New PMTA uncertainty

4 February 2021

The U.S. Food and Drug Administration (FDA) displayed the final rule for the Premarket Tobacco Product Application (PMTA) in the federal register, but it did not get published on 19 January 2021.

A day later on 20 January, a memo from The White House Chief of Staff ordered the withdrawal of any rules that did not publish in the federal register on that day, therefore this final rule has been withdrawn at the current time.

This means that once again the electronic cigarette and vaping industry in the US is in limbo, applying for PMTA approval with no published final rule available.

ADACT’s Chief Regulatory Officer, Damien Bové, said “This raises two key questions — Will the new administration ask for changes to the rules for affected products? Will this affect any applications which have already already filed? The situation is still developing so please check ADACT’s social media channels for updates.”

To book a meeting about PMTA, please call ADACT on +44(0)1302 986 088 or email [email protected].

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