contained in the agency’s “Deeming Rule” against “premium...more
On April 23, 2020, the U.S. District Court for the District of Maryland granted the U.S. Food and Drug Administration’s (FDA or the Agency) request for an extension of the submission deadline for certain deemed tobacco...more
In recent weeks, the news has been full of stories of vaping-related illnesses and deaths. An eighth person has now died from a vaping-related illness, and reports state that hundreds more have been sickened with severe...more