FDA Asks for and Receives PMTA Extension Due to COVID-19
The original May 12th FDA PMTA (Premarket Tobacco Product Application) deadline is fast approaching, but manufacturers have a little more breathing room to get their paperwork in. Recognizing the stresses placed on many industries—including government regulators, manufacturers, and retailers—due to COVID-19, the FDA filed a request for an extension on the deadline in Federal District Court. On April 3rd, the FDA PMTA extension request was granted, pushing back the deadline while still encouraging manufacturers to complete and submit their paperwork as soon as possible.
Premarket Tobacco Applications are filed by manufacturers who are offering new or modified tobacco products—including vaping liquids and pre-filled vapes—for sale on the market. While manufacturers of products introduced after August 8th, 2016, have needed to file an FDA PMTA before they can be sold, existing products were allowed to remain on the market at the time, with PMTAs to be filed in the future. After a series of policy and court decisions, the final deadline was to be May 12th for the manufacturers of these products to file their paperwork.
An extremely contagious novel coronavirus emerged in Asia in late 2019. With the spread of what is now known as COVID-19 into a worldwide pandemic, almost every industry in every country has had to alter their daily operations in an attempt to control its spread. Recognizing how this changed the landscape in which manufacturers and retailers were attempting to comply with the FDA PMTA deadline, on March 30th, 2020, the FDA filed a request for a 120-day extension, citing the unusual and extreme nature of the difficulties caused by shelter-in-place orders, quarantines, labor shortages, and the need for essential services to take priority during the pandemic response.
THE JUDGE’S DECISION
April 3rd, 2020, Federal Judge Paul Grimm for the District of Maryland approved the FDA PMTA extension, setting a new due date of September 9th, 2020. While many manufacturers had likely already submitted paperwork, this helps protect the ability of those affected to continue to offer their products. Once the PMTA is submitted, they will be able to continue selling while the FDA PMTA is in review. If approved, sales will continue, and if rejected, manufacturers have the opportunity to submit appeals and revisions, meaning that there’s no reason to worry as long as they have their initial filings in by the deadline.
WHAT THIS MEANS FOR YOUR VAPING
Right now, this means it’s business as usual for your favorite vape flavors. As we approach the deadline, we’ll be watching closely for any updates from manufacturers, but right now there’s no need to worry about your juice supply being disrupted. Follow our blog to stay up-to-date on the latest developments in FDA PMTA and vaping news. Sign up for rewards and get big savings on your vape and gear from Ziip Stock.