As the U.S. nicotine pouch market gradually moves toward regulatory clarity and enters a phase of accelerated growth, industry attention is shifting from the demand side to the execution side. In an interview with 2Firsts, U.S.-based nicotine pouch manufacturer Rena World explains why, before the market fully scales, manufacturing capability, quality systems, and regulatory readiness are becoming decisive factors in determining competitive success.

Key Highlights

• As the U.S. Food and Drug Administration (FDA) continues to grant Marketing Granted Orders (MGOs) to nicotine pouch products through the PMTA pathway, the U.S. nicotine pouch market is entering a stage with a clearer regulatory trajectory. Industry focus is shifting from “whether nicotine pouches will grow” to “how expanding demand can be supplied in a stable and compliant manner.”
• Unlike the early development of e-cigarettes—where companies often captured market share first and built manufacturing capacity later—competition in nicotine pouches is increasingly concentrating on upstream factors such as manufacturing systems, quality control, and compliance execution.
• U.S. domestic nicotine pouch manufacturing remains highly fragmented. Local capacity that simultaneously combines systematic R&D, stable large-scale production, and regulatory execution capability remains limited, and structural supply-side constraints are becoming increasingly evident.
• For brands seeking to enter or expand in the U.S. market, manufacturing capability and compliance systems are no longer back-end considerations, but front-loaded prerequisites that must be planned and validated alongside commercial expansion.
• Rena World has chosen to invest early in high-standard U.S. domestic manufacturing—before the market fully scales— aiming to compete in the next phase of the U.S. nicotine pouch market based on manufacturing system maturity rather than sheer capacity size.

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Regulatory Clarity Marks a Turning Point

On December 19, 2025, the FDA officially granted MGOs to six on! PLUS nicotine pouch products through the PMTA pathway. This decision was widely regarded as a key milestone in the regulatory evolution of nicotine pouches, signaling a transition from early-stage uncertainty to a clearer and more operational regulatory framework.

With regulatory pathways becoming more defined, market demand has already been validated. Over the past several years, nicotine pouches have steadily increased their penetration within the U.S. nicotine consumption landscape, emerging as one of the fastest-growing product categories.

Strong sales performance and continued investment by leading brands have shifted industry focus from “whether nicotine pouches will grow” to “how growing demand can be supplied reliably and at scale.” Media reports previously indicated that Philip Morris International’s U.S. business (PMI US) plans to invest approximately USD 600 million in building a new ZYN nicotine pouch manufacturing facility in the United States.

This raises a fundamental question: unlike the early e-cigarette industry’s “market first, manufacturing later” approach, is the nicotine pouch category forming a new competitive logic—one in which manufacturing capability, quality systems, and compliance execution must be established before full-scale market expansion?

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Rena World Bets on the Window—Not the Hype

Rena World did not enter the nicotine pouch space at the peak of market hype. According to the company, the decision dates back to 2024, when a U.S. nicotine pouch brand proactively approached Rena World seeking a domestic manufacturing partner. Rena World’s U.S.-based R&D and manufacturing platform, Rena Labs & Manufacturing, was gradually built and put into operation based on this assessment.

The brand’s requirements were simple but difficult to fulfill: stable U.S.-based production combined with high standards for quality and compliance. At the time, few domestic manufacturers met these criteria, and after multiple rounds of engagement, the brand ultimately selected Rena World.

Unlike many later entrants, Rena World’s founders have long worked in regulated-product manufacturing, particularly pharmaceutical-grade production. This background enabled the team to recognize early on that nicotine pouches are not a category that can be scaled quickly through low-threshold capacity alone.

Rena World concluded that as regulatory clarity improves and brand demand consolidates around compliance and scale, demand for high-standard domestic manufacturing would emerge before the market fully explodes. Delaying capacity build-out until peak demand would significantly amplify execution and compliance risks.

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Structural Weaknesses in U.S. Nicotine Pouch Manufacturing

Despite strong demand growth and clearer regulation, Rena World notes that U.S. nicotine pouch manufacturing has not undergone a corresponding structural upgrade. Domestic production remains fragmented, with many products relying on overseas contract manufacturing or cross-border supply chains.

In the U.S., manufacturers that combine systematic R&D, scalable production, and robust compliance execution remain limited in number. While fragmented models may suffice in early market stages, their limitations become increasingly pronounced as brands enter mainstream retail channels and face tighter regulatory scrutiny.

Technical challenges also intensify with scale. Nicotine pouches are not simple fill-and-pack products; formulation, particle morphology, and moisture content directly affect nicotine release profiles and user experience. Issues that may be negligible in small batches can materially impact consistency and compliance once production scales.

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Manufacturing Systems Must Serve Both Compliance and Scale

Drawing on pharmaceutical manufacturing experience, Rena World emphasizes that its focus is not on individual machines or isolated processes, but on whether the overall system is reproducible, auditable, and regulator-ready. According to publicly disclosed materials, Rena World operates a facility previously run under FDA current Good Manufacturing Practice (cGMP) standards and is upgrading it to a GMP-ready manufacturing site with cleanrooms and quality-control laboratories.

In this framework, compliance is not treated as an external constraint but as an integral component of the manufacturing system itself. Quality control, data integrity, and traceability are embedded throughout the process to support long-term, stable operations rather than one-off regulatory reviews.

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Capacity Expansion Must Align with System Maturity

Rena World’s current U.S. manufacturing setup corresponds to a first-phase capacity exceeding 50 million cans per year. This phase is designed not to maximize scale, but to ensure stable supply for compliant brands while validating system stability, reproducibility, and regulatory robustness under continuous operation.

Based on this foundation, Rena World has planned a second phase of expansion, with total annual capacity expected to exceed 150 million cans in 2026. The company stresses that this expansion is contingent on the proven reliability of its existing quality and process-control systems.

In Rena World’s view, capacity itself is not the end goal of manufacturing, but a reflection of system maturity. Only when capacity growth advances in parallel with quality, compliance, and execution capabilities can manufacturing truly support the next stage of market competition.

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U.S. Manufacturing Is Becoming a Standard, Not an Option

As regulation becomes clearer and the market continues to expand, Rena World believes U.S. domestic manufacturing is shifting from an optional strategy to a baseline requirement in the nicotine pouch category. Cross-border supply chains and ad hoc manufacturing arrangements increasingly expose risks in compliance stability, supply responsiveness, and trade or policy uncertainty.

By contrast, U.S.-based manufacturing offers greater controllability in meeting regulatory requirements, reducing tariff and supply-chain risks, and aligning with mainstream retail channels and consumer preferences for “Made in USA” products.

In this environment, compliance is no longer a phase-specific task but a system-wide requirement spanning manufacturing, logistics, and sales. Brands that fail to address manufacturing and compliance early may see these issues rapidly magnified as volumes grow, ultimately constraining channel expansion and market performance.

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Conclusion

Overall, the U.S. nicotine pouch market is transitioning from early exploration to a new stage shaped jointly by compliance, scale, and execution capability. As regulatory pathways become clearer and demand continues to grow, manufacturing is no longer a back-end support function but a core infrastructure determining whether companies can compete sustainably.

In this context, “U.S. manufacturing” represents more than production location—it reflects a combination of high-standard manufacturing, advanced R&D capability, systematic compliance execution, and deep understanding of local markets and channels. As this shift deepens, the evolution of U.S. nicotine pouch manufacturing is expected to play an increasingly central role in shaping the industry’s competitive landscape.