OMB Completes Review Of FDA PMTA Proposed Rule

The White House Office of Management and Budget on Tuesday (Sept. 10) wrapped up its review of FDA’s premarket tobacco application (PMTA) proposed rule, which would establish content and format requirements for PMTAs. The conclusion of OMB’s review, which began in June , indicates FDA could move to issue the proposed rule soon, which would align with demands the vaping industry has made in a lawsuit asking a Kentucky district court to enjoin the agency from taking any enforcement action...