The US FDA has authorized 4 more on! Nicotine pouches, increasing the total number of authorized products to 30. This decision is the latest result of the nicotine pouch review pilot, and the real-time communication and problem-solving methods formed by the pilot are being used for a wider range of category reviews. Helix’s authorized products have also expanded from on! PLUS to the earlier launched on! Series. However, currently all authorized nicotine pouches still come from PMI and Altria subsidiaries, and regulatory access to the US market remains highly concentrated.
The US FDA Has Authorized 4 More on! Nicotine Pouches Quick overview of key points
- New authorization: FDA authorizes 4 more on! Nicotine pouches, increasing the total number of authorized products in the United States to 30.
- Change in review mechanism: The FDA has stopped expanding the pilot scope and started using the real-time communication and problem-solving methods formed by the pilot for all nicotine pouch PMTA reviews.
- Product line expansion: Previously authorized was the on! PLUS series, and this time the new on! Product line is launched earlier, with two batches of authorization for different specific products.
- Regulatory concentration: Currently, all 30 authorized nicotine pouches come from companies under Philip Morris International and Altria.
On the afternoon of August 4th Eastern Time, the U.S. Food and Drug Administration (FDA) announced that it has authorized four new nicotine pouch products to be launched through the Premarket Tobacco Product Application (PMTA) pathway, bringing the total number of nicotine pouches authorized by the FDA to 30.
This decision is also a follow-up result of the FDA nicotine pouch review pilot. The FDA has stopped adding new products to the pilot program and plans to use the real-time communication and problem-solving methods developed during the pilot for all nicotine pouch PMTA reviews. This means that US regulatory agencies are shifting from testing new processes for a small number of applications to establishing a normalized review process covering the entire nicotine pouch category.
Reference: Pilot Program Update: FDA Authorizes 4 New Nicotine Pouches | FDA
4 products have been authorized, increasing the total number of authorized products in the United States to 30
The products authorized for listing this time are Rich Berry 2 mg, Cappuccino 2 mg, Cappuccino 4 mg, and Autumn Spice 2 mg, involving berry, cappuccino, and spice flavors.
The product is produced by Helix Innovations LLC and sold under the on! Brand. Helix is a subsidiary of Altria Group, a tobacco company in the United States.
The FDA stated that its scientific review found that compared to other oral tobacco and smokeless tobacco products, most of the harmful and potentially harmful components (HPHCs) in these four products have lower levels, with multiple components having levels so low that they cannot be quantitatively determined.
For adults aged 21 and above who currently smoke cigarettes or use smokeless tobacco products, the FDA states that switching entirely to authorized nicotine pouches may reduce exposure to multiple harmful chemicals. However, using both cigarettes and nicotine pouches at the same time does not bring the same level of risk reduction.
PMTA is an important regulatory pathway for new tobacco and nicotine products to enter the legal market in the United States. The FDA needs to determine whether a product is “appropriately protecting public health” based on the evidence submitted by the applicant regarding its ingredients, toxicology, usage behavior, and population health effects.
This judgment not only considers the potential benefits that adult tobacco users may gain from switching products, but also includes the risks that the product may pose to adolescents and those who currently do not use tobacco products.
The FDA has issued Marketing Grant Orders (MGOs) for the above-mentioned products, which are authorized only for the four specific products listed in the announcement. This does not mean that the product is safe, nor does it mean that the product has obtained the usual “FDA approval”.
Reference: Nicotine Pouch Products Authorized by the FDA | FDA
FDA shifts from small-scale product trials to optimizing the entire category review
The FDA will launch a pilot program for nicotine pouch PMTA review in September 2025, selecting some applications to test whether it can improve communication and review efficiency between applicants and the FDA without lowering scientific review standards.
In the traditional PMTA review process, if the FDA finds gaps in the application materials, it may issue a formal deficiency letter to the company, requesting additional data or answering questions. The pilot program has increased real-time communication during the evaluation period, allowing applicants to be informed of some material gaps earlier and prepare supplementary information in advance.
The FDA stated that this approach shortens the time required for applicants to respond to defect letters and improves the efficiency of scientific review. In December 2025, six on! PLUS nicotine pouches became the first batch of market authorization results generated by the pilot program. The FDA stated that it completed the decision about three months after initiating scientific review, setting a record for the fastest PMTA review of nicotine pouches.
In May 2026, the FDA further stated that it will no longer add new products to the pilot program. Applications that have entered the pilot program will continue to undergo evaluation, and the communication and evaluation methods developed during the pilot program will be incorporated into the processing flow of all nicotine pouch PMTAs. The FDA also refers to real-time communication as a review mode that can be replicated outside of pilot programs.
This does not mean that the FDA has lowered the market threshold for nicotine pouches. The changes mainly occur in the review process and communication methods, and each product still needs to independently submit sufficient evidence to prove that it meets the public health standards required by US law.
There are differences in the bag body, material, and nicotine content between the two generations of ON! Products
The authorized products this time are the earlier launched on! Product line, and the 6 products authorized in December 2025 belong to the on! PLUS series.
Both product lines are produced by Helix. According to the official website and company announcement of Altria, on! PLUS is positioned as the next generation nicotine pouch, featuring proprietary soft touch materials and a larger, seamless pouch design. The previously authorized on! PLUS products are mint, tobacco, and holly flavors, with nicotine content indicated as 6mg and 9mg; The authorized on! Products this time are 2 milligrams and 4 milligrams.
Nicotine pouches can usually be classified into dry and wet types based on their moisture content in product form. The finished product of dry products has a relatively low moisture content and needs to be gradually wetted by oral saliva during use; Wet products contain more moisture when they leave the factory, and the bag body is usually softer.
However, water content alone cannot determine the rate of nicotine release. Factors such as formula acidity, filler particles, soluble components, bag material, and product size can also affect the release and absorption of nicotine in the oral cavity.
A product characterization study published in Scientific Reports classified the tested on!, ZYN, VELO, Dryft, and Rogue samples as dry products, and Volt and Loop as wet products. The study measured that the moisture content of the tested on! Sample was about 4.48%, but its nicotine release rate was still faster than some products with higher moisture content, indicating that the rule of “wet release faster, dry release slower” is not universally valid.
Ochia’s public information mainly emphasizes the changes in bag material, size, and user experience of on! PLUS, and does not directly define on! And on! PLUS as dry and wet product lines in this FDA announcement.
The two batches of FDA decisions are also independent of each other. The previous authorization for on! PLUS will not automatically overwrite the original on! Products, and this decision does not constitute a unified authorization for the entire on! Brand or all of its products.
30 authorized products still come from two major tobacco groups
As of this decision, the FDA has authorized a total of 30 nicotine pouch products. Among them, 20 are ZYNs produced by Swedish Match USA, and the other 10 are 6 on! PLUS and 4 on! Products produced by Helix.
Swedish Match currently belongs to Philip Morris International (PMI), while Helix belongs to Altria. Therefore, all nicotine pouches currently authorized by the FDA for marketing come from companies under two large international tobacco groups.
This structure cannot directly equate to the sales or market share of the nicotine pouch market in the United States, but it indicates that FDA authorized products are still concentrated in a small number of applicants. A more efficient review process does not mean that products can bypass scientific evidence requirements.
In June 2026, the FDA issued a modified risk tobacco product (MRTP) authorization to 20 ZYN products, allowing them to use a specific risk reduction statement approved by the FDA. The 4 on! Products obtained this time are only PMTA marketing authorization, and Helix is not allowed to make similar risk propaganda modifications.
