It has recently been announced that the deadline for submissions has been extended providing manufacturers additional time to develop higher quality, more complete applications informed by additional guidance from the agency.
The agency plans to issue this guidance describing a new enforcement policy shortly. Under expected revised/extended timelines, applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.
Really great news all round it seems. The advocacy groups are really excited about this move by the FDA as it means more time to put forward a stronger case for vaping.
As you are no doubt aware, Aspire has joined many of the advocate groups and associations, like SEVIA USA, the Global Vaping Standards Association, and the Canadian Vaping Association.
We’ve funded all these associations especially SEVIA USA where Aspire is a founder member. Furthermore, we intend to put our full weight behind them and, helped by the extension of the FDA PMTA, we look to find a positive and favorable outcome in any and all negotiations.
However the original “deeming rule” still exists in its original form. That’s what we need to change. This announcement gives us more time to do that.