Key Points
- New Authorizations: The FDA authorized four additional on! nicotine pouches, bringing the total number of authorized products to 30.
- Review Shift: The agency has stopped expanding the pilot and is applying its communication and review practices across all nicotine pouch PMTAs.
- Portfolio Expansion: Earlier authorizations covered on! PLUS, while the latest decisions apply to products from the existing on! line.
- Regulatory Concentration: All FDA-authorized nicotine pouches currently come from subsidiaries of Philip Morris International or Altria.
2Firsts,
August 5, 2026
On the afternoon of Aug. 4, U.S. Eastern Time, the U.S. Food and Drug Administration (FDA) authorized four additional nicotine pouch products through the premarket tobacco product application (PMTA) pathway, bringing the total number of FDA-authorized nicotine pouches to 30.
The products — Rich Berry 2 mg, Cappuccino 2 mg, Cappuccino 4 mg and Autumn Spice 2 mg — are manufactured by Helix Innovations LLC and sold under the on! brand. Helix is an operating company of Altria Group.
The authorizations are the latest decisions arising from the FDA’s nicotine pouch pilot program. The agency has stopped adding products to the pilot and said it intends to apply lessons from the program across its review of all nicotine pouch PMTAs.
Four products take the authorized total to 30
The FDA said its scientific review found that the four products contained lower levels of most harmful and potentially harmful constituents than other oral and smokeless tobacco products. Many of those constituents were present at levels too low to be quantified, according to the agency.
Adults aged 21 and older who smoke cigarettes or use smokeless tobacco may reduce their exposure to a range of harmful chemicals if they switch completely to FDA-authorized nicotine pouches, the FDA said. It added that using nicotine pouches alongside cigarettes would not provide the same degree of risk reduction.
Under the PMTA pathway, the FDA assesses whether allowing a product onto the market would be appropriate for the protection of public health. That assessment considers potential benefits for adults who currently use tobacco products as well as risks to young people and people who do not use tobacco.
The orders apply only to the four products named in the decision. They do not mean the products are safe or “FDA approved,” and they do not authorize Helix to market them with modified-risk claims.
Pilot practices move into wider nicotine pouch reviews
The FDA launched the nicotine pouch pilot in September 2025 to test measures intended to improve the efficiency of PMTA reviews while maintaining what the agency described as rigorous scientific standards.
The program introduced more frequent real-time communication between the FDA and applicants, allowing missing information and questions to be addressed earlier in the scientific review. The agency said the process had shortened the time applicants needed to respond to deficiency letters and made scientific reviews more efficient.
The first decisions under the pilot came in December 2025, when the FDA authorized six on! PLUS products in mint, tobacco and wintergreen varieties, with labeled nicotine contents of 6 mg and 9 mg. The FDA said it completed those reviews in record time after using direct communication with the applicant.
In May, the agency said no additional products would be added to the pilot. Applications already included in the program would continue through review, while lessons from the pilot would be incorporated into the review of all nicotine pouch PMTAs. The FDA also described real-time communication as a model it intended to use more widely.
The Aug. 4 authorizations are therefore more than an additional set of product decisions. They come as the FDA moves review practices tested with a limited group of applications into its broader handling of the nicotine pouch category.
For applicants, earlier communication may reduce uncertainty over missing evidence and deficiencies. It does not lower the legal or scientific standard that products must meet before receiving marketing authorization.
FDA authorization now covers two on! product lines
The latest decision covers products from the existing on! line, rather than the on! PLUS range authorized in December 2025.
Both product lines are manufactured by Helix. Altria describes on! PLUS as a next-generation oral nicotine pouch using a proprietary soft-feel material and a larger, seamless pouch design. The company submitted its first on! PLUS PMTAs in June 2024.
The four products authorized on Aug. 4 carry labeled nicotine contents of 2 mg or 4 mg. The six on! PLUS products authorized in 2025 carry 6 mg or 9 mg.
The two rounds are separate regulatory decisions covering specific products. Authorization of on! PLUS did not automatically extend to the existing on! line, and neither decision amounts to authorization of the on! brand as a whole.
The latest action broadens Helix’s authorized portfolio across two product lines, several flavors and nicotine contents ranging from 2 mg to 9 mg. It also illustrates the FDA’s product-by-product approach: applications are assessed on the evidence submitted for each specific product, rather than through a single decision covering an entire brand or product family.
Authorized products remain concentrated among two groups
Of the 30 nicotine pouch products now authorized by the FDA, 20 are ZYN products manufactured by Swedish Match USA, a subsidiary of Philip Morris International. The other 10 are the six on! PLUS products authorized in December and the four on! products covered by the latest decision.
All nicotine pouches authorized by the FDA so far are therefore manufactured by subsidiaries of two major international tobacco groups: Philip Morris International and Altria.
That concentration refers to the FDA authorization list and is not, by itself, a measure of the wider U.S. market or its sales shares. It does show that products from only two corporate groups have so far secured marketing authorization in the category.
The pilot may make parts of the review process more efficient and give applicants earlier opportunities to address deficiencies. The current authorization list nevertheless remains narrow, while each applicant must still provide sufficient scientific evidence for the FDA to determine that marketing the specific product would be appropriate for the protection of public health.
The 20 ZYN products received separate modified-risk tobacco product orders in June 2026, allowing them to be marketed with a specific FDA-authorized risk claim. The latest on! decisions are marketing authorizations only and do not permit comparable modified-risk claims.
For the latest developments in the PMTA process, continue to follow 2Firsts.
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