FDA Clears PMTA Backlog 6-Year Vape Application Data Reveals Changes

The data covering the 2020-2025 fiscal year by the FDA shows that the PMTA system for vapes has undergone significant structural changes after early centralized filing. A large number of applications have been stuck in the acceptance stage for a long time and have not yet entered substantive review. Starting from 2023, the number of pending applications has significantly decreased, and several industry insiders have reported that the initial feedback cycle for PMTA in the second half of 2025 has been shortened.

Quick overview of key points

• PMTA applications experienced a concentrated outbreak in the early stages of regulation, followed by a rapid decline. During the 2020-2022 fiscal year, the FDA received approximately 26.6 million PMTAs for vapes, and the number of new applications has significantly decreased since then.
• The backlog mainly forms during the acceptance stage. During the peak period of application, millions of applications are stuck in the acceptance stage and have not yet entered substantive review.
• The handling actions for the 2023 fiscal year are highly focused on the front-end. That year, the FDA issued over 17 million Refusal of Acceptance (RTA) applications, with a limited number of new applications added during the same period.
• The stock of pending applications has subsequently significantly decreased. Official data shows that the number of pending PMTAs in the fiscal years 2024 and 2025 is significantly lower than before.

For many years, vape companies attempting to enter the US market have almost reached a consensus: PMTA audit cycles are long, measured in years, and the results are highly uncertain. Many companies therefore default to PMTA as a long-term project lasting 3 to 5 years or even longer, and subsequently delay or abandon the actual application investment.
The latest official data released is changing this judgment

In December 2025, the US Food and Drug Administration (FDA) released an update
《Tobacco Product Applications: Metrics & Reporting》， For the first time, the system disclosed the complete operational status of the Vape PMTA for the fiscal years 2020 to 2025. Data shows that the FDA has processed the vast majority of applications submitted in the early stages of regulatory initiation, and the long-standing backlog that has plagued the industry is clearly diminishing.

How does backlog form and how is it cleared

Data shows that during the 2020-2022 fiscal year, the FDA received approximately 26.6 million PMTA applications for vapes. Among them, a large number of applications are submitted in front of key regulatory nodes, which quickly increases the system load. The real turning point will occur in the 2023 fiscal year.

At that time, the FDA issued 17.27 million Rejections of Acceptance (RTA) for vape products, while only about 14000 new applications were received during the same period. Such a disparate proportion clearly indicates that the focus of regulatory action has shifted towards centralized adjudication of historical inventory.
During the same period, disposable flavored vapes reached a phase high in the US market. Before the backlog of PMTA was cleared, the uncertainty of regulatory results led most market participants to not consider PMTA as a core consideration in the short term.
Entering the fiscal year 2024 (October 2023 to September 2024), the annual new application volume of vape PMTA has dropped to the lowest level in six years, with only 3631 appli

How acceptance backlog can change market behavior

During the peak application period, a large number of vape PMTAs remained in the Acceptance stage for a long time, neither entering substantive review nor being explicitly rejected. From a business perspective, time is passing, but regulatory results are still pending. This kind of front-end backlog even affected market behavior at one point.

Several industry insiders have pointed out that around 2024, the main purpose for some companies to submit PMTAs is not through acceptance, but to obtain STN (Submission Tracking Number) as soon as possible to cope with the compliance document numbers required for export filing and US customs declaration.
At that time, it often took six months or even longer for an application that was not submitted with the goal of being accepted to receive a rejection of acceptance (RTA). This time window is often sufficient to cover the entire commercial lifecycle of disposable vape products.
As these pending applications are centrally cleared, this operational space also disappears.

The pace is accelerating

The latest data for the fiscal year 2025 shows that the number of pending acceptances in the PMTA for vapes has decreased to 33486, compared to 193777 in the fiscal year 2024 and 287886 in the fiscal year 2023.
This change means that a large number of applications are no longer in a pending state before being accepted for a long time.
At the same time, enterprise feedback shows that from the second half of 2025, the decision-making speed of PMTA in the acceptance stage will significantly accelerate, and the submission cycle to Accepted or RTA will generally be shortened to about one month, with some cases even shorter.
In May 2025, the FDA publicly announced that it had completed its first AI assisted scientific review pilot and began deploying artificial intelligence tools across the entire agency. By the end of that year, the FDA management further stated that the agency had become the first federal regulatory agency to systematically apply AI at the agency wide level, with related technologies being used to support the workflow of document processing, data analysis, and review personnel.
The FDA has repeatedly emphasized that AI does not replace scientific judgment, and its core role is to reduce administrative burden and minimize repetitive work. Many industry insiders believe that the introduction of AI is likely one of the factors that will significantly accelerate the processing pace of PMTA applications in the Acceptance stage in the second half of 2025.

Entering the next stage

Based on changes in existing data, the industry’s time expectations for PMTA are undergoing adjustments. On the one hand, as the historical backlog is systematically digested, the pace of review is accelerating, especially in the acceptance and front-end adjudication stages; On the other hand, the recent announcement by the FDA that it will hold a PMTA roundtable meeting for small and medium-sized vape companies is also seen as a signal that under existing review standards, the approval of PMTA will no longer be limited to a few large enterprises in the future.
For practitioners, PMTA is shaking two long held beliefs: the audit cycle is no longer assumed to be a “long cycle of more than three years”, and future MGO recipients may no longer be limited to a few large enterprises.

Reference: Tobacco Product Applications: Metrics & Reporting | FDA

According to the FDA’s PMTA system query, it was found that. At present, there are not many vap companies that have passed this certification, only JOY LLC, Logic Technology Development LLC, and R.J. Reynolds Vapor Company. None of them are from Chinese vape manufacturers or vape factories.
Moreover, judging from the product models, they are not fruit flavored vapes or disposable vapes. According to my judgment, the number of enterprises that can pass PMTA certification in the near future will not be too many.

More articles about PMTA:

FDA Launched Web-based PMTA Optimize Tobacco Application System

FDA’s Latest PMTA Decisions: Which Vape Products Made The Cut?

Which Chinese Vape Companies Have Passed PMTA Certification