FROM THE TONY ABBOUD/VTA – FDA TO ISSUE GUIDANCE DEFERRING DEADLINES BY THREE MORE MONTHS.

BREAKING (GOOD) NEWS: FDA TO ISSUE GUIDANCE DEFERRING DEADLINES BY THREE MORE MONTHS.

VTA has been working closely with Breathe Easier Alliance of Alabama (BEAA) on an administration strategy for the past couple months. Last week, we met with senior leadership at HHS emphasizing the need to re-evaluate the deeming regulation. Earlier today, Stacey Hamilton, President of BEAA and VTA Board Member, informed us that FDA sought an extension of its briefing schedule in Cyclops Vapor v. FDA so that the FDA could re-evaluate the deeming.

Sure enough, this afternoon FDA announced that it is doing so in all cases and that it is going to issue guidance to defer enforcement of all future compliance deadlines for all newly deemed products by an additional 3 months so that new leadership at the FDA and the Department of Health and Human Services can have additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits.

This is an important step forward in our D.C. efforts. Stay tuned for more to come.

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Author: pbusardo