On February 16, 2021, FDA issued a progress report for the review of premarket tobacco applications (PMTAs) for vape products that were submitted on or before September 9, 2020. FDA spent years preparing for the thousands of applications they received and hired additional staff for processing the onslaught of data. While the review is still in progress, this update offers a few insights into the new landscape of vape regulation.

Many Applied

FDA is still processing PMTA applications from the September deadline. To date they have received over 15,000 applications for 4.8 million products from 230 companies.

Variation in Substance and Quality

FDA has received a wide range of formats and substance in the PMTA applications. Some brand submitted an individual PMTA for each product, others submitted one application for their entire line. Some applications are sparsely populated, others contain pages and pages of data for each document. Many only loosely followed formatting guidelines, further slowing the review process.

Many Have Already Been Rejected

As of today, out of roughly 87,000 products that have gone through acceptance review, 3,100 applications were not accepted for further review due to failure to meet basic requirements. Following filing review, 29,000 products have been filed (including 293 products filed by BRS), while 1650 have received refuse to file letters due to insufficient documents in their application. These numbers are expected to grow as product applications undergo substantiative review, the final phase which assesses the contents of each document.

A List is Coming

To date, FDA has issued 30 warning letters to companies that have not submitted a PMTA for their products. This will soon expand to companies that had applications rejected due to lack of content or poor application quality.

Further, in the near future FDA will be releasing the “List of Deemed New Tobacco Products with Timely Applications” which will include products that were on the market prior to August 8, 2016 that also submitted and accepted PMTA prior to the September 2020 deadline. This list will aid retailers in determining which products can be legally carried in their stores. While FDA has not issued a firm date for the release of the list, they assert that it will be soon.

There May Still Be Time

Despite the FDA’s valiant efforts, the sheer volume of product applications is keeping the PMTA review process slow moving. Following acceptance, the queue for substantiative review prioritizes large volume manufacturers and is otherwise randomized (learn more about review stages here). This means that companies who wish to bolster their applications following insights from the newly released Perception and Intents Guidelines and PMTA Final Rule may still be able to amend their applications before review starts (amendments will not be accepted once notification of substantiative review is received, unless requested by FDA).

Blackbriar Regulatory Services provides gap analyses for PMTA applications following a trusted formula that has carried all of our clients through initial review phases. We can identify weak areas in your PMTA and provide solutions for strengthening them. Contact us today to learn more about how we can be of assistance with your PMTA application or how we can help manage your post market reporting needs after your application is accepted!

Article written by MARA UNKEFER – Director of Consumer Research at Blackbriar Regulatory Services