November 2, 2020: Received formal confirmation of PMTA Acceptance. Meaning, all submissions have been accepted by the FDA for the next step of preliminary scientific review.
NOTE: The FDA plans to post a list of the deemed new tobacco products that were on the market in the U.S. as of Aug. 8, 2016, (us for example) are still on the market now, and for which a premarket submission was made by Sept. 9, 2020. However, it may take a while, possibly 6 months or longer, for such a list to be compiled.
August 31, 2020.
Today's action concludes a costly and multi-year application process launched in advance of FDA's September 9, 2020 deadline for PMTAs.
The first step began August 2016, when we successfully received our "Tobacco Product Numbers/TN's" as issued from the FDA during the mandated registration and product listing process.
This is key milestone for us as we continue to offer quality products responsibly, while affording adult tobacco consumers an alternative to combustible tobacco products.
In summary, for now, its business as usual.
Since this is generally a wholesaler (ie. retail stores that sell our products) topic, we post updates about these events and actions here: