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.


Benefits of subscription plans:

  • Stay informed of any legal and market change in the sector that impacts your organization
  • Maximise resources by getting market and legal data analysis daily in one place
  • Make smart decisions by understanding how the regulatory and market landscape evolves
  • Anticipate risks in your decisions by monitoring regulatory changes that impact your organization

Need help?

Contact a sales representative right now and don’t wait

Email us