PMTA - TFN

March 30th, 2022

To all Our Loyal Customers and Vendors, 

Since the passing of the Omnibus Bill, BLVK has been navigating through the new regulatory landscape on the newly-deemed synthetic nicotine products.  We are proud to announce that we are working with the American Vapor Manufacturers (AVM) to manage, submit, and deliver a new premarket tobacco application (PMTA) on all existing and new BLVK synthetic nicotine products.  Given the AVM’s incredible relationship on all levels of the regulatory environment, we are confident in their ability to show the FDA that the American vaping industry is alive, ready, and willing to take on whatever the challenge may be.

Char Owen, Vice President of the AVM states: “At the American Vapor Manufacturers, we are striving to help lead the industry to a beneficial relationship with the FDA.  This includes helping companies navigate the regulatory framework as well as improving to improve the communication between the FDA and the industry.  The end goal is to bring us to a smoke-free future.”

 BLVK’s number one responsibility is to provide full transparency before, during, and after the PMTA process.  This is why, in addition to announcing our partnership with the AVM, we are also providing market confidence to all our loyal customers, distributors, and retailers of our intent to submit the full catalog of BLVK synthetic nicotine products through a new PMTA. 

The full list of submitted products can be found below.

 Thank you for your continued support.

 Tobacco Free Nicotine Products being submitted:

BLVK TFN Freebase Series
WYTE TFN Freebase Series
FRZN TFN Freebase Series
TBCO TFN Freebase & SALT Series
Hundreds TFN Freebase Series
SALT TFN Series
SALT PLUS TFN Series
BLVK Pink TFN Series
BLVK N’ Yellow TFN Series
BLVK Fusion TFN Series
Aloe TFN Series
Ello TFN Disposables Series
Ello Plus TFN Disposable Series
Ello XL TFN Disposable Series

 

To all Our Loyal Customers and Vendors, 

As many of you are already aware, the recent Omnibus Bill, which includes legislation that extends the FDA’s jurisdiction to cover Tobacco-Free Nicotine products was signed into law. This begins a very short timeline of introducing all Tobacco-Free Nicotine products into the market by April 10, 2022, with a new Premarket Tobacco Application due May 10, 2022. The FDA also has a deadline to make its decision regarding potential marketing orders by July 9th, 2022.
BLVK is aware of the incredibly short timelines present and are up to the task of remaining compliant in the eyes of the FDA. We would like to assure each and every one of our customers and vendors that we will continue to manufacture and distribute our products until the FDA gives us an answer pending our re-submitted PMTAs.

This is not the first time our industry has faced eradication; and this will certainly not be the last. BLVK consistently adapts to new situations that arise that aren’t always in our control. Nevertheless, we as a brand will continue to thrive not just for our own sake, but for the thousands of customers worldwide to deliver a truly premium vaping experience.