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.
July 2020: In preparation for the PMTA deadline of Wednesday, September 9th 2020, we have prepared our submissions in an industry-standard PMTA submission format for all SKU's.
August 2019: Strengthening our alliances in preparation of the 2020 PMTA deadline. Including documenting historical data regarding lab certifications and University study participation.
August 1st, 2018: Completed compliance needs to the FDA Required Labeling and Warning Statements for Tobacco / Vapor / E-liquid Products rules. To begin manufacturing of updated requirements August 9, 2018.
July 2nd, 2018: In accordance with the FDA Required Labeling and Warning Statements for Tobacco / Vapor / E-liquid Products we are working to retool equipment, redesign labels, marketing and more to ensure compliance. Effective Date: August 10, 2018.
December 7th, 2016: In accordance with the original FDA Compliance Period for Registration and Product Listing (December 31, 2016) and section 905 of the Tobacco Control Act, we have successfully received our Tobacco Product Numbers (approximately 1800) from the FDA. These were received as a result of mandatory filings August 2016.
July 25th, 2016; Contact us for our General Certifications of Compliance Pursuant to the Consumer Product Safety Commission (CPSC) product safety regulations 16 CFR Title 16 Part 1700 (1700.15 / 1700.20).
Since this is generally a wholesaler (ie. retail stores that sell our products) topic, we post updates about these events and actions here: