Key Points
- Market access is becoming more fragmented: PMTA alone no longer determines commercial access, as state product directories, import enforcement, taxation, licensing and channel requirements increasingly affect continued sales.
- Foreign manufacturers may face greater regulatory responsibility: The FDA’s proposed establishment registration and product listing requirements could bring overseas brand owners, manufacturers and supply-chain companies into more direct regulatory oversight.
- Product categories face different outlooks: 2Firsts said heated tobacco products, nicotine pouches and vaping products are moving into distinct regulatory and competitive stages, requiring category- and product-specific investment decisions.
- Companies face three strategic paths: Alan Zhao advised businesses to choose between continued compliance investment and long-term U.S. participation, redirecting resources toward other categories or markets, or remaining exposed to the higher risks of the unauthorized market.
- New conditions require sustained market-access capabilities: Brand owners and manufacturers need to move beyond one-time applications and manage products, manufacturing sites, imports, state-level access and supply-chain compliance on an ongoing basis.
2Firsts，
SHENZHEN, China, July 28, 2026
U.S. market access for tobacco and nicotine products is becoming increasingly dependent on more than a single federal application, as state-level requirements, foreign-manufacturer oversight, import enforcement and supply-chain documentation play a larger role in commercial decisions.
Against that backdrop, 2Firsts held its 2026 U.S. Market Compliance and Development Mid-Year Briefing in Shenzhen, China, on July 28. More than 20 company representatives participated in person and online, including executives and compliance professionals from vaping, nicotine pouch, heated tobacco and related supply-chain companies.
Shenzhen is one of the world’s main manufacturing and supply-chain hubs for vaping products, making changes in U.S. regulation particularly relevant to companies operating in the region.
The event, held under the theme “New Landscape, New Opportunities, New Strategies,” reviewed developments in the first half of 2026, the U.S. Food and Drug Administration’s proposed tobacco product establishment registration and product listing requirements, and the strategic choices facing companies in the second half of the year.
It was 2Firsts’ second U.S.-focused industry briefing in less than two months. On June 11, the company held a compliance session in Shenzhen focused on strengthening Premarket Tobacco Product Application (PMTA) support readiness across the vaping, heated tobacco and nicotine pouch supply chains. Together, the two events form part of 2Firsts’ continuing work on U.S. market access, manufacturing compliance and supply-chain preparation.
The central message at the July briefing was that commercial opportunity remains in the U.S. market, but regulatory and business conditions are diverging sharply across product categories, individual products and companies. The key question is no longer simply whether the market offers opportunity, but which products remain worth long-term investment and whether a company can sustain access over time.
Market Opportunities Remain, but Access Is Becoming More Fragmented
Echo Guo, co-founder and chief operating officer of 2Firsts, reviewed the main market and regulatory developments of the first half of 2026. She said market access, rather than demand alone, is becoming an increasingly important competitive variable.
“PMTA remains an important part of market access, but it is no longer sufficient on its own to ensure that a product can be sold nationwide,” Guo said.
Companies now face requirements beyond federal product review. State product directories, manufacturer certifications, licensing and taxation can affect whether a product qualifies for sale in a particular jurisdiction. Import enforcement, judicial review and compliance checks by distributors and retailers are also influencing commercial access.
As a result, the same product may face different directory status, tax treatment, origin requirements or enforcement conditions from one state to another. Companies that previously managed the United States as a single national market may increasingly need to make investment and distribution decisions according to the specific product, state and regulatory status involved.
Conditions are also diverging across categories. Nicotine pouches are moving into broader competition involving product authorization, brand strength, distribution, pricing and regulatory status. The regulatory path for heated tobacco products has become comparatively clearer, while vaping products continue to face uncertainty involving authorization timelines, state restrictions, import enforcement and supply-chain oversight.
Strong consumer demand therefore does not necessarily translate into stable market access. Companies can no longer assume that the size of the overall U.S. market justifies the same level of investment across every product in their portfolio.
Proposed Rules Could Bring Foreign Manufacturers Further Into FDA Oversight
Kurt Yang, compliance partner at 2Firsts and a PMTA compliance specialist, discussed the FDA’s proposed tobacco product establishment registration and product listing requirements, together with developments related to Tobacco Product Manufacturing Practice (TPMP) requirements.
Under the current proposal, if finalized, certain foreign specification developers, brand owners, original design and contract manufacturers, fillers and repackagers supplying the U.S. market could be required to register manufacturing establishments and maintain product listing information before relevant products are imported into the United States.
The information involved could extend beyond a one-time company filing. Product identifiers, manufacturing activities, packaging and labeling information, product changes and certain market-related records may need to be maintained and updated over time.
“Establishment registration and product listing do not mean that the products concerned have received FDA marketing authorization,” Yang said.
He said registration and listing are intended to identify manufacturing entities, facilities and related products, while marketing authorization remains a separate regulatory process. Because the requirements remain proposed, the final scope, timing and implementation details will depend on any final rule adopted by the FDA.
For foreign manufacturers, the potential significance goes beyond an additional administrative procedure. Some factories have historically treated U.S. compliance primarily as the responsibility of brand owners or PMTA applicants. If establishments, product information and manufacturing records are brought more directly into the regulatory framework, manufacturers’ own quality systems, document consistency and ability to maintain records could play a greater role in supplier selection.
U.S. brand owners may consequently look beyond cost, production capacity and delivery performance when assessing manufacturing partners. A factory’s ability to support product listings, PMTA documentation, quality records, customer audits and regulatory updates may increasingly influence whether it remains part of a brand’s long-term supply chain.
Four Market Judgments and Three Strategic Paths
Alan Zhao, co-founder and chief executive officer of 2Firsts, set out four core judgments on the U.S. market. First, he said the FDA’s long-term direction remains supportive of new tobacco and nicotine products that can meet the applicable public health standard, even though product reviews, enforcement policy and regulatory signals may remain uncertain in the short term. Second, heated tobacco products, nicotine pouches and vaping products are moving into different regulatory and competitive stages, with risks increasingly diverging by category. Third, the rapid growth of nicotine pouches is redistributing consumers, retail resources and regulatory attention. Fourth, vaping regulation could extend further beyond product authorization to manufacturing establishments, product listings, imports and supply-chain responsibilities around 2027.
“Even if foreign-manufacturer registration requirements are not implemented until 2027, the regulatory expectation is already influencing the next decisions made by brand owners, manufacturers and supply-chain companies,” Zhao said. “Brand owners need to take a longer-term view of whether their existing contract manufacturers could present compliance risks, and may require stronger compliance commitments and assurances from those partners.”
Based on those judgments, Zhao outlined and predicted three broad strategic paths for companies. Businesses with competitive products, stable customers and the resources to sustain long-term investment may continue funding compliance and seek durable growth in the United States. Companies without a sufficiently strong product or resource base may instead accelerate cash recovery and redirect investment toward other categories or emerging markets. Those that neither invest in long-term compliance nor actively change direction could remain exposed to the substantially higher enforcement and commercial risks of the unauthorized market.
Zhao said the first two paths should be chosen according to a company’s actual circumstances, while the third is more likely to be the high-risk consequence of failing to make a clear strategic decision. The central question is no longer simply whether opportunities remain in the United States, but whether a company’s products, funding, customers and supply chain can support long-term participation.
New Conditions Require New Strategies, and Opportunity Will Favor Companies Built for Sustained Access
2Firsts said new opportunities in the U.S. market are unlikely to depend solely on a single product or a short-term regulatory window. They will increasingly depend on whether companies can integrate product planning, manufacturing, imports, state-level access and channel management into an ongoing market strategy.
For brand owners, this means assessing manufacturing sites and supply-chain readiness earlier, including whether existing partners can consistently provide traceable and updatable product and manufacturing records. Manufacturers, meanwhile, need to move beyond responding to isolated customer document requests and build internal systems capable of supporting product listings, quality reviews, customer audits and continuing regulatory communication.
During the discussion, participants raised questions about the outlook for establishing manufacturing operations in the United States, the regulatory classification of 6-methyl nicotine products, and the respective responsibilities of brand owners, applicants and contract manufacturers. 2Firsts specialists shared their views based on current regulatory developments and industry practices.
Following the event, several participants continued discussions with 2Firsts compliance specialists and scheduled follow-up corporate compliance strategy assessments to examine their product portfolios, manufacturing arrangements, supply-chain readiness and potential U.S. market-access pathways.
2Firsts said the changing regulatory and commercial environment requires companies to move beyond waiting for final rules. Businesses need to identify risks earlier, reassess product investment and build the systems required to sustain market access. Following its June briefing on PMTA support readiness across the supply chain and the July mid-year event, 2Firsts will continue organizing U.S.-focused industry sessions and providing market research, strategic assessments and compliance support covering PMTA, foreign-establishment registration and product listing, Tobacco Product Manufacturing Practice requirements, state-level regulation and supply-chain compliance.
About 2Firsts Compliance Solutions
2Firsts Compliance Solutions is the global compliance service platform under 2Firsts, providing cross-market and cross-category compliance support for new tobacco and nicotine product companies. U.S. PMTA compliance services are one of its core capabilities, covering U.S. market entry strategy, PMTA pathway design, Acceptance Letter, Filing Letter, Full PMTA, state-level registration, TPMF/TPMP filing and supply chain compliance support. Since launching these services in 2024, 2Firsts has provided diversified compliance support to brands, manufacturers, technology providers and supply chain companies in China and worldwide. It is committed to reducing compliance difficulty and trial-and-error costs for companies, while supporting a more compliant and sustainable global indutry.
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.
Book a Free Preliminary U.S. Market Access and Compliance Strategy Assessment
To help companies assess how developments in the U.S. market and emerging regulatory expectations may affect their businesses, 2Firsts is offering free preliminary U.S. market access and compliance strategy assessments for companies involved in vaping products, heated tobacco products, nicotine pouches and related supply chains.
Brand owners, PMTA applicants, manufacturers and supply-chain companies may consult with the 2Firsts team on product portfolio and long-term investment strategies, PMTA pathways, proposed foreign-establishment registration and product listing requirements, TPMF and TPMP, state-level market access, manufacturing quality systems, customer audit readiness and supply-chain compliance.
Contact: Alan Zhao
Email: alan@2firsts.com
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