Kealani Distribution v. FDA

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Case overview

Case Number:

25-40135

Court:

Appellate - 5th Circuit

Nature of Suit:

2899 Other Statutes

  1. December 02, 2025

    5th Circ. Wary Of FDA Process Behind Rule For New Vapes

    A Fifth Circuit panel appeared skeptical Tuesday that the U.S. Food and Drug Administration properly accounted for how a new rule for premarket authorization of new tobacco products would affect small businesses in the industry.

  2. June 04, 2025

    Vape Cos. Urge 5th Circ. To Toss FDA Vape Marketing Rule

    A group of small e-cigarette companies is asking the Fifth Circuit to revive their suit challenging the U.S. Food and Drug Administration's rule for premarket authorization of new tobacco products, saying the FDA failed to account for how the rule would affect small businesses.

  3. March 27, 2025

    Vaping Interests Take Challenge To FDA Rule To 5th Circ.

    A coalition of vaping interests challenging the U.S. Food and Drug Administration's marketing and recordkeeping regulations has taken the dispute to the Fifth Circuit after a lower district judge tossed the lawsuit, which claimed many in the industry were prohibited from seeking FDA approval for multiple products at once because of the high cost of applying.