The FDA’s request for an extension to the PMTA deadline has been granted. The new deadline for filing submissions is Wednesday 9th September.
The unprecedented global COVID-19 pandemic had caused major issues for ENDS manufacturers who were working towards the original 12th May deadline. Concerns around restricted laboratory resources as well as reduced staffing levels at the Center for Tobacco Products (CTP) were seen as major factors in the decision.
What does this mean?
As stated above, the new date for filing a submission is now 9th September. For ENDS manufacturers who file by this date, a grace period of 12 months will be granted to continue trading whilst your application is reviewed. This is unless the FDA decide to take any action on your submission during this period.
The additional time will allow us to potentially on-board some more HPHC testing. This could be to support a new application or to bolster an on-going PMTA project with additional scientific data.
To discuss how Hall can support you with your PMTA submission get in touch today