Juul’s new suit against US FDA seeks materials withheld in suspended MDO

Juul Labs is asking a judge to order the US Food and Drug Administration (FDA) to release information related to its now-vacated denial of the company’s premarket tobacco application (PMTA), calling the withholding of material “part of a troubling pattern of decreasing transparency at the agency”.

In a lawsuit filed 20th September, lawyers for Juul said they served the FDA with two requests for the “scientific disciplinary reviews” behind its decision to reject the PMTA and order all Juul products off the US market. The requests were made “less than a day” after the FDA issued its marketing denial order (MDO) to Juul on 23rd June.

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      Juul Labs is asking a judge to order the US Food and Drug Administration (FDA) to release information related to its now-vacated denial of the company’s premarket tobacco application (PMTA), calling the withholding of material “part of a troubling pattern of decreasing transparency at the agency”.

      In a lawsuit filed 20th September, lawyers for Juul said they served the FDA with two requests for the “scientific disciplinary reviews” behind its decision to reject the PMTA and order all Juul products off the US market. The requests were made “less than a day” after the FDA issued its marketing denial order (MDO) to Juul on 23rd June.

      ...

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      Need help?

      Contact a sales representative right now and don’t wait

      Erik Galavis
      +34 654 320 547
      Email Erik