US PMTA application STN number application process
Date：2025-10-13 10:07:50 Classification
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The complete process and key points for obtaining a Substantive Tobacco Product Notice Number (STN) when applying for a PMTA for vaping products from the US FDA are summarized in conjunction with the FDA's latest policies and operational requirements:
I. Core Definition and Function of the STN Number
1. Essentials of the STN Number
- It is a unique identification number assigned by the FDA to e-cigarette products that have passed the initial PMTA review, marking the entry of the application into the substantive review phase.
- It is not final approval, but merely indicates that the completeness of the materials has been reviewed, and further evaluation is still required.
2. Scope of Mandatory Application
- All new vaping products sold in the US market.
II. The Complete STN Application Process (4-Step Detailed Explanation)
Step 1: Preparatory Phase (Document Preparation)
1. Core Study Report (Must be issued by an FDA-approved laboratory):
- Toxicology Analysis: Potential health effects of long-term use;
- Composition Release Report: Nicotine release, heavy metals (lead/cadmium), carbonyl compounds (formaldehyde), etc.;
- Youth Usage Propensity Assessment: Analysis of the product's appeal to adolescents.
2. Product and Manufacturing Documents:
- Complete technical specifications (circuit diagram, atomization principle), production process flow, and quality control standards.
3. Market Impact Report:
- Comparison with existing e-vaporization products and analysis of the overall public health impact.
Step 2: Submit PMTA Application
1. Submit through the FDA Electronic Gateway (ESG):
- Complete FDA Form 3653 and upload all study data and documents by module.
Step 3: Preliminary Review and STN Assignment
1. FDA Initial Review:
- Checks the completeness of the application materials, format compliance, and basic safety.
2. Conditions for Obtaining an STN:
- Complete application materials ➜ Assigned STN and proceed to substantive review;
- Incomplete application materials ➜ Received RTF (Refuse-to-File) letter.
Step 4: Substantive Review and Final Approval
- Review focuses on: Reasonableness of toxicology data and public health impact conclusions.
- Result:
- Approved ➜ Marketing Authorization (MO) issued;
- Rejected ➜ Product sales prohibited.
Dezewei Testing has successfully assisted many companies in applying for STNs with complete application materials. The application process takes approximately one week.
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