IPURE  Successfully Submits TPMF and Obtains FDA STN Number

Strengthening Global Compliance and Empowering Chinese Brands to Go Global with Confidence

Recently, iPure officially submitted its Tobacco Product Master File (TPMF) to the U.S. Food and Drug Administration (FDA) and successfully obtained the Submission Tracking Number (STN).
This milestone marks a significant step forward in iPure’s development of a global compliance system for vapor products and provides efficient, professional compliance solutions for partners entering the U.S. market.

TPMF: A Strategic “Bridge” to the U.S. Market

TPMF is part of the FDA’s regulatory framework for tobacco products. It allows manufacturers to centrally register key technical data—such as e-liquid formulations, raw material sources, toxicological profiles, manufacturing processes, and quality control standards—and authorize downstream brand owners to reference the TPMF through its STN during PMTA (Premarket Tobacco Product Application) submissions.

Compared to brands submitting individual documentation from scratch, TPMF greatly streamlines the PMTA process, making it a standard entry route for global e-liquid and raw material suppliers targeting the U.S. market.

Building a Professional Advantage: iPure’s Systematic Compliance Capabilities

As a leading vapor technology company in China, iPure has long focused on e-liquid R&D, testing, and global regulatory research, forming a complete technical ecosystem that spans upstream innovation to downstream supply.

1. R&D Excellence

A senior flavor design team with over 15 years of experience, familiar with consumer preferences in the U.S., EU, Middle East, and Southeast Asia

Independent flavor labs and a proprietary formulation database, enabling fast customization and iterative development

Comprehensive alignment with PMTA (U.S.) and TPD (EU) regulations to ensure formula stability and toxicological compliance for global market access

· 

2. Global Regulatory Compliance Expertise

Real-time monitoring of policy changes from FDA (U.S.), TPD (EU), MHRA (UK), and Southeast Asian regulatory bodies

Full-service compliance support, including PMTA registration guidance, technical document preparation, and TPMF referencing strategies

Successfully assisted clients in completing EU TPD registrations, Middle East ECAS certifications, and other cross-border regulatory filings

3. Manufacturing and Supply Chain Capabilities

Monthly bulk e-liquid production capacity exceeding 1,500 tons, with flexible OEM/ODM services for bottled or barreled formats

GMP-compliant facilities with food-grade cleanroom filling environments

A full-process ERP system enabling traceable, quality-controlled operations from order placement to delivery

What the STN Means: Accelerated Compliance for Our Partners

The Submission Tracking Number (STN) is issued by the FDA to acknowledge a successfully filed TPMF. Once granted, the STN may be cited by brand owners during their PMTA submissions, offering significant benefits:

Reduced documentation workload and faster submission preparation

Minimized risks of redundant or inconsistent technical materials

Accelerated PMTA review timeline, helping brands reach the market sooner

For Chinese vaping brands planning to expand into the U.S., partnering with a supplier that has a registered TPMF and valid STN provides a critical competitive edge.

Conclusion: Compliance Is the New Standard for Global Expansion

As the global e-cigarette industry shifts toward compliance-driven growth, adherence to regulatory standards has become more than a requirement—it’s a defining metric of a company’s professionalism and international mindset.

iPure will continue to leverage its technical strength and regulatory expertise to provide end-to-end services—including TPMF filing, PMTA registration, formulation compliance, toxicology testing, and export customization—helping Chinese brands expand globally with confidence and integrity.

For TPMF STN authorization or inquiries about our full-range PMTA services, please contact our professional regulatory team.