The Supreme Court held in Drug Administration v. R.J. Reynolds Vapor Co. that retailers of e-cigarette products are “persons adversely affected” by an FDA denial order under the Family Smoking Prevention and Tobacco Control Act (TCA), and therefore have standing to seek judicial review.Continue Reading Decision Alert: Supreme Court Affirms Retailers’ Right To Judicial Review Under The Tobacco Control Act
Decision Alert: Supreme Court Upholds FDA Denial of E-Cigarette Products
On April 2, 2025, in a significant decision in FDA v. Wages and White Lion Investments, LLC, the Supreme Court unanimously upheld the Food and Drug Administration’s (FDA) decision denying marketing authorization for certain e-cigarette products. The Court held that the FDA’s decision was not “arbitrary and capricious,” finding it consistent with the agency’s pre-decisional guidance and statutory mandate.Continue Reading Decision Alert: Supreme Court Upholds FDA Denial of E-Cigarette Products
Up in Smoke: The Supreme Court Explores Who Can Challenge FDA Orders Under the Family Smoking Prevention and Tobacco Control Act—and Where.
In FDA v. R.J. Reynolds Vapor Co., the Supreme Court will decide whether an e-cigarette manufacturer can seek review of the FDA’s denial of its marketing application in a forum where it does not reside by joining a retailer who does.Continue Reading Up in Smoke: The Supreme Court Explores Who Can Challenge FDA Orders Under the Family Smoking Prevention and Tobacco Control Act—and Where.
Supreme Court To Determine Limits of Arbitrary and Capricious Agency Action
In FDA v. Wages and White Lion Investments, LLC,the Supreme Court is set to decide whether the court of appeals erred in ruling that the Food and Drug Administration’s (FDA) denial of authorization for new e-cigarette products was arbitrary and capricious.Continue Reading Supreme Court To Determine Limits of Arbitrary and Capricious Agency Action