On October 30, 2026, the U.S. Food and Drug Administration authorized the marketing of 24 Velo nicotine pouches through the premarket tobacco product application (PMTA) pathway. The products are made by Modoral Brands Inc., part of Reynolds American, British American Tobacco’s U.S. arm. They are the first BAT nicotine pouches to pass the agency’s review: until now, every authorized pouch came either from Philip Morris International’s Swedish Match or from Altria’s Helix Innovations.
Eight products, 24 authorizations
The figure of 24 needs some unpacking. The FDA authorized eight products, each sold in three different packaging types. All contain 4 mg of nicotine and belong to two lines:
- Velo Mini Pouch: Crema, Lime, Orange Crema and Passion Fruit;
- Velo Mini Pouch 2: Crema, Lime, Orange Crema and Cinnamon.
That makes five distinct flavors in total, since Crema, Lime and Orange Crema appear in both lines. The FDA’s list of authorized nicotine pouches simply numbers the three packaging types “Container 1”, “Container 2” and “Container 3”, without describing them.
Child-resistant packaging
All three packaging types are certified child-resistant. The FDA says packaging is part of its scientific review, as it affects product stability, shelf life, moisture levels and safety.
The issue is far from cosmetic. In September 2025, the agency urged nicotine pouch manufacturers to use child-resistant packaging after a steady rise in exposures reported to U.S. poison centers between April 2022 and March 2025. About 72% of these cases involved children under five. Toxic effects have been reported in young children at nicotine doses as low as 1 to 4 mg, a range that includes a single Velo pouch.
What the FDA found
According to the agency, the 24 products contain lower levels of harmful and potentially harmful constituents (HPHCs) than cigarettes and smokeless tobacco. Many of these constituents were too low to quantify, and several carcinogens linked to a higher risk of oral cancer among smokeless tobacco users were not measurable at all.
The FDA concluded that the products meet the public health standard set by the 2009 Family Smoking Prevention and Tobacco Control Act. This standard weighs the potential benefit for adults aged 21 and over who switch completely from cigarettes or smokeless tobacco against the risks for young people and non-users. The agency insists on the word “completely”: dual use, it notes, does not provide the same health benefit.
67 authorized pouches
With this decision, the number of FDA-authorized nicotine pouches rises to 67. The first 20, all Zyn products from Swedish Match, were authorized in January 2025, nearly five years after their applications were filed. Altria’s six on! PLUS pouches followed in December 2025, then six on! pouches in August 2026, along with 11 Zyn Ultra pouches, including an 11 mg version, the strongest authorized to date.
On June 30, 2026, the 20 original Zyn products also became the first nicotine pouches allowed to carry a modified risk claim: using Zyn instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis. A PMTA authorization such as the one granted to Velo does not allow any reduced-risk claim.
A fast-track pilot
The Velo applications were reviewed under the nicotine pouch pilot program launched by the FDA in September 2025 to streamline PMTA reviews, notably through real-time communication with applicants. The agency says the pilot has led to faster resolution of issues, shorter response times to deficiency letters and more efficient scientific reviews.
In August, the FDA counted 23 pilot authorizations out of 43. With Velo, every pouch authorized since the original 20 Zyn products, 47 in all, has gone through the pilot. The program is now closed to newcomers: in May 2026, the FDA announced that no additional products would be added to it, and that its lessons would be applied to the review of all nicotine pouch applications.
The fast track was not that fast for Velo. Decisions on pilot applications were initially expected by the end of 2025. In April 2026, Reuters reported that the Velo and Zyn applications were still pending, as agency scientists hesitated over the potential risks to youth and other non-users, according to three sources. The FDA declined to comment on these concerns.
The program has drawn criticism from the start. Citing internal meeting transcripts, Reuters reported in September 2025 that an FDA official had told staff the agency was being pressured by its leadership, including at the White House, to review nicotine pouches more efficiently. The pilot covered pouches from four companies: PMI (Zyn Ultra), Altria (on! and on! PLUS), Reynolds (Velo mini) and Turning Point Brands (Fre and Alp). According to the news agency, the acting director of the FDA’s Center for Tobacco Products said the agency was not under pressure to lower its scientific standards. A second Reuters report stated that, under the pilot, the FDA would drop the requirement for manufacturers to submit product-specific studies in several areas. To date, no Turning Point Brands pouch appears on the FDA’s list.
The Velo decision also comes as the FDA moves to replace its 2021 PMTA rule, which governs the authorization of every new e-cigarette, e-liquid and nicotine pouch in the United States.
