2Firsts
Shenzhen, June 12, 2026
2Firsts Compliance Services held a U.S. compliance briefing in Qianhai, Shenzhen, on June 11, focusing on how companies across the vaping, heated tobacco and nicotine pouch supply chains can strengthen their ability to support U.S. PMTA requirements. More than a dozen company representatives joined the event in person or online, including companies involved in vaping products, heated tobacco, e-liquids, manufacturing and related supply chain services, as well as China-based representatives of international compliance firms.
Under the theme “From Manufacturing Competition to Compliance Competition,” the event reflected 2Firsts’ view that opportunities remain in the U.S. nicotine market, but regulatory enforcement and customer selection standards are changing. For brands and suppliers serving the U.S. market, PMTA applications, product documentation, manufacturing consistency, quality controls, document traceability and age-verification technologies are increasingly being incorporated into product access, risk-control and supplier-evaluation decisions by U.S. customers.
U.S. Compliance Expectations Are Reaching Deeper into the Supply Chain
At the event, 2Firsts said U.S. compliance expectations are increasingly reaching beyond brand owners to manufacturers, e-liquid companies, component suppliers, technology providers and other supply chain participants. In the past, suppliers competed largely on price, product design and delivery. Going forward, their ability to support PMTA submissions, customer audits and ongoing compliance may affect whether they are shortlisted as preferred suppliers for U.S. projects.
For supply chain companies, U.S. compliance readiness is moving from a back-office function to a factor that can influence customer acquisition and supplier selection. When U.S. brands assess suppliers, the speed of compliance document response, document consistency and traceability may become as important as pricing, delivery and product development.
For brand owners, insufficient supply chain readiness may extend PMTA preparation timelines, create inconsistencies across documentation, weaken manufacturing consistency evidence, and affect later customer audits and product change management. As a result, supplier readiness is becoming an increasingly important variable in U.S. market strategy for brand owners.
Alan Zhao: U.S. Customers Will Reassess Supplier Readiness
Alan Zhao, co-founder and CEO of 2Firsts, said in his presentation that the U.S. market is moving from product competition toward access competition and compliance competition. For Chinese suppliers, the key question is no longer only whether opportunities still exist in the U.S. market, but whether a company has the systems and documentation needed to be trusted and used by U.S. brand customers.
Zhao said brand owners may adjust their PMTA timelines according to market windows and regulatory developments, but suppliers cannot afford to wait until customers make formal requests. Document systems, batch records, manufacturing traceability, raw-material management and quality-control procedures are difficult to build quickly after a customer asks for them. Companies that establish systematic documentation and auditable systems earlier will be in a stronger position when customers make supplier decisions.
He said supply chain compliance upgrades should not be treated as a paperwork exercise, but as part of a company’s ability to serve U.S. customers. Suppliers that can support PMTA documentation, customer audits and long-term compliance responses more efficiently and reliably are more likely to become preferred partners for U.S. brand customers.
Kurt Yang: PMTA Review Requires Stronger Manufacturing, Quality and Traceability Records
Kurt Yang, compliance partner at 2Firsts and a PMTA compliance expert, gave a detailed presentation on the requirements placed on suppliers under the PMTA framework. He said PMTA is not only an application issue for brand owners. Manufacturing, quality, R&D, testing and traceability information provided by suppliers may directly affect the completeness and review readiness of a customer’s PMTA submission.
Yang analyzed common issues related to product identification, manufacturing information, test method validation, quality management systems, batch records, raw-material management, stability studies, risk-control requirements such as child-resistant packaging, device function verification and other risk-control measures. He said that for ODM/OEM manufacturers, e-liquid companies, nicotine suppliers, core component suppliers and compliance technology providers, systematic, auditable and continuously updated documentation and quality systems have become unavoidable requirements when supporting U.S. customer PMTA projects.
During the Q&A session, Yang also responded to questions from companies on PMTA documentation preparation, TPMF/TPMP pathways, production quality systems, customer audits and compliance documentation systems.
2Firsts Presents a Dual-Track TPMF + TPMP Framework
During the event, 2Firsts introduced its U.S. compliance upgrade framework for companies across the nicotine product supply chain. Built around PMTA requirements, the framework covers product documentation management, raw-material and supplier management, manufacturing records, quality management systems, testing and verification, batch traceability, change control, customer document response and ongoing document updates.
2Firsts said the framework is designed to help companies in vaping, heated tobacco, nicotine pouches and related supply chains move from passively providing documents to becoming partners that can support U.S. brand customers in compliance submissions and customer audits on an ongoing basis.
