What's a PMTA and What Do They Mean?

"A Premarket Tobacco Product Application (PMTA) can be submitted by any person for any new tobacco product seeking an FDA marketing order, under section 910(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act. A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health."

Straight from the FDA themselves, a brief explanation of what exactly the PMTA is and why they want them. Submissions for products that were on the market as of August 8th, 2016 were due by September 9th, 2020 in order to receive a one year market extension. Any products introduced after the August date will need removed from the market while the FDA reviews the submission.

The PMTA process, in short, consists of six steps before formal approval from the FDA is granted. Pre-application meetings, acceptance, filing, review, action, and post market reporting.

Starting from the top, pre-submission meetings consist of representatives from the manufacturer meeting directly with the FDA to present their submission plans as well as inform the FDA of the products that will be submitted.

Following the submission of the PMTA by the company, an acceptance letter is issued by the FDA to inform the submitting company that the submission contains enough information to move further into the process. Acceptance by the FDA doesn't quite mean that the product will be approved, and more information may need to be provided.

Once an acceptance letter has been issued, the PMTA submission will go through a filling review. This step involves a full document review to ensure that the FDA has enough information, on both scientific data and marketing data, to make an informed decision. Two outcomes can happen here: acceptance letter issuance, or refusal to accept.

Substantive review follows up with a significantly more in-depth review of the data provided. It's at this point that the FDA considers whether a product is suitable for the open market. Many factors are reviewed including the overall environmental impact of a product, including manufacturing waste and packaging waste, as well as any byproducts that may be discarded or hazardous waste disposal. This step is where the majority of the FDAs final decision will be made.

Once the agency has completed its full review of all provided data, the "Action" stage takes place. This means that either a marketing order is provided, allowing the products to enter the market with the FDAs approval, or no marketing order is issued, meaning that the product will need removed from the market if it hasn't been already.

After navigating the murky waters of the PMTA process, products that remain on the market require quite a bit of attention to appease the FDA. Reporting is required following the approval process to continue reinforcing that the marketed products are still meeting all of the criteria set in the PMTA and not falling into the hands of minors.

There is a multitude of brands that have submitted their applications to the FDA, however, to date none have moved past the filling stage. The entire industry is on its toes, hoping for the best, knowing that the outcomes of these applications will shape the future of the entire industry. Until we start seeing some progress on these applications, the industry will push on as it always has.

References and Useful Links:

FDAs Overview of the PMTA Process: https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications

FDAs Next Steps Information: https://www.fda.gov/tobacco-products/ctp-newsroom/next-steps-sept-9-premarket-submissions

Naked 100 PMTA Status: https://vapepmta.com/vendor-details/1599665973178x964483467421676900

Charlies Chalk Dust PMTA Status: https://vapepmta.com/vendor-details/1599603114845x138052243417718900