Cover image:Screenshot of the U.S. Food and Drug Administration (FDA) announcement authorizing the marketing of 24 VELO nicotine pouch products. Source: FDA website.
Key Points
FDA Authorization: The FDA authorized 24 VELO nicotine pouch products from a British American Tobacco subsidiary, increasing the total number of authorized pouches from 43 to 67, up 55.8%.
Products and Flavors: All newly authorized products contain 4 mg of nicotine and span two product lines and five flavor names, including lime and passion fruit, with three certified child-resistant packaging formats.
Industry Competition: VELO received its first FDA marketing authorization, bringing BAT into an authorized nicotine pouch portfolio previously limited to PMI and Altria products.
Review Pilot: The 24 VELO authorizations bring the total number of products authorized through the FDA's nicotine pouch PMTA pilot to 47.
Scientific Assessment: The FDA reported lower levels of harmful and potentially harmful constituents than in cigarettes and smokeless tobacco products, while weighing potential benefits for adults who switch completely against risks to youth and non-users.
2Firsts
October 30, 2026
The U.S. Food and Drug Administration (FDA) authorized 24 VELO nicotine pouch products on October 30, bringing the total number of FDA-authorized nicotine pouches from 43 to 67, an increase of 55.8%.
The products are made by Modoral Brands Inc., a subsidiary of Reynolds American within British American Tobacco (BAT). The decision marks the first FDA marketing authorization for VELO nicotine pouches, adding BAT to the list of major tobacco companies with authorized nicotine pouch products in the United States, alongside Philip Morris International (PMI) and Altria.
Two VELO Product Lines, All Containing 4 mg of Nicotine
The newly authorized products belong to two lines, VELO Mini Pouch and VELO Mini Pouch 2. Each pouch weighs 400 mg and contains 4 mg of nicotine.
VELO Mini Pouch comes in four flavors: Crema, Lime, Orange Crema and Passion Fruit. VELO Mini Pouch 2 offers Crema, Lime, Orange Crema and Cinnamon. Together, the two lines cover five distinct flavor names.
Each of the eight named products is authorized in three packaging formats, bringing the total to 24 products.
The FDA said packaging is an important part of its review because it can affect product stability, shelf life, moisture and safety. All three packaging formats incorporate certified child-resistant packaging, which the agency has previously encouraged to reduce accidental nicotine exposure among young children.
From ZYN to VELO: FDA Authorizations Reach 67 Products
The October 30 decision represents the largest single batch of nicotine pouch marketing authorizations since the FDA first authorized products in the category in January 2025.
On January 16, 2025, the FDA authorized the first 20 nicotine pouch products, all under PMI's ZYN brand.
On December 19, 2025, the agency authorized six on! PLUS products made by Altria subsidiary Helix Innovations LLC, marking the first marketing decisions under its nicotine pouch review pilot program.
Further authorizations followed in August 2026. Four on! products received marketing authorization on August 4, followed by two additional on! products on August 19. On August 21, the FDA authorized 11 ZYN ULTRA products, bringing the cumulative total to 43.
The addition of 24 VELO products raises that total to 67, an increase of nearly 56% in a single announcement. The authorized portfolio now includes nicotine strengths ranging from 2 mg to 11 mg per pouch, across multiple flavors and product formats.
BAT Joins PMI and Altria in the FDA-Authorized Nicotine Pouch Market
Before the latest decision, the FDA's authorized nicotine pouch list consisted entirely of products from two manufacturers: Swedish Match USA, a PMI subsidiary, and Altria's Helix Innovations.
Swedish Match accounted for 31 authorized ZYN and ZYN ULTRA products, while Helix had 12 on! and on! PLUS products. BAT now joins them through Modoral Brands, with 24 authorized VELO products.
VELO was already sold in the United States before the announcement. The October 30 decision grants formal marketing authorization to specific VELO products following FDA scientific review.
The decision adds BAT to an FDA-authorized nicotine pouch portfolio previously limited to PMI and Altria products, broadening the range of authorized options in the U.S. market.
FDA's Nicotine Pouch Pilot Delivers Further Authorizations
The 24 VELO products were reviewed under the FDA's nicotine pouch pilot program, launched in September 2025 to streamline premarket tobacco product application (PMTA) reviews.
The program introduced more direct communication between applicants and FDA reviewers, quicker resolution of application deficiencies and more efficient scientific reviews.
By August 21, 2026, the FDA had authorized 23 nicotine pouch products through the pilot. With the addition of the 24 VELO products, that number has reached 47. The agency has also begun applying lessons from the pilot to other PMTA reviews.
In its latest announcement, the FDA said its evaluation found that the authorized VELO products contained lower levels of harmful and potentially harmful constituents (HPHCs) than cigarettes and smokeless tobacco products, with many substances present at levels too low to quantify.
The agency also reported no measurable levels of several carcinogenic HPHCs, including some associated with increased oral cancer risk among smokeless tobacco users.
The FDA said its assessment considered the potential benefits for adults aged 21 and older who completely switch from cigarettes or smokeless tobacco products to potentially lower-risk alternatives, alongside the risks to youth and non-users.
2Firsts will continue to cover regulatory developments, product innovation and industry trends in the U.S. tobacco and nicotine markets. Follow 2Firsts for further news and analysis.
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