What are Zone pouches?
Zone is a nicotine pouch brand launched in the U.S. in February 2024. Zone nicotine pouches are manufactured by TJP Labs in Canada and marketed by ITG Brands, a subsidiary of Imperial Brands, in the U.S. In June 2023, Imperial acquired a range of 14 nicotine pouch products, sold under the L!X brand, from TJP Labs for £65 million (plus a deferred payment based on 5-year sales volumes) in order to facilitate the entry to the U.S. nicotine pouch market. In 2024, Imperial started sellling these pouches in the U.S. under the Zone brand. However, TJP Labs still manufactures Zone nicotine pouches for ITG Brands.
Zone is sold in more 70k stores in the U.S. ITG aims to expand the distribution as the retail availability of Zone brand is still limited compared to the market leader, ZYN which is sold in more than 140k stores. Zone is the 5th largest nicotine pouch brand in the U.S. (after ZYN, on!, VELO and Rogue) with 2.7% national share (5.3% share in the existing footprint). Each Zone can contain 20 nicotine pouches and the Manufacturer’s Suggested Retail Price (MSRP) is $4.99 a can. However Zone retails at as low as $2.59 (i.e. almost at a 50% discount to the MSRP) on various online stores – for less than half the ZYN (15-pouch can) price.
What are Zone flavors?
Zone spit-free pouches are available in 7 different flavors and in two nicotine strength: 6 mg and 9mg. Below is the complete list of Zone flavors, ranked in the order of preference:
| Zone Flavors | Flavor Descriptions |
| Wintergreen | Crisp, refreshing wintergreen flavor. A top choice among users, appreciated for its invigorating and satisfying taste |
| Spearmint | Smooth and slightly sweet mint flavor. Another top choice. Praised for its smooth and slightly sweet profile, offering a balanced and refreshing experience |
| Peppermint | A burst of cool, lightly spiced peppermint. Known for its strong and cooling flavor, delivering a powerful and invigorating taste appreciated by mint enthusiasts |
| Mint | A cool, freshening mint flavor. Noted for its clean and crisp taste, providing a straightforward and refreshing experience |
| Citrus | Tangy, sweet orange citrus flavor. A zesty and vibrant taste, providing a refreshing option with a pleasant aftertaste |
| Dragonfruit | Sweet and tropical, juicy flavor. An exotic option with sweet and slightly tangy flavor, offering a pleasant departure from more traditional options |
| Tobacco | Classic tobacco flavor with a smooth, dark, aromatic finish. An authentic tobacco flavor, described as a smooth transitionary product from traditional snuff (dipping tobacco) |
Zone contains synthetic nicotine and is 100% tobacco-free. Zone pouches are described as extra soft, preventing dryness and providing prolonged flavor release. This design aims to enhance user comfort and satisfaction during use. Zone emphasizes that their pouches deliver immediate nicotine satisfaction and a reliable user experience that remains consistent from start to finish. ITG claims that Zone product is differentiated from competitors through its soft pouch material which delivers higher moisture content, long lasting flavour, and a more satisfying nicotine experience.
Consumer feedback on Zone nicotine pouches includes a mix of positive and critical points. Many users appreciate the soft and slim design, which provides a comfortable mouthfeel and fits discreetly under the lip without causing irritation. The nicotine release is often described as smooth and consistent, delivering a satisfying buzz without an overwhelming hit. In terms of flavors and aroma, consumers have praised the variety, especially the mint and citrus options, for their crisp, refreshing taste and long-lasting flavor. However, some users have noted that certain flavors, like tobacco and dragonfruit, could be more pronounced. The moisture balance is generally well-received, ensuring a gradual release of both flavor and nicotine, but a few reviewers mention that the experience can feel slightly dry over time.
Zone Nicotine Pouches: Marketing
Zone partners with Kyle Busch and the No. 8 Chevrolet car from Richard Childress Racing in the 2025 NASCAR Cup Series.
Zone Nicotine Pouches: Regulatory Disputes
April 2026: FDA Allows Zone Nicotine Pouch Sales to Continue During RTF Legal Challenge
A U.S. court dispute involving Zone nicotine pouches – sold by ITG Brands, the U.S. subsidiary of Imperial Brands – will not result in an immediate halt to product sales. The U.S. Food and Drug Administration told the court it does not intend to take enforcement action to stop the manufacture or sale of the products while the case is ongoing.
The legal challenge stems from the FDA’s Refuse-to-File (RTF) decision on premarket tobacco product applications (PMTAs) for Zone nicotine pouches. An RTF means the agency declined to accept the applications for full scientific review, citing deficiencies or incompleteness, rather than issuing a formal marketing denial. ITG Brands argues that the FDA improperly applied this standard and effectively blocked a pathway to authorization without fully evaluating the products. The company is seeking judicial intervention to compel the FDA to accept and review its applications under the PMTA framework.
The FDA maintains that its actions fall within its regulatory authority and has not committed to approving the products. However, it has indicated it will exercise enforcement discretion during the litigation, allowing Zone pouches to remain on the market while the legal process unfolds.
The case highlights ongoing tensions in the U.S. nicotine pouch market, where a number of products remain commercially available despite lacking formal authorization, often due to regulatory delays or procedural disputes. The outcome could have broader implications for how the FDA handles PMTA submissions – particularly the use of RTF decisions – and whether companies can continue selling products while their regulatory status remains unresolved.
March 2026: FDA Refuse-to-File Decision on Zone Nicotine Pouches Sparks Legal Challenge
The U.S. Food and Drug Administration issued a Refuse-to-File (RTF) letter for the Zone nicotine pouch premarket tobacco product applications submitted by ITG Brands, the U.S. subsidiary of Imperial Brands, in March 2026, triggering a legal challenge over the agency’s regulatory process.
A Refuse-to-File decision means the FDA determined that the applications were not sufficiently complete to begin formal scientific review, rather than issuing a marketing denial. Under the U.S. tobacco regulatory framework, the FDA is generally expected to either accept an application for review, approve it, or deny it. In this case, the company argues that the agency instead refused to accept the application, effectively preventing the products from moving forward in the authorization process.
ITG Brands filed a lawsuit in U.S. federal court arguing that the FDA unlawfully refused to file the Zone applications after the products had already spent years in regulatory review. The company claims the agency stalled the process and then rejected the applications as incomplete rather than making a final approval or denial decision, which it argues is inconsistent with federal law governing tobacco product applications. The lawsuit seeks to force the FDA to accept and review the applications, rather than leaving them in regulatory limbo through an RTF decision.
The case could have wider implications for the U.S. nicotine pouch market and the broader premarket tobacco product application (PMTA) process. The use of Refuse-to-File decisions is controversial because it allows the FDA to avoid making a formal approval or denial decision, potentially delaying market entry or regulatory clarity for new nicotine products. If the court rules against the FDA, the agency may be required to accept and scientifically review more nicotine pouch applications, which could affect the regulatory pathway for future products in the category.
The FDA’s March 2026 Refuse-to-File decision on Zone nicotine pouches has become a significant legal and regulatory dispute, highlighting tensions between nicotine manufacturers and regulators over the PMTA process. The outcome of the case could influence how the FDA handles nicotine pouch applications and whether companies can continue selling products while regulatory decisions remain unresolved.
