FDA Launched Web-based PMTA Optimize Tobacco Application System

The US FDA has launched a web-based PMTA submission process, which may drive grey market products towards compliance

According to the FDA official website, on December 3, 2025, the US Food and Drug Administration (FDA) announced the official launch of a new version of the web-based tobacco product pre-market application form, covering two main paths: Premarket Tobacco Product Application(PMTA)and Substantial Equivalence(SE). The new version of the table has been opened on the CTP Portal NextGen. It not only sends a clear signal of accelerating the pace of review, but also marks a turning point for the long gray USA vape market to turn white.

This update not only includes the main application and supplementary application (amendment) forms, but also adds a unique identification (unique-ID/grouping) form applicable to product grouping. The new version of the form includes:

• Form 4057 (PMTA main application)
• Form 4057a (PMTA Supplementary Information)
• Form 4057b (PMTA Grouping/Unique Identification)
• Form 3965 (SE main application)
• Form 3965a (Supplementary Information for SE)
• Form 3965b (SE Grouping/Unique Identification)

The new version of the web form provides step-by-step guidance, draft saving, multi-user collaboration, and built-in verification tools to help applicants ensure the completeness and standardization of materials before submission.
The FDA explicitly states that currently only PMTA and SE have switched to the new version of the web spreadsheet; Other tobacco product related submissions, such as ingredient lists, harmful ingredient reports, existing product information, etc., still follow the traditional process of eSubmitter or PDF upload.
The FDA stated that this update aims to improve the efficiency, effectiveness, and transparency of application review. The new version of the table includes multiple revisions formed after collecting public opinions during the OMB review process.
CTP Portal NextGen will continue to serve as the unified communication portal for all tobacco product compliance applications.

Why are it difficult for China vape factory or vape brand to pass PMTA

Taking into account the above factors, the main challenges for China vape manufacturers are:
1. Lack of scientific research, toxicology, safety, and regulatory compliance capabilities – Many Chinese manufacturers have rich experience in exports and contract manufacturing, but lack systematic design and compliance preparation for US regulations (tobacco+public health+safety).
2. High costs, long processes, and the need to invest a large amount of resources – for small and medium-sized manufacturers, the financial and technological barriers are extremely high.
3. High approval standards and low pass rate – most applications are ultimately rejected, with a low success rate, and even with the investment of resources, it may not necessarily be possible to “pass the hurdle”.
4. High requirements for supply chain/responsibility chain/documentation/English materials – For OEM models and export-oriented manufacturers, meeting these requirements requires restructuring the entire production and export system.
Therefore, many Chinese vape manufacturers have found that “wanting to sell their products to the United States” is no longer simply about outsourcing and exporting, but requires “starting from research and development+manufacturing+compliance+branding+legal+safety” – this is a structural challenge for traditional model manufacturers.

If you, as a vape manufacturer, only declare a “basic equipment model” or “single e-liquid formula/SKU/flavor/nicotine concentration” PMTA, you may invest tens of thousands to about 500000 US dollars; But if the product line is complex (multiple flavors, concentrations, specifications, smoking accessories+e-liquid combinations, etc.), the cost will be very high – each SKU may need to be separately applied/tested, so the overall investment may reach millions/tens of millions of dollars.