Manufacturer sues FDA for ‘irreparable harm’ despite PMTA reconsideration

Florida-based e-cigarette manufacturer Bidi Vapor has taken the US Food and Drug Administration (FDA) to court claiming it suffered “continued irreparable harm” from being given a marketing denial order (MDO) for its vaping products – despite the agency having put the company’s application back under review.

A motion for “stay pending review” filed with the US Court of Appeals for the Eleventh Circuit in Atlanta, Georgia claims Bidi faces “immense financial losses” as a result of the MDO issued by the FDA in response to its premarket tobacco product application (PMTA).