Company goes to Supreme Court after judge rejects stay of US FDA denial order

Michigan-based Breeze Smoke is asking the US Supreme Court to stay a Food and Drug Administration (FDA) marketing denial order (MDO) after the Court of Appeals for the Sixth Circuit recently decided not to grant its motion because the company “has not shown a strong likelihood of success on the merits”.

The Court of Appeals ruled that “the FDA reasonably concluded that Breeze Smoke’s application did not meet the TCA’s [Tobacco Control Act] requirements that new tobacco products be appropriate for the protection of the public health”.

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      Michigan-based Breeze Smoke is asking the US Supreme Court to stay a Food and Drug Administration (FDA) marketing denial order (MDO) after the Court of Appeals for the Sixth Circuit recently decided not to grant its motion because the company “has not shown a strong likelihood of success on the merits”.

      The Court of Appeals ruled that “the FDA reasonably concluded that Breeze Smoke’s application did not meet the TCA’s [Tobacco Control Act] requirements that new tobacco products be appropriate for the protection of the public health”.

      ...

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      Need help?

      Contact a sales representative right now and don’t wait

      Erik Galavis
      +34 654 320 547
      Email Erik