If you’re the FDA, you get sued when you enforce violations of the Tobacco Control Act (TCA) for selling e-cigarettes that haven’t received premarket authorization from FDA (see here), and you get sued when you don’t. Or rather, when you put out a Guidance saying …
Last week, FDA’s Civil Money Penalty (CMP) authority suffered its most severe blow to date: the U.S. Court of Appeals for the Fifth Circuit vacated FDA’s imposition of a CMP, against a retailer for selling unauthorized tobacco products, as unconstitutional under the Seventh Amendment and SEC …
On June 24, 2026, the Fifth Circuit denied a petition brought by VDX Distro (VDX), an e-cigarette company, asking the court to review FDA’s decision to reject marketing authorization for its e-cigarette products. See VDX Distro, Inc. v. FDA, No. 24-60537 (5th Cir. 2026). By way …
A few months ago, we blogged about a Texas U.S. District Court’s Wulferic ruling that FDA’s civil monetary penalty (CMP) provision for tobacco products contained at 21 U.S.C. § 333(f)(9) is unconstitutional under the Seventh Amendment and SEC v. Jarkesy, 603 U.S. 109 (2024). Wulferic, LLC …
Late last week, the U.S. District Court for the Northern District of Texas ruled that FDA’s civil monetary penalty (CMP) provision for tobacco products contained at 21 U.S.C. § 333(f)(9) is unconstitutional. Relying on the Supreme Court’s recent decision in SEC v. Jarkesy, 603 U.S. 109 …
Last week, the Supreme Court issued a unanimous decision in FDA v. Wages & White Lion Investments, LLC, No. 23-1038 (Apr. 2, 2025) that affirms FDA’s denial of authorization to market flavored vape products. This opinion, which overrules a Fifth Circuit decision that FDA had …
On January 21, 2025, the Trump administration withdrew FDA’s proposed ban on menthol cigarettes, which the Biden administration initially introduced in 2022. This move is the latest step in FDA’s long, uncertain, and controversial journey to ban menthol cigarettes. For some background (which is covered in …
During the final week of the Biden administration, on January 15, 2025, FDA issued a proposed rule that, if finalized, would establish a maximum nicotine level in cigarettes and other combusted tobacco products, including most cigars and pipes, through its authority under Section 907 of …
It took only 3 months. In June, the Supreme Court ruled that the SEC cannot use its administrative authority to impose civil penalties for securities fraud on the ground that these penalties violate the U.S. Constitution’s Seventh Amendment right to a jury trial. See SEC …
You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. To quote the Fifth Circuit: “It was the regulatory equivalent of Romeo sending Mercutio on a wild goose chase—and then …
All companies dread the logistics, cost, and reputational harm associated with conducting a recall when necessary to remove or correct products in the field. But the more prepared a company is for a potential recall, the less pressure it will feel when a situation necessitates …
On October 12, 2021, FDA authorized the marketing of R.J. Reynolds (RJR) Vapor Company’s Vuse Solo electronic nicotine delivery system (ENDS) device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2. …
It seems that although FDA giveth, the ITC taketh away. IQOS is a tobacco heating system in which “heatsticks” (reconstituted tobacco blended with glycerin) are electrically heated to release nicotine-containing aerosol, but the tobacco is not combusted. Because IQOS was classified as a cigarette by FDA, …
The Food & Drug Administration (FDA) announced on April 29, 2021 that it is working towards banning menthol flavored cigarettes, committing itself to issuing a proposed product standard to prohibit menthol as a characterizing flavor in cigarettes “within the next year.” In the same announcement, …
On July 7, 2020, a unanimous panel of the D.C. Circuit held that FDA violated the Tobacco Control Act (TCA) and the Administrative Procedure Act by failing to study whether the extensive health warnings required on cigars would actually lower the number of smokers in …
