FDA & Product Rules

FDA Authorizes 24 Velo Nicotine Pouches, Bringing Its Authorized List to 67

FDA authorized 24 Velo nicotine pouches from Modoral Brands on October 30, 2026: eight 4 mg Velo Mini Pouch and Mini Pouch 2 flavors, each in three child-resistant containers, bringing the authorized pouch list to 67.

E-commerce 4 Internet Marketers Editorial

A gray-haired man sits at a lamp-lit desk with a printed list and five colored tins as snow falls past a dark window.
On a snowy evening, a gray-haired man at a lamp-lit desk sits beside a printed list and a row of five colored tins, the kind of side-by-side check stores now face as FDA adds 24 Velo pouches to its authorized list.

The U.S. Food and Drug Administration (FDA) authorized 24 Velo nicotine pouches on October 30, 2026, the first Velo products to reach the agency’s list of pouches that can be legally sold in the United States. The products are made by Modoral Brands Inc., all contain 4 mg of nicotine, and were cleared through the premarket tobacco product application (PMTA) pathway, the review a new tobacco product must pass before it can be marketed.

The decision brings FDA’s authorized nicotine pouch list to 67 products from three manufacturers. Swedish Match USA accounts for 31 ZYN and ZYN ULTRA products, Helix Innovations LLC for 12 on! and on! PLUS products, and Modoral for the 24 Velo additions. FDA states on that page that these “are the only nicotine pouch products that may be lawfully sold in the United States.”

Eight flavors, three containers, 24 products

The authorization covers two product lines. Velo Mini Pouch is authorized in Crema, Lime, Orange Crema and Passion Fruit. Velo Mini Pouch 2 is authorized in Crema, Lime, Orange Crema and Cinnamon. Each of those eight products is listed in three packaging types, which is how eight names become 24 authorizations.

FDA treats packaging as part of the product. In its announcement, the agency said the type of container “can greatly affect the product in areas such as stability, shelf life, moisture and safety,” and that all three authorized packages use certified child-resistant designs. FDA had urged pouch makers in September 2025 to adopt child-resistant packaging after poison center reports climbed, with about 72% of nicotine pouch exposure cases involving children under 5.

Reviewed under FDA’s pouch pilot

FDA said the Velo applications were reviewed under the nicotine pouch pilot program it launched in September 2025, which relies on more frequent contact with applicants to resolve deficiencies during review. When the pilot began, the authorized list held 20 products, all ZYN. It has more than tripled since then.

FDA said its review found lower levels of harmful and potentially harmful constituents in the Velo products than in cigarettes and smokeless tobacco, and that authorization does not mean a product is safe or “FDA approved.”

What the list does and does not tell a store

The list names each Velo product by line, weight, flavor and strength, then adds “Container 1,” “Container 2” or “Container 3.” It does not describe what those containers look like, so a product page photo or a distributor’s item name may not be enough to show which package a store is actually selling. Retailers that want to match a Velo SKU to an authorized entry will need the package details from Modoral or their distributor.

Anything outside the eight named products sits outside the authorization. A Velo pouch in another flavor, another nicotine strength or another pouch format is not on the list as of November 11, 2026. The same is true for the other brands on it, where authorization is tied to specific flavors and strengths rather than to the brand as a whole.

FDA says it updates the authorized pouch page on the day of an authorization, adds new products to its Searchable Tobacco Products Database the next day, and refreshes a downloadable flyer version within one to two business days. The October 30 page already reflects all 24 Velo entries.

Why the list matters at checkout

The authorized list is also the plainest document a pouch retailer can hand a payment partner. A store processing through a specialty provider such as Tower Payments can show which Velo SKUs match an entry down to the container, which is a stronger record than a brand name alone. EC4IM’s nicotine pouch compliance checklist covers the shipping, age and platform rules that sit alongside FDA authorization.

State rules still apply on top of federal authorization. South Dakota, for example, is moving to ban online nicotine sales by licensed retailers from January 1, 2027, regardless of whether a pouch appears on FDA’s list.

A larger list with narrow entries

FDA’s October 30 decision gives Velo its first legal footing in the U.S. pouch market and pushes the authorized list to 67 products across ZYN, on! and Velo. The authorization is narrow, though. It covers eight 4 mg products in three specific child-resistant containers, and stores that carry Velo will need to confirm flavor, strength and package for each SKU before treating it as authorized.

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