The PMTA has affected everyone in the Vaping Industry; consumers, brands, vape stores. Some of us have lost the ability to purchase our favorite flavor or device, some of us have had to succumb to larger more financially robust brands, some of us have had to permanently close the doors to our family-owned businesses. Right now, when our industry is most desperate for answers, confusion and misinformation is clogging up the internet.

What is the "Premarket Tobacco Application (PMTA)"?

Let’s start at the beginning. On May 10th, 2016, the FDA published the “Deeming Rule”. This rule announced that all vaping products and devices were to be regulated the same way combustible cigarettes and other tobacco-containing nicotine products were (these regulations refer to the 2009 Tobacco Control Act). On August 8th, 2016, The FDA officially deemed e-cigarettes and vaping products as tobacco products. This would force all vaping products introduced to the market after 2/15/07 (practically before vaping existed) to file a PMTA (Pre-Market Tobacco Application). Due to the extreme cost of the PMTA submission process, this announcement came as a death sentence to the majority of the vaping industry.

In July of 2017, FDA Commissioner Gotlieb delayed the PMTA application deadline from August 8th, 2018 to until August 8th, 2022. The US vaping industry had some time to prepare

Fast-forward to May 15th, 2019 - when everything changed. With only 10 months’ notice, Judge Grimes overturned the original PMTA extension and court-ordered a PMTA deadline of May 12th, 2020. The FDA ultimately postponed the filing deadline to September 9th, 2020 due to the COVID-19 pandemic.
PMTA timeline.

What Does the PMTA Mean to Me?

The bottom line is this: if your vape product was not on the market for sale on or before August 8, 2016 and a complete PMTA was not filed for each specific vaping product, to include by milligram strength by 04:00pm on September 9th, 2020 – that product can no longer legally exist for sale on the US Market. This means that 99% of the vaping industry has vanished overnight.

If a PMTA was filed for, this means that the specific “SKUS” (flavor/mg, device color, etc.) that have been filed for can stay on the US market until the FDA either approves or denies the Application. Because the FDA has up to 1 year to approve or deny all 9/9/20 PMTA submissions, they will be issuing letters to manufacturers who have submitted PMTAs - either accepting or denying the submission. These Acceptance Letters serve as an indicator that a specific product is okay to continue to purchase or to sell in your shop or on your website.
At PMTA Verified, we do all the research, so you don’t have to! Stick with us and we will continue to update you on PMTAs that have been filed, application status/ FDA acceptance letters, and breaking PMTA news alerts.

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