Earlier this month, we reported on a lawsuit filed by U.S. Smokeless Tobacco Company (UST) challenging the FDA’s issuance of Not Substantially Equivalent Orders for a smokeless tobacco product. The FDA has now moved to dismiss the lawsuit for lack of subject matter jurisdiction after rescinding the NSE orders at issue.
The FDA filed its Motion to Dismiss on April 20. After UST filed its Complaint, the FDA apparently determined that “certain scientific and technical information in UST’s substantial equivalence reports . . . was not adequately assessed at the time the agency issued its NSE Orders and that further consideration of that information may change the outcome of the substantial equivalence determination.” Accordingly, the FDA rescinded the NSE Orders as invalid and also vacated its January 2018 Appeal Decision that affirmed the NSE Orders. The FDA has indicated that it will continue is review of UST’s submissions, and that it anticipates completing its review by July 2018.
Now that the FDA has withdrawn the challenged actions, it says that the court lacks subject matter jurisdiction over the dispute. The FDA argues that UST’s claims are moot because all of UST’s claims seek relief from the now-rescinded and vacated decisions. The FDA also asserts that because the SE Reports at issue remain under active review, UST’s claims are not ripe. Alternatively, the FDA seeks a stay of the litigation pending its final determination on the reports at issue.
We will continue to report on this case as it progresses.