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Sixth Circuit· 11/12/2021

Breeze Smoke, LLC v. FDA

Citations

  • 18 F.4th 499

How courts have described this case

Verbatim parenthetical descriptions written by other courts when citing this decision. Ranked by citation-network relevance.

  • holding that “the FDA’s 2019 guidance does not qualify as ‘longstanding’”
  • holding that “the FDA’s 2019 guidance does not qualify as ‘longstanding’”
  • upholding the FDA’s determination that generalized evidence included in an open-system e-liquid application could not overcome the clear preference of children for flavored e-cigarettes
  • “Considering all of Breeze Smoke’s evidence, we disagree with Breeze Smoke, and with our colleagues on the Fifth Circuit, who say that the FDA orchestrated a ‘surprise switcheroo.’”
  • “declin[ing] to embrace” petitioner’s claim “that the FDA’s willingness to consider some forms of evidence, explicitly phrased as such, required the FDA to accept that evidence as meeting a statutory requirement even where the FDA found the evidence unsatisfactory”
  • denying a judicial stay from a substantially similar marketing denial order

Source: CourtListener parenthetical corpus (CC0).

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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.