Key Points
- PMI is expanding its ZYN dry-pouch line to 1.5 mg, 3 mg, 6 mg and 8 mg, with 1.5 mg and 8 mg newly added.
- ZYN 3 mg and 6 mg dry-pouch products are scheduled to move from 15 to 20 pouches per can in the fourth quarter of 2026.
- ZYN ULTRA is commercially available, with FDA authorization covering 10 products at 9 mg and one 11 mg Smooth product.
- As of September 10, the FDA’s public authorization list does not show the 1.5 mg and 8 mg strengths. PMI has disclosed additional ZYN PMTA submissions but has not publicly linked them to those products.
2Firsts
September 11, 2026
According to information released by Philip Morris International’s U.S. business on September 9, 2026, the company is expanding its ZYN portfolio with new 1.5 mg and 8 mg dry-pouch strengths and plans to move its existing 3 mg and 6 mg products from 15 to 20 pouches per can in the fourth quarter.
ZYN ULTRA is also commercially available. Based on PMI’s stated portfolio, the ZYN brand spans strengths from 1.5 mg to 11 mg, although FDA marketing authorization status differs by product.
ZYN Dry-Pouch Line Adds 1.5 mg and 8 mg
PMI said its flagship ZYN dry nicotine pouch line is expanding to include 1.5 mg, 3 mg, 6 mg and 8 mg strengths.
The 1.5 mg and 8 mg products are new additions, extending the line below and above the existing 3 mg and 6 mg strengths.
In an Editor’s Note accompanying the September 9 release, PMI U.S. lists the 1.5 mg, 3 mg, 6 mg and 8 mg ZYN dry-pouch products as commercially available.
The 1.5 mg and 8 mg products, however, do not appear on the FDA’s public list of authorized nicotine pouches as of September 10. Public materials do not identify which PMTA submissions cover the two strengths or their current stage of review.
3 mg and 6 mg Products to Move From 15 to 20 Pouches Per Can
PMI is also changing the package format of its core ZYN dry-pouch products.
The company said its 3 mg and 6 mg products will move from 15 to 20 pouches per can in the fourth quarter of 2026.
Once the transition is completed, the 3 mg and 6 mg dry-pouch products will use the same 20-pouch-per-can format as ZYN ULTRA.
PMI did not specify the pouch count per can for the new 1.5 mg and 8 mg dry-pouch products, nor did it say those strengths are part of the packaging transition.
PMI has previously told investors that it is adjusting ZYN’s pricing and portfolio structure to address different consumer needs and strengthen its competitive position in the U.S. nicotine pouch market.
ZYN ULTRA Is Commercially Available, With FDA Authorization Covering 10 Products at 9 mg and One at 11 mg
ZYN ULTRA is another major part of PMI’s U.S. nicotine pouch expansion this year.
The line uses a higher-moisture format than the flagship ZYN dry pouches and offers higher nicotine strengths.
The FDA authorized 11 ZYN ULTRA products in August 2026, including 10 products at 9 mg and one 11 mg Smooth product.
PMI previously said other 11 mg variants remained under FDA scientific review.
The authorization therefore should not be described as covering all 11 mg ZYN ULTRA products. Based on currently available FDA records, the Smooth product is the 11 mg variant confirmed to have marketing authorization.
Key U.S. ZYN Product Specifications and FDA Authorization Status
The table below summarizes PMI’s latest product disclosures and the FDA’s public authorization records as of September 10, 2026.
Product Line | Nicotine Strength | Pouches per Can | PMI-Reported Commercial Status | FDA Marketing Authorization Status | Current Change |
ZYN Dry | 1.5 mg | Not disclosed | Listed by PMI U.S. as commercially available | Not shown on FDA public authorization list as of Sept. 10 | New strength |
ZYN Dry | 3 mg | 15 → 20 in Q4 | Commercially available | Authorized | Pack-size change |
ZYN Dry | 6 mg | 15 → 20 in Q4 | Commercially available | Authorized | Pack-size change |
ZYN Dry | 8 mg | Not disclosed | Listed by PMI U.S. as commercially available | Not shown on FDA public authorization list as of Sept. 10 | New strength |
ZYN ULTRA | 9 mg | 20 | Commercially available | 10 products authorized | Higher-moisture, higher-strength line |
ZYN ULTRA Smooth | 11 mg | 20 | Commercially available | 1 product authorized | FDA-authorized 11 mg variant |
Other ZYN ULTRA variants | 11 mg | 20* | PMI has disclosed additional variants | Previously under FDA scientific review | Not all 11 mg variants are authorized |
*Specific SKU specifications and regulatory status should be confirmed against PMI product information and FDA authorization records.