As part of the framework, 2Firsts presented a dual-track TPMF and TPMP service model. TPMF, or Tobacco Product Master File, focuses on turning a supplier’s product, process, quality, manufacturing or technical information into a master-file asset that can be referenced by authorized customers in PMTA-related submissions. TPMP focuses on gap analysis and optimization of a company’s internal production, quality, R&D, raw-material, traceability and change-control systems, improving readiness for U.S. customer audits, PMTA documentation requests and ongoing compliance requirements.
Through TPMF, suppliers can consolidate key information into a master-file asset that can be referenced by authorized customers in PMTA-related submissions. Through TPMP, companies can assess and optimize internal production, quality, R&D, raw-material, traceability and change-control systems. Together, the two approaches may help suppliers improve customer documentation response efficiency and reduce the pressure of repeatedly disclosing sensitive technical information.
2Firsts said its supply chain compliance services are not only intended to support Chinese suppliers in upgrading their documentation and quality systems, but also to help U.S. brand customers more effectively identify, evaluate and work with supply chain partners that can support PMTA-related requirements.
Client Work Highlights Common PMTA Support Risks
At the event, 2Firsts also shared practical issues observed in its recent client service work, focusing on the challenges suppliers face when supporting U.S. brand customers’ PMTA applications. These issues include customers suddenly requesting PMTA support documents while internal company files remain scattered; inconsistent documentation between R&D and production teams; insufficient batch records and change-control records; testing data that cannot be directly used in customer submissions; repeated disclosure of sensitive formula or process information; and difficulty proving manufacturing consistency and quality-control practices quickly during customer audits.
2Firsts said a supplier’s ability to meet procurement requirements in the past does not necessarily mean it can meet PMTA support requirements. The issue is often not a lack of manufacturing capacity, but the absence of systems to record, present and maintain existing controls in a way customers can use. For companies seeking to serve U.S. brand customers, early organization of documentation systems, clear boundaries for sensitive information disclosure, customer document response mechanisms and continuous update processes can help reduce communication costs and audit-related risks.
Companies Focus on Customer Audits and Age Verification as 2Firsts Launches U.S. Nicotine Market VIP Membership Program
Post-training survey feedback showed that participating companies were particularly focused on PMTA documentation preparation, TPMP and production quality systems, TPMF and Tobacco Product Master File development, age-verification technology and customer compliance audits.
2Firsts also launched its U.S. Nicotine Market VIP Membership Program during the event. The program is designed for brands, manufacturers and suppliers focused on the U.S. nicotine market, including vaping products, heated tobacco and nicotine pouches. It includes U.S. market briefings, dedicated online livestream sessions, offline closed-door exchanges, preliminary corporate compliance diagnostics and access to industry resources. 2Firsts said the program is not a general industry chat group, but a continuing information service and preliminary compliance assessment entry point for companies monitoring the U.S. market, regulation and compliance landscape.
2Firsts said it will continue to organize focused briefings and enterprise support activities around U.S. PMTA requirements, supply chain compliance, TPMF/TPMP, age-verification technology and key regulatory developments, helping companies improve documentation, traceability and quality-management readiness for U.S. market cooperation.
Appendix I: About 2Firsts Compliance Solutions
2Firsts Compliance Solutions is the global compliance service platform of 2Firsts, providing cross-market and cross-category compliance support for next-generation tobacco and nicotine product companies. U.S. PMTA compliance services are one of its core service capabilities, covering U.S. market access for brands, PMTA application pathway design, Acceptance Letters, Filing Letters, Full PMTA, state-level registrations, TPMF/TPMP filings and supply chain compliance support.
Since launching these services in 2024, 2Firsts has provided a range of compliance services to multiple brands, manufacturers, technology suppliers and supply chain companies in China and globally. The platform is committed to reducing compliance complexity and trial-and-error costs for companies, while supporting the industry’s participation in global market competition in a more compliant and sustainable manner.
Appendix II: Book a Free Preliminary Supply Chain Compliance Diagnostic
To help supply chain companies identify initial gaps in their U.S. market compliance readiness, 2Firsts is now offering free preliminary U.S. supply chain compliance diagnostic appointments for companies involved in vaping products, heated tobacco, nicotine pouches and related supply chains.
Companies may discuss PMTA documentation preparation, TPMF/TPMP pathways, production quality systems, customer audit responses, age-verification technology adoption and U.S. market compliance planning with the 2Firsts team.
Contact: Alan Zhao
Email: alan@2firsts.com