The table shows that the latest portfolio changes fall into two separate categories: 1.5 mg and 8 mg are new nicotine strengths, while 3 mg and 6 mg are undergoing a pack-size change from 15 to 20 pouches per can.
FDA Public Authorization List Does Not Show 1.5 mg or 8 mg
The regulatory status of the new 1.5 mg and 8 mg strengths is a key point in the latest portfolio expansion.
As of September 10, 2026, neither strength appears on the FDA’s public list of authorized nicotine pouches.
The FDA’s publicly authorized ZYN products include the 20 products at 3 mg and 6 mg authorized in 2025, as well as 11 ZYN ULTRA products authorized in August 2026.
The FDA says the 43 products on its current list are the only nicotine pouch products that may lawfully be sold in the United States.
PMI U.S., however, lists the 1.5 mg and 8 mg ZYN dry-pouch products as commercially available in its September 9 release.
Public materials reviewed by 2Firsts do not explain the difference or identify which PMTA submissions cover the two new strengths.
PMI Has Previously Disclosed Additional ZYN PMTA Filings
PMI has previously disclosed in filings with the U.S. Securities and Exchange Commission that it submitted applications for additional ZYN products beyond the original 20 products.
A June 2025 SEC filing said the original 20 ZYN PMTAs were submitted in March 2020.
For other ZYN products submitted after September 9, 2020, PMI said at the time that the applications had not yet received FDA decisions and that the products were not being sold in the United States.
PMI later said in its annual disclosures that it had made, and expected to continue making, additional submissions to the FDA to market other ZYN products in the U.S.
Public FDA records and PMI disclosures, however, do not identify whether the new 1.5 mg and 8 mg products are covered by those submissions or specify their PMTA numbers or current review status.
What can be established from public information is that PMI U.S. lists the two strengths as commercially available, while they do not appear on the FDA’s public authorization list as of September 10.
ZYN’s Regulatory and Product Footprint Continues to Expand
ZYN has expanded significantly in both regulatory status and product range in the United States over the past two years.
In January 2025, the FDA authorized 20 ZYN nicotine pouch products through the PMTA pathway, covering 10 flavors at 3 mg and 6 mg strengths.
In June 2026, the FDA issued modified risk granted orders for those 20 products, allowing them to carry a specific risk-reduction claim.
In August 2026, the agency authorized 11 ZYN ULTRA products, further expanding the number of ZYN products with marketing authorization.
At the same time, PMI’s new ZYN manufacturing facility in Aurora, Colorado, began commercial production in July 2026. The company says the site will increase its domestic nicotine pouch supply capacity.
The addition of 1.5 mg and 8 mg strengths, the shift of 3 mg and 6 mg products to 20-pouch cans, and the expansion of ZYN ULTRA broaden PMI’s stated ZYN portfolio across nicotine strengths, moisture formats and pack sizes.
Regulatory Status of New Strengths Remains a Key Watchpoint
For ZYN, portfolio expansion and FDA regulatory status are increasingly moving in parallel.
The 3 mg and 6 mg products and certain ZYN ULTRA products have clear FDA marketing authorizations, while the new 1.5 mg and 8 mg strengths do not appear on the agency’s public authorization list as of September 10.
PMI has confirmed that it continues to submit additional ZYN applications to the FDA, but public materials do not currently establish whether the 1.5 mg and 8 mg products are among the applications under review.
As the FDA continues efforts to improve nicotine pouch PMTA review efficiency, whether the two new strengths subsequently appear on the agency’s authorization list will be a key regulatory development to watch in PMI’s U.S. ZYN strategy.
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Cover Image: PMI U.S. / ZYN
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